Release – Tier-1 MNO Awards Multimillion-Dollar Award to Comtech for Large Messaging Contract

Research News and Market Data on CMTL

MELVILLE, N.Y.–(BUSINESS WIRE)–Oct. 3, 2022– October 3, 2022– Comtech (NASDAQ: CMTL), announced today that it has been awarded a contract for over $30 million with a multinational data networking and telecommunications equipment company for their text messaging platform.

As a pioneer in the SMS industry providing messaging solutions globally since 1996, Comtech has deep experience with its customers’ networks, use cases, and messaging features. Comtech’s messaging solutions have 99.999% reliability, minimize costs to customers and increase end-user loyalty and satisfaction.

“We have been working with this customer of over 20 years to supply reliable text messaging services. In 2019, we started working on migration of our in-network messaging application to a cloud-native, architecture-based messaging platform,” said Jay F. Whitehurst, President of Comtech Trusted Location. “We are pleased to announce that we have entered into a global licensing agreement with our partner and have inked a multi-year deal to provide a containerized messaging platform to a major tier-1 US-based mobile network operator.”

Comtech’s containerized Short Messaging Service Center (cSMSC) is a highly reliable, multi-protocol SMS delivery cloud-native platform that enables common use cases including person-to-person text messaging, application-to-person, machine-to-machine/Internet of Things (IoT), and various other advanced applications in legacy 4G and 5G networks. Comtech’s cSMSC solution is a containerized architecture-based messaging application, which complies with various worldwide telecommunications standards, Network Functions Virtualization (NFV), as well as Management and Orchestration (MANO) Requirements. The cSMSC will be deployed as a Containerized Network Function (CNF).

“At Comtech, I aim to combine our terrestrial and wireless expertise with our space and satellite technologies to exploit emerging opportunities arising from the convergence of communications infrastructure. I believe the need for constant connectivity will create ongoing demand to blend terrestrial, wireless, and satellite networks. This convergence of terrestrial and satellite communications networks will truly enable IoT connectivity on a global scale and aligns exceptionally well with Comtech’s core technologies. The launch of the cSMSC is an important step towards delivering on that roadmap,” said Ken Peterman, Comtech’s Chairman, President and CEO.

About Comtech

Comtech Telecommunications Corp. is a leading global provider of next-generation 911 emergency systems and secure wireless communications technologies to commercial and government customers around the world. Headquartered in Melville, New York and with a passion for customer success, Comtech designs, produces and markets advanced and secure wireless solutions. For more information, please visit www.comtech.com.

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 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

Investor Relations
Robert Samuels
631-962-7102
robert.samuels@comtech.com

Source: Comtech Telecommunications Corp.

Release – Vera Bradley To Donate Percentage Of Sales To Breast Cancer Research For National Breast Cancer Awareness Month

Research, News, and Market Data on VRA

Oct 3, 2022

Company To Donate 100% Of Primary Net Proceeds From 1982 Collection NFTs, 100% Of Net Proceeds From Limited-Edition Hope Charity Pouch, And 20% Of Purchase Price From “Rose Toile” And “Happiness Returns Pink” Prints To The Vera Bradley Foundation For Breast Cancer

FORT WAYNE, Ind., Oct. 03, 2022 (GLOBE NEWSWIRE) — Vera Bradley, Inc. (NASDAQ: VRA) today announced that Vera Bradley, its iconic American bag and luggage lifestyle brand, will donate 100% of primary net proceeds from its second NFT drop; 100% of net proceeds from its limited-edition Hope Charity Pouch; and 20% of the purchase price of its new Rose Toile and Happiness Returns Pink patterns, to the Vera Bradley Foundation for Breast Cancer (the “Foundation”) in support of National Breast Cancer Awareness Month.

Vera Bradley’s second NFT drop, the 1982 Collection, is now available for purchase through The World of Vera Bradley, the brand’s new metaverse concept, or via OpenSea. The 1982 Collection is comprised of 1,982 generative backgrounds derived from 40 archived prints to commemorate the year the company was founded. Priced at $19.82 USD*, the 1982 Collection appeals to crypto lovers and breast cancer awareness supporters alike, with 100% of Vera Bradley’s primary net proceeds benefiting the Foundation, focusing its unique utility on advocacy and fundraising.

Designed to honor and give hope to those affected by breast cancer, Vera Bradley’s limited-edition Hope Charity Pouch features the word “HOPE,” surrounded by delicate floral embellishments and boldly emblazoned on a canvas zip-closure pouch. The Hope Charity Pouch, available online at www.verabradley.com and in Vera Bradley Full Line Stores nationwide, is priced at $20, with 100% of net proceeds directed to the Foundation.

Vera Bradley’s newest prints with a purpose, Rose Toile and Happiness Returns Pink, also support the critical, life-saving research taking place at the Vera Bradley Foundation Center for Breast Cancer Research at Indiana University School of Medicine in Indianapolis. For every purchase of a style in Rose Toile and Happiness Returns Pink through October 31, 2022, Vera Bradley will donate 20% of the purchase price (up to a maximum contribution of $100,000) to the Foundation. Styles range in price from $4 – $155 and are available now in Vera Bradley Full Line Stores, participating Vera Bradley retailers nationwide, and online at www.verabradley.com.

“Vera Bradley has championed breast cancer research since 1993 when our co-founders Barbara Bradley Baekgaard and Patricia R. Miller established the Vera Bradley Foundation for Breast Cancer in memory of their dear friend, Mary Sloan,” noted Daren Hull, Vera Bradley Brand President. “With support from Vera Bradley’s customers and communities, the Foundation has since donated more than $38 million to fund research pursuing innovative and improved treatments that enable women and men to thrive, not just survive, after a breast cancer diagnosis. We invite our customers to join us in funding even more progressive research this October by purchasing Vera Bradley’s breast cancer awareness items or donating to the Vera Bradley Foundation for Breast Cancer.”

*Please Note: The exact USD retail price will depend on gas prices at time of purchase.

ABOUT VERA BRADLEY
Vera Bradley, based in Fort Wayne, Indiana, is a leading designer of women’s handbags, luggage and other travel items, fashion and home accessories, and unique gifts. Founded in 1982 by friends Barbara Bradley Baekgaard and Patricia R. Miller, the brand is known for its innovative designs, iconic patterns, and brilliant colors that inspire and connect women unlike any other brand in the global marketplace. Visit www.verabradley.com and follow @verabradley to learn more.

ABOUT VERA BRADLEY FOUNDATION FOR BREAST CANCER
The Vera Bradley Foundation for Breast Cancer raises funds for breast cancer research to find a cure and to improve the lives of the many affected by this disease. The Foundation has contributed $38.6 million to the Vera Bradley Foundation Center for Breast Cancer Research at the Indiana University School of Medicine and has pledged to raise a total of $50 million. The Center is focused on developing and dramatically improving therapies for some of the most difficult-to-treat types of breast cancer. Funds are raised through special events, partner events, and individual donations. For more information, visit www.verabradley.org.

CONTACTS
877-708-VERA (8372)
Mediacontact@verabradley.com

Hunter PR for Vera Bradley
verabradley@hunterpr.com

Photos accompanying this announcement are available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/ef5b555c-eb53-4e47-a57e-5ce7237887cd
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Release – Engine Gaming’s, Frankly Media and Aggregated Media Announce Partnership

Research, News, and Market Data on GAME

10/03/2022

Frankly initiates monetization of Aggregated Media’s A8 Esports Digital Linear Channel while maximizing target audience reach

NEW YORK, NY / ACCESSWIRE / October 3, 2022 / Frankly Media (“Frankly”), a digital publishing platform used to create, distribute and monetize content across all digital channels and wholly-owned subsidiary of Engine Gaming and Media, Inc. (NASDAQ:GAME)(TSXV:GAME), today announced a partnership with Aggregated Media (“A8”), an esports and video game culture media company. The partnership enables Frankly to monetize A8’s content via their premium yield advertising services and maximize their audience reach through Frankly’s video streaming platform, mobile apps and OTT/CTV.

“We’ve been extremely impressed with Frankly’s highly skilled Programmatic Advertising and SaaS resources. The team is very hands on, helping us every step of the way. We’re also utilizing their video streaming and app platforms to assist our content creators to easily ingest and distribute our esports and gaming content to an ever-increasing esports and gaming audience,” commented Erik Reynolds, President of Aggregated Media.

Frankly Media offers an integrated suite of gaming, news and entertainment solutions that help its customers modernize their digital ecosystem, maximize their audience reach and engagement, and fully monetize their display, audio and video content. Frankly’s fully integrated solution suite includes premium yield advertising solutions that include ad sales, ad operations, audience insights and performance analytics, website/cms, video streaming for Live, VOD and FAST Channels, Mobile Apps, OTT/CTV Apps, and Audience Engagement widgets.

“Aggregated Media is a perfect partnership for the Engine Gaming & Media family. We are thrilled to be serving their team and are working hard to optimize the monetization of their content, maximize their audience reach and modernize their digital ecosystem,” offered Lou Schwartz, CEO, Engine Gaming & Media.

About Aggregated Media

Backed by Nations Ventures and Stadia Ventures (Spring 2022 Accelerator Program), Aggregated Media or A8 for short, is an esports content platform of 30+ Twitch, Youtube, podcast, and social media shows reaching more than 6.5 million unique esports fans that has solved the challenge of delivering the higher engagement of microinfluencers at the same scale as some of the biggest influencers in the world. A8 partners with world class content creators, esports teams, networks and tournament organizers to co-produce, broadcast, distribute and monetize content across multiple media platforms. For more information: info@aggregatedmedia.com.

About Frankly Media

Frankly Media provides a complete suite of solutions that give publishers a unified workflow for creating, managing, publishing, and monetizing digital content to any device while maximizing audience value and revenue. Frankly delivers publishers and their audiences the solutions to meet the dynamic challenges of a multi-screen content distribution world.

Frankly’s comprehensive advertising services maximize ROI for our customers, including direct sales and programmatic ad support. With the release of our server-side ad insertion (SSAI) platform, Frankly is well-positioned to help video producers take full advantage of the growing market in addressable advertising.

Frankly’s technology products include a ground-breaking online video platform for Live, VOD, and Live-to-VOD workflows, a full-featured CMS with rich storytelling capabilities, and native apps for iOS, Android, Apple TV, Fire TV, and Roku. The company is headquartered in New York, with offices in Atlanta. Frankly Media is a Subsidiary of Engine Media and Media, Inc.

About Engine Gaming and Media, Inc.

Engine Gaming and Media, Inc. (NASDAQ:GAME) (TSX-V: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.

For more information, please contact:

Engine Gaming Investor Relations
Shannon Devine
MZ Group
Email: shannon.devine@mzgroup.us

SOURCE: Engine Gaming & Media Holdings, Inc.



View source version on accesswire.com:
https://www.accesswire.com/718145/Engine-Gamings-Frankly-Media-and-Aggregated-Media-Announce-Partnership

Release – Lineage Establishes New R and D Facility in U.S. and Expands Current GMP Manufacturing Facility in Israel

Research, News, and Market Data on LCTX

October 3, 2022 at 8:00 AM EDT

Expansions Expected to Support Process Development and Production of Current and Future Cell Transplant Programs

CARLSBAD, Calif.–(BUSINESS WIRE)–Oct. 3, 2022– Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today the opening of a new research and development (R&D) facility in Carlsbad, California, and the expansion of its Good Manufacturing Practice (GMP) manufacturing facility based in Jerusalem, Israel. Lineage’s new Carlsbad facility will broaden the Company’s R&D capabilities in the U.S. and support the development of current and future allogeneic cell transplant programs. The expansion of Lineage’s Israel-based facility will increase the Company’s infrastructure, including development and optimization of larger-scale clinical manufacturing processes, and continued execution under its ongoing collaboration with Roche and Genentech for RG6501 (OpRegen®), a retinal pigment epithelium cell replacement therapy which has completed enrollment in a Phase 1/2a clinical trial for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

“We have elected to increase our R&D footprint at our existing GMP manufacturing facility and establish a new R&D facility in Carlsbad, California,” stated Brian M. Culley, Lineage CEO. “These steps will permit us to expand our process development and analytical testing capabilities and conduct exploratory work on future programs, whether owned by us or our current or future partners. This move also is expected to reduce our reliance on certain vendors, which may reduce costs and risks of timeline uncertainty or supply chain disruption. The additional capacity also can help us become an even more capable partner in prospective alliances for new products and allow us to explore additional uses for our current cell transplant programs.”

Mr. Culley added, “Challenges in the biotech sector are unlikely to persist indefinitely. We believe it is important to take steps, even in this environment, to be positioned for a future recovery. The modest investments we are making today, partially offset by the termination of the lease for our research facility in Alameda, California in January of next year, will help centralize our operations and put us in a position of greater readiness for future success.”

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include five allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit www.lineagecell.com or follow the company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: the potential benefits of the new and expanded facilities to the Company and its operations, including the broadening of the Company’s R&D capabilities, increasing development and optimization of larger-scale clinical manufacturing processes, the expansion of the Company’s process development and analytical testing capabilities and ability to conduct exploratory work on future programs, the increase in the Company’s manufacturing facilities, the decreased reliance on certain vendors, the reduction in costs and risks of timeline uncertainty and supply chain disruption, and the improvement in the Company’s position of greater readiness for future success. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that potential benefits of the new and expanded facilities to the Company and its operations may not be realized as quickly as expected or at all; that we may need to allocate our cash to unexpected events and expenses causing us to use our cash more quickly than expected; that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that competing alternative therapies may adversely impact the commercial potential of OpRegen; that Roche and Genentech may not successfully advance OpRegen or be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; that we may not establish new partnerships or expand existing collaborations; that we do not successfully broaden awareness of our mission or accomplishments; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

View source version on businesswire.comhttps://www.businesswire.com/news/home/20221003005286/en/

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963

LifeSci Advisors
Daniel Ferry
(daniel@lifesciadvisors.com)
(617) 430-7576

Russo Partners – Media Relations
Nic Johnson or David Schull
(Nic.johnson@russopartnersllc.com)
(David.schull@russopartnersllc.com)
(212) 845-4242

Source: Lineage Cell Therapeutics, Inc.

Release – Tonix Pharmaceuticals Announces IND Clearance for TNX-601 ER as a Potential Treatment for Major Depressive Disorder

Research, News, and Market Data on TNXP

October 03, 2022 7:00am EDT

TNX-601 ER, Tianeptine Hemioxalate, is an Extended-Release Tablet for Once-a-Day Dosing

Phase 2 Clinical Trial of TNX-601 ER Expected to Start First Quarter 2023

CHATHAM, N.J., Oct. 03, 2022 (GLOBE NEWSWIRE) —  Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to support a Phase 2 clinical trial with TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation of tianeptine as a potential treatment for major depressive disorder (MDD)1. Tianeptine is a new molecular entity in the U.S. that is being developed under the 505(b)(1) pathway. Tianeptine sodium (amorphous) immediate release (IR) tablets have been available in Europe and many countries in Asia and Latin America for the treatment of depression over more than three decades since it was first marketed in France in 1989. Tianeptine’s activity is mechanistically distinct from traditional monoaminergic treatments for depression available in the U.S. including the selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), and tricyclic antidepressants (TCAs).

“This is an important milestone as we advance TNX-601 ER into clinical development,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-601 ER is a novel, oral, extended-release once-daily tablet. Studies from across the globe conducted over more than 30 years show that immediate-release (IR) tianeptine sodium formulations have comparable efficacy to SSRIs and TCAs, fewer drug-drug interactions, and are associated with a lower incidence of sexual dysfunction compared with SSRIs, SNRIs and TCAs. We expect that our new once-daily formulation will maintain these properties while also providing convenience and adherence advantages over the three-times-a-day dosing of these IR tianeptine sodium products. We expect to initiate the Phase 2 trial in MDD in the first quarter of 2023, with the potential for additional future indications in posttraumatic stress disorder and neurocognitive dysfunction from corticosteroids.”

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. The proposed mechanism of action of TNX-601 ER is distinct from traditional monoaminergic antidepressants, in that its principal mechanism in MDD is believed to be through indirect modulation of glutamatergic neurotransmission. It is notable that in multiple placebo-controlled and comparative studies that tianeptine demonstrates efficacy on par with both SSRIs and tricyclic antidepressants, while showing a more favorable tolerability profile, lacking the sedative, autonomic, cardiovascular and side effects on memory and attention of TCAs and a low incidence of sexual side effects, nausea, and sleep disruption as compared with SSRIs.2,3

In addition to its glutamatergic properties, tianeptine has weak µ-opioid receptor agonist properties and has been linked to illicit misuse at much higher doses than those reported to be effective in the treatment of MDD4. Previously, Tonix was developing a naloxone-containing tablet, TNX-601 CR (tianeptine oxalate and naloxone controlled-release) for MDD, that was designed to mitigate the risk of parenteral abuse. TNX-601 ER is also designed with abuse deterrent properties but without the µ-opioid receptor antagonist naloxone. The abuse-deterrent properties include gel forming polymers which impede extraction for illicit misuse. In addition, the tablet’s hardness makes it difficult to crush, cut or grind to fine particle size, which hinders efforts to misuse by nasal insufflation or intravenous route.

1TNX-601 ER is an investigational new drug and is not approved for any indication.
2McEwen, B.S., et al. Neurobiological properties of the antidepressant tianeptine. Molecular Psychiatry 2010, 15, 237-249.
3Paparrigopoulos, T.J., et al. Sleep and antidepressant medication. WPA Bulletin on Depression 2007, 11 (33), 7-11.
4Lauhan, R., et al. Tianeptine abuse and dependence: case report and literature review. Psychosomatics 2018, 59 (6), 547–553.

About the Phase 2 Study

Tonix is proposing to conduct a registration-quality, potentially pivotal, Phase 2, 6-week, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of TNX-601 ER monotherapy in male and female subjects aged 18 to 65 years (inclusive), with current MDD as defined by DSM-5 criteria at screening and a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥ 25 at baseline. A total of 300 participants are planned to be randomized to two treatment arms across approximately 30 clinical trial sites in the U.S. The study is expected to have a single unblinded interim analysis for sample size re-estimation when the study has results of the first 50% of efficacy evaluable patients, pending agreement on the comprehensive statistical analysis plan with the FDA.

About Depression
According to the National Institute of Mental Health, an estimated 21 million adults in the U.S. in 2020 experienced at least one major depressive episode1, with highest prevalence among individuals aged 18-25 at a rate of 17.0%. For approximately 2.5 million adults in the U.S., adjunctive therapies are necessary for depression treatment.2,3 Depression is a condition characterized by symptoms such as a depressed mood or loss of interest or pleasure in daily activities most of the time for two weeks or more, accompanied by appetite changes, sleep disturbances, motor restlessness or retardation, loss of energy, feelings of worthlessness or excessive guilt, poor concentration, and suicidal thoughts and behaviors. These symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The majority of people who suffer from depression do not respond adequately to initial antidepressant therapy.4

1Data Courtesy of SAMHSA on Past Year Prevalence of Major Depressive Episode Among U.S. Adults (2020). Retrieved from http://www.nimh.nih.gov/health/statistics/major-depression.shtml.
2IMS NSP, NPA, NDTI MAT-24-month data through Aug 2017.
3Kubitz N, et al. (2013) PLOS One,. 8(10):e76882. doi: 10.1371/journal.pone.0076882. PMID: 24204694.
4Rush AJ, et al. (2007) Am J. Psychiatry 163:11, pp. 1905-1917 (STAR*D Study).

About TNX-601 ER
TNX-601 ER is a novel oral formulation of tianeptine hemioxalate designed for once-daily daytime dosing that is now in the IND (Investigational New Drug) stage of development for the treatment of MDD. Tianeptine sodium (amorphous) immediate release (dosed three times daily) was first marketed for depression in France in 1989 and has been available for decades in Europe, Russia, Asia, and Latin America for the treatment of depression. Tianeptine sodium has an established safety profile from decades of use in these jurisdictions. Currently there is no tianeptine-containing product approved in the U.S. and no extended-release tianeptine product approved in any jurisdiction. Tonix discovered a novel hemioxalate salt of tianeptine that may provide improved stability, consistency, and manufacturability compared to known salt forms of tianeptine. Tianeptine is believed to work in depression as an indirect modulator of the glutamatergic system, without direct binding NMDA, AMPA or kainate receptors. Tianeptine reverses stress induced increases in AMPA receptor trafficking, restoring hippocampal long-term potentiation and reversing the neuroplastic changes from stress and corticosteroid exposure. Tianeptine and its MC5 metabolite are also weak µ-opioid receptor agonists, that present a potential abuse liability if illicitly misused in large quantities (8-80 times the therapeutic dose for depression). In patients who were prescribed tianeptine for depression, the French Transparency Committee found an incidence of misuse of approximately 1 case per 1,000 patients treatedsuggesting low abuse liability when used at the antidepressant dose in patients prescribed tianeptine for depression. Clinical trials have shown that cessation of a therapeutic course of tianeptine did not appear to result in dependence or withdrawal symptoms following 6-weeks2,3,4–6, 3-months7, or 12-months8 of treatment. Tianeptine’s reported pro-cognitive and anxiolytic effects as well as its ability to attenuate the neuropathological effects of excessive stress responses suggest that it may also be used to treat posttraumatic stress disorder. TNX-601 ER is expected to have patent protection through 2037.

1Haute Authorite de Sante; Transparency Committee Opinion. Stablon 12.5 Mg, Coated Tablet, Re- Assessment of Actual Benefit at the Request of the Transparency Committee. December 5, 2012.
2Emsley, R., et al. J. Clin. Psychiatry 2018, 79 (4)
3Bonierbale M, et al. Curr Med Res Opin 2003, 19(2):114-124.4Guelfi, J. D., et al. Neuropsychobiology 1989, 22 (1), 41–48.
5Invernizzi, G. et al., Neuropsychobiology 1994, 30 (2–3), 85–93.
6Lepine, J. P., et al. Hum. Psychopharmacol. 2001, 16 (3), 219–227.
7Guelfi, J. D. et al., Neuropsychobiology 1992, 25 (3), 140–148.
8Lôo, H. et al., Br. J. Psychiatry. Suppl. 1992, No. 15, 61–65.

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 first half 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.

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 October 3, 2022

Great Lakes Dredge & Dock (GLDD) – More Awards


Monday, October 03, 2022

Great Lakes Dredge & Dock Corporation is the largest provider of dredging services in the United States. In addition, Great Lakes is fully engaged in expanding its core business into the rapidly developing offshore wind energy industry. The Company has a long history of performing significant international projects. The Company employs experienced civil, ocean and mechanical engineering staff in its estimating, production and project management functions. In its over 131-year history, the Company has never failed to complete a marine project. Great Lakes owns and operates the largest and most diverse fleet in the U.S. dredging industry, comprised of approximately 200 specialized vessels. Great Lakes has a disciplined training program for engineers that ensures experienced-based performance as they advance through Company operations. The Company’s Incident-and Injury-Free® (IIF®) safety management program is integrated into all aspects of the Company’s culture. The Company’s commitment to the IIF® culture promotes a work environment where employee safety is paramount.

Joe Gomes, Senior Research 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.

More Awards. In the last week of the Federal government’s fiscal year, Great Lakes was the recipient of additional work. The Department of Defense contract awards reports four additional significant wins totaling a cumulative $109.8 million of potential new business.

Sole Awards. The Company received a $26.6 million award for dredging with work to be performed in Savannah, Georgia; Brunswick, Georgia; Wilmington, North Carolina; Morehead City, North Carolina; and Charleston, South Carolina; a $12.195 million contract for dredging with work to be performed in Irvington, Alabama; and a $21.531 million award for beach re-nourishment in Cape May, New Jersey.


Get the Full Report

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. 

Metals & Mining Third Quarter 2022 Review and Outlook


Monday, October 03, 2022

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

Refer to the bottom of the report for important disclosures

Mining companies outperform broader market. During the third quarter, mining companies (as measured by the XME) declined 2.1% compared to a loss of 5.3% for the S&P 500 index. The VanEck Vectors Gold Miners (GDX) and Junior Gold Miners (GDXJ) ETFs were down 11.9% and 7.9%, respectively. Gold, silver, copper, zinc, and lead futures prices fell 6.8%, 6.2%, 8.5%, 8.8%, and 0.4%, respectively. The commodity price declines reflect expected impacts of Federal Reserve monetary policy on interest rates, U.S. dollar strength, and the economic environment.

Outlook for precious metals. The U.S. Dollar Index rose 7.1% during the third quarter, while the yield on a 10-year treasury note increased from 3.0% to 3.8% as of September 30. While higher rates and a strong U.S. dollar pose significant headwinds for gold, an inflection point may be reached as investors seek to preserve value amid deteriorating economic conditions, increasing geopolitical uncertainty, and market volatility. While down 7.9% year-to-date through September 30, the price of gold has remained relatively resilient this year despite challenging headwinds. Not being able to benefit from strengthening gold prices, investors have focused more on silver’s industrial applications which make it more sensitive to economic expectations.

Industrial metals demand expected to remain challenged. The decline in industrial metals prices reflect concerns about economic growth in the U.S. and abroad. While the long-term investment case for owning industrial metals mining companies remains favorable, industrial metals prices may remain challenged into 2023.

Putting it all together. Precious metals prices may strengthen in advance of industrial metals. Therefore, investors may desire to lean into precious metals mining names to benefit from a positive shift in investor sentiment. While it may take longer for industrial metals to recover, an eventual return to economic growth could result in strong prices due to potential supply and demand imbalances.


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All statements or opinions contained herein that include the words “we”, “us”, or “our” are solely the responsibility of Noble Capital Markets, Inc.(“Noble”) and do not necessarily reflect statements or opinions expressed by any person or party affiliated with the company mentioned in this report. Any opinions expressed herein are subject to change without notice. All information provided herein is based on public and non-public information believed to be accurate and reliable, but is not necessarily complete and cannot be guaranteed. No judgment is hereby expressed or should be implied as to the suitability of any security described herein for any specific investor or any specific investment portfolio. The decision to undertake any investment regarding the security mentioned herein should be made by each reader of this publication based on its own appraisal of the implications and risks of such decision.

This publication is intended for information purposes only and shall not constitute an offer to buy/sell or the solicitation of an offer to buy/sell any security mentioned in this report, nor shall there be any sale of the security herein in any state or domicile in which said offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or domicile. This publication and all information, comments, statements or opinions contained or expressed herein are applicable only as of the date of this publication and subject to change without prior notice. Past performance is not indicative of future results. Noble accepts no liability for loss arising from the use of the material in this report, except that this exclusion of liability does not apply to the extent that such liability arises under specific statutes or regulations applicable to Noble. This report is not to be relied upon as a substitute for the exercising of independent judgement. Noble may have published, and may in the future publish, other research reports that are inconsistent with, and reach different conclusions from, the information provided in this report. Noble is under no obligation to bring to the attention of any recipient of this report, any past or future reports. Investors should only consider this report as single factor in making an investment decision.

IMPORTANT DISCLOSURES

This publication is confidential for the information of the addressee only and may not be reproduced in whole or in part, copies circulated, or discussed to another party, without the written consent of Noble Capital Markets, Inc. (“Noble”). Noble seeks to update its research as appropriate, but may be unable to do so based upon various regulatory constraints. Research reports are not published at regular intervals; publication times and dates are based upon the analyst’s judgement. Noble professionals including traders, salespeople and investment bankers may provide written or oral market commentary, or discuss trading strategies to Noble clients and the Noble proprietary trading desk that reflect opinions that are contrary to the opinions expressed in this research report.
The majority of companies that Noble follows are emerging growth companies. Securities in these companies involve a higher degree of risk and more volatility than the securities of more established companies. The securities discussed in Noble research reports may not be suitable for some investors and as such, investors must take extra care and make their own determination of the appropriateness of an investment based upon risk tolerance, investment objectives and financial status.

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The following disclosures relate to relationships between Noble and the company (the “Company”) covered by the Noble Research Division and referred to in this research report.
Noble is not a market maker in any of the companies mentioned in this report. Noble intends to seek compensation for investment banking services and non-investment banking services (securities and non-securities related) with any or all of the companies mentioned in this report within the next 3 months

ANALYST CREDENTIALS, PROFESSIONAL DESIGNATIONS, AND EXPERIENCE

Senior Equity Analyst focusing on Basic Materials & Mining. 20 years of experience in equity research. BA in Business Administration from Westminster College. MBA with a Finance concentration from the University of Missouri. MA in International Affairs from Washington University in St. Louis.
Named WSJ ‘Best on the Street’ Analyst and Forbes/StarMine’s “Best Brokerage Analyst.”
FINRA licenses 7, 24, 63, 87

WARNING

This report is intended to provide general securities advice, and does not purport to make any recommendation that any securities transaction is appropriate for any recipient particular investment objectives, financial situation or particular needs. Prior to making any investment decision, recipients should assess, or seek advice from their advisors, on whether any relevant part of this report is appropriate to their individual circumstances. If a recipient was referred to Noble Capital Markets, Inc. by an investment advisor, that advisor may receive a benefit in respect of
transactions effected on the recipients behalf, details of which will be available on request in regard to a transaction that involves a personalized securities recommendation. Additional risks associated with the security mentioned in this report that might impede achievement of the target can be found in its initial report issued by Noble Capital Markets, Inc.. This report may not be reproduced, distributed or published for any purpose unless authorized by Noble Capital Markets, Inc..

RESEARCH ANALYST CERTIFICATION

Independence Of View
All views expressed in this report accurately reflect my personal views about the subject securities or issuers.

Receipt of Compensation
No part of my compensation was, is, or will be directly or indirectly related to any specific recommendations or views expressed in the public
appearance and/or research report.

Ownership and Material Conflicts of Interest
Neither I nor anybody in my household has a financial interest in the securities of the subject company or any other company mentioned in this report.

Will Oil Spike as EU Deadline Approaches?

Image Credit: Tim Reckmann (Flickr)

Russia’s Energy War: Putin’s Unpredictable Actions and Looming Sanctions Could Further Disrupt Oil and Gas Markets

Russia’s effort to conscript 300,000 reservists to counter Ukraine’s military advances in Kharkiv has drawn a lot of attention from military and political analysts. But there’s also a potential energy angle. Energy conflicts between Russia and Europe are escalating and likely could worsen as winter approaches.

One might assume that energy workers, who provide fuel and export revenue that Russia desperately needs, are too valuable to the war effort to be conscripted. So far, banking and information technology workers have received an official nod to stay in their jobs.

The situation for oil and gas workers is murkier, including swirling bits of Russian media disinformation about whether the sector will or won’t be targeted for mobilization. Either way, I expect Russia’s oil and gas operations to be destabilized by the next phase of the war.

The explosions in September 2022 that damaged the Nord Stream 1 and 2 gas pipelines from Russia to Europe, and that may have been sabotage, are just the latest developments in this complex and unstable arena. As an analyst of global energy policy, I expect that more energy cutoffs could be in the cards – either directly ordered by the Kremlin to escalate economic pressure on European governments or as a result of new sabotage, or even because shortages of specialized equipment and trained Russian manpower lead to accidents or stoppages.

Dwindling Natural Gas Flows

Russia has significantly reduced natural gas shipments to Europe in an effort to pressure European nations who are siding with Ukraine. In May 2022, the state-owned energy company Gazprom closed a key pipeline that runs through Belarus and Poland.

In June, the company reduced shipments to Germany via the Nord Stream 1 pipeline, which has a capacity of 170 million cubic meters per day, to only 40 million cubic meters per day. A few months later, Gazprom announced that Nord Stream 1 needed repairs and shut it down completely. Now U.S. and European leaders charge that Russia deliberately damaged the pipeline to further disrupt European energy supplies. The timing of the pipeline explosion coincided with the start up of a major new natural gas pipeline from Norway to Poland.

Russia has very limited alternative export infrastructure that can move Siberian natural gas to other customers, like China, so most of the gas it would normally be selling to Europe cannot be shifted to other markets. Natural gas wells in Siberia may need to be taken out of production, or shut in, in energy-speak, which could free up workers for conscription.

Restricting Russian Oil Profits

Russia’s call-up of reservists also includes workers from companies specifically focused on oil. This has led some seasoned analysts to question whether supply disruptions might spread to oil, either by accident or on purpose.

One potential trigger is the Dec. 5, 2022, deadline for the start of phase six of European Union energy sanctions against Russia. Confusion about the package of restrictions and how they will relate to a cap on what buyers will pay for Russian crude oil has muted market volatility so far. But when the measures go into effect, they could initiate a new spike in oil prices.

Under this sanctions package, Europe will completely stop buying seaborne Russian crude oil. This step isn’t as damaging as it sounds, since many buyers in Europe have already shifted to alternative oil sources.

Before Russia invaded Ukraine, it exported roughly 1.4 million barrels per day of crude oil to Europe by sea, divided between Black Sea and Baltic routes. In recent months, European purchases have fallen below 1 million barrels per day. But Russia has actually been able to increase total flows from Black Sea and Baltic ports by redirecting crude oil exports to China, India and Turkey.

Russia has limited access to tankers, insurance and other services associated with moving oil by ship. Until recently, it acquired such services mainly from Europe. The change means that customers like China, India and Turkey have to transfer some of their purchases of Russian oil at sea from Russian-owned or chartered ships to ships sailing under other nations’ flags, whose services might not be covered by the European bans. This process is common and not always illegal, but often is used to evade sanctions by obscuring where shipments from Russia are ending up.

To compensate for this costly process, Russia is discounting its exports by US$40 per barrel. Observers generally assume that whatever Russian crude oil European buyers relinquish this winter will gradually find alternative outlets.

Where is Russian Oil Going?

The U.S. and its European allies aim to discourage this increased outflow of Russian crude by further limiting Moscow’s access to maritime services, such as tanker chartering, insurance and pilots licensed and trained to handle oil tankers, for any crude oil exports to third parties outside of the G-7 who pay rates above the U.S.-EU price cap. In my view, it will be relatively easy to game this policy and obscure how much Russia’s customers are paying.

On Sept. 9, 2022, the U.S. Treasury Department’s Office of Foreign Assets Control issued new guidance for the Dec. 5 sanctions regime. The policy aims to limit the revenue Russia can earn from its oil while keeping it flowing. It requires that unless buyers of Russian oil can certify that oil cargoes were bought for reduced prices, they will be barred from obtaining European maritime services.

However, this new strategy seems to be failing even before it begins. Denmark is still making Danish pilots available to move tankers through its precarious straits, which are a vital conduit for shipments of Russian crude and refined products. Russia has also found oil tankers that aren’t subject to European oversight to move over a third of the volume that it needs transported, and it will likely obtain more.

Traders have been getting around these sorts of oil sanctions for decades. Tricks of the trade include blending banned oil into other kinds of oil, turning off ship transponders to avoid detection of ship-to-ship transfers, falsifying documentation and delivering oil into and then later out of major storage hubs in remote parts of the globe. This explains why markets have been sanguine about the looming European sanctions deadline.

One Fuel at a Time

But Russian President Vladimir Putin may have other ideas. Putin has already threatened a larger oil cutoff if the G-7 tries to impose its price cap, warning that Europe will be “as frozen as a wolf’s tail,” referencing a Russian fairy tale.

U.S. officials are counting on the idea that Russia won’t want to damage its oil fields by turning off the taps, which in some cases might create long-term field pressurization problems. In my view, this is poor logic for multiple reasons, including Putin’s proclivity to sacrifice Russia’s economic future for geopolitical goals.

Russia managed to easily throttle back oil production when the COVID-19 pandemic destroyed world oil demand temporarily in 2020, and cutoffs of Russian natural gas exports to Europe have already greatly compromised Gazprom’s commercial future. Such actions show that commercial considerations are not a high priority in the Kremlin’s calculus.

How much oil would come off the market if Putin escalates his energy war? It’s an open question. Global oil demand has fallen sharply in recent months amid high prices and recessionary pressures. The potential loss of 1 million barrels per day of Russian crude oil shipments to Europe is unlikely to jack the price of oil back up the way it did initially in February 2022, when demand was still robust.

Speculators are betting that Putin will want to keep oil flowing to everyone else. China’s Russian crude imports surged as high as 2 million barrels per day following the Ukraine invasion, and India and Turkey are buying significant quantities.

Refined products like diesel fuel are due for further EU sanctions in February 2023. Russia supplies close to 40% of Europe’s diesel fuel at present, so that remains a significant economic lever.

The EU appears to know it must kick dependence on Russian energy completely, but its protected, one-product-at-a-time approach keeps Putin potentially in the driver’s seat. In the U.S., local diesel fuel prices are highly influenced by competition for seaborne cargoes from European buyers. So U.S. East Coast importers could also be in for a bumpy winter.

This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and thoughts of Amy Myers Jaffe, Research professor, Fletcher School of Law and Diplomacy, Tufts University.

What To Watch Out For October 3rd – October 7th, 2022

Monitoring the Week Ahead – Week Ending October 8th

Today is the first trading week of the new quarter and the first in October. It’s the start of what many hope will be a market turnaround and a strong positive close to the year.

Taking the new month and new quarter one day at a time, below are events scheduled this week that could prove important to our Channelchek subscribers. US data and events will be heavy most days this week, opening with the ISM Manufacturing Survey Monday and ending with monthly Employment on Friday. A variety of Fed Governors will be talking on a number of critical subjects, those talks most likely to move markets are listed.

All times are Eastern Time.

Monday 10/3

  • Noble Capital Markets in Chicago, interview E.W. Scripps (attend live)
  • 9 am Raphael Bostick, Federal Reserve Bank of Atlanta, President/CEO, Discusses technology and Disruption. Follow
  • US Construction Spending 10 am –  This reports the dollar value of new construction activity on residential, non-residential, and public projects. Construction spending fell 0.4 percent in July, marking the sixth straight lower-than-expected result. August’s consensus is a 0.1 percent decline.
  • ISM Manufacturing Index 10 am –  The survey gathers information from managers about the general direction (tracked in volumes) of production, new orders, order backlogs, inventories, employment, supplier deliveries, exports, and imports. It was 52.8 in each of the last two reports, this shows the ISM manufacturing index has stabilized at a level of modest growth. September’s consensus is 52.4.
  • TD Ameritrade’s Investor Movement Index 12:30 – The Investor Movement Index, (IMX), is a behavior-based index created by TD Ameritrade designed to shed insight into Main Street sentiment. The IMX strives to measure what investors are actually doing and how they are positioned in the markets. The index is a snapshot, but when compared to previous periods may be helpful to uncover trends or changes in focus.

Tuesday 10/4

  • Noble Capital Markets in Chicago, interview E.W. Scripps in Milwaukee (attend live)
  • Factory orders are a leading indicator. It is the dollar amount of new orders for both durable and nondurable goods. Factory orders are seen gaining 0.2 percent in August, which would follow a 1.0 percent decline in July. Durable goods orders, which have already been released and are one of two major components of this report, fell 0.2 percent in the month.
  • The Labor Department’s JOLTS has in recent years been referred to as the “Quits” report. The report tracks monthly changes in job openings and contains rates on hiring and quitting. The word JOLTS stands for Job Openings and Labor Turnover Survey.

Wednesday 10/4

  • OPEC meeting. OPEC meetings and the announcements post meeting with changes to production quotas, raising or lowering the global supply of crude oil can have a dramatic impact on energy prices, which currently have been feeding into inflation and business costs. The Organization of Petroleum Exporting Countries and associate members meet monthly.
  • U.S. MBA Mortgage Applications at 7 am. This is a gauge of both the demand for housing and economic momentum. Families and individuals are usually feeling comfortable and confident in their own financial position to buy a house. The changes in housing provide data that has a significant multiplier effect acting on the economy as other purchases follow. The indicated change in economic activity impacts many industries and investment markets.
  • U.S. International Trade in Goods and Services at 8:30. Trade numbers are available by export, import, and trade balance for six principal end-use commodity categories. The numbers will be for August and are expected to show a deficit of $68.0 billion for total goods and services trade which would compare with a $70.6 billion deficit in July. Advance data on the goods side of August’s report showed a nearly $3 billion narrowing in the deficit.
  • The U.S. PMI Composite (Final) or Purchasing Managers Index released at 9:45 am is based on a monthly survey collected from over 400 U.S. companies. The companies provide a leading indicator of what is occurring in the private sector economy.  At 49.2, the first indicator for September showed improvement from August’s 43.7. No change at 49.2 is the expectation for the final.
  • The U.S. Energy Information Administration (EIA) Petroleum report 10:30 am. This report provides weekly information on petroleum inventories in the U.S., whether produced here or abroad. The level of inventories helps determine prices for petroleum products. The report is comprehensive and viewed by people in the industry at all levels.

Thursday 10/6

  • The Challenger Job-Cut Report at 7:30 am provides insight into where layoffs are occurring. There is industry and state-level detail, which makes it more insightful than a weekly jobless claims reports.
  • The Jobless Claims report is released each Thursday at 8:30. Jobless claims for the October 1 week are expected to come in at 203,000 versus 193,000 in the prior week, which was much lower than expected.
  • The U.S. Energy Information Administration (EIA) Natural Gas report 10:30 am. This report provides weekly information on natural gas inventories in the U.S., whether produced here or abroad. With winter approaching in the northern hemisphere, unresolved natural gas distribution issues in Europe have heightened the attention paid to this report.

Friday 10/7

  • U.S. Employment situation at 8:30 am is possibly the most closely followed of all economic indicators. It establishes the official unemployment rate. the employment situation is a set of monthly labor market indicators based on two separate reports: the establishment survey, which tracks 650,000 worksites and offers the nonfarm payroll and average hourly earnings headlines, and the household survey, which interviews 60,000 households. August was the fifth straight month, and in seven of the last eight, payroll growth exceeded expectations. One widely followed estimate is that nonfarm payrolls rose 250,000 in September.
  • U.S. Wholesale Inventories at 10 am. Wholesale trade measures the dollar value of sales made and inventories held by merchant wholesalers. It is a component of business sales and inventories
  • Federal Reserve Governor Lisa Cook, 1 pm address at Peterson Institute for International Economics. Watch
  • U.S. Consumer Credit, released at 3 pm is expected to show an increase to $25.0 billion in August versus a $23.8 billion increase in July.

What Else

The U.S. markets have been taking good news as bad and bad news as good when it relates to the economy. The reasons are fear that if the economy shows too much strength, the Fed will continue its aggressive fight to tame it, possibly overshooting.

A quarterly report Metal & Mining Q3 was released Monday by Noble Capital Markets. Check back with Channelchek this week for other quarter-end industry reports, including energy expected on Tuesday.

When investing and trading, always be aware of your surroundings and what may be lurking in the next influential speech, event, or report. Wishing you all a profitable week.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.federalreserve.gov/newsevents/calendar.htm

https://www.channelchek.com/news-channel/noble_on_the_road___noble_capital_markets_in_person_roadshow_series

http://global-premium.econoday.com/byweek.asp?cust=global-premium

https://www.marketwatch.com/economy-politics/calendar

Stock Market Launch Never Happened in September

Image Credit: NASA Kennedy (Flickr)

Looking Back at September and Forward to the Fourth Quarter

September is behind us, and so are the first three quarters of 2022. Yet still, other than the U.S. dollar, there hasn’t been a moonshot in any major market or sector. September 2022 is best characterized by saying a few markets tried to get off the ground, but not unlike the Artemis rocket that was scheduled to go to the moon on September 3rd, the launches were scrubbed and are now on-hold. Maybe they’ll fly in October.

Below we look at the month behind us in stocks, bonds, gold, and crypto. We do this with confidence that they won’t all be grounded forever – and look to find clues as to how the final quarter of the year may treat investors.

Major Market Indicators Tracked Closely

Source: Koyfin

Out of the four closely followed benchmarks, Nasdaq 100, S&P 500, Russell 2000, and Dow 30, there was no runaway index either massively outperforming or underperforming. During the second week in September, the indexes teased that they were ready for take-off after they strung together several consecutive days where they were each up 1%-3%.

Reasons for the bounce that week include that a few of the indexes were approaching a technical floor, through which they’d be considered in a bear market. Stocks rarely break through support levels on their first try. In fact, they often bounce by a large degree.

Adding to the stock market’s climb to as much as up 4% on the month were strong economic numbers, which gave some participants comfort that the economy is still producing jobs and will withstand the Fed’s withdrawing accommodation. Others saw the sign of strong numbers as a sign that the Fed would drive up rates, drag the economy into a recession, and then ease policy by bringing rates back down. This forward-looking reasoning had them bullish.

Eventually, as the month moved along and Jay Powell, the chairman of the Federal Reserve, continued reiterating the central bank’s resolve, stock market investors stopped fighting the Fed – from  September 12th, until month-end, the indexes dropped between 12%-14%

Sectors Within S&P Index

Source: Koyfin

The two standout sectors within the S&P 500 include Health Care which was least negative at down 1.90%, and Biotech, down 4.42%. While this performance doesn’t seem like something to get overly excited about, the dynamics which have taken these two only half as down as the broader index are worth looking into. Both health care and biotech had once been in the stratosphere during the early and mid-pandemic era. As the potential for further benefit waned, these segments fell from their stratospheric highs. Currently, there is potential as large pharmaceutical companies are flush with cash from the pandemic, sit with patents approaching expiration, and biotech, with fresh patents and current R&D on the next generation of medicine, running low on funds. These conditions are ripe for partnerships and acquisitions to accelerate between the two. This may include some individual biotech companies surprising investors with some very good news in the coming months.

On the weak side is technology, which also is still coming down from the pandemic-induced high. The index is down 11.09%. Utilities are also underperforming the broader indexes as higher fuel costs for electric companies and higher interest rates erode the attractiveness of dividends paid on these stocks.

Gold and Bitcoin Performance

Source: Koyfin

Two non-equity assets, each claiming to be a safe haven during any market, political, or economic upheaval, outperformed the broader stock markets during September. Gold maintained its steady as she goes pace with very little volatility, while bitcoin had dramatic days on the up and downside, with each less than 3% lower than where they began the month.

Fixed Income Performance

Source: Koyfin

Interest rates were the topic on everyone’s mind throughout the month. Government bonds are valued 3.48% less than they were at the start of September, with uncharacteristic volatility late in the month as markets first began to fear the worst and then reversed with the BOE announcement that it would resume a less restrictive and possibly easier monetary policy.

High-yield bonds more closely track equities (and even bitcoin) than the interest rate markets. These bonds of less creditworthy issuers spent almost half the month in the positive before underperforming treasuries, which were in the red for all of the month. Tips or inflation-indexed treasuries shed 6.89% for its investors. The securities are sold off a spread to a similar maturity treasury, so they will generally move in the same direction. The Fed holds on its balance sheet a large (as a percentage outstanding) of these securities, this has disrupted the bonds’ use as either a hedge against inflation or a gauge to see where the markets think inflation is heading.

A number of Fed governors spoke during the last week of September. They are united in their message that they are only just beginning to move monetary policy to a place where the economy is in a healthy situation where inflation isn’t eroding the dollar’s purchasing power. None have begun to hint that the policy statement from the November 2nd meeting will look any different than the last.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.washingtonpost.com/technology/2022/09/03/artemis-launch/

www.koyfin

Bassett Furniture (BSET) – Reports Fiscal Third Quarter Results


Friday, September 30, 2022

Bassett Furniture Industries, Incorporated manufactures, markets, and retails home furnishings in the United States. The company operates in three segments: Wholesale, Retail, and Logistical Services. It is involved in the design, manufacture, sourcing, sale, and distribution of furniture products to a network of company-owned and licensee-owned Bassett Home Furnishings (BHF) retail stores, as well as independent furniture retailers; and wood and upholstery operations. As of September 16, 2017, the company operated a network of 91 company-and licensee-owned stores. It also provides shipping, delivery, and warehousing services to customers in the furniture industry. In addition, the company owns and leases retail store properties. It also distributes its products through other multi-line furniture stores, Bassett galleries or design centers, specialty stores, and mass merchants. Bassett Furniture Industries was founded in 1902 and is based in Bassett, Virginia.

Joe Gomes, Senior Research 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.

3Q22 Results. Revenue for the fiscal third quarter ended August 27, 2022 was $118 million, up 12.5% over the prior year period. Wholesale revenue rose 8.3% to $79 million, while Retail revenue rose 21.0% to $70.9 million. Excluding a $4.6 million one-time gain, operating income was $6.1 million, up 22.1%. Bassett reported net income from continuing operations of $7.8 million, or $0.84 per share, compared to net income from continuing operations of $3.4 million, or $0.35 per share, in the prior year. We had forecast revenue of $120 million and EPS from continuing operations of $0.65.

Retail the Star. Once again, Bassett’s retail network was the quarter’s star performer, with “best ever” third quarter deliveries of $70.9 million and $4.5 million of operating profit. Segment operating profits in the first nine months exceed any full year performance to date.


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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. 

Axcella Therapeutics (AXLA) – Interim Analysis Shows Signs of Early Efficacy


Friday, September 30, 2022

Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and non-alcoholic steatohepatitis (NASH), and the reduction in risk of overt hepatic encephalopathy (OHE) recurrence. The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

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.

Axcella Announced Positive Interim NASH Results.  An interim analysis from the Phase 2b EMMPACT Study of AXA1125 in non-alcoholic steatohepatitis (NASH) showed improvements in measures of liver fibrosis and liver fat. The data presented was from patients who had been treated for 12 and 24 weeks of the 48-week treatment period. The study is continuing as planned, and we believe the interim data raise the probability of success for the trial.

Study Design and Analysis. The EMMPACT study was designed to test two doses of AXA1125 against placebo.  Patients receive either placebo, low dose (45.2g/day), or high dose (67.8g/day) twice daily for 48 weeks. It has a target enrollment of 270 patients with biopsy-confirmed Stage 2 or Stage 3 NASH, divided into three arms with 90 patients each. The interim analysis used non-invasive tests to evaluate reduction in liver fibrosis and inflammation.


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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. 

Wisdom of Crowds in Predicting and Forecasting

Image Credit: slgckgc (Flickr)

Nobel Prizes, Election Outcomes and Sports Championships – Prediction Markets Try to Foresee the Future

Who will win Nobel Prizes in 2022? Wikipedia posits a handful of contenders for Physiology or Medicine, about 20 different possible winners for the Peace Prize and several dozen potential winners of the Literature Prize. But since the Swedish Academy never announces nominees in advance, there are few insights indicating who will win, or even if the eventual winner is on a given list.

Are there ways to predict the future winners?

The Delphi approach, named after the oracle in ancient Greece, gathers multiple rounds of opinions from a group of experts to generate a prediction. Gambling firms provide betting odds on the likelihood that specific competitors will win. Crowdsourced competitions, such as the Yahoo Soccer World Cup “Pick-Em,” have participants predict individual contest winners and then aggregate the results.

Another approach is a prediction market that provides insight into what people expect will happen in the future by creating a stock market-like environment to capture the “wisdom of the crowd.” Groups and crowds often are collectively smarter than individuals when many independent opinions are combined.

This article was republished  with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and thoughts of Daniel O’Leary, Professor of Accounting and Information Systems, University of Southern California.

As an accounting and information systems professor at the University of Southern California, I investigate issues related to the crowd both in my research and in my teaching. Here’s how prediction markets harness what the crowd thinks to forecast the future.

The Wisdom of the Market

In prediction markets, participants buy and sell stocks. Each stock’s price is tied to a different event happening in the future. Information about the future is captured in the stock prices.

For instance, in a prediction market focused on the Nobel Peace Prize, maybe Greta Thunberg is trading at $0.10 while Pope Francis is trading at $0.15, and the stocks for the entire group of candidates add up to sum to $1. The prices reflect the traders’ aggregated beliefs about the probability of their winning – a higher price means a higher perceived likelihood of winning.

Examples of Prediction Markets

Anyone can get in on the prediction game by trading on one of these markets or even just checking out which stocks are up or down.

Market nameURLAffiliated university
Iowa Electronic Marketshttps://iemweb.biz.uiowa.edu/University of Iowa
PredictIthttps://www.predictit.org/University of Wellington
Hollywood Stock Exchangehttps://www.hsx.com/N/A
Polymarkethttps://polymarket.com/marketsN/A
Table: The Conversation, CC-BY-ND  Get the data

Prediction markets have various ways of setting stock prices. The Iowa Electronic Markets took following approach during the 2020 U.S. presidential election:

  • Stock DEM2020 pays off $1 if the Democratic candidate wins, and $0 otherwise,
  • Stock REP2020 pays off $1 if the Republican candidate wins, and $0 otherwise.

The stock prices capture the probabilities of each candidate winning, in two mutually exclusive events. If the price of DEM2020 is $0.52, then that is treated as the probability of that event occurring – a 52% chance. If DEM2020 is $0.52, then REP2020 is $0.48.

Prediction markets may use real money, or they can use play money. Google’s market used what it called “Goobles,” while the Hollywood Stock Exchange uses Hollywood Dollars. The Iowa Electronic Markets and PredictIt, both sponsored by universities, use real money. Researchers have found that there are no differences in the performance of markets using real money versus those using play money.

Although using play money makes it possible for many people to participate, one potential challenge for prediction markets that don’t use real money is gaining and maintaining interested participants. Despite using different devices to keep up engagement, such as leader boards indicating who has accumulated the biggest portfolio, there is literally no money on the table to keep participants interested in the market.

Market participants who know more about the game might better predict winners. Image Credit: Marco verch (Flickr)

Participants Bring Their Knowledge to the Market

Prediction markets and crowdsourcing do not function in a vacuum.

Researchers have found that information about events finds its way into the prediction processes from various sources. For example, when I analyzed the relationship between the betting odds and the Yahoo Pick-Em crowd’s guesses for the 2014 FIFA World Cup, I found that there was no statistical difference between the proportion of correct guesses in each. My conclusion is that either the crowd’s guesses incorporated the betting odds information or the crowd’s guesses added up to the same result by some other means.

Generally, prediction markets use play money or are run by non-profit universities to study markets, elections and human decision making. Although gambling houses can take bets for many activities, external prediction markets are more restricted in the activities they can be used to investigate, and are typically limited to elections. However, internal prediction markets – run within a corporation, for instance – can explore almost any topic of interest.

Typically, prediction markets function better with informed participants. Although using so-called inside information is illegal in some markets, including the New York Stock Exchange, there generally are no such limitations in prediction markets, or other crowdsourcing approaches. If those with inside information were to participate in a prediction market, it would likely lead to more accurate stock prices, as insiders make trades informed by their knowledge. However, if others find out that a participant has inside information, then they may very well try to gain access to that info, follow the insider’s actions or even decide to leave the unfair market.

The accuracy of prediction markets depends on many factors, including who is in the market, what their biases are and how heterogeneous the participants are. Accuracy can also depend on how many people are in the market – more is generally better – and the extent to which they are informed about the events of interest.

Researchers have found that prediction markets have outperformed polls in presidential elections roughly 75% of the time. But accurate results are not guaranteed. For example, prediction markets did not correctly predict that Donald Trump would win the U.S. presidency in 2016.

Who Will be in Stockholm for the Ceremony?

In 2011, Harvard University economics faculty had a real-money prediction market site, referred to as “the world’s most accurate prediction market.” The site had been used for predicting the Nobel Prize in Economics, but Harvard advised the site to shut down.

I couldn’t find any current public prediction markets active for the 2022 Nobel Prizes.

For the moment, perhaps the closest to participating in a Nobel prediction market would be to place a bet at one of the gambling houses that takes bets on the Nobel Prizes. Or find a Nobel Prize Pick-Em site, propose such an event to an existing prediction market or build your own prediction market using some of the available software.

If you know of one, let me know, I want to play.