Mark Reichman, Senior Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Weaker than expected Yauricocha financial results. Sierra Metals’ subsidiary Sociedad Minera Corona S.A, whose principal asset is the Yauricocha mine in Peru, recently filed its financial results for the fourth quarter and full year 2022. Fourth quarter and full year EBITDA were $(6.1) million and $14.2 million, respectively, compared with $19.0 million and $88.0 million during the prior year periods. Recall Sierra holds an 81.8% interest in Corona whose financial results have not been adjusted for the 18.2% non-controlling interest.
Lowering estimates. We have lowered our fourth quarter and full year 2022 EBITDA and EPS estimates to reflect weaker than expected performance at the Yauricocha mine in Peru. We forecast fourth quarter EBITDA and EPS of $(3.5) million and $(0.07), respectively, compared to our previous estimates of $0.4 million and $(0.05). For the full year, we project EBITDA of $10.0 million and a loss per share of $(0.17) compared with our previous estimates of $13.9 million and $(0.15), respectively. Our 2023 EBITDA and EPS estimates remain unchanged at $37.3 million and $(0.04). While our quarterly estimates reflect steady improvement, operational uncertainty associated with production at the company’s mines clouds our confidence in 2023 estimates.
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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.
Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product, Covaxin, is a killed-virus vaccine for COVID-19 in-licensed from Bharat Biotech (India). The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.
Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Financial Results Were Within Expectations. Ocugen reported 4Q22 and FY2022 Net Loss of $21.9 million or $(0.10) per share, and $81.4 million or $(0.38) per share for FY2022. Cash on hand as of December 31 was $90.9 million or $0.41 per share, which management projects will fund operations through 1Q24. On its quarterly conference call, management discussed recent milestones and development programs in gene therapy, cellular therapy, and vaccines.
Ophthalmology Programs Are Advancing. Ocugen filed an IND for OCU200 to begin Phase 1 clinical trial in diabetic macular edema (DME), meeting the expected timeframe. Trial enrollment is expected to begin in 2Q23. A second IND filing is expected during 2Q23 for OCU410 in dry AMD and OCU410ST in Stargardt disease. The Phase 1/2 dose testing OCU400 in retinitis pigmentosa (RP) escalation phase previously completed enrollment for the RP cohort, with enrollment continuing in the Leber congenital amaurosis (LCA) patient cohort. Phase 3 is expected to start by year-end 2023.
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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.
Defense Metals Corp. is a mineral exploration and development company focused on the acquisition, exploration and development of mineral deposits containing metals and elements commonly used in the electric power market, defense industry, national security sector and in the production of green energy technologies, such as, rare earths magnets used in wind turbines and in permanent magnet motors for electric vehicles. Defense Metals owns 100% of the Wicheeda Rare Earth Element Property located near Prince George, British Columbia, Canada. Defense Metals Corp. trades in Canada under the symbol “DEFN” on the TSX Venture Exchange, in the United States, under “DFMTF” on the OTCQB and in Germany on the Frankfurt Exchange under “35D”.
Mark Reichman, Senior Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Favorable crushing and grinding test results. Defense Metals reported favorable crushing and grinding (comminution) results using multiple samples extracted from the Wicheeda deposit. The results will help determine the design of the crushing and grinding plant which will be included in the company’s Wicheeda REE project preliminary feasibility study (PFS) that is expected to be completed in the first quarter of 2024.
The importance of starting off right. Crushing and grinding is the first step in processing mined material where ore is reduced to sand-like particles suitable for upgrading by flotation or other means. It accounts for a fairly significant percentage of the mineral processing plant energy requirements, production cost, and carbon emission profile.
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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.
Codere Online refers, collectively, to Codere Online Luxembourg, S.A. and its subsidiaries. Codere Online launched in 2014 as part of the renowned casino operator Codere Group. Codere Online offers online sports betting and online casino through its state-of-the art website and mobile application. Codere currently operates in its core markets of Spain, Italy, Mexico, Colombia, Panama and the City of Buenos Aires (Argentina). Codere Online’s online business is complemented by Codere Group’s physical presence throughout Latin America, forming the foundation of the leading omnichannel gaming and casino presence in the region.
Michael Kupinski, Director of Research, Noble Capital Markets, Inc.
Patrick McCann, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Strong Q4, better than expected. The company reported year-over-year Q4 net gaming revenue growth of 70% to €37.7 million, illustrated in Figure #1 Q4 Results. The quarterly revenue growth marked an acceleration compared with Q3 revenue growth of 54%. Notably, full-year net gaming revenue of €123 million was better than guidance of €115 million to €120 million.
CEO change, strong management bench. The company announced that Moshe Edree will step down as CEO and begin serving as Executive Vice Chairman. Aviv Sher is assuming the role of CEO, having previously served as the company’s COO. Mr. Sher has worked in the industry for more than 15 years.
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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.
Most vaccines, from measles to Covid-19, require a series of multiple shots before the recipient is considered fully vaccinated. To make that easier to achieve, MIT researchers have developed microparticles that can be tuned to deliver their payload at different time points, which could be used to create “self-boosting” vaccines.
In a new study, the researchers describe how these particles degrade over time, and how they can be tuned to release their contents at different time points. The study also offers insights into how the contents can be protected from losing their stability as they wait to be released.
Using these particles, which resemble tiny coffee cups sealed with a lid, researchers could design vaccines that would need to be given just once, and would then “self-boost” at a specified point in the future. The particles can remain under the skin until the vaccine is released and then break down, just like resorbable sutures.
This type of vaccine delivery could be particularly useful for administering childhood vaccinations in regions where people don’t have frequent access to medical care, the researchers say.
“This is a platform that can be broadly applicable to all types of vaccines, including recombinant protein-based vaccines, DNA-based vaccines, even RNA-based vaccines,” says Ana Jaklenec, a research scientist at MIT’s Koch Institute for Integrative Cancer Research. “Understanding the process of how the vaccines are released, which is what we described in this paper, has allowed us to work on formulations that address some of the instability that could be induced over time.”
This approach could also be used to deliver a range of other therapeutics, including cancer drugs, hormone therapy, and biologic drugs, the researchers say.
Jaklenec and Robert Langer, the David H. Koch Institute Professor at MIT and a member of the Koch Institute, are the senior authors of the new study, which appears today in Science Advances. Morteza Sarmadi, a research specialist at the Koch Institute and recent MIT PhD recipient, is the lead author of the paper.
Staggered Drug Release
The researchers first described their new microfabrication technique for making these hollow microparticles in a 2017 Science paper. The particles are made from PLGA, a biocompatible polymer that has already been approved for use in medical devices such as implants, sutures, and prosthetic devices.
To create cup-shaped particles, the researchers create arrays of silicon molds that are used to shape the PLGA cups and lids. Once the array of polymer cups has been formed, the researchers employed a custom-built, automated dispensing system to fill each cup with a drug or vaccine. After the cups are filled, the lids are aligned and lowered onto each cup, and the system is heated slightly until the cup and lid fuse together, sealing the drug inside.
This technique, called SEAL (StampEd Assembly of polymer Layers), can be used to produce particles of any shape or size. In a paper recently published in the journal Small Methods, lead author Ilin Sadeghi, an MIT postdoc, and others created a new version of the technique that allows for simplified and larger-scale manufacturing of the particles.
In the new Science Advances study, the researchers wanted to learn more about how the particles degrade over time, what causes the particles to release their contents, and whether it might be possible to enhance the stability of the drugs or vaccines carried within the particles.
“We wanted to understand mechanistically what’s happening, and how that information can be used to help stabilize drugs and vaccines and optimize their kinetics,” Jaklenec says.
Their studies of the release mechanism revealed that the PLGA polymers that make up the particles are gradually cleaved by water, and when enough of these polymers have broken down, the lid becomes very porous. Very soon after these pores appear, the lid breaks apart, spilling out the contents.
“We realized that sudden pore formation prior to the release time point is the key that leads to this pulsatile release,” Sarmadi says. “We see no pores for a long period of time, and then all of a sudden we see a significant increase in the porosity of the system.”
The researchers then set out to analyze how a variety of design parameters, include the size and shape of the particles and the composition of the polymers used to make them, affect the timing of drug release.
To their surprise, the researchers found that particle size and shape had little effect on drug release kinetics. This sets the particles apart from most other types of drug delivery particles, whose size plays a significant role in the timing of drug release. Instead, the PLGA particles release their payload at different times based on differences in the composition of the polymer and the chemical groups attached the ends of the polymers.
“If you want the particle to release after six months for a certain application, we use the corresponding polymer, or if we want it to release after two days, we use another polymer,” Sarmadi says. “A broad range of applications can benefit from this observation.”
Stabilizing the Payload
The researchers also investigated how changes in environmental pH affect the particles. When water breaks down the PLGA polymers, the byproducts include lactic acid and glycolic acid, which make the overall environment more acidic. This can damage the drugs carried within the particles, which are usually proteins or nucleic acids that are sensitive to pH.
In an ongoing study, the researchers are now working on ways to counteract this increase in acidity, which they hope will improve the stability of the payload carried within the particles.
To help with future particle design, the researchers also developed a computational model that can take many different design parameters into account and predict how a particular particle will degrade in the body. This type of model could be used to guide the development of the type of PLGA particles that the researchers focused on in this study, or other types of microfabricated or 3D-printed particles or medical devices.
The research team has already used this strategy to design a self-boosting polio vaccine, which is now being tested in animals. Usually, the polio vaccine has to be given as a series of two to four separate injections.
“We believe these core shell particles have the potential to create a safe, single-injection, self-boosting vaccine in which a cocktail of particles with different release times can be created by changing the composition. Such a single injection approach has the potential to not only improve patient compliance but also increase cellular and humoral immune responses to the vaccine,” Langer says.
This type of drug delivery could also be useful for treating diseases such as cancer. In a 2020 Science Translational Medicine study, the researchers published a paper in which they showed that they could deliver drugs that stimulate the STING pathway, which promotes immune responses in the environment surrounding a tumor, in several mouse models of cancer. After being injected into tumors, the particles delivered several doses of the drug over several months, which inhibited tumor growth and reduced metastasis in the treated animals.
Stock Market Performance – Looking Back at February, Forward to March
The months seem to go by quickly. And as satisfying as January was for most stock market investors, February left people with 2022 flashbacks. High inflation, or what more inflation could mean for monetary policy, again was the culprit weighing on investors’ minds and account values. One consideration is that investors are now entering March and are faced with very negative sentiment. This could actually be bullish and may lead the major indexes on a wave upward.
The next scheduled FOMC meeting is March 21-22. By then, we will have seen another round of inflation numbers as CPI (March 14) and the PCE index (March 15) are both released during the same week, otherwise known as the ides of March. While the Fed is wrestling with stubborn inflation, it is keeping an eye on the strong labor markets. Although low unemployment is desirable, tight labor markets are helping to drive prices up. The Fed is looking to find a better balance.
The three broad stock market indices (S&P 500, Nasdaq 100, and Russell 2000) are positive on the year, the Dow went negative on the 21st of February. The Nasdaq 100 and Russell 2000 have gained 9.70% and 8.22% respectively year-to-date, while the S&P is a positive 3.21% and the Dow Industrials is a negative 1.45%.
Each of the four closely watched indexes shown above began falling off as soon as January ended. It has only totalled a partial reversal, but the overall negative sentiment rose through February.
Viewing the indices from a year-to-date perspective, all but the Dow are well above their historical average pace.
Of the 11 S&P market sectors (SPDRs) only one was in positive territory for the month. This is Technology (XLK) and was barely positive at .08%. That is followed by Industrials (XLI), which fell a mere .07%. This demonstrates the flaw in using the Dow 30 Industrials (declined 4.07%) which is not as broad of an index or a great gauge of stock market direction. The third top performer was Financials (XLF) which returned a negative 2.26%. Financial firms tend to benefit from higher yields, especially if the yield curev steepens, the curve currently has negative spreads out longer.
Of the worst performers are Utilities (XLU), down 7.45%. Many investors in utilities these stocks for dividend yield; as US government bonds pay more interest, they make utility stocks less attractive. Real Estate is also affected by higher rates as underlying assets (properties) decline and the attractiveness of its dividends diminish with high rates available elsewhere. The Energy sector (XLE) was the third worst. Energy is taking its lead from what is happening between Russia and the rest of Europe.
Looking Forward
Income and consumer spending have held strong in early 2023. This would seem to put off any chance of a recession beginning this quarter or next. Earnings reported for the fourth quarter have been mixed. Public companies are dealing with their own increased costs of doing business.
The Fed raising rates one, two, or three more times in 2023 is fully expected. What became less certain is whether they will continue to rely on 25bp increments or if another 50bp is on tap in March or beyond. The Fed began raising rates last March, a large impact has yet to be felt, and it is not expected to take a wait-and-see approach soon.
February’s small decline after a large January run-up is not unusual activity. In fact the short month has typically been one of the worst of the year for the U.S. stock market. Historically, the S&P 500 has performed better in March and April. How much better? Since 1928, the S&P 500 has averaged a 0.5% gain in March and a 1.4% gain in April.
Take-Away
The market was given a lot to think about in February. Inflation stopped trending down, earnings were not exciting, and participants had amassed better gains than they had in previous months. It was time for some to take some chips off the table and look for an opportunity to get back in.
March, which historically has been positive, will allow investors to see if the tick-up in inflation is a trend or an aberration and whether negative sentiment, with money on the sidelines, makes the current market more of a buy than a sell.
VANCOUVER, BC, Feb. 28, 2023 /PRNewswire/ – Defense Metals Corp. (“Defense Metals” or the “Company“) (TSXV: DEFN) (OTCQB: DFMTF) (FSE:35D) is pleased to report favourable comminution results on multiple samples extracted from the Wicheeda deposit. The data allows the design of the crushing and grinding plant that will be an integral part of the planned Wicheeda development. These data are essential inputs to the upcoming pre-feasibility study (PFS).
Comminution, i.e., crushing and grinding, will be the first step in the processing of material mined from the Wicheeda deposit. In the process, coarse, as-mined, rocks are reduced in size to sand-like particles, typically less than 1 mm in size, and suitable for upgrading by flotation or other means. Comminution usually accounts for a significant percentage of the energy demand, production cost and carbon footprint of a mineral processing plant.
John Goode, Metallurgy Advisor, stated: “Comminution tests on seventeen variability samples and a Master Composite show that the ore is soft, amenable to conventional grinding operations and has a low abrasion index. The recent results confirm, and expand on data obtained from a 30 t bulk sample taken in 2019. The data show that a conventional semi-autogenous grinding (SAG) mill-ball mill circuit will work well and that grinding energy and supply costs will be relatively low.”
Key Highlights:
The Wicheeda variability samples and Master Composite were studied using the industry-standard SMC test to determine amenability to, and sizing design parameters for, SAG processing. The A x b value averaged 97 and the SAG Circuit Specific Energy (SCSE) averaged 7 kWh/t indicating a very soft ore.
The Bond rod mill work index test was applied to the Master Composite and returned a value of 10 kWh/t – which again indicates a very soft feed material.
The Bond ball mill work index test was applied to all samples and resulted in an average of 10 kWh/t using a 65-mesh closing screen. This again indicates a very soft feed material.
A standard Bond abrasion test was performed on the Master Composite and returned a value of 0.059 g meaning a very low consumption of grinding balls and mill liners is anticipated.
The Bond ball mill work index and abrasion index data for these new samples are very similar to the values obtained on the 2019 bulk sample taken from the Wicheeda deposit giving additional confidence in the new data. Comminution data for the 2019 bulk sample were used during preparation of the 2021 Independent Preliminary Economic Assessment1.
Methodology
Seventeen variability samples and a Master Composite were made from drill core taken from the Wicheeda deposit. The variability samples covered different lithologies, depths, areas and grades of the deposit. The Master Composite had a mass of 260 kg and included all lithologies in the approximate ratios of their mass in the deposit.
SGS Lakefield performed all of the comminution tests. The SMC testing protocol is an industry-standard method of evaluating the amenability of material to grinding in a semi-autogenous grinding (SAG) mill. The Bond rod and ball mill indices and abrasion index are also industry-standard tests performed on crushed ore and are essential to the accurate sizing of a grinding circuit.
The comminution data will be used, along with other information, during the upcoming pre-feasibility study (PFS) to design the comminution circuit for the Wicheeda project.
PDAC Convention, Toronto, March 5 – 8, 2023
The Company is also pleased to announce that it will be attending this year’s Prospector’s and Developer’s Annual Convention (PDAC) in Toronto, Ontario, Canada from Sunday, March 5 to Wednesday, March 8, 2023.
The Company’s management team, members of the Board of Directors and technical advisors will be available during the convention (www.pdac.ca/convention) and invite you to drop by Booth #2500 in the Investors Exchange in the Metro Toronto Convention Centre from March 5 – 7, 2023, 10 a.m. to 5 p.m. and March 8, 2023, 9 a.m. to 12 p.m. to discuss the Company’s latest activities and plans for 2023 and onward.
In addition, we invite you to attend the following presentation at PDAC, which includes Kris Raffle, P.Geo, a director of the Company, presenting on behalf of Defense Metals at 2:14 p.m.: Electric materials / Rare earth elements (REE), Room 801B – MTCC Level 800.
Qualified Person
The scientific and technical information contained in this news release, as it relates to the Wicheeda Rare-Earth Project, has been reviewed and approved by John Goode, P. Eng., who is a Qualified Person as defined by National Instrument 43-101 and who has provided the technical information relating to metallurgy in this news release.
About the Wicheeda REE Property
Defense Metals 100% owned, 4,262-hectare (~10,532-acre) Wicheeda REE property is located approximately 80 km northeast of the city of Prince George, British Columbia; population 77,000. The Wicheeda REE Project is readily accessible by all-weather gravel roads and is near infrastructure, including hydro power transmission lines and gas pipelines. The nearby Canadian National Railway and major highways allow easy access to the port facilities at Prince Rupert, the closest major North American port to Asia.
The 2021 Wicheeda REE Project Preliminary Economic Assessment technical report (“PEA”) outlined a robust after-tax net present value (NPV@8%) of $517 million and an 18% IRR1. This PEA contemplated an open pit mining operation with a 1.75:1 (waste:mill feed) strip ratio providing a 1.8 Mtpa (“million tonnes per year”) mill throughput producing an average of 25,423 tonnes REO annually over a 16 year mine life. A Phase 1 initial pit strip ratio of 0.63:1 (waste:mill feed) would yield rapid access to higher grade surface mineralization in year 1 and payback of $440 million initial capital within 5 years.
About Defense Metals Corp.
Defense Metals Corp. is a mineral exploration and development company focused on the acquisition, exploration and development of mineral deposits containing metals and elements commonly used in the electric power markets, defense industry, national security sector and in the production of green energy technologies, such as, rare earths magnets used in wind turbines and in permanent magnet motors for electric vehicles. Defense Metals owns 100% of the Wicheeda Rare Earth Element Deposit located near Prince George, British Columbia, Canada. Defense Metals Corp. trades in Canada under the symbol “DEFN” on the TSX Venture Exchange, in the United States, under “DFMTF” on the OTCQB and in Germany on the Frankfurt Exchange under “35D”.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.
Cautionary Statement Regarding “Forward-Looking” Information
This news release contains “forward–looking information or statements” within the meaning of applicable securities laws, which may include, without limitation, statements relating to advancing the Wicheeda REE Project, completion of the PFS, attending PDAC, the Company’s plans for its Wicheeda REE Project, expected results and outcomes from the comminution data, the technical, financial and business prospects of the Company, its project and other matters. All statements in this news release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Although the Company 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 may differ materially from those in the forward-looking statements. Such statements and information are based on numerous assumptions regarding present and future business strategies and the environment in which the Company will operate in the future, including the price of rare earth elements, the anticipated costs and expenditures, the ability to achieve its goals, that general business and economic conditions will not change in a material adverse manner, that financing will be available if and when needed and on reasonable terms. Such forward-looking information reflects the Company’s views with respect to future events and is subject to risks, uncertainties and assumptions, including the risks and uncertainties relating to the interpretation of exploration and metallurgical results, risks related to the inherent uncertainty of exploration and development and cost estimates, the potential for unexpected costs and expenses and those other risks filed under the Company’s profile on SEDAR at www.sedar.com. While such estimates and assumptions are considered reasonable by the management of the Company, they are inherently subject to significant business, economic, competitive and regulatory uncertainties and risks. Factors that could cause actual results to differ materially from those in forward looking statements include, but are not limited to, continued availability of capital and financing and general economic, market or business conditions, adverse weather and climate conditions, failure to maintain or obtain all necessary government permits, approvals and authorizations, failure to maintain community acceptance (including First Nations), risks relating to unanticipated operational difficulties (including failure of equipment or processes to operate in accordance with specifications or expectations, cost escalation, unavailability of personnel, materials and equipment, government action or delays in the receipt of government approvals, industrial disturbances or other job action, and unanticipated events related to health, safety and environmental matters), risks relating to inaccurate geological, metallurgical and engineering assumptions, decrease in the price of rare earth elements, the impact of Covid-19 or other viruses and diseases on the Company’s ability to operate, an inability to predict and counteract the effects of COVID-19 on the business of the Company, including but not limited to, the effects of COVID-19 on the price of commodities, capital market conditions, restriction on labour and international travel and supply chains, loss of key employees, consultants, or directors, increase in costs, delayed results, litigation, and failure of counterparties to perform their contractual obligations. The Company does not undertake to update forward–looking statements or forward–looking information, except as required by law.
1 Independent Preliminary Economic Assessment for the Wicheeda Rare Earth Element Project, British Columbia, Canada, dated January 6, 2022, with an effective date of November 7, 2021, and prepared by SRK Consulting (Canada) Inc. is filed under Defense Metals Corp.’s Issuer Profile on SEDAR (www.sedar.com).
Continued progress for programs targeting eye diseases with the submission of an IND application for OCU200
Expanded portfolio now includes inhaled vaccines for COVID-19, seasonal flu, and a combination COVID-19+seasonal flu vaccine
MALVERN, Pa., Feb. 28, 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 fourth quarter and full year 2022 financial results along with a general business update.
“We continue to grow and advance as a diversified biotechnology organization as reflected in our accomplishments of 2022,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “Our pipeline has been expanded to appropriately address the current challenges and gaps in the fight against COVID-19, application of OCU410 to address Stargardt (a rare eye disease), and our novel approach to address dry age-related macular degeneration (dAMD)—a disease affecting vision in over 266 million people worldwide.
“Following FDA concurrence in the fourth quarter of 2022 on a confirmatory Phase 3 clinical trial design for NeoCart®, we are developing internal capabilities to move our regenerative medicine asset, NeoCart®, into the clinic next year.”
“The FDA has granted expanded orphan drug designations to OCU400 for the treatment of retinitis pigmentosa (RP) and Leber congenital amaurosis (LCA),” said Dr. Musunuri. “These broad, gene-agnostic designations are encouraging at this stage in the development of OCU400.”
“During our first decade, we have built a strong foundation for addressing the diseases and conditions we aim to treat. We delivered on our promise to file an OCU200 IND in the first quarter of 2023 and look forward to delivering on important milestones in 2023, especially regarding preliminary efficacy data for gene therapy product OCU400, as we progress toward realizing our long-term vision to address unmet medical needs through courageous innovation,” Dr. Musunuri concluded.
Business Updates
Ophthalmic Gene Therapies
OCU400 – Established the high dose as the maximum tolerable dose, completed retinitis pigmentosa patient enrollment, and continuing to enroll patients with LCA to receive the high dose. Ocugen intends to initiate a Phase 3 clinical trial near the end of 2023.
OCU410 and OCU410ST – Executing IND-enabling studies and intend to submit IND applications in the second quarter of 2023 to initiate Phase 1/2 clinical trials in dry AMD (geographic atrophy) and Stargardt disease.
Ophthalmic Biologic Product
OCU200 – Submitted an IND application on February 27, 2023 to initiate a Phase 1 clinical trial targeting diabetic macular edema.
Regenerative Cell Therapies
NeoCart® – Received concurrence from the FDA on the confirmatory Phase 3 clinical trial design. Ocugen intends to initiate the Phase 3 clinical trial in the first half of 2024. Ocugen is renovating its facility to accommodate cGMP manufacturing of NeoCart® for clinical trials and beyond.
Vaccines Portfolio
OCU500 Series – Developing a novel mucosal vaccine platform which includes OCU500, a bivalent COVID-19 inhaled vaccine; OCU510, a seasonal quadrivalent flu inhaled vaccine; and OCU520 a combination quadrivalent seasonal flu and bivalent COVID-19 inhaled vaccine.
COVAXIN™ (BBV152) – Completed enrollment in Phase 2/3 immuno-bridging and broadening clinical trial in fourth quarter 2022.
Financial Results
Fourth quarter — Research and development expenses for the three months ended December 31, 2022, were $17.2 million compared to $7.1 million for the three months ended December 31, 2021. General and administrative expenses for the three months ended December 31, 2022, were $6.9 million compared to $7.5 million for the three months ended December 31, 2021. Ocugen reported a $0.10 net loss per common share for the three months ended December 31, 2022, compared to a $0.07 net loss per common share for the three months ended December 31, 2021.
Full year — Research and development expenses for the year ended December 31, 2022, were $49.8 million compared to $35.1 million for the year ended December 31, 2021. General and administrative expenses for the year ended December 31, 2022, were $35.1 million compared to $22.9 million for the year ended December 31, 2021. Ocugen reported a $0.38 net loss per common share for the year ended December 31, 2022, compared to a $0.30 net loss per common share for the year ended December 31, 2021.
Ocugen’s cash, cash equivalents, restricted cash, and investments totaled $90.9 million as of December 31, 2022, compared to $95.1 million as of December 31, 2021. The Company estimates that its current cash, cash equivalents, and investments will enable it to fund its operations into the first quarter of 2024. The Company had 221.6 million shares of common stock outstanding as of December 31, 2022.
Conference Call and Webcast Details
Ocugen has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the financial results and recent business highlights. Ocugen’s senior management team will host the call, which will be open to all listeners. There will also be a question-and-answer session following the prepared remarks.
Attendees are invited to participate on the call or webcast using the following details:
Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers Conference ID: 8912239 Webcast: Available on Ocugen’s 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.
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 IR@ocugen.com
Blackboxstocks, Inc. is a financial technology and social media hybrid platform offering real-time proprietary analytics and news for stock and options traders of all levels. Our web-based software employs “predictive technology” enhanced by artificial intelligence to find volatility and unusual market activity that may result in the rapid change in the price of a stock or option. Blackbox continuously scans the NASDAQ, New York Stock Exchange, CBOE, and all other options markets, analyzing over 10,000 stocks and up to 1,500,000 options contracts multiple times per second. We provide our users with a fully interactive social media platform that is integrated into our dashboard, enabling our users to exchange information and ideas quickly and efficiently through a common network. We recently introduced a live audio/video feature that allows our members to broadcast on their own channels to share trade strategies and market insight within the Blackbox community. Blackbox is a SaaS company with a growing base of users that spans 42 countries; current subscription fees are $99.97 per month or $959.00 annually. For more information, go to: www.blackboxstocks.com .
Joe Gomes, Managing Director – Generalist Analyst, Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
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CEO Form 4. On February 27th, the SEC released a Form 4 filing by CEO Gust Kepler that reported Mr. Kepler’s purchase of 1,130,002 BLBX shares on February 23rd at a price of $3 per share. The purchased increased Mr. Kepler’s direct common stock holding to 3,462,070 shares. According to the Company, this was a private transaction not conducted on an exchange. Mr. Kepler also owned 3,269,998 Series A Preferred shares as of December 27, 2022 that can be converted into common shares.
Investor Reaction. On Monday, BLBX shares rose 47% to close at $0.81 on 16.8 million shares traded. Normal average daily volume is 554,000 shares and the last time BLBX shares traded consistently in the $3 level was back in 2021, excluding a one-time spike in the share price in April 2022.
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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.
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.
Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.
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Triple Therapy Advances. PDS Biotech announced that the FDA has agreed to requirements for a registration trial using PDS0101 “Triple Combination” therapy in head and neck cancer. The study will test the combination of PDS0101, PDS0301, and a commercially available checkpoint inhibitor. We believe the changes from the previous trial should make regulatory approval faster, with additional tumor types added after market entry.
New Combination Eliminates An Unapproved Checkpoint Inhibitor. The new Triple Combination uses PDS010 to stimulate an immune response against the HPV antigen, PDS0301 to stimulate a robust immune response, and a checkpoint inhibitor to allow the immune system to recognize the tumor cells. The previous trial included bintrafusp alfa, an experimental checkpoint inhibitor. We believe the change to an approved checkpoint inhibitor simplifies the regulatory path.
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Mark Reichman, Senior Research Analyst, Natural Resources, Noble Capital Markets, Inc.
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Park Place hydrogeological study. LithiumBank Resources released results from a hydrogeological study at its 100% owned Park Place Lithium Brine Project located 180 kilometers west of Edmonton, Alberta, and 50 kilometers south of the company’s other flagship Boardwalk lithium brine project. The hydrogeological study was completed by Matrix Solutions and will be incorporated into a NI 43-101 compliant technical report and resource estimate which is expected in the second quarter of 2023.
Surprisingly favorable results. The hydrogeological study indicates Park Place hosts a combined 76.3 cubic kilometers of lithium-bearing brine, including 49.8 cubic kilometers within the Leduc Formation and 26.5 cubic kilometers within the Swan Hills Formation. By comparison, the company’s Boardwalk projects hosts 17.1 cubic kilometers of lithium-bearing brine. As a result, Park Place may be considered the largest reported lithium-rich brine project by volume in North America held by a single operator.
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Mark Reichman, Senior Research Analyst, Natural Resources, Noble Capital Markets, Inc.
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Eskay VMS project. The company’s Eskay Volcanogenic Massive Sulphide (VMS) project encompasses 52,600 hectares of highly prospective property within proximity to several world class gold deposits, including the adjacent past-producing Eskay Creek Mine, a high-grade gold-silver rich VMS deposit that is considered the world’s most precious metal-rich volcanogenic massive sulfide deposit. Based on Eskay’s exploration program, a new model of the tectonic architecture of the Eskay Mining District has identified three anticlines that wholly or partially underlay Eskay Mining’s property. The company’s new model suggests the flanks of each of these three anticlines are prospective for Eskay Creek-style VMS mineralization.
Recent drill results. Eskay recently released drilling results from the 2022 program at the TV and Tarn Lake targets. Drilling returned 1.51 grams of gold per tonne and 25.39 grams of silver per tonne over 43.1 meters and 2.84 grams of gold per tonne and 22.17 grams of silver per tonne over 16.4 meters in extensional drilling at the TV deposit. Assay results from the maiden drill program at Tarn Lake have defined an 80-meter-long open-ended trend of gold mineralization that dips in a west-northwestern direction.
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Money Supply Numbers Show the Fed is Making Headway
Money Supply, as reported by the Federal Reserve, fell by the largest amount ever recorded. This significant year-on-year drop shows the Fed’s tight monetary policy at work. However, despite the dramatic decline of cash available to consumers, the pace of increase that led up to the twelve-month period was even more dramatic. This indicates the Fed is not even close to finished draining liquidity from the economy, which serves to push up the cost of money (interest rates).
What is M2, how does it impact spending, and how much lower can the money supply go to reach “normal”? Let’s explore.
The M2 Report
Data for January, released on February 28th, showed a negative growth rate of 1.7% versus a year ago. This is both the biggest yearly decline and also the first time ever it has contracted in consecutive months. The monthly rate of change has been falling consistently since mid-2021. As indicated on the chart below, it follows a historic peak of 27% growth in February 2021.
Money Supply is a measure of household liquidity, it includes household cash on hand, savings and checking deposits, and money market mutual funds. The level had been growing slowly, keeping pace with low inflation until 2020. In response to pandemic-related economic risks, the economy was then flooded with cash by the Fed. Like any other oversupply, this oversupply causes money’s value to decline – a recipe for inflation.
For almost a year, the Fed has been draining liquidity from the US economy. This includes the well-publicized retargeting of overnight bank lending rates which are accomplished by contracting the aggregate amount of cash banks hold in reserves. Draining liquidity also includes quantitative tightening by the Fed, not repurchasing maturing securities.
The Fed’s tightening is having an impact on savings and cash available to households. Although the consumer is still spending, the decline in savings makes the spending pace unsustainable. Unrelated to M2, but as important, is that consumer borrowing is up, and this, too, can not stay on an upward trajectory forever. The Fed’s actions have a lag time, but it is becoming obvious that there will come a point when consumers will need to change their spending habits downward. This is how inflation is expected to be reeled in, but it isn’t certain whether it is being reeled in at a pace where the Fed can succeed at reaching the 2% inflation rate goal – particularly in light of the last inflation number actually being higher than the previous month.
Where We Are Now
Although M2 growth rates declined at a pace shattering all records, levels are still abnormally high. To put numbers on it, Money Supply remains 39% higher than it was before the Covid-19 pandemic, just three years ago. In other words, the amount of liquidity in the economy is still significant, and too much money chasing too few goods and services lead to rising prices.
The current M2 of $21.27 trillion is nearly $6 trillion higher than the pre-pandemic level. At this point, money in the economy has surpassed real gross domestic product levels, a momentous shift that first happened in 2020 when the Fed flooded the economy with cash as the pandemic hit.
All of this indicates the Fed is actually being patient despite the dramatic tightening over the past year. It also makes it clear that they are not done mopping up the Covid-19 monetary mess. And investors shouldn’t be surprised to see their resolve continue until balances are more in-line with moderate inflation rates.
Take Away
The still elevated M2, despite its record yearly decline, is feeding inflation. The Fed is making headway removing fuel to the inflation fire.
However, consumers that historically have continued to spend at near unchanged levels, even when their disposable income no longer supports it, do eventually adjust. When this adjustment occurs, economic activity will slow. That’s when the Fed will be on the path to winning its inflation fight. Then perhaps we may actually get a pivot in monetary policy.
