Release – ISG to Announce First-Quarter Financial Results

Research News and Market Data on III

4/6/2023

STAMFORD, Conn.–(BUSINESS WIRE)– Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm, said today it will release its first-quarter financial results on Monday, May 8, 2023, at approximately 4:15 p.m., U.S. Eastern Time.

The firm will host a conference call with investors and industry analysts at 9 a.m., U.S. Eastern Time, the following day, Tuesday, May 9. Dial-in details are as follows:

  • The dial-in number for U.S. participants is +1 833-470-1428.
  • International participants should call +1 404-975-4839.
  • The security code to access the call is 417295.

Participants are requested to dial in at least five minutes before the scheduled start time.

A recording of the conference call will be accessible on ISG’s website (www.isg-one.com) for approximately four weeks following the call.

About ISG

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

Source: Information Services Group, Inc.

Release – Maple Gold Reports Final Assay Results at Eagle and Completes More than 7,000 Metres of Deep Drilling at Telbel

Research News and Market Data on MGMLF

Vancouver, British Columbia–(Newsfile Corp. – April 6, 2023) – Maple Gold Mines Ltd. (TSXV: MGM) (OTCQB: MGMLF) (FSE: M3G) (“Maple Gold” or the “Company“) is pleased to report results from the final 20% of assays that were received from the previously completed 14,720 metres (“m”) of drilling at the 100%-controlled Eagle Mine Property (“Eagle”). The Company is also pleased to report that more than 7,000 m have now been completed (6,000 m planned) at the Telbel Mine area of the Joutel Project, which is held by a 50/50 joint venture (the “JV”) between the Company and Agnico Eagle Gold Mines Limited.

The final batch of assays received from completed drilling at Eagle correspond to approximately 3,000 m of the 14,720 m drilled to-date. The results continue to demonstrate continuity of mineralization and the potential significance of the multiple horizons/splays to the northwest of the former Eagle mine. Highlights include (see Table 1 and Figure 1 for highlighted results from all Maple Gold drilling at Eagle to-date):

  • EM-22-008W intersected 6.2 grams per tonne (“g/t”) gold (“Au”) over 2.0 m in the South Mine Horizon (“SMH”) and 4.2 g/t Au over 3.9 m in sediments further downhole.
  • EM-22-006W1 intersected multiple intercepts including 6.5 g/t Au over 1.2 m and 2.0 g/t Au over 3.0 m in the SMH and 2.3 g/t Au over 3.0 m at the microgabbro/Harricana sediment contact further downhole.
  • EM-22-006W4 intersected 4.0 g/t Au over 0.7 m within a broader 1.1 g/t Au over 14.2 m intercept within the SMH.
  • EM-22-017A intersected 2.9 g/t Au over 2.0 m and additional lower grade over broader near-surface intervals (1.0 g/t Au over 15.5 m from 93 m downhole).

“We have come along way since first consolidating the Joutel ground into our JV property package,” stated Matthew Hornor, CEO of Maple Gold. “All of our exploration and drilling work along the past-producing Eagle-Telbel mine trend is designed with the aim of defining high-grade zones of gold mineralization and additional mineral resources to complement the established potentially bulk-mineable resource present at Douay. Our first year of drilling at Eagle has more than covered our exploration spending commitments to earn a 100% interest and we are now in position to finalize our compilation and model updates to support focused follow-up drilling in areas we believe have the most promise to deliver additional high-quality ounces.”

Overview Summary and Key Takeaways from Drilling at Eagle

The Eagle-Telbel Mine trend produced 1.1 Moz at 6.5 g/t Au from 1974 – 1993, during a period when the price of gold averaged approximately $350 per ounce. During the first year of the JV (2021), all historical mining, stope and drilling data was digitized to underpin a new 3D geological model. The Company signed an option agreement to acquire a 100% interest in the Eagle Mine Property (see press release July 19, 2021) and has since completed more than 21,500 m of drilling across the 4 km long Eagle-Telbel Mine trend, with 14,720 m at Eagle (see Figure 1) and more than 7,000 m (assays pending) of JV drilling at Telbel.

The Company’s drilling to-date at Eagle has served to confirm that gold mineralization is not limited to a narrow stratigraphic interval (Eagle-Telbel Mine Horizon) but instead covers a significantly broader stratigraphic interval of over 100 m straddling the Harricana Deformation Zone. Drill core observations also support the Company’s concept of a significant structural component to gold mineralization in the form of an orogenic gold overprint.

Figure 1: Plan view map showing drilling to-date at Eagle with highlighted intercepts.

To view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/3077/161492_7df1f170b47df93c_001full.jpg

Several highlights from the Company’s first year of drilling at Eagle are summarized below (see Figure 1 above for locations):

  • EM-22-005: 4.0 g/t Au over 7.5 m, including 6.4 g/t Au over 3.0 m
  • EM-22-009: 11.4 g/t Au over 3 m, including 24.4 g/t Au over 1 m
  • EM-22-013: 2.3 g/t Au over 10.4 m, including 5.0 g/t Au over 3.2 m
  • EM-22-015: 10.3 g/t Au over 7.8 m, including 41.1 g/t Au over 1.0 m
  • EM-22-015: 4.3 g/t Au over 3.9 m, including 7.4 g/t Au over 1.5 m
  • EM-22-016: 3.1 g/t Au over 7.3 m, including 4.0 g/t Au over 3.6 m

When combining the Company’s drilling results and observations with notable historical results and new geophysical data, several priority target areas emerge along the SMH and North Mine Horizon (“NMH”); including multiple cross-plunging target concepts that will form part of the focus for the Company’s next phase of drilling (~5,000 m). The Company has initiated target definition and permitting work for a planned summer 2023 follow-up program at Eagle (see press release March 16, 2023) and priority follow-up targets will also be defined at Telbel once assay results have been received and interpreted from the first phase of deep drilling.


Figure 2: Oblique view showing SMH and NMH trends with grade contouring and highlighted pierce points with corresponding intercepts and target areas.

To view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/3077/161492_7df1f170b47df93c_002full.jpg

Table 2: Highlighted Assay Results from Maple Gold Drilling at Eagle to-date

HoleUTMEUTMNAzimuthPlungeLength (m)FromToIntervalAu g/t
EM-22-001690565548633440.6-66.8356.6132.0134.62.61.7
including     133.7134.60.94.4
EM-22-002690565548633422.0-52.4243183.2185.01.82.1
EM-22-002     200.4205.04.72.4
including     200.4202.42.13.8
EM-22-003690642548632259.1-70.5288Narrow intercepts <1 g/t Au
EM-22-004690673548612049.9-56.0288139.0141.02.01.2
EM-22-005690758548604322.6-75.7714346.0360.014.02.2
including     346.0353.57.54.0
including     350.0353.03.06.4
EM-22-006690737548582825.9-63.2777.75539.3543.03.71.3
EM-22-007690736548582623.9-73.2985877.0878.01.02.0
EM-22-009690921548563917.571.41009920.4921.00.610.8
EM-22-009     951.0956.05.01.6
EM-22-009     984.0993.09.04.0
EM-22-009     990.0993.03.011.4
EM-22-009     991.0993.02.015.5
including     992.0993.01.024.4
EM-22-010690841548579532.5-71.4570539.5540.00.514.0
EM-22-010     543.0544.01.08.3
EM-22-010W690841548579534.1-61.2932921.0922.01.03.7
EM-22-011690547548585956.7-62924858.3859.00.73.2
EM-22-012691098.7548541335.3-78.612841232.21234.32.12.0
EM-22-013690757.5548604363.8-69.8327257.0267.410.42.3
including     257.0260.23.25.0
EM-22-014690565548633464.5-67.9646231.0231.70.74.6
EM-22-015690757.5548604345-50.1408142.5148.66.11.6
EM-22-015     164.9165.50.74.8
EM-22-015     217.1221.03.94.3
including     218.5220.01.57.4
EM-22-015     228.0235.87.810.3
including     228.5232.84.315.9
including     230.0231.01.041.1
EM-22-015     246.7248.41.74.3
including     247.5248.40.97.1
EM-22-015     252.2255.02.81.8
EM-22-016690757.8548604345.1-62.6297193.0206.213.22.2
including     193.0200.37.33.1
including     196.0199.63.64.0
EM-22-016     202.0206.24.21.7
EM-22-017A690643548632241.3-55.7620193.5109.015.51.0
including     97.0103.06.01.4
EM-22-017A     137.0144.07.01.4
including     141.0143.02.02.9
EM-22-005W69079554861362.2-65.5364364.3365.81.51.3
      624.0625.01.01.2
EM-22-006W1690736.7548582829.5-57435.2476.0479.03.02.0
EM-22-006W1     482.8484.01.26.5
EM-22-006W1     652.0655.03.02.3
including     653.5654.10.66.6
EM-22-009W2A690921548563921.4-65.9634828.0830.02.01.4
EM-22-010W1690841548579530.8-62361583.5584.00.51.5
EM-22-008W690737548582845.6-58.1377527.0529.02.06.2
EM-22-008W     630.1634.03.94.2
including     631.0632.51.56.8
EM-23-006W4690737548582824.5-39.4236472.0486.214.21.1
including     472.0477.45.41.4
including     481.6482.30.74.0
EM-23-006W4     521.0523.62.61.9
EM-22-012W691098.7548541320-45.6524.71095.31097.42.11.2

Notes: Drill holes EM-22-006W, EM-22-006X, EM-22-008 and EM-22-009W1 returned no significant assays. Drill hole EM-22-017 was lost at 51 m. True widths estimated at 40% to 70% of downhole width depending on the hole inclination.

Qualified Person

The scientific and technical data contained in this press release was reviewed and prepared under the supervision of Fred Speidel, M. Sc., P. Geo., Vice-President Exploration of Maple Gold. Mr. Speidel is a Qualified Person under National Instrument 43-101 Standards of Disclosure for Mineral Projects. Mr. Speidel has verified the data related to the exploration information disclosed in this press release through his direct participation in the work.

Quality Assurance (QA) and Quality Control (QC)

The Company implements strict Quality Assurance (“QA”) and Quality Control (“QC”) protocols at Eagle covering the planning and placing of drill holes in the field; drilling and retrieving the NQ-sized drill core; drill hole surveying; core transport; core logging by qualified personnel; sampling and bagging of core for analysis; transport of core from site to the Val d’Or, Québec AGAT laboratory; sample preparation for assaying; and analysis, recording and final statistical vetting of results. Check assays for gold are being done on a sample subset at ALS’ laboratory in Val d’Or. For a complete description of protocols, please visit the Company’s QA/QC webpage at www.maplegoldmines.com.

About Maple Gold

Maple Gold Mines Ltd. is a Canadian advanced exploration company in a 50/50 joint venture with Agnico Eagle Mines Limited to jointly advance the district-scale Douay and Joutel gold projects located in Québec’s prolific Abitibi Greenstone Gold Belt. The projects benefit from exceptional infrastructure access and boast ~400 km2 of highly prospective ground including an established gold resource at Douay (SLR 2022) that holds significant expansion potential as well as the past-producing Eagle, Telbel and Eagle West mines at Joutel. In addition, the Company holds an exclusive option to acquire 100% of the Eagle Mine Property.

The district-scale property package also hosts a significant number of regional exploration targets along a 55 km strike length of the Casa Berardi Deformation Zone that have yet to be tested through drilling, making the project ripe for new gold and polymetallic discoveries. The Company is well capitalized and is currently focused on carrying out exploration and drill programs to grow resources and make new discoveries to establish an exciting new gold district in the heart of the Abitibi. For more information, please visit www.maplegoldmines.com.

ON BEHALF OF MAPLE GOLD MINES LTD.

“Matthew Hornor”

B. Matthew Hornor, President & CEO

For Further Information Please Contact:

Mr. Joness Lang
Executive Vice-President
Cell: 778.686.6836
Email: jlang@maplegoldmines.com

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 PRESS RELEASE.

Forward Looking Statements:

This press release contains “forward-looking information” and “forward-looking statements” (collectively referred to as “forward-looking statements”) within the meaning of applicable Canadian securities legislation in Canada, including statements about exploration work and results from current and future work programs. Forward-looking statements are based on assumptions, uncertainties and management’s best estimate of future events. Actual events or results could differ materially from the Company’s expectations and projections. Investors are cautioned that forward-looking statements involve risks and uncertainties. Accordingly, readers should not place undue reliance on forward-looking statements. For a more detailed discussion of such risks and other factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements, refer to Maple Gold Mines Ltd.’s filings with Canadian securities regulators available on www.sedar.com or the Company’s website at www.maplegoldmines.comThe Company does not intend, and expressly disclaims any intention or obligation to, update or revise any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

Release – Schwazze Launches EDW – A New Ready-To-Roll, Half Ounce Pre-Ground Flower Product

Research News and Market Data on SHW

April 6, 2023

OTCQX: SHWZ 
NEO: SHWZ

EDW | EVERY DAY WEED for EVERY DAY THAT ENDS IN A ‘Y’

DENVER, April 6, 2023 /CNW/ – Regional, multi-state cannabis operator, Schwazze, (OTCQX: SHWZ) (NEO: SHWZ) (“Schwazze” or the “Company”), announces today the expansion of its in-house product portfolio with the launch of a new pre-ground, ready-to-roll flower brand, EDW or Every Day Weed. EDW is available now in Colorado with expansion plans for New Mexico coming soon.

   

As pre-rolls continue to capture flower market share year over year, EDW is designed for the cannabis consumer who wants great flower and consumes it regularly. Pre-ground flower requiring no grinder, EDW is sold in a half-ounce resealable package and is available in indica, sativa and hybrid dominances. The packaging is very lightweight, portable, convenient and comes with its own custom pack of rolling papers, perfect for groups and social gatherings.

“We’re excited to expand our product portfolio with the EDW brand. Schwazze is focused on building a high-quality house of wholesale brands that also deliver great value to cannabis consumers. Given the growth of pre-rolls over the last two years, we are happy to offer a convenient “roll your own” option for our customers,” said Nirup Krishnamurthy, President of Schwazze.

EDW is now available at both Schwazze-owned Star Buds and Emerald Fields retail chains throughout Colorado, among other dispensaries.

About Schwazze

Schwazze (OTCQX: SHWZ  NEO: SHWZ) is building a premier vertically integrated regional cannabis company in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. Schwazze’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition.

Medicine Man Technologies, Inc. was Schwazze’s former operating trade name. The corporate entity continues to be named Medicine Man Technologies, Inc. Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth.

Forward-Looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “plan,” “will,” “may,” “continue,” “predicts,” or similar words. Forward-looking statements include the guidance provided regarding the Company’s 2023 performance and annual capital spending. Forward-looking statements are not guarantees of future events or performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified. Consequently, actual events and results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; (v) difficulties in securing regulatory approval to market our products and product candidates; (vi) our ability to successfully execute our growth strategy in Colorado and New Mexico and outside those states, (vii) our ability to identify and consummate future acquisitions that meet our criteria, (viii) our ability to successfully integrate acquired businesses and realize synergies therefrom, (viii) the uncertainty in the application of federal, state and local laws to our business, and any changes in such laws, and (ix) our ability to achieve the target metrics. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise except as required by law.

   

View original content to download multimedia:https://www.prnewswire.com/news-releases/schwazze-launches-edw–a-new-ready-to-roll-half-ounce-pre-ground-flower-product-301791330.html

SOURCE Schwazze

V2X, Inc. (VVX) – A $440 Million Contract from the Navy


Thursday, April 06, 2023

For more than 70 years, Vectrus has provided critical mission support for our customers’ toughest operational challenges. As a high-performing organization with exceptional talent, deep domain knowledge, a history of long-term customer relationships, and groundbreaking technical expertise, we deliver innovative, mission-matched solutions for our military and government customers worldwide. Whether it’s base operations support, supply chain and logistics, IT mission support, engineering and digital integration, security, or maintenance, repair and overhaul, our customers count on us for on-target solutions that increase efficiency, reduce costs, improve readiness, and strengthen national security. Vectrus is headquartered in Colorado Springs, Colo., and includes about 8,100 employees spanning 205 locations in 28 countries. In 2021, Vectrus generated sales of $1.8 billion. For more information, visit the company’s website at www.vectrus.com or connect with Vectrus on Facebook, Twitter, and LinkedIn.

Joe Gomes, Managing Director – Generalist Analyst, Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

A New Award. Yesterday, V2X was awarded a maintenance contract from the U.S. Navy to provide aircraft maintenance support for Naval Test Wing Pacific (NTWP) VX-30 and VX-31 at Point Mugu, CA and China Lake, CA. The maintenance will consist of flightline maintenance, logistics, and technical support for the two weapons development and test squadrons. The contract is for $440 million and has a seven year period that will end in 2030.

Expanding into the Navy. The specific contract awarded yesterday is the sister to the contract given by the Navy towards Naval Test Wing Atlantic, awarded in April of 2022, also won by Vertex. With the merger of Vertex and Vectrus, the Navy accounted for 24.7% of total revenue for 2022. With both Naval Test Wings contracted under V2X along with a stronger revenue base towards the Navy following the merger, we believe V2X is well positioned to continue to win additional work with the Navy.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

ChitogenX Inc. (CHNXF) – New Private Placement Offering Announced


Thursday, April 06, 2023

Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Replaces terminated original placement. The original best efforts private placement expected to close near the end of February for gross proceeds up to $4.35 million (currencies in Canadian $), subject to a $3 million minimum, under a listed issuer exemption prospectus, was terminated. The new offering is a non-brokered $2.5 million gross proceeds private placement.  Of the original two parts in the February offering, the non-brokered $1.75 million gross proceeds private placement at $0.225/unit portion has closed.

Offering terms revised slightly. The smaller new offering carries slightly different terms than the originally announced listed issuer exemption offering.  The new offering units are now priced at $0.20/unit (vs. $0.225/unit), with 12.5 million units being offered. Each unit consists of one Class A share of common and one purchase warrant exercisable at $0.35 with a 5 year expiration. After 6 months, if the volume weighted average trading price exceeds $0.50 for 10 consecutive trading days, ChitogenX can accelerate the expiration date. This new offering is expected to close around April 14, 2023.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

LithiumBank Resources (LBNKF) – Gaining Momentum


Thursday, April 06, 2023

Mark Reichman, Senior Research Analyst, Natural Resources, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Collaboration with Invest Alberta. LithiumBank executed a Memorandum of Understanding with Invest Alberta Corporation (IAC) to support the development of a lithium production facility at the company’s Boardwalk brine project. Established as a crown corporation of the Government of Alberta, Invest Alberta promotes Alberta as an investment destination of choice to investors in Canada and internationally. LithiumBank’s commercial lithium production facility in northern Alberta could factor importantly in Alberta becoming a destination for critical mineral resource development and as a partner in the electrification supply chain.

Why is this collaboration important? With teams in Calgary and Edmonton along with 11 international locations, IAC connects industry, government partners, and economic development organizations and provides services to facilitate investment in Alberta. The organization will support LithiumBank by promoting the Boardwalk project domestically and internationally, facilitate relationships with key stakeholders and senior government officials, and bolster LithiumBank’s relationships with post-secondary institutions to create a qualified talent pipeline in support of the project.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Should You Buy at the Closing Bell and Sell at the Open?

Image Credit: Florin Cee (Flickr)

Much of Market Performance, in Some Cases All, Occur When the Market is Closed

All traders and most investors have experienced this. From one market close to the next, indexes or stocks rise by 1.5% – 3%, and yet there was never a clear opportunity to make a dime after the market open. The frustration is because the market opened with much or all of the day’s gain baked in. It has been proven to be accurate that the most significant revaluation of stocks occurs during the 17 hours when the market is closed, not the 7-hours when it’s open. And any long-term chart will show that the direction of revaluation over time has been upward. Details, along with other phenomena related to night moves, are discussed below.

Background

 Historically, stock markets have had a positive return, and most of this change occurs while the exchanges are closed or not during regular trading hours. Historically the tendency is to make most of its daily move between the closing and opening bell.

This has been shown in research papers through the years, and there are even ETFs which purport to take advantage of this statistical phenomenon. Of course this is not an everyday occurrence, in fact today (4/6/23), the S&P 500 opened lower than its previous close but began moving higher than the open around noon.

A well-researched scholarly paper had been published demonstrating these price movements and offered the explanation that stock prices behave very differently with respect to their sensitivity to beta when markets are open for trading versus when they are closed. The paper titled,  Asset Pricing: A Tale of Night and Day, by Henderschott, Livdan, and Rösch explained, “stock returns are positively related to beta overnight whereas returns are negatively related to beta during the trading day.”

Image Source: Asset Pricing aTale of Day and Night

 One goal of the research was to test the hypothesis that a securities performance relative to beta is only positive during certain periods. In the paper the researchers tested specific days or months by examining the CAPM validity during different time periods within each day, including all times and all days during the week. The authors wrote, “when the stock market is closed, beta is positively related to the cross section of returns. In contrast, beta is negatively related to returns when the market is open.”

The overall thrust of the findings in the 47-page paper are encapsulated in the chart above which plots the performance during opened and closed periods against different beta groupings of stocks over 25 years.

Can Investors Use this Information?

Most retail trading today is commission free, but there is still a bid offer spread and other slippage. For those that would prefer to not have to be active each day, twice a day, Nightshares ETFs were formed to exploit this phenomenon, with a set it and forget it approach. On the surface it would seem to make sense for long term investors. You could own the S&P 500 index ETF, or increase beta exposure for a potentially better performance with a small-cap index ETF.

The founder of Night Shares, Bruce Lavine, pointed out in an interview that over the 20 years through the end of 2022, the SPDR S&P 500 ETF SPY, 0.31% produced a buy-and-hold return of 9.7% annualized. Three-quarters of that return — 7.5% — was produced while the NYSE was closed.

The numbers are even more pronounced in the case of the small-cap Russell 2000 Index, according to Lavine. Over the same 20-year period, all of the index’s net return was produced overnight; during the day session, it actually lost ground on balance. In other words, small-cap portfolios that out-returned large-cap would have been better off if they were not exposed during the day.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://faculty.wharton.upenn.edu/wp-content/uploads/2013/06/draft20130612pp-full.pdf

https://www.marketwatch.com/story/youll-make-the-most-money-in-the-stock-market-during-these-specific-and-suprising-hours-bdd55215?mod=home-page

https://www.ftserussell.com/

The FDA’s Action Plan Regarding Artificial Intelligence and Machine Learning

Image Credit:  Interscatter Data Sharing Contact Lens, UW News (Flickr)

The Challenges Surrounding AI/ML are Taken Head on by the FDA

Should artificial intelligence or machine learning (AI/ML) be allowed to alter FDA approved software in medical devices? If so, where should the guardrails be set? The discussions and debates surrounding AI/ML are heated; some believe the technology may destroy humanity, while others look forward to the speed of advancement it will allow. The FDA is getting out ahead on this debate. This week the agency drafted a list of “guiding principles” intended to begin developing best practices for machine learning within medical devices.

Background

The FDA views its role as protecting patients while at the same time avoiding standing in the way of progress. In the case of ML, not preventing the modification of medical treatments or procedures that would improve outcomes. AI/ML has the potential to more quickly evaluate data sets, improve diagnosis, adjust how used, and overall alter processes based on what is learned.  

On April 3, the FDA drafted AI-Enabled Medical Device Life Cycle Plan Guidance, with a comment period ending July 3, 2023.  The U.S. regulator’s proposal attempts to find science-based requirements for medical devices powered by artificial intelligence and machine learning. The overall goal is to not slow the implementation of improved new devices that may quickly be modified, updated, and rapidly deliver an improved response to new data.  

Greg Aurand, Senior Healthcare Services & Medical Devices Analyst at Noble Capital Markets, summed up the purpose for the FDA’s actions in this way: “The FDA needs to move cautiously, but they don’t wish to slow down healthcare improvements on an ongoing basis.” Aurand gave examples where machine learning has the potential to make better assessments, better decipher data sets such as antibiotic resistance, and improve results while perhaps taming medical expenses. He said, “new draft guidelines from the FDA should make it easier for approval of modifications to occur so previously unrecognized improvements may occur within the guidelines, and the process is less static.”

How is Artificial Intelligence Likely to Revise Medical Devices?

As is written into the FDA guidance, “Artificial intelligence (AI) and machine learning (ML) technologies have the potential to transform health care by deriving new and important insights from the vast amount of data generated during the delivery of health care every day. Medical device manufacturers are using these technologies to innovate their products to better assist health care providers and improve patient care.”  

The FDA accepts that a great benefit of AI/ML in software is its ability to learn from real-world use and experience, then the ability to improve its own performance.

How is the FDA Expected to Regulate AI/ML Devices?  

Traditionally, the FDA reviews medical devices and improvements through a premarket pathway for approval. The FDA may also review and clear modifications to medical devices, including software as a medical device, depending on the significance or risk posed to patients by that modification. The industry is going through a paradigm shift which the FDA is helping to enable.

The FDA’s current paradigm of medical device regulation was not designed for adaptive artificial intelligence. Under the FDA’s current approach to software modifications it anticipates that many of these artificial intelligence and machine learning-driven software changes to a device need a premarket review. The new regulation is expected to create broader parameters of pre-approval to allow adjustments with set allowable boundaries.

A new framework envisioned by the FDA includes a “predetermined change control plan” in premarket submissions. This plan would include the types of anticipated modifications, referred to as “Software as a Medical Device Pre-Specifications”.  The associated methodology used to implement those changes in a measured and controlled approach that manages risk the FDA calls the “Algorithm Change Protocol.”

Take Away

Artificial intelligence will transform many industries, and while some want to hit the pause button on progress, the FDA is trying to define how much control can be left to machine learning. The Guidance released in April with a three-month comment period is expected to allow medical equipment and software designers to progress into the unknown, with all stakeholders having as their goal better outcomes for patients.

If you wish to send requested comments to the FDA, the agency requests it be received by July 3, 2023 to ensure the agency considers your comment on the draft guidance before it begins work on the final version of the guidance.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial

https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device

https://www.fda.gov/media/145022/download

https://www.fda.gov/media/166704/download

Release – Comtech Welcomes Descartes Labs as New EVOKE Technology Partner

Research News and Market Data on CMTL

Apr 5, 2023 9:12 AM

MELVILLE, N.Y. –
Apr. 5, 2023–Comtech (NASDAQ: CMTL) announced today that Descartes Labs will become the Company’s third publicly revealed EVOKE technology partner.

As the third publicly announced EVOKE technology partner, Descartes Labs will work with Comtech to infuse the power of artificial intelligence (AI), Machine Learning (ML), predictive intelligence, and monitoring insights across Comtech’s business verticals. Such data services and solutions are intended to serve Comtech commercial and government customers across the globe and represent a cornerstone of Comtech’s commitment to continually improving the customer experience with innovative services and solutions.

“As our latest EVOKE technology partner, Descartes Labs brings one of the world’s fastest cloud-native supercomputers and industry leading geospatial data analysis capabilities that will enable us to provide commercial and government customers with powerful new insights and services,” said Ken Peterman, President and CEO, Comtech. “We will work together to quickly deliver smart-insight powered technologies that can make the world a better, safer place that leaves no one behind in today’s technology driven society.”

Descartes Labs, Inc. and its wholly owned subsidiary Descartes Labs Government, is a geospatial analytics company that focuses on rapidly prototyping dual-use commercial AI and ML solutions for Government and Fortune 500 companies.

“There is tremendous value in the alliance between Descartes Labs and Comtech,” said Richard Davis, CEO, Descartes Labs. “We are honored to be selected as one of the first EVOKE technology partners. Our core mission is to find the signal in the noise created by a myriad of global data sets using AI/ML. Together with Comtech, we will develop data products that address the growing demand for insights that rely on the fusion of data derived from space technologies, telecommunications networks, and earth observation sensors. The solutions to problems we can solve together is only limited by our own creativity.”

EVOKE is Comtech’s Innovation Foundry, which is led by the company’s Chief Growth Officer, Anirban Chakraborty, and is dedicated to creating and accelerating transformational changes across the global technology landscape. EVOKE engages with customers, partners, and suppliers to push the boundaries of technologies that will lay the foundation of connectivity as well as shape future societies and ecosystems.

About Comtech

Comtech Telecommunications Corp. is a leading global technology company providing terrestrial and wireless network solutions, next-generation 9-1-1 emergency services, satellite and space communications technologies, and cloud native capabilities to commercial and government customers around the world. Our unique culture of innovation and employee empowerment unleashes a relentless passion for customer success. With multiple facilities located in technology corridors throughout the United States and around the world, Comtech leverages our global presence, technology leadership, and decades of experience to create the world’s most innovative communications solutions.For more information, please visit www.comtech.com.

About Descartes Labs

Descartes Labs (DL), and its wholly-owned government subsidiary, Descartes Labs Government, Inc. (DLG), solve the world’s most complex problems. They offer customers an accelerated ability to address operational needs by transforming the world’s data into actionable and predictive insights that impact climate change, sustainability, food security, mission-critical intelligence, humanitarian efforts, and safeguards natural resources at the speed of relevance. DL and DLG’s solutions and services offer unique advantages to our customers that are grounded in an ever-expanding portfolio of dual-use commercial products and capabilities which are enabled by our core technology stack. Descartes Labs is an industry innovator, transforming data to decisions around the world. Descartes Labs is headquartered in Santa Fe, New Mexico.

Forward-Looking Statements

Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results and performance could differ materially from such forward-looking information. The Company’s Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such Securities and Exchange Commission filings.

PCMTL

View source version on businesswire.com: https://www.businesswire.com/news/home/20230404006122/en/

Investor Relations

Robert Samuels

631-962-7102

robert.samuels@comtech.com

Media Contact

Jamie Clegg

480-532-2523

jamie.clegg@comtech.com

Release – Alvopetro Announces March 2023 Sales Volumes and Record Q1 2023 Sales Volumes

Research News and Market Data on ALVOF

Apr 05, 2023

CALGARY, AB, April 5, 2023 /CNW/ – Alvopetro Energy Ltd. (TSXV: ALV) (OTCQX: ALVOF) announces March 2023 average sales volumes of 2,690 boepd, including natural gas sales of 15.4 MMcfpd, associated natural gas liquids sales from condensate of 120 bopd and 8 bopd of oil sales, based on field estimates. Overall, our sales volumes averaged 2,767 boepd in the first quarter of 2023, an increase of 2% from the fourth quarter of 2022 and a new quarterly record for Alvopetro.

Corporate Presentation

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

Social Media

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

Twitter – https://twitter.com/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:bbls                        =              barrelsboepd                     =             barrels of oil equivalent (“boe”) per daybopd                       =             barrels of oil and/or natural gas liquids (condensate) per dayMMcf                      =             million cubic feetMMcfpd                  =             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.

Forward-Looking Statements and Cautionary Language. This news release contains “forward-looking information” within the meaning of applicable securities laws. The use of any of the words “will”, “expect”, “intend” and other similar words or expressions are intended to identify forward-looking information. Forward–looking statements involve significant risks and uncertainties, should not be read as guarantees of future performance or results, and will not necessarily be accurate indications of whether or not such results will be achieved. A number of factors could cause actual results to vary significantly from the expectations discussed in the forward-looking statements. These forward-looking statements reflect current assumptions and expectations regarding future events. Accordingly, when relying on forward-looking statements to make decisions, Alvopetro cautions readers not to place undue reliance on these statements, as forward-looking statements involve significant risks and uncertainties. More particularly and without limitation, this news release contains forward-looking information concerning the expected natural gas sales and gas deliveries under the Company’s long-term gas sales agreement. The forward–looking statements are based on certain key expectations and assumptions made by Alvopetro, including but not limited to expectations and assumptions concerning the performance of producing wells and reservoirs, foreign exchange rates, well development and operating performance, the timing of regulatory licenses and approvals, equipment availability, the success of future drilling, completion, testing, recompletion and development activities, expectations regarding Alvopetro’s working interest and the outcome of any redeterminations, environmental regulation, including regulation relating to hydraulic fracturing and stimulation, the ability to monetize hydrocarbons discovered, the outlook for commodity markets and ability to access capital markets, general economic and business conditions, the impact of the COVID-19 pandemic, weather and access to drilling locations, the availability and cost of labour and services, 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.comTSX-V: ALV, OTCQX: ALVOF

SOURCE Alvopetro Energy Ltd.

Release – Tonix Pharmaceuticals Announces Poster Presentations at the American Association for Cancer Research Annual Meeting 2023

Research News and Market Data TNXP

April 05, 2023 7:00am EDT

Data from Animal Studies on TNX-1700 (recombinant TFF2 – albumin fusion peptide) in Syngeneic Models of Colorectal and Gastric Cancer Will be Presented

CHATHAM, N.J., April 05, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that two posters with research results on TNX-1700 (recombinant TFF2 – albumin fusion peptide) will be presented as posters at the American Association for Cancer Research (AACR) Annual Meeting being held April 14-19, 2023, in Orlando, Fla. These data demonstrate that targeting myeloid-derived suppressor cells (MDSCs) using mTNX-1700, a murine TFF2 – murine serum albumin fusion peptide (mTFF2-MSA) provides additive benefits to PD-1 blockade therapy in advanced and metastatic syngeneic mouse models of colorectal and gastric cancer.

Copies of the Company’s posters will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference.   Additional meeting information can be found on the AACR website.

Presentation #1  
    
Title:  MDSC-targeted TFF2-MSA suppresses tumor growth and increases survival in anti-PD-1 treated MC38 and CT26.wt murine colorectal cancer models
    
Authors:  Bruce L. Daugherty1, Rebecca J. Boohaker2, Rebecca Johnstone2, Karr Stinson2, Jin Qian3, Timothy C. Wang3, Seth Lederman1
    
   1. Tonix Pharmaceuticals, Inc., 26 Main Street, Suite 101, Chatham, NJ 07928
2. Southern Research, 2000 9th Ave S, Birmingham, AL 35205
3. Division of Digestive and Liver Diseases, Irving Cancer Research Center, Columbia University Medical Center, New York, NY 10032, USA
    
Topic:  Oncolytic Viruses, Anticancer Vaccines, and Other Immunomodulatory Therapies
    
Location:  Orange County Convention Center, Orlando, Fla.
    
Section:  24, #704
    
Date:  Sunday, April 16, 2023
    
Time:  1:30 p.m. – 5:00 p.m. ET
    
    
Presentation #2
    
Title:  MDSC-targeted TFF2-MSA synergizes with PD-1 blockade therapy in diffuse-type gastric cancer
    
Authors:  Jin Qian1, Sandra Ryeom1, Bruce Daugherty2, Seth Lederman2, Timothy C. Wang12.
    
   1. Division of Digestive and Liver Diseases, Irving Cancer Research Center, Columbia University Medical Center, New York, NY 10032, USA

2. Tonix Pharmaceuticals, Inc., 26 Main Street, Suite 101, Chatham, NJ 07928
    
Title:  Combination Immunotherapies 1
    
Location:  Orange County Convention Center, Orlando, Fla.
    
Section:  21, #5088
    
Date:  Tuesday, April 18, 2023
    
Time:  1:30 p.m. – 5:00 p.m. ET


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 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. Enrollment in a Phase 2 study has been completed, and topline results are expected in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), in development for chronic migraine, is currently enrolling with interim data expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation being developed as a treatment for major depressive disorder (MDD), is also currently enrolling with interim data expected in the fourth 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 second 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 second quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox, for which a Phase 1 study is expected to be initiated in the second half of 2023. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease portfolio also includes TNX-3900 and TNX-4000, classes of broad-spectrum small molecule oral antivirals.

*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, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

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

Olipriya Das, Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com
(646) 942-5588

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

Source: Tonix Pharmaceuticals Holding Corp.

Released April 5, 2023

Release – V2X to help ready U.S. Navy air defense

Research News and Market Data on VVX

Company Release – 4/5/2023

V2X awarded O-level maintenance contract for Naval Test Wing Pacific

MCLEAN, Va., April 5, 2023 /PRNewswire/ — Vertex, a V2X company (NYSE: VVX), was awarded a $440 million contract by the U.S. Navy to provide aircraft maintenance support for Naval Test Wing Pacific (NTWP) VX-30 and VX-31 at Point Mugu, CA and China Lake, CA. Under this contract, V2X, under its legacy company Vertex, is the chosen provider of flightline maintenance, logistics, and technical support for the two weapons development and test squadrons. This important mission complements NAVAIR’s efforts to develop, test and sustain the Navy’s most current suite of capabilities.

“V2X is honored to be selected to support the critical test and evaluation activities performed at Naval Test Wing Pacific,” said Chuck Prow, V2X CEO. “Our established history  and record of performance providing maintenance, repair, overhaul and technical support for a variety of Naval Aviation platforms demonstrate our commitment to maintaining high levels of mission readiness.”

NTWP provides safe, effective, and efficient ground and flight test, airborne flight test support, and experimental operations of manned and unmanned aircraft, weapons, and weapons systems for the Department of the Navy.

This contract has a seven-year award period ending in March 2030.

ABOUT V2X

V2X is a leading provider of critical mission solutions and support to defense clients globally, formed by the 2022 Merger of Vectrus and Vertex to build on more than 120 combined years of successful mission support. The Company delivers a comprehensive suite of integrated solutions across the operations and logistics, aerospace, training, and technology markets to national security, defense, civilian and international clients. Our global team of approximately 15,000 employees brings innovation to every point in the mission lifecycle, from preparation to operations to sustainment, as it tackles the most complex challenges with agility, grit, and dedication.

For Media Inquiries:
Jackie Hampton
Media Director
Jacqueline.hampton@kglobal.com
443-814-0693

For Investors:
V2X, Inc.
Mike Smith, CFA
719-637-5773
michael.smith@vectrus.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/v2x-to-help-ready-us-navy-air-defense-301790310.html

SOURCE V2X, Inc.

Tonix Pharmaceuticals (TNXP) – Pipeline Products With Clinical Milestones Move Forward, Some Early Stage Products Are Discontinued


Wednesday, April 05, 2023

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-15001 which is a humanized monoclonal antibody targeting CD40-ligand 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 second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’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, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Product Pipeline Has Been Trimmed. Tonix announced that it will be focusing on developing pipeline products with near-term clinical milestones and plans to stop development of some early-stage programs. Development will continue for the CNS, infectious disease, and immunology products, but some research and COVID-19 programs will be discontinued. This allocates resources and funding to products that are most likely to impact the stock.

The CNS, Infectious Disease, and Immunology Programs Will Continue. Tonix will continue development of its CNS programs in fibromyalgia, depression, migraine, and cocaine intoxication. The immunology and rare disease programs will continue in organ transplant rejection, cancer, and Prader-Willi syndrome (an orphan disease). Biodefense and Infections Disease programs in smallpox/monkeypox and radioprotection continue, while most programs related to COVID-19 and Post Traumatic Stress Disorder (PTSD) will be discontinued.


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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.