Page 321 – Channelchek

Release – ZyVersa Therapeutics Reports Second Quarter 2023 Corporate and Financial Results

Posted on August 22, 2023August 22, 2023 by aweinsoff@channelchek.com

Aug 21, 2023

Key Highlights:

Advanced clinical development initiatives for Cholesterol Efflux Mediator™ VAR 200, with planned initiation of a Phase 2a clinical trial in diabetic kidney disease (DKD) in the first quarter of 2024
Granted a European patent covering Phase 2a-ready Cholesterol Efflux Mediator^TM VAR 200 (2-hydroxypropyl-beta-cyclodextrin) for use in diabetic nephropathy/diabetic kidney disease
Published new white paper detailing the critical role of inflammasome ASC in inflammatory diseases, and the potential of Inflammasome ASC Inhibitor IC 100 to address multiple CNS and non-CNS diseases
Added Dr. Douglas Golenbock to ZyVersa’s Inflammatory Disease Scientific Advisory Board to support advancement of Inflammasome ASC Inhibitor IC 100

WESTON, Fla., Aug. 21, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq-GM: ZVSA; “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory diseases who have unmet medical needs, today provides a corporate update and reports financial results for the second quarter of 2023 ending June 30, 2023.

“The second quarter of 2023 was a period of continued progress at ZyVersa as we completed key corporate, developmental, regulatory and financial initiatives designed to position the company to achieve value-building milestones involving our Cholesterol Efflux Mediator™ VAR 200 and Inflammasome ASC Inhibitor IC 100,” said Stephen C. Glover, Co-founder, Chairman, Chief Executive Officer, and President of ZyVersa. “We are pleased to report our VAR 200 program is progressing as planned, and we anticipate initiation of a Phase 2a clinical trial in diabetic kidney disease (DKD) in the first quarter of 2024. For our Inflammasome ASC Inhibitor IC 100, we are completing final preclinical activities to enable submission of an Investigational New Drug (“IND”) application and initiation of a first-in-human clinical trial in 2024.”

Mr. Glover concluded: “This is a very exciting time for ZyVersa as we seek to create shareholder value through the development of first-in-class drugs at the forefront of renal and inflammatory diseases. Significant value-building milestones are expected to be achieved for Cholesterol Efflux Mediator^TM VAR 200 and Inflammasome ASC Inhibitor IC 100 over the remainder of 2023 and early 2024 to increase shareholder value.”

SECOND QUARTER AND RECENT PROGRAM UPDATES

Phase 2a-Ready Cholesterol Efflux Mediator™ VAR 200

European patent was granted covering VAR 200 for use in diabetic nephropathy/diabetic kidney disease
Planning and key initiatives are underway to initiate a Phase 2a clinical trial in patients with DKD, with initial patient enrollment expected by first quarter 2024

Inflammasome ASC Inhibitor IC 100

Continued to provide support for the mechanism of action of Inflammasome ASC Inhibitor IC 100 with consistent evidence across peer-reviewed academic literature on the role of inflammasomes in the pathogenesis of a broad range of diseases including Parkinson’s disease, Alzheimer’s disease, lupus nephritis, peripheral arterial disease, juvenile idiopathic arthritis, and alcoholic hepatitis
Enhanced Inflammatory Disease Scientific Advisory Board with the addition of Dr. Douglas Golenbock, a pioneer and internationally recognized authority in the field of innate immunity
Dr. Golenbock is The Neil and Margery Blacklow Chair in Infectious Diseases and Immunology and Professor and Chief, Division of Infectious Diseases and Immunology at the UMass Chan Medical School

SECOND QUARTER FINANCIAL RESULTS

Since its inception in 2014 through June 30, 2023, ZyVersa has not generated any revenue and has incurred significant operating losses and negative cash flows from its operations. Based on our current operating plan, we expect our cash of $0.2 million as of June 30, 2023, will only be sufficient to fund our operating expenses and capital expenditure requirements on a month-to-month basis. ZyVersa will need additional financing to support its continuing operations. ZyVersa will seek to fund its operations through public or private equity or debt financings or other sources, which may include government grants and collaborations with third parties.

Research and development expenses were $1.2 million for the three months ended June 30, 2023, an increase of $0.5 million or 69.7% from the three months ended June 30, 2022. The increase is primarily attributable to an increase of $0.5 million in the costs of manufacturing of IC 100.

General and administrative expenses were $3.9 million for the three months ended June 30, 2023, an increase of $2.8 million or 237.5% from the three months ended June 30, 2022. The increase is primarily attributable to $1.2 million of common stock granted to certain stockholders in exchange for increasing the duration of their lockup period for certain common stockholdings, $0.5 million in professional fees associated with being a public company, a $0.5 million increase in marketing costs for investor and public relations, $0.4 million in director and officer insurance, and $0.2 million for bonus accruals.

Pre-tax losses were $86.3 million for the three months ended June 30, 2023, an increase of $84.3 million compared to a pre-tax loss of approximately $2.0 million, for the three months ended June 30, 2022. The higher net loss reported for the three months ended June 30, 2023 is primarily due to the impairment of in-process research and development and impairment of goodwill of $69.3 million and $11.9 million, respectively, compared to none for the three months ended June 30, 2022. The impairment is a result of the decline in ZyVersa’s market capitalization as of June 30, 2023.

Net losses were $78.5 million for the three months ended June 30, 2023, an increase of $76.5 million compared to a net loss of approximately $2.0 million for the three months ended June 30, 2022. A deferred tax benefit of $7.8 million for the three months ended June 30, 2023, compared to no tax benefit or expense during the three months ended June 30, 2022, resulted from the impairment of the in-process research and development.

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq-GM: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 developed to ameliorate renal lipid accumulation that damages the kidneys’ filtration system in patients with glomerular kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s additional financing and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Corporate and IR Contact
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641

Media Contacts
Casey McDonald
cmcdonald@tiberend.com
646-577-8520

Dave Schemelia
Dschemelia@tiberend.com
609-468-9325


ZYVERSA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS

			Successor
			June 30,			December 31,
			2023			2022
			(Unaudited)
Assets

Current Assets:
	Cash		$	228,693		$	5,902,199
	Prepaid expenses and other current assets			886,911			225,347
	Vendor deposits			–			235,000
		Total Current Assets		1,115,604			6,362,546
Equipment, net				12,133			17,333
In-process research and development				30,806,158			100,086,329
Goodwill				–			11,895,033
Security deposit				–			46,659
Operating lease right-of-use asset				53,898			98,371

		Total Assets	$	31,987,793		$	118,506,271

Liabilities, Temporary Equity and Stockholders’ Equity

Current Liabilities:
	Accounts payable		$	8,144,033		$	6,025,645
	Accrued expenses and other current liabilities			2,281,026			2,053,559
	Operating lease liability			59,625			108,756
		Total Current Liabilities		10,484,684			8,187,960
Deferred tax liability				1,441,467			10,323,983
		Total Liabilities		11,926,151			18,511,943

Commitments and contingencies (Note 8)

	Successor redeemable common stock, subject to possible redemption,
	0 and 65,783 shares outstanding as of June 30, 2023 and
	December 31, 2022, respectively			–			331,331
Stockholders’ Equity:
	Successor preferred stock, $0.0001 par value, 1,000,000 shares authorized:
	Series A preferred stock, 8,635 shares designated, 200 and 8,635 shares issued
	and outstanding as of June 30, 2023 and December 31, 2022, respectively			–			1
	Series B preferred stock, 5,062 shares designated, 5,062 shares issued
	and outstanding as of June 30, 2023 and December 31, 2022			1			1
	Successor common stock, $0.0001 par value, 110,000,000 shares authorized;
	23,669,074 and 9,016,139 shares issued at June 30, 2023 and December 31, 2022,
	respectively, and 23,666,915 and 9,016,139 shares outstanding as of
	June 30, 2023 and December 31, 2022, respectively			2,367			902
	Additional paid-in-capital			107,044,663			104,583,271
	Accumulated deficit			(86,978,221	)		(4,921,178	)
	Treasury stock, at cost, 2,159 and 0 shares at June 30, 2023
	and December 31, 2022, respectively			(7,168	)		–
		Total Stockholders’ Equity		20,061,642			99,662,997

		Total Liabilities, Temporary Equity and Stockholders’ Equity	$	31,987,793		$	118,506,271


ZYVERSA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS


			Successor			Predecessor			Successor			Predecessor
			For the Three			For the Three			For the Six			For the Six
			Months Ended			Months Ended			Months Ended			Months Ended
			June 30,			June 30,			June 30,			June 30,
			2023			2022			2023			2022
Operating Expenses:
	Research and development		$	1,220,576		$	719,395		$	2,276,519		$	1,786,357
	General and administrative			3,929,225			1,164,013			7,465,362			3,465,382
	Impairment of in-process research and development			69,280,171			–			69,280,171			–
	Impairment of goodwill			11,895,033			–			11,895,033			–
		Total Operating Expenses		86,325,005			1,883,408			90,917,085			5,251,739

		Loss From Operations		(86,325,005	)		(1,883,408	)		(90,917,085	)		(5,251,739	)

Other (Income) Expense:
	Interest (income) expense			314			140,404			(765	)		308,468
	Change in fair value of derivative liabilities			–			(19,600	)		–			192,500

		Pre-Tax Net Loss		(86,325,319	)		(2,004,212	)		(90,916,320	)		(5,752,707	)
		Income tax benefit		7,812,226			–			8,859,277			–
		Net Loss		(78,513,093	)		(2,004,212	)		(82,057,043	)		(5,752,707	)
		Deemed dividend to preferred stockholders		(7,915,836	)		(331,200	)		(7,915,836	)		(331,200	)
		Net Loss Attributable to Common Stockholders	$	(86,428,929	)	$	(2,335,412	)	$	(89,972,879	)	$	(6,083,907	)


		Net Loss Per Share
		– Basic and Diluted	$	(4.84	)	$	(0.10	)	$	(6.66	)	$	(0.25	)

		Weighted Average Number of
		Common Shares Outstanding
		– Basic and Diluted		17,855,762			24,167,257			13,517,314			24,167,257

Release – Ocugen Provides Business Update With Second Quarter 2023 Financial Results

Posted on August 22, 2023August 22, 2023 by aweinsoff@channelchek.com

Research News and Market Data on OCGN

August 21, 2023

PDF Version

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

• Investigational New Drug (IND) Applications Cleared for Novel Gene Therapies for Geographic Atrophy Secondary to AMD and for Stargardt Disease

• OCU400 Clinical Study Results Update Expected This Quarter

MALVERN, Pa., Aug. 21, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today reported second quarter 2023 financial results along with a general business update.

“We continue to advance our pipeline to provide solutions for patients living with serious diseases but without effective treatment options,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “It remains our plan to start dosing patients across all of our ophthalmology programs by the end of the year and we are very enthusiastic about the FDA clearance of our INDs for OCU410 and OCU410ST for a form of Geographic Atrophy and Stargardt disease, respectively.”

During important meetings in the second quarter of 2023, including The Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting and BIO International, the Company continued to educate key stakeholders about the science behind its innovative modifier gene therapy platform and next-generation inhalation vaccine candidates aimed at enhancing durability and reducing transmission.

This quarter, Ocugen plans to share updated data results on OCU400 from its Phase 1/2 clinical trial in patients with retinitis pigmentosa. The Company also continues to have ongoing conversations with government agencies towards obtaining support of its inhaled vaccines for COVID-19 and flu.

“We remain dedicated to our mission to develop cutting-edge therapies with a commitment to ensuring global market access,” said Dr. Musunuri. “We are executing plans consistent with our long-term strategy of delivering multiple products to market targeting unmet medical needs utilizing first-in-class platform technologies in gene therapies, cell therapies and vaccines.”

Ophthalmic Gene Therapies

OCU400 – Phase 3 adult trial to be initiated near the end of 2023/early 2024, subject to the outcome of the ongoing Phase 1/2 trial and discussions with the FDA on the proposed Phase 3 trial plan.
OCU410 and OCU410ST – IND applications to initiate Phase 1/2 trials for both OCU410 and OCU410ST were cleared by the FDA and the Company plans to initiate Phase 1/2 trials by the end of 2023.

Regenerative Cell Therapies

NeoCart^® – Manufacturing facility construction for NeoCart is on target to be completed by the end of 2023, as planned. The Company plans to initiate the Phase 3 trial in the second half of 2024.

Vaccines Portfolio

Inhaled Mucosal Vaccine Platform – The Company is continuing the internal development of its inhaled mucosal vaccine platform to achieve IND readiness and intends to submit an IND application in 2024, provided it receives government funding. The Company has submitted multiple proposals to obtain government funding and is continuing discussions with relevant government agencies regarding developmental support for its inhaled mucosal vaccine platform.

Second Quarter 2023 Financial Results

The Company’s cash, cash equivalents, and investments totaled $70.6 million as of June 30, 2023, compared to $90.9 million as of December 31, 2022. The Company had 256.5 million shares of common stock outstanding as of June 30, 2023.
Total operating expenses for the three months ended June 30, 2023 were $23.7 million and included research and development expenses of $14.2 million and general and administrative expenses of $9.6 million. Research and development expenses for the three months ended June 30, 2023 included a non-recurring, non-cash expense of $4.4 million as a result of the impairment of the short-term asset for the advanced payment for the supply of COVAXIN as well as the associated loss on the disposal of related fixed assets. This compares to total operating expenses for the three months ended June 30, 2022 of $19.6 million that included research and development expenses of $9.0 million and general and administrative expenses of $10.6 million.
Ocugen reported a $0.10 net loss per common share for the three months ended June 30, 2023 compared to a $0.09 net loss per common share for the three months ended June 30, 2022.

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

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

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 6803433
Webcast: Available on the events section of the Ocugen investor site

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

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

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements include, but are not limited to, statements regarding our clinical development activities and related anticipated timelines. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Communications
IR@ocugen.com

(Tables to follow)

OCUGEN, INC. CONSOLIDATED BALANCE SHEETS (in thousands) (Unaudited)

	June 30, 2023			December 31, 2022
Assets
Current assets
Cash and cash equivalents	$	70,578		$	77,563
Marketable securities		—			13,371
Prepaid expenses and other current assets		2,874			7,558
Total current assets		73,452			98,492
Property and equipment, net		11,720			6,053
Other assets		3,804			4,087
Total assets	$	88,976		$	108,632
Liabilities and stockholders’ equity
Current liabilities
Accounts payable	$	3,881		$	8,062
Accrued expenses and other current liabilities		7,787			9,900
Operating lease obligations		526			498
Current portion of long term debt		1,266			—
Total current liabilities		13,460			18,460
Non-current liabilities
Operating lease obligations, less current portion		3,308			3,587
Long term debt, net		1,472			2,289
Other non-current liabilities		455			244
Total liabilities		18,695			24,580
Stockholders’ equity
Convertible preferred stock		1			1
Common stock		2,566			2,217
Treasury stock		(48	)		(48	)
Additional paid-in capital		320,181			294,874
Accumulated other comprehensive income		22			26
Accumulated deficit		(252,441	)		(213,018	)
Total stockholders’ equity		70,281			84,052
Total liabilities and stockholders’ equity	$	88,976		$	108,632

OCUGEN, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share amounts) (Unaudited)

	Three months ended June 30,						Six months ended June 30,
		2023			2022			2023			2022
Operating expenses
Research and development	$	14,169		$	9,007		$	23,727		$	16,922
General and administrative		9,564			10,558			17,757			20,677
Total operating expenses		23,733			19,565			41,484			37,599
Loss from operations		(23,733	)		(19,565	)		(41,484	)		(37,599	)
Other income (expense), net		808			94			2,061			109
Net loss	$	(22,925	)	$	(19,471	)	$	(39,423	)	$	(37,490	)

Shares used in calculating net loss per common share — basic and diluted		238,311,498			215,862,977			231,952,888			210,806,330
Net loss per share of common stock — basic and diluted	$	(0.10	)	$	(0.09	)	$	(0.17	)	$	(0.18	)

Century Lithium Corp. (CYDVF) – Collaboration with Koch is Yielding Significant Benefits

Posted on August 22, 2023August 22, 2023 by cpereira@noblefcm.com

Tuesday, August 22, 2023

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

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

Collaboration with Koch. Century Lithium is collaborating with Koch Technology Solutions (KTS) in the application of Koch’s proprietary Li-Pro equipment for the direct lithium extraction (DLE) portion of Century’s pilot plant where lithium is recovered from leach solution. Work continues within the DLE section to further increase lithium grades in solution and potentially eliminate a major evaporation step from the process.

Li-Pro leads to significant improvements. With the introduction of KTS’ Li-Pro system into the DLE stage of the pilot plant, the grades of the intermediate lithium solution produced at the pilot plant have increased while unwanted elements have been reduced. Lithium grades improved from 1,430 parts per million lithium to 6,780 parts per million lithium resulting in an increase in the ratio of lithium to total dissolved solids from 0.018 to 0.085 and a reduction in sodium from 25,580 parts per million sodium to 8,220 parts per million sodium. Preliminary internally assayed lithium solution grades have exceeded 8,000 parts per million lithium.

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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.

No Suit, No Tie, No Problem – What Happens in Jackson Hole?

Posted on August 22, 2023August 22, 2023 by phoffman@channelchek.com

What to Expect Out of This Year’s Jackson Hole Symposium

Since 1978, the Federal Reserve Bank of Kansas City has sponsored an annual event to discuss an important economic issue facing the U.S. and world economies. From 1982, the symposium has been hosted at the Jackson Lake Lodge at Grand Teton National Park, in Wyoming. The event brings together economists, financial market participants, academics, U.S. government representatives, and news media to discuss long-term policy issues of mutual concern. The 2023 Economic Policy Symposium. “Structural Shifts in the Global Economy,” will be held Aug. 24-26.

Those attending are selected based on each year’s topic with consideration for regional diversity, background, and industry. In a typical year, about 120 people attend.

The event features a collegiate feel with thoughtful discussion among the participants. The caliber and status of participants and the important topics being discussed draw substantial interest from the financial community in the symposium. Despite the interest in the annual event, The Jackson Hole event works best as a smaller open discussion, attendance at the event is limited.

Similarly, although the Federal Reserve District Bank receives numerous requests from media outlets worldwide, press attendance is also limited to a group that is selected to provide important transparency to the symposium, but not overwhelm or influence the proceedings. All symposium participants, including members of the press, pay a fee to attend. The fees are then used to recover event expenses.

Source: Federal Reserve, Kansas City, MO

What’s discussed?

The Kansas City Fed chooses the topic each year and asks experts to write papers on related subtopics. To date, more than 150 authors have presented papers on topics such as inflation, labor markets and international trade. All papers are available online.

Papers provided to the Bank in advance and presented at the annual economic policy symposium will be posted online at the time they are presented at the event. Other papers, such as conference comments, are posted as they become available. Additionally, transcripts of the proceedings are posted on the website as they become available, a process that generally takes a few months. Finally, the papers and transcripts are compiled into proceedings books which are both posted on the website and published in a volume that is available online or in print, free of charge.

Worldwide Representation

The goal of the Economic Policy Symposium when it began was to provide a vehicle for promoting public discussion and exchanging ideas. Throughout the event’s history in Jackson Hole, attendees from 70 countries have gathered to share their diverse perspectives and experiences.

This year’s theme will explore several significant, and potentially long-lasting, developments affecting the global economy. While the immediate disruption of the pandemic is fading, there likely will be long-lasting aftereffects for how economies are structured, both domestically and globally, as trade networks shift, and global financial flows react. Similarly, the policy response to the pandemic and its aftermath could have persistent effects as economies adjust to rapid shifts in the stance of monetary policy and a substantial increase in sovereign debt. The papers will share how these developments are likely to affect the context for growth and monetary policy in the coming decade.

The full agenda will be available at the start of the event on Thursday, Aug. 24 at 8 p.m. ET/6 p.m. MT. Federal Reserve Chair Jerome Powell’s remarks will be streamed on the Kansas City Fed’s YouTube channel, on Friday, Aug. 25 at 10:05 a.m. ET/8:05 a.m. MT. Papers and other materials will be posted on the Kansas City Fed’s website as they are presented during the event.

What Else

The markets seem to be expecting hawkish comments from the US Central Bank President on Friday at Jackson Hole. This is being priced in, as investors expect the Fed Chair may say something that spooks the bond market which naturally impacts stocks. There has been a lot of talk about how central banks globally should treat target inflation, all ears will be on that subject.

Paul Hoffman

Managing Editor, Channelchek

Are Reverse Stock Splits a Red Flag?

Posted on August 22, 2023August 22, 2023 by phoffman@channelchek.com

There are Many Reasons for a Reverse Split; All are Designed to Benefit Stakeholders

So far this quarter, there have been 59 reverse stock splits. These include industries as diverse as the apparel company Digital Brands Group (DBGI), which is consolidating its shares today, and Blue Apron (APRN), an e-commerce food prep provider, back on July 8th. In theory, this is a financial arrangement similar to asking for a $100 bill in exchange for five $20 dollar bills. But the reasons are more complicated and diverse. Understanding why a company you own, or are considering buying or shorting shares in, is consolidating ownership units can help you understand if the new shares are more likely to gain or lose value.

Background

As with the exchange of smaller denominated bills for larger ones, a reverse stock split is an action in which a company reduces its total outstanding shares while proportionally increasing the price per new share. It’s done by the company’s registrar by combining a certain number of existing shares into a single new share. For example, a 1-for-10 reverse stock split would result in every 10 shares of the company being converted into 1 new share.

From the shareholder side, their percentage ownership in the company remains unchanged; the value of that percentage will change as market forces revalue those shares.

Reasons for a Reverse Split

A corporate action such as a reverse split is not inexpensive for the company, so if it is conducting one, it must see a benefit. The primary reasons range from crisis management to an attempt to broaden the share’s appeal.

The category of crisis management includes working to prevent delisting from an exchange. The major stock exchanges have minimum share price requirements. If a company’s stock price falls below this minimum, it will be delisted from the exchange. Back in March, Bed Bath and Beyond went to shareholders asking for permission to do a reverse split in order to not be delisted for having a stock price lower than the Nasdaq threshold. The company was criticized as it showed that management did not have confidence that the price would rise on its own. At times when a company is approaching the minimum threshold for being listed on an exchange, they will look to do a reverse split, this can boost the per share price and prevent delisting.

In some cases there isn’t a crisis; management is simply managing perception in an effort to improve the stock’s image. This is because a stock that trades at a low price may be perceived as being risky or unpopular. A reverse stock split can give the appearance of a more valuable stock, which may attract more investors.

Conforming to the requirements of certain buyers, specifically institutional investors may also lead to a reverse split. Many institutional investors have minimum investment requirements. A reverse stock split can help to make a stock more attractive to these investors.

Bringing up the dollar price to simplify trading is another reason. A reverse stock split can make it easier to trade a stock, especially if the shares have a price below one dollar.

The Caution Signs When a Company Undergoes a Reverse Split

There are certainly potential negatives to shareholders when a company has a reverse stock split. For example, a reverse stock split can decrease liquidity, making it less liquid; for example, it may be more difficult to buy or sell.

Some investors may view a reverse stock split as a negative signal about the company’s financial health; if the action isn’t expected to cure the ailment, it may serve to feed into a growing list of things investors don’t like about the company.

Shareholders could wind up owning a lesser portion of the company if the split results in fractional shares. For example, if the stock you own 97 shares in reverse 1 for 10. You’ll receive 9 shares and, most often, the cash equivalent of seven shares.

Ultimately, whether or not a reverse stock split is a good idea for a company depends on the specific circumstances. Investors should carefully consider the pros and cons before making a decision about whether or not to buy or sell a stock that has undergone or is being talked about as considering a reverse stock split. In most cases only board of director approval is required.

Opportunity for Investors?

The opportunities for investors after a reverse stock split depends on the reasons for the split. If the split is done to prevent delisting, it is likely that the stock price will increase in the short term. However, if the split is done for other reasons, such as to improve the stock’s image or to make it more attractive to institutional investors, the long-term impact on the stock price is uncertain. Remember, management presumably got board approval as they thought it was in the best interest of the company; as a shareholder, you are technically an owner and would reap any benefit of it turning out to be a good move.

Take Away

A reverse stock split means the number of shares owned will be reduced, but the ownership level will remain the same. The price per share will increase, but the market capitalization of the company will change little. The reverse stock split may have a negative impact on the liquidity of the stock. It may also be seen as a negative by some investors.

Overall, reverse stock splits are always conducted for with the best interest of the company onwers in mind. But the reasons for the move, and if it will be successful needs to be evaluated by stockholders.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.prnewswire.com/news-releases/dbgi-announces-1-for-25-reverse-stock-split-effective-august-22-2023-301905859.html

https://www.securitieslawyer101.com

Release – Bowlero Corp. Expands in Michigan

Posted on August 21, 2023August 21, 2023 by aweinsoff@channelchek.com

Research News and Market Data on BOWL

08/21/2023

Definitive agreements signed to acquire Merri-Bowl Lanes and BAM! Entertainment Center

RICHMOND, Va.–(BUSINESS WIRE)– Bowlero Corp. (NYSE: BOWL), the global leader in bowling entertainment, announced today they have entered into definitive agreements to acquire Merri-Bowl Lanes and BAM! Entertainment Center in Michigan. These acquisitions mark the company’s 4^th and 5^th locations in the state and are expected to close in the fall of 2023.

Located in Livonia, MI, Merri-Bowl Lanes is a traditional 35,000-square-foot center featuring 40 lanes of bowling. This location is a family-fun destination, showcasing a diverse array of entertainment experiences, including league play, youth and adult tournaments, parties, and events.

BAM! Entertainment Center, located in Holland, is a one-stop entertainment destination featuring 29 lanes of bowling and a multitude of dynamic offerings, including a laser tag arena, axe throwing, a high ropes course, and an expansive arcade. This entertainment center is also home to VIP party rooms, extensive menu options, and full-service bars.

“Our expansion in Michigan furthers our commitment to contributing a world-class experience across the country,” stated Thomas Shannon, Founder, President, and CEO of Bowlero Corp. “These acquisitions align with our ongoing strategic growth initiatives of buy, build and convert. We look forward to our continued growth as we welcome these additions to our portfolio.”

About Bowlero Corp

Bowlero Corp. is the global leader in bowling entertainment, media, and events. With more than 325 bowling centers across North America, Bowlero Corp. serves more than 30 million guests each year through a family of brands that includes Bowlero and AMF. In 2019, Bowlero Corp. acquired the Professional Bowlers Association, the major league of bowling, which boasts thousands of members and millions of fans across the globe. For more information on Bowlero Corp., please visit BowleroCorp.com

For Media:
PR@BowleroCorp.com

For Investors:
IRSupport@BowleroCorp.com

Source: Bowlero Corp

Release – Century Lithium Reports On Testing With Saltworks And Production Of Battery Grade Lithium Carbonate

Posted on August 21, 2023August 21, 2023 by aweinsoff@channelchek.com

Research News and Market Data on CYDVF

August 21, 2023 – Vancouver, Canada – Century Lithium Corp. (TSXV: LCE) (OTCQX: CYDVF) (Frankfurt: C1Z) (Century Lithium or the Company) is pleased to report testing results at Saltworks Technologies, Inc. (Saltworks) in Richmond, Canada, and additional production of high-purity lithium carbonate (Li₂CO₃) using product solutions from the Company’s Lithium Extraction Facility (Pilot Plant) in Amargosa Valley, Nevada, USA. The solutions tested at Saltworks were derived from leaching of claystone from the Company’s 100%-owned Clayton Valley Lithium Project (Project) in Nevada; and processed at the Pilot Plant via direct lithium extraction (DLE) to produce an intermediate concentrated lithium solution (DLE eluent).

“It is very positive to see consistency in our high-purity, 99.87%, lithium carbonate product grades from our Pilot Plant this year” stated Bill Willoughby, President, and CEO of Century Lithium. “The highlight though, is the almost five-fold increase in lithium grade in the concentrated lithium solution generated at the Pilot Plant. This was achieved through collaboration with Koch Technology Solutions and their Li-Pro^TM system, and its integration into Century Lithium’s chloride-based leaching process.”

Highlights

Repeated production of high-purity (99.87%) battery-grade lithium carbonate
Improved lithium concentrations in DLE eluent
Reduced volume of solution in downstream treatment and recycling
Potential to eliminate evaporation from the post DLE process flowsheet
Active testing underway to further improve DLE eluent grade

Lithium Carbonate Assay Results

Saltworks has once again produced battery-grade lithium carbonate (Li₂CO₃) from the DLE eluent produced at the Pilot Plant. The table below is a comparison of Saltworks’ 2023 results for Li₂CO₃, DLE eluent Batch 2, with the previously reported results from DLE eluent Batch 1 (see May 25, 2023 news release). Also shown are the constituent levels for battery grade Li₂CO_3,as published by two major producers. The assays results were finalized by Saltworks and independently assayed by SGS Canada, Inc. These results show consistency in composition of both the DLE eluent produced by the Pilot Plant earlier in the year and the resulting Li₂CO₃product produced by Saltworks, achieving 99.871% content versus 99.875% reported previously.

Li₂CO₃Assay Results
		Century Li₂CO₃ Batch 2 (August 2023)	Century Li₂CO₃ Batch 1 (May 2023)	Reference Grades
Li₂CO₃	wt%	99.871	99.875	>99.5
H₂O	wt%	0.05	0.03	0.2 to <0.5
Na	wt%	0.027	0.047	0.03 to <0.05
Ca	wt%	0.012	0.009	0.01 to <0.04
Fe	Wppm	3	3	<5 to 10
Al	Wppm	3	<2	<10 to 10
Cu	Wppm	3	<4	<5 to 10
Ni	Wppm	<5	<5	<6 to 10
Zn	Wppm	<5	13	<5 to 10
Cl	wt%	0.01	0.008	<0.01
Notes: wt% (weight percent), wppm (weight parts per million), calculated Li₂CO₃ purity based on sum of impurities measured above detection limit. Reference grades are from published specifications from two major producers of battery grade Li₂CO₃

Scroll right to view more

Lithium in DLE Eluent

As recently reported (see August 9, 2023 news release), Century Lithium collaborated with Koch Technology Solutions (KTS), a Koch Engineered Solutions’ (KES) company, and integrated KTS’ Li-Pro^TM system into the DLE stage of the Pilot Plant. This work has increased the grades of the DLE eluent (intermediate lithium product solution) several fold. These changes are outlined in the table below, as reported by analyses from Saltworks.

DLE Eluate Assay Results
Batch	1	2	3	4	5
Lithium (Li) (ppm)	1,430	1,610	1,885	3,970	6,780
Sodium (Na) (ppm)	22,400	25,850	24,150	19,100	8,220
Total dissolved solids (TDS) (ppm)	77,450	77,850	82,600	78,300	79,300
Li:TDS	0.018	0.021	0.023	0.051	0.085
Li:Na	0.064	0.062	0.078	0.208	0.825
Notes: DLE eluent for Batch 1 and 2 used to produce Li₂CO₃cited above.

Scroll right to view more

Batches 1, 2 and 3 are DLE eluents produced during the first quarter of 2023. Li₂CO₃ production was carried out to completion in batches 1 and 2 but the processing of Batch 3 was put on hold due to its similarity to batches 1 and 2 and the improvements seen in the grades of batches 4 and 5. These improvements in lithium grade from 1,430 parts per million (ppm) to 6,780 ppm, increase in the ratio of lithium to total dissolved solids (TDS) from 0.018 to 0.085, and reduction in sodium from 25,850 ppm to 8,220 ppm all occurred with the introduction of KTS’ Li-Pro^TM system into the DLE stage of the Company’s Pilot Plant.

Implications for Lithium Carbonate Production

The increase in lithium (Li) grade and the Li:TDS ratio has positive implications for the size and costs of the lithium carbonate production portion of the lithium extraction process at the Project. Within the Saltworks flowsheet, these higher values equate to a lower volume of solution to be treated and a proportionate decrease in the amount of water that must be removed (evaporated) prior to lithium carbonate precipitation. This will also affect the recycled solutions within the lithium carbonate production stage by reducing the volume of solutions moved in this stage and other leaching areas of the processing plant.

The information derived from the Pilot Plant, including the test results from the combination of Century Lithium’s DLE process and KTS’ Li-Pro^TM system, and recent component changes at the Saltworks laboratory, is supplemental to the Feasibility Study for the project. The design basis for the Feasibility Study was established at a Li:TDS ratio of 0.02.

The Saltworks flowsheet targets a lithium grade of 10,000 to 20,000 ppm (10-20 g/L) for precipitation. Work with KTS at the DLE stage at the Pilot Plant has seen preliminary, internally assayed, lithium solution grades of over 8,000 ppm in the DLE eluent. Work is continuing within the DLE area to further increase lithium grades in solution, creating the scope to reduce solution volumes and the potential to eliminate a major evaporation step from the process flowsheet. As a supplement to the Feasibility Study, the Company is pursuing these potential cost and size savings with Saltworks.

Moving Forward

Work on the Feasibility Study continued throughout the six months ended June 30, 2023, with more than 20,000 consultant hours expended since its commencement. Following receipt of initial values from our consultants, Wood PLC and thyssenkrupp nucera, the Company is conducting internal reviews to assess optimization and cost reduction opportunities; work which is underway. In June 2023, the Company engaged Kiewit Industrial Group in Lone Tree, Colorado to assist with the review of project designs and estimates with attention to site development, material and supply costs, and construction methods. One optimization opportunity, reducing or eliminating the use of thickeners for tailings separation in the process configuration, was implemented and is under trial at the Pilot Plant.

The Company’s collaboration with KTS is underway, utilizing KTS’ Li-Pro^TM equipment in the DLE section of the Pilot Plant, where lithium is selectively recovered from the leach solution while deleterious elements are rejected. Testing with KTS is expected to continue through the 3^rd quarter while KTS collects information to prepare an engineering design and cost estimate for a full-scale deployment of Li-Pro^TM system which will supplement the Company’s Feasibility Study.

Qualified Person

Todd Fayram, MMSA-QP and Daniel Kalmbach, CPG, are the qualified persons as defined by National Instrument 43-101 and have approved the technical information in this release.

About Century Lithium Corp.

Century Lithium Corp. (formerly Cypress Development Corp.) is an advanced stage lithium company, focused on developing its 100%-owned Clayton Valley Lithium Project in west-central Nevada, USA. Century Lithium is currently in the pilot stage of testing on material from its lithium-bearing claystone deposit at its Lithium Extraction Facility in Amargosa Valley, Nevada and progressing towards completing a Feasibility Study and permitting, with the goal of becoming a domestic producer of lithium for the growing electric vehicle and battery storage market.

ON BEHALF OF CENTURY LITHIUM CORP.
WILLIAM WILLOUGHBY, PhD., PE
President & Chief Executive Officer

For further information, please contact:
Spiros Cacos | Vice President, Investor Relations
Direct: +1 604 764 1851
Toll Free: 1 800 567 8181
scacos@centurylithium.com
centurylithium.com

NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THE CONTENT OF THIS NEWS RELEASE.

Cautionary Note Regarding Forward-Looking Statements

This release includes certain statements that may be deemed to be “forward-looking statements”. Forward-looking statements are subject to risks, uncertainties and assumptions and are identified by words such as “expects,” “estimates,” “projects,” “anticipates,” “believes,” “could,” “scheduled,” and other similar words. All statements in this release, other than statements of historical facts, that address events or developments that management of the Company expects, are forward-looking statements. Although management believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance, and actual results or developments may differ materially from those in the forward-looking statements. The Company undertakes no obligation to update these forward-looking statements if management’s beliefs, estimates or opinions, or other factors, should change. Factors that could cause actual results to differ materially from those in forward-looking statements, include market prices, exploration, and development successes, continued availability of capital and financing, and general economic, market or business conditions. Please see the public filings of the Company at www.sedar.com for further information.

Release – Tonix Pharmaceuticals Announces Results of Pre-IND Meeting with FDA for TNX-801 as a Potential Vaccine to Prevent Mpox and Smallpox

Posted on August 21, 2023August 21, 2023 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

August 21, 2023 7:00am EDTDownload as PDF

Phase 1/2 Clinical Trial of TNX-801 for the Prevention of Mpox and Smallpox to Commence Following Submission of an IND

TNX-801 is Based on a Proprietary Live Virus Vaccine Platform Designed to Stimulate Durable T-Cell Immunity

TNX-801 Vaccination Protected Animals from a Lethal Challenge with Monkeypox in Preclinical Testing

CHATHAM, N.J., Aug. 21, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that it received the official written response from a Type B pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA) to develop TNX-801¹ (recombinant horsepox virus, live vaccine) as a potential vaccine to protect against mpox disease (formerly known as monkeypox) and smallpox. Tonix believes the FDA feedback provides a path to agreement on the design of a Phase 1/2 study and the overall clinical development plan. The Phase 1/2 clinical trial will assess the safety, tolerability, and immunogenicity of TNX-801, following the submission and clearance of an IND.

“The FDA’s response to the pre-IND meeting marks an important milestone in the development of TNX-801 since we have FDA concurrence on the proposed manufacturing, toxicology studies, and the Phase 1/2 clinical design,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix. “TNX-801 is believed to be closely related to Edward Jenner’s original smallpox vaccine.^2-10 Jenner’s live virus smallpox vaccine – the first vaccine – remains one of the most effective vaccines in history, since it typically provided lifetime immunity with a single dose, prevented forward transmission of the smallpox virus, and ultimately eradicated the disease. TNX-801 has an attenuated phenotype relative to modern vaccinia viruses, which comprise a group of vaccine viruses that evolved from Jenner’s vaccine during passage in man and animals for over 100 years. When live virus vaccinia vaccination was routinely practiced in Africa, mpox was kept out of the human population.”^2,11

TNX-801 is a live replicating attenuated vaccine based on horsepox that is believed to protect against smallpox and mpox, primarily by eliciting a T-cell response evidenced by the “take”. The “take” is a functional measure of protective T-cell immunity validated by the eradication of smallpox. TNX-801 is administered with a single dose, can be readily scaled up for manufacturing using proven technology and can be distributed and stored without requiring a costly and cumbersome ultra-cold supply chain. Live replicating vaccines have the potential to induce durable T-cell immunity, prevent serious illness after infection and block forward transmission. Tonix reported positive preclinical efficacy data, demonstrating that TNX-801 vaccination protected non-human primates against lethal challenge with mpox.¹²

“More than 30,000 people have contracted mpox in the U.S. so far during the 2022-23 epidemic,”¹³ said Dr. Zeil Rosenberg, Executive Vice President, Medical at Tonix. “The recent cluster of mpox in Chicago revealed breakthrough cases of mpox in individuals who had been vaccinated with the currently authorized non-replicating vaccine, which is administered in two doses.¹⁴ In contrast, TNX-801 is delivered intradermally with only one dose and therefore may achieve higher rates of community protection by eliminating drop-out between doses and limiting forward transmission. Moreover, relying on only one approved mpox vaccine at present is a risk for the global supply chain that has already led to insufficient availability of vaccine to meet global health needs, especially in Africa.”

Dr. Rosenberg added, “We believe TNX-801 could make a global impact on mpox and the risk of smallpox because of its potential durable T-cell immune response, the ability to manufacture at scale, to use a lower dose than non-replicating vaccines. The current formulation is a frozen liquid, but we believe that future lyophilized versions can be stored and shipped at standard refrigeration. Moreover, we believe the low dose of TNX-801 makes this technology amenable for future implementation in microneedle delivery systems.”

Dr. Lederman concluded, “In addition to its potential use as a vaccine, TNX-801 also has the potential as a viral vector platform, for which versions can be developed to protect against a host of infectious diseases beyond smallpox and mpox, including COVID-19. In light of the recent resurgence in COVID cases across the country with the new EG.5 “Eris” variant, we believe that the horsepox recombinant pox virus platform may provide next generation vaccines to prevent future outbreaks.”

About TNX-801*
TNX-801 is a live virus vaccine based on horsepox^2,11. Horsepox and vaccinia are closely related orthopoxviruses that are believed to share a common ancestor. TNX-801 is believed to be more closely related to Jenner’s vaccinia vaccine than modern vaccinia vaccines, which appear to have evolved by deletions and mutations to a phenotype of larger plaque size in tissue culture and greater virulence in mice. Molecular analysis shows that horsepox is closer than modern vaccinia vaccines in DNA sequence to the vaccine discovered and disseminated by Dr. Edward Jenner.^2-10Vaccine genome researchers have recently shown the contemporaneous use of horsepox and horsepox-related viruses in the United States as smallpox vaccines in the 1860’s^9,10. Additionally they found a remarkable degree of identity with the circa 1860 U.S. smallpox vaccine VK05 and the 1976 Mongolian horsepox isolate called MNR-76, upon which Tonix’s TNX-801 is based.^3,5 These recent discoveries are further steps in establishing that what is called ’horsepox‘ today was used to vaccinate against smallpox in the 19^th century. Dr. Edward Jenner invented vaccination in 1798 and the procedure was called “vaccination” because the inoculum material was initially obtained from lesions on the udders of cows affected by a mild disease known as cowpox². ‘Cow’ is ‘vacca’ in Latin. However, Dr. Jenner suspected that cowpox originated from horsepox.² Subsequently, Dr. Jenner and others immunized against smallpox using material directly obtained from horses. The use of vaccines from horses was sometimes called ‘equination’ from the Latin ‘equus’ which means ‘horse’. Equination and vaccination were practiced side-by-side in Europe⁶. The small plaque size in culture of TNX-801 appears identical to the U.S. Centers for Disease Control publication of the natural isolate¹². Relative to vaccinia, horsepox has substantially decreased virulence in mice³. Tonix’s TNX-801 vaccine candidate is administered intradermally. The major cutaneous reaction or “take” to vaccinia vaccine was described by Dr. Edward Jenner in 1796 and has been used since then as a biomarker for protective immunity to smallpox, including in the World Health Organization’s (WHO) accelerated smallpox eradication program that successfully eradicated smallpox in the 1960’s.

TNX-801 is in the pre-IND stage and has not been approved for any indication.
Jenner E. “An Inquiry Into the Causes and Effects of the Variole Vaccinae, a Disease Discovered in Some of the Western Counties of England, Particularly Gloucestershire and Known by the Name of the cow‐pox.” London: Sampson Low, 1798.
Noyce RS, et al. (2018) PLoS One. 13(1):e0188453
Schrick L, et al. (2017) N Engl J Med 377:1491-1492
Tulman ER, et al. (2006) J Virol. 80(18):9244-58.
Esparza J, et al. (2017) Vaccine. 35(52):7222-7230.
Esparza J, et al. (2020) Vaccine. 38(30):4773-4779.
Qin L, et al. (2015) J Virol. 89(3):1809-24.
Brinkmann A, et al, (2020) Genome Biology 21:286
Duggan A, et al. (2020) Genome Biology 21:175 https://doi.org/10.1186/s13059-020-02079-z
Noyce RS, et al., (2023) Viruses. 15(2):356.
Trindade GS, et al. (2016) Viruses. 8(12):328.
McQuiston JH, et al. (2023) The CDC Domestic Mpox Response — United States, 2022–2023. MMWR Morb Mortal Wkly Rep. 72(20):547–552
Faherty EAG, et al.(2023) Emergence of an mpox cluster primarily affecting persons previously vaccinated against mpox-Chicago, Illinois, March 18-June 12, 2023. MMWR Morb Mortal Wkly Rep. , 72(25);696-698.

Tonix Pharmaceuticals Holding Corp.^*

Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial subsidiary markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment of a potentially confirmatory Phase 3 study in the third quarter of 2023, with topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 proof-of-concept study has been completed, and topline results are expected in the third quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily oral formulation being developed as a treatment for major depressive disorder (MDD), that completed enrollment in a Phase 2 proof-of-concept study in the third quarter of 2023, with topline results expected in the fourth quarter of 2023. TNX-4300 (estianeptine) is a single isomer version of TNX-601, small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. Relative to tianeptine, estianeptine lacks activity on the µ-opioid receptor while maintaining activity in the rat Novel Object Recognition test in vivo and the ability to activate PPAR-β/δ and neuroplasticity in tissue culture. TNX-1900 (intranasal potentiated oxytocin), is in development for preventing headaches in chronic migraine, and has completed enrollment in a Phase 2 proof-of-concept study with topline data expected in the fourth quarter of 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs. 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 third quarter of 2023. Tonix’s rare disease development 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 development 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 rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.

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

Tonix Medicines has contracted to acquire the Zembrace SymTouch and Tosymra registered trademarks. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc.

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; risks related to the failure to successfully market any of our products; 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.

Investor Contact

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

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

Media Contact

Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
(919) 360-3039

Source: Tonix Pharmaceuticals Holding Corp.

Released August 21, 2023

Release – Ocugen To Host Conference Call on Tuesday, August 22 At 8:30 A.M. ET To Discuss Business Updates And Second Quarter 2023 Financial Results

Posted on August 21, 2023August 21, 2023 by aweinsoff@channelchek.com

Research News and Market Data on OCGN

August 18, 2023

PDF Version

MALVERN, Pa., Aug. 18, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that it will host a conference call and live webcast to discuss the Company’s second quarter 2023 financial results and provide a business update at 8:30 a.m. ET on Tuesday, August 22, 2023.

Ocugen will issue its 2Q23 financial results on Monday, August 21, 2023. Following the press release, the Company will hold the conference call on Tuesday, August 22 at 8:30 a.m. ET. Attendees are invited to participate in the call using the following details:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 6803433
Webcast: Available on the events section of the Ocugen investor site

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

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

Contact:
Tiffany Hamilton
Head of Communications
Tiffany.Hamilton@ocugen.com

AZZ Inc. (AZZ) – Initiating Coverage With an Outperform Rating and $60 Price Target

Posted on August 21, 2023August 21, 2023 by cpereira@noblefcm.com

Monday, August 21, 2023

Michael Heim, Senior Vice President, Equity Research Analyst, Energy & Transportation, Noble Capital Markets, Inc.

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

AZZ Inc. is North America’s largest independent hot-dip galvanizing and coil coating solution company. AZZ has two operating divisions – Metal Coatings and Precoat Metals. Metal Coatings provides a wide range of high-quality metal finishing and coating services that protect from the destruction of metallic corrosion including galvanizing and other forms of coating and plating. Precoat Metals is engaged in the growing use of coil coated metal, often referred to as prepainted metal because the metal is painted prior to, rather than after, fabrication.

The shares of AZZ trade at a sharp discount to other coating companies. We believe the discount also reflects a more leveraged balance sheet following recent acquisitions. Positive free cash flow will allow the company to pay down debt. As the company deleverages, we believe it will see valuation multiples rise to levels approaching peer companies.

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).

AMC Converting APEs and Reverse Splitting

Posted on August 21, 2023August 21, 2023 by phoffman@channelchek.com

AMC Theatres APE Units Will Cease to Exist After Thursday

The last day of trading for AMC Entertainment (AMC) Preferred Equity Units (APE) is Thursday, August 24^th. The dividend shares that were provided 1:1 for AMC shareholders one year ago, will be converted to AMC common stock, which will then be the only class of stock AMC Entertainment has outstanding. But the company still has mounds of debt, which is part of the reason for rolling the preferreds into common shares. The move doubles the number of common shares outstanding, which the company then has plans to address.

On August 11, the wild ride shareholders had been on got a bit wilder as a Delaware Court judge gave the green light to AMC proceeding with a revised plan to convert its preferred shares. This drove up shares of APE units and down the price of AMC common stock.

Month to date, APE units, which will not be trading by the end of the week, are up nearly 15% while AMC common stock is down over 37%. Since the court notice, volume has been significantly higher in both preferred and common.

The single AMC common share class is part of the movie theater chain’s recovery from the pandemic era debt built up. AMC is also planning a reverse 1-for-10 split of its common stock and an increase in its authorized common shares.

In Form 8-K filed with the SEC last week, AMC explained that the reverse stock split is expected to also occur on Aug. 24. The market will open on August 25^th with the conversion complete, and the ticker APE delisted from the New York Stock Exchange.

Expectations of the stock-conversion is that AMC will be more resilient and will eliminate capital-raising inefficiencies of APE units trading at a significant discount to AMC shares, said CEO Adam Aron.

Analysts expect the shares to converge around the $3 price range.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://public.com/learn/ape-stock-amc-dividend#:~:text=%24APE%20is%20a%20new%20class,22.

https://courts.delaware.gov/Opinions/Download.aspx?id=351520

Is Nvidia Stock Positioned for a Classic Slide?

Posted on August 21, 2023August 21, 2023 by phoffman@channelchek.com

What History Says About MegaCap Companies with NVDA’s Multiples

What’s riskier, a stock like Nvidia that has been moving up since the start of the year and has now risen more than 200%, or the stock you pick by throwing a dart at the Wall Street Journal? Nvidia (NVDA) will report earnings on Wednesday, the report has a significant risk of disappointing, even if it exceeds forecasts.

Background

The last time Nvidia reported quarterly results, the chip maker forecasted record revenue that was far above anything it had accomplished before. Naturally, investors sent the stock up and then up some more to the level we see today. On Wednesday, August 23^rd, the company will share the actual results of its second-quarter earnings. If it doesn’t deliver or exceed expectations, there may be a lot of disappointed investors. Plus, a repeat projection of future earnings growth would seem necessary to maintain its trajectory. Nvidia’s current valuation is extremely high, it has been the poster child of the AI investment boom, it would seem there are more scenarios where it will disappoint the frenzy in the market for the stock then there are positives for a company with such high valuations.

What Does History Say?

The phrase “the bigger they are, the harder they fall” was used in the context of the stock market as early as the 19th century. In 1873, the New York Stock Exchange crashed, and many investors lost their life savings. The crash was blamed on the overvaluation of stocks. Since then, there have been a number of times the market and individual stocks have come to terms with the idea that the price has gotten ahead of itself, causing speculators to flee, causing a sharp decline.

Nvidia was big and has gotten bigger. As it relates to its report on second-quarter earnings on Wednesday, analysts have been expressing positive expectations. In a “buy the rumor sell the news” way of thinking, this alone may cause the stock price to deflate after the report.

An article published by Barron’s on August 21^st points out, using data from WisdomTree, that Nvidia has a price-to-projected sales ratio, of 25, this jumps to a whopping 40 when using 12-month trailing sales.

The company now holds the distinction of having the highest price-to-sales ratio in the S&P 500. It is only the 100^th company to hold that title since the 1960s. Tech companies had been in this position 27 times, and utilities a mere once. What has happened to these mega-cap hot stocks in the years to follow?

Image: Research conducted for stocks for the long run 6th edition, Jeremy Siegel w/ Jeremy Schwartz (2022).

Over the next year, the average price-to-sales monsters saw their price rise 12% versus the average for the market of 11%. Then, over the next three years, the average stock dropped 4% annually, compared to the market’s 9% rise. The relative fall off continued over the next five years, as the average for these stocks had fallen 2%, versus the market’s 10% gain, according to a book by Wharton economic professor Jeremy Siegel.

As illustrated in the table above, the underperformance is even greater for the tech companies that hold the biggest price-to-sales ratios. And the median performance for stocks at these price-to-sales ratios is even worse.

Take Away

Based on its guidance, there is little doubt that Nvidia is on track to post results that are beyond enviable. At least a dozen equity analysts have recently raised price targets on NVDA. But can the news be good enough in light of its current pricing and the history of tech stocks that have come before? NVDA would have been a great stock to have bought months ago and held; the current probabilities, based on history, now suggest the run-up is over, and the potential for a decline within a year has increased dramatically.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.marketwatch.com/story/expectations-for-nvidias-earnings-are-massive-will-they-even-matter-b054a1?mod=search_headline

https://www.marketwatch.com/story/the-history-of-companies-with-nvidia-like-valuations-isnt-a-good-one-17f46efe?mod=home-page

The Week Ahead – Jackson Hole, Johannesburg, Consumer Sentiment

Posted on August 20, 2023August 20, 2023 by phoffman@channelchek.com

Powell’s Talk at the Jacksonhole Symposium Won’t be Until Friday

The light economic calendar is likely to take a backseat to the annual Jackson Hole Symposium this week and the BRICS summit in Johannesburg, South Africa. In Jackson Hole, the overriding theme is “Structural Shifts in the Global Economy”. The annual meeting is intended to have an overriding academic tone, but the number of Fed policymakers involved allows the markets to listen for any meaningful interest rate bias. The expected focus is on remarks from those actually conducting monetary policy, US central bankers. Powell is scheduled to give his speech on the “Economic Outlook” at 10:05 ET on Friday. Meanwhile, 9,900 miles away, the BRICS group of major emerging economies – Brazil, Russia, India, China and South Africa – will hold its heads of state and government summit in Johannesburg from Aug. 22-24. South African President Cyril Ramaphosa, Chinese President Xi Jinping, Brazil’s President Luiz Inacio Lula da Silva and Indian Prime Minister Narendra Modi are expected to attend in person. Russian President Vladimir Putin will not attend in person, as there is an arrest warrant out related to the war in Ukraine. He is expected to attend virtually. The markets will be interested to see if the group expands by allowing other countries,also any news related to the New Development Bank (NDB) sometimes called the BRICS bank, and all around economic cooperation.

Stocks may also take their cue from interest rates and the longer end of the yield curve, which has begun adjusting with rising rates for longer-dated maturities.

Monday 8/21

• There is no key data being released and no expected talks or events with market implications.

Tuesday 8/22

• 7:30 AM ET, Richmond Fed President Thomas Barkin is scheduled to speak. Recent comments from Barkin have been hopeful. Barkin recently said the greater-than-expected easing in inflation in June may be an indication that the US economy can have a “soft landing,” returning to price stability without a damaging recession.

• 10:00 AM ET, the Existing Home Sales annual rate for July is to be at the same level as it was in June, 4.16 million. The National Association of Realtors has been citing a lack of available inventory for the slow pace of sales as existing homeowners are choosing to keep their lower mortgage rates.

• 2:30 PM ET, Chicago Fed President Austan Goolsbee is scheduled to speak. Goolsbee has made it clear he is on the fence as to whether tightening at the September meeting is warranted.

Wednesday 8/23

• 9:45 AM ET, Purchasing Managers Index (PMI) composite for services is expected to show that the number holds above 50 in July, as it has for the last six PMI releases. As for manufacturing, the consensus is 48.8, which would be down a bit from the 49 reported in June.

• 10:00 AM ET, New Home Sales in July, a month before mortgage rates began their recent spike, is expected to move higher to a 702,000 annual rate after slowing to 697,000 in June which, though lower than expected, was still the second highest rate in more than a year.

• 10:30 PM ET, EIA The Energy Information Administration (EIA) provides the Petroleum Status Report weekly with information on petroleum inventories in the US, whether produced in the US or abroad. The level of inventories helps determine prices for petroleum products.

• 8:30 PM ET, BRICS Summit.

• 11:00 PM ET, Jackson Hole Symposium.

Thursday 8/24

• 8:30 AM ET, Durable Goods Orders are forecast to fall 4% for August after a 4.6% increase in July, pushed higher by aircraft orders. Ex-transportation orders are forecast to be up 0.2%, with core capital goods orders unchanged.

• 4:30 AM ET, The Fed’s Balance Sheet is expected to have decreased by $31.208 billion to $8.146 trillion for the seven day period ending August 23. This would be a $61.5 billion decline. Market participants and Fed watchers look to this weekly set of numbers to determine, among other things if the Fed is on track with its stated quantitative tightening (QT) plan.

Friday 8/25

• 10:00 AM ET, Consumer Sentiment is expected to end August at 71.2, unchanged from August’s mid-month flash with year-ahead inflation expectations also expected to be unchanged at 3.3%.

• 10:05 AM ET, US Federal Reserve Chairman is expected to give his address at Jackson Hole.

What Else

Have you attended an in-person roadshow organized by Noble Capital Markets? Noble has been reaching out to retail and institutional investors and holding these events designed for investors to meet management teams. Investors have been able to discover more about their companies, often enough to make an informed decision. The forum has been getting rave reviews from investors and company management teams. Use this link to see if a roadshow is scheduled near you.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://tradingeconomics.com/calendar

https://us.econoday.com/byweek.asp?cust=us