Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines.The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
2Q23 Included Data Presentations and Preparations For New Trials. Ocugen reported a 2Q23 loss of $23.7 million or $(0.10) per share. The R&D expense of $14.2 million included a non-cash impairment charge of $4.3 million related to COVAXIN supplies and fixed assets. Excluding the non-cash charge, R&D of $9.7 million was consistent with our expectations. Cash on June 30, 2023 was $70.6 million.
Two New Products Are Expected To Start Phase 1/2 Trials. During the quarter, IND applications to start clinical trials for OCU410ST in Stargardt disease and OCU410 in Geographic Atrophy (GA) in dry age-related macular degeneration (dry AMD) were filed as expected and cleared FDA review. Phase 1/2 trials for both products are expected to begin before year-end.
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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.
While it is no secret that there has been a migration of the finance and investment community out of New York and California, other than piecing together vehicle registrations to count people, there have been few hard numbers put on the firms and their AUM that have pulled out. This week, Bloomberg put hard numbers on the exodus, and it’s worse than most imagined. Looking at corporate filings back to the end of 2019, it found that more than 17,000 firms have moved. The two states have lost assets under management (AUM), within their borders, totaling more than $1 trillion.
This has also meant a lot of above average paying jobs, which saps tax revenue, and stresses state budgets. The commercial real estate markets in the two high-tax states have also taken a big hit as deep-pocketed tenants have packed up and left at a time when remote and hybrid work have already bled demand.
The Bloomberg piece makes clear that New York City remains the global center for asset management, but while New York is being slowly drained, it is “fueling a boom” down south. The article discusses the soaring Miami home prices and lifestyle improvements. In Dallas, the finance industry is expanding at a pace reminiscent of the 1980s oil bust. Charles Schwab moved to the area in 2020, and now Goldman Sachs and Wells Fargo are working to create office space to accommodate thousands of employees.
The moves continue to be inspired by costs and weather, and now face-to-face meetings are easier as the Dallas or Boca Raton associate is no longer an “out-of-towner”. The migration has dramatically increased the growth of professionals in the industry, in areas that previously had very few financial firms.
“The Sun Belt is continuing to change – no longer just a place of traditional industries like oil and gas, no longer just focused on tourism, of focusing on the retirement community,” Bloomberg quotes Amy Liu, interim President of the Brookings Institute, as saying.
From the beginning of 2020 through the end of the first quarter 2023, more than 370 investment companies decided to make a move. The companies represent 2.5% of the US total, and manage $2.7 trillion in assets. A high percentage was from the Northeast and the West Coast to Florida and Texas. But, North Carolina and Tennessee together grew by $600 billion in assets now managed within their borders. This is primarily from Alliance Bernstein moving out of New York and to Nashville, and Allspring Global Investment out of San Franciso and to Charlotte.
The AUM Migration by Region (Q1 2020 – Q1 2023)
Washington State saw three firms leave during this period, but the assets under management in the state dropped 19% as a result, as Fisher Investments was one of the three. Connecticut, a long-time suburb of the Big Apple is known for the hedge funds that have been headquartered there and enjoying lower taxes than in “the city.” The proximity to New York and the rising Connecticut taxes were traded by enough firms that Florida now has more assets under management than Connecticut.
Florida acquired the most assets from the migration from New York, Ark Investment Management, run by Cathie Wood, and Carl Icahn’s Icahn Capital Management were prominent names. Ken Griffin’s Citadel from Chicago is altering the South Florida skyline as it builds out offices, and DoubleLine moved from Los Angeles to Florida’s West Coast.
Smaller firms are on the move too. Whether they are following the sun, or the wealthy baby boomers, Palm Beach saw 37 investment advisors relocate, and Miami experienced an influx of 63 advisors.
The AUM in these new states is being enhanced by wealthy individuals also picking up and moving from their higher-tax residences. Tiger 21, a worldwide network of more than 1200 high net-worth investors, with assets over $150 billion, has grown its Florida chapter.
Take Away
The only thing that stays the same is change, as the saying goes. The pandemic brought on a lot of changes that most did not see coming. The migration out of places widely viewed as more difficult to live in because of costs, or year-round temperatures includes powerful financial firms. These firms are bringing in professionals who are accustomed to a certain way of conducting business. Until recently, the ability to do business this way did not fully exist in the areas where their firms have relocated – now it does.
Blackrock’s Support for ESG May Have Been Unsustainable
Blackrock, a firm with a reputation for strongly supporting ESG resolutions, having voted yes on 47% of them in 2020, voted down 93% in the past year. The company provided the reasons for shunning 371 proposals out of 399 in its annual Stewardship Report released on August 23rd. With $9.4 trillion under management, investors pay attention to the investment manager. This gives it the power, whether it likes it or not, to create trends as others follow its lead. Should the company’s adjusted position on ESG be taken as something others want to mimic? The reasons given leave that in question.
BlackRock is the world’s largest asset manager. As such, the funds it manages own significant amounts of shares of a broad array of public companies. The Blackrock funds vote on important matters related to the underlying companies if a corporate resolution requires a shareholder vote. Think of the ETF or mutual fund as a trust, and the fund manager, Blackrock, gets to vote on behalf of the assets in the trust. Whereas if an investor owns individual shares of a company, they get to decide and vote themselves, either at a board meeting or more likely, through a proxy statement. Certainly, the amount of control over the decisions of corporations worldwide given to an asset manager of this size is immense.
Each year, the company files a report on its voting during the proxy season. It broke records by voting down 91% of all shareholder proposals and against 93% of those focused on environmental and social issues during the 2023 proxy year. The 7% of ESG proposals that BlackRock supported this year is down sharply from 2022, when BlackRock’s investment stewardship team supported 24% of such proposals, and from 2021, when it supported 47%.
BlackRock’s Investment Stewardship team, makes the voting decisions on both management and shareholder proposals on behalf of BlackRock’s clients. It said the large number of “NO” votes this year is partly related to a huge influx of shareholder proposals. These were described as “poor quality” by the BIS team, either because they were “lacking economic merit,” were “overly prescriptive” and “sought to micromanage a company’s strategy,” or were simply redundant, asking a company to do something it had already done, the Stewardship Report said.
BlackRock’s support for management proposals (not shareholder proposals), which accounted for more than 99% of the roughly 172,000 proposals voted on by BIS, remained high at 88%.
BlackRock’s trend of voting against shareholder proposals is largely in line with other fund managers. The median shareholder support for environmental and social proposals in the U.S. fell sharply from 25% in 2022 to just 15% in the 2023 proxy year.
The firm has backed away from ESG as a term if not a concept. The most recent CEO newsletter did not include the acronym at all, and during a June interview, CEO Larry Fink said he does not use the term, he gave this reason, “I’m not blaming one side or the other, but it has been totally weaponized,” Mr. Fink said. “In my last CEO letter, the phrase ESG was not uttered once, because it’s been unfortunately politicized and weaponized.” He now has a reluctance to have his firm associated with the term ESG after a wave of backlash from both sides of the political spectrum.
In December 2022, Florida’s chief financial officer announced that the state would pull $2 billion worth of assets managed by BlackRock, the largest such divestment by a state opposed to the asset manager’s environmental, social and corporate governance (ESG) policies. BlackRock also lost some of its business of oil rich Texas from its government pension funds because of its ESG policies. Louisiana and Missouri, have also taken steps to divest from BlackRock.
Although not specifically stated in the report, Blackrock fund managers still support the idea that good corporate citizenship could in turn, benefit shareholders. But they will no longer be out front as though ESG factors are the most important criteria. Earlier this month S&P Global Ratings decided it would not provide ESG ratings separate from its credit ratings. Instead, S&P will factor in all of the obligors’ business practices as it relates to risk of non-payment, and assign only a credit rating.
The term has become polarizing as differing political philosophies tend to stand together in support of ESG issues being taken into investment consideration, and other political leanings stand opposed to the not fully developed concept. This has hurt Blackrock.
Republican politicians have been probing Blackrock’s business dealings and asking conservative-leaning state pension funds to divest from the company, which they say has unfairly excluded the traditional energy sector.
On the other hand, environmental activists have lambasted Mr. Fink and his company for not doing enough to stop climate change, protesting in front of BlackRock’s headquarters and heckling senior executives at public speaking engagements. In June Blackrock began providing high-level security to protect Mr. Fink and others in management.
Take Away
When you put your money into most mutual funds, you give away the power that comes with voting on important matters to the underlying shares held by the trust of which you are a part owner. As mutual funds and ETFs have grown, more of the power to guide companies has been handed to the elite running asset management companies.
The growth in popularity in “sustainability” investing caused a rush from investors to these funds, which then needed to place assets in the limited number of companies in the segment. This caused a rise in the share prices of the companies and a rise in the popularity of the funds. Many investors were indifferent to ESG, but not indifferent to making money, they also jumped in. Companies quickly caught on and adjusted their logos to include leaves and the color green, altering some business practices.
While the leadership that Blackrock provides may signal the eventual demise of the term ESG, there has always been, and will always be an interest in putting your money where your heart is. The concept will live, but with Blackrock’s lead, the acronym may transform to something that is less political and less likely to cause protests outside of his home.
CULVER CITY, Calif., Aug. 22, 2023 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail” or “the Company”), a leading, global independent developer and publisher of interactive digital entertainment, today announced that its indie publishing sub-label, Wandering Wizard, will be showcasing its latest games, Survivor Mercs, West Hunt and Expedition Agartha, at the upcoming PAX West 2023 event in Seattle, running from September 1 through 4, 2023.
Survivor Mercs, developed by Wolperginger Games, is an Early Access roguelite action game that blends the bullet-heaven and extraction shooter genre for a challenging single-player experience where no two gameplay runs are alike. West Hunt, developed by NewGen Studio, is a one-to-six-player social deduction game set in the Old West. The game allows players to immerse themselves in the Wild West as hardworking townsfolk, sheriffs, or outlaws. Expedition Agartha, developed by Matrioshka Games, is an Early Access multiplayer First Person Looter Survival game that challenges players to explore a mysterious island in the Lost Continent of Mu and uncover the secrets of Agartha.
After the commendable reception at PAX East 2023 held in Boston earlier in March, Wandering Wizard is excited to reconnect with fans and industry professionals from the West Coast at this notable event and generate buzz around its latest games. PAX West 2023 is one of the largest gaming conventions in North America, providing an ideal opportunity for Wandering Wizard to promote its games and expand its reach.
At booth 608 on the 4th Floor of the Seattle Convention Center, Wandering Wizard will provide visitors with the opportunity to get hands-on gameplay experience with West Hunt and Expedition Agartha. Additionally, a demo presentation of Survivor Mercs will be available at the booth. The onsite team from Wandering Wizard will be available for discussion, offering insight into game development. In addition, visitors stand a chance to win Early Access codes, exclusive merchandise, both on-site and online.
Jim Tsai, Chief Executive Officer of Snail, commented: “The upcoming PAX West 2023 provides an unparalleled platform for Wandering Wizard to engage with the expansive gaming community. Our dedicated team at Wandering Wizard strives to deliver top-tier gaming experiences with a distinct emphasis on player feedback and sustained improvement. As we approach PAX West 2023, we look forward to showcasing our game offerings and enhancing our visibility.”
About Snail, Inc.
Snail is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs and mobile devices.
Forward-Looking Statements
This press release contains statements that constitute forward-looking statements. Many of the forward-looking statements contained in this press release can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “may,” “predict,” “continue,” “estimate” and “potential,” or the negative of these terms or other similar expressions. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding Snail’s intent, belief or current expectations. These forward-looking statements include information about possible or assumed future results of Snail’s business, financial condition, results of operations, liquidity, plans and objectives. The statements Snail makes regarding the following matters are forward-looking by their nature: growth prospects and strategies; launching new games and additional functionality to games that are commercially successful, including the launch of ARK: Survival Ascended, ARK: The Animated Series and ARK 2; expectations regarding significant drivers of future growth; its ability to retain and increase its player base and develop new video games and enhance existing games; competition from companies in a number of industries, including other game developers and publishers and both large and small, public and private Internet companies; its relationships with third-party platforms such as Xbox Live and Game Pass, PlayStation Network, Steam, Epic Games Store, the Apple App Store, the Google Play Store, My Nintendo Store and the Amazon Appstore; expectations for future growth and performance; and assumptions underlying any of the foregoing.
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 MediatorTM 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 MediatorTM 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.
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
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
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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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.
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.
Source: Federal Reserve, Kansas City, MO
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.
Source: Federal Reserve, Kansas City, MO
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.
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.
TheCaution 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.
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 4th and 5th 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
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-ProTM 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 Li2CO3, 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 Li2CO3 product produced by Saltworks, achieving 99.871% content versus 99.875% reported previously.
Li2CO3 Assay 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-ProTM 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-ProTM 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-ProTM 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-ProTM 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 3rd quarter while KTS collects information to prepare an engineering design and cost estimate for a full-scale deployment of Li-ProTM 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
NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THE CONTENT OF THIS NEWS RELEASE.
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 atwww.sedar.com for further information.
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 horsepox2,11. 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.2-10 Vaccine genome researchers have recently shown the contemporaneous use of horsepox and horsepox-related viruses in the United States as smallpox vaccines in the 1860’s9,10. 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 19th 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.
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.
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 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.
