Author: cpereira@noblefcm.com

Onconova Therapeutics (ONTX) – Transaction Forms A New Company In Virology and Oncology

Posted on by cpereira@noblefcm.com


Wednesday, April 03, 2024

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation. Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in a combination trial with estrogen blockade in advanced endometrial cancer. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also evaluating opportunities for combination studies with narazaciclib in additional indications. Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies. These studies include a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma.

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.

Onconova Merges With Trawsfynydd Therapeutics To Form Traws Pharma, Inc. Onconova announced a business combination with Trawsfynydd Therapeutics, a private company developing products for influenza and COVID-19. The new company will be called Traws Pharma Inc, and will add antivirals to narazaciclib and rigosertib. Upon completion, it will raise $14 million in a private placement to bring its cash balance to about $28 million.

Combination Brings New Drugs With Several Near Term Milestones. Trawsfynydd brings antiviral drugs for influenza and COVID-19. TRX100 (viroksavir) inhibits the cap-dependent endonuclease required by the influenza virus for replication. Preclinical studies have shown efficacy against wild-type virus and strains that have resistance to current drugs. It has completed Phase 1, with data showing safety, tolerability, and pharmacokinetics that have potential dosing advantages. A dose-extension study will evaluate two increased doses. Following dose selection, Phase 2 is expected to begin in 2H24.


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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 (OCGN) – Progress In Clinical Trials Overshadows FY2023 Filing Delay

Posted on by cpereira@noblefcm.com


Wednesday, April 03, 2024

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.

10-K Filing Has Been Delayed. Ocugen announced that it has not filed its 10-K for FY2023 and will be restating FY2022 and first three quarters of FY2022. The restatement is due to errors in non-cash cost recognition related to collaborative agreements. We do not believe these restatements affect operating cash flow for these periods or the current cash balance. Cash on December 31, 2023, was reported at $39.5 million, which we estimate is sufficient to fund operations through 4Q24.

OCU400 Phase 3 Trial Is Expected To Begin Shortly. Ocugen reported that it is awaiting final clearance from the FDA to begin its Phase 3 trial testing OCU400 in retinitis pigmentosa (RP). Although timing of FDA actions can be unpredictable, patient treatment is expected to begin during April 2024. The trial will test OCU400 in RP with an enrollment of 300 patients, divided into an arm with the RHO mutation and a “mutation agnostic” arm with any RP-associated mutation. Each will randomize patients 2:1, with 50 treated patients and 25 control patients in each arm.


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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. 

Century Lithium Corp. (CYDVF) – Clayton Valley Lithium Project Feasibility Study Expectations

Posted on by cpereira@noblefcm.com


Wednesday, April 03, 2024

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.

Feasibility study expected shortly. Century’sClayton Valley lithium project is among the most advanced pre-permitted lithium projects in North America. In2023, the company focused on pilot plant operations with the results of a project feasibility study (FS) expected to be released within the next couple of weeks. The full report will be available approximately 45 days later. While production is expected to be consistent with the earlier preliminary feasibility study (PFS), we expect a phased approach to full scale production.

Feasibility study expectations. While we expect the feasibility study to reflect higher capital and operating costs, the economics may improve relative to the PFS due to several factors. These include: 1) a higher base case pricing assumption for lithium carbonate equivalent that could be in the range of US$22,000 to US$30,000 per tonne compared to US$9,500 per tonne used in the PFS, 2) a potential economic benefit from the by-product sales of sodium hydroxide, 3) the leaching process will be based on using hydrochloric acid instead of sulfuric acid, and 4) the project will likely incorporate lower cost renewable power. 


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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. 

Xcel Brands (XELB) – Opportunistically Fills Its Coffers

Posted on by cpereira@noblefcm.com


Wednesday, March 27, 2024

Xcel Brands, Inc. 1333 Broadway 10th Floor New York, NY 10018 United States https:/Sector(s): Consumer Cyclical Industry: Apparel Manufacturing Full Time Employees: 84 Key Executives Name Title Pay Exercised Year Born Mr. Robert W. D’Loren Chairman, Pres & CEO 1.27M N/A 1958 Mr. James F. Haran CFO, Principal Financial & Accou

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

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

Additional capital secured. On March 15, 2024, the company announced the completion of a secondary offering, which raised expected net proceeds of $2.2 million. In our view, there were several reasons for the offering, including funding start up costs for potential strategic partnerships in the pipeline, and gaining institutional interest. We view the capital raise favorably and believe it could enhance both revenue and cash flow growth.

Strategic partnerships. In December 2023, the company announced an exciting strategic partnership with Christie Brinkley to develop a lifestyle and apparel brand, TWRHLL, for distribution in retail and livestream commerce. Notably, Christie Brinkley will serve as the face of the brand and will make media appearances to promote TWRHLL’s product release, which is scheduled for spring 2024. Notably, Ms. Brinkley’s star power could illuminate the company’s new platform, ORME.


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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. 

Lifeway Foods (LWAY) – Momentum Increasing Stock Price, Moving to Market Perform

Posted on by cpereira@noblefcm.com


Wednesday, March 27, 2024

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

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

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

Moving to Market Perform. With the shares shooting past our recently raised $16 price target, we are lowering our rating to Market Perform from Outperform. LWAY shares over the last month have increased from $12.31 to $19.16 as of yesterday’s close.

Momentum in 2024. Year-to-date, LWAY shares have increased 42.9%. Over the last five trading days, average daily volume (ADV) has been just over 221,565 shares. The last three months have had an ADV of 59,642. We believe the increased volume is a reflection on the Company’s operational performance, with the Company recently capping a record year in revenue. The takeover speculation still looms around the Company, which also could be a driver of the price.


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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. 

Labrador Gold Corp. (NKOSF) – Take-Aways from a Recent Management Presentation

Posted on by cpereira@noblefcm.com


Wednesday, March 27, 2024

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.

Focus on Newfoundland. Labrador Gold’s President and Director, Dr. Roger Moss, recently delivered a presentation to the Toronto Geological Discussion Group entitled “The Kingsway Gold Project: Acquisition and Exploration in the Newfoundland Gold Rush.” Labrador Gold is advancing its flagship Kingsway gold project in the Central Newfoundland Gold Belt. The company is nearing completion of a 100,000-meter drilling program targeting high-grade gold mineralization along a 12-kilometer section of the Appleton Fault Zone with assays still pending. 

A retrospective. Dr. Moss discussed Labrador Gold’s history from its founding in 2017, when it was focused on gold in the Florence Lake Greenstone Belt at its Hopedale project in Labrador, to its March 2020 acquisition of its flagship Kingsway project in Newfoundland. While Labrador has funded exploration at both projects, drilling has centered on Kingsway in recent years. During the Q&A, Dr. Moss indicated that following several years of drilling at Kingsway, the company may take some time to evaluate and analyze results to date before embarking on the next phase of drilling at Kingsway.


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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. 

Direct Digital Holdings (DRCT) – Hits The Reset Button

Posted on by cpereira@noblefcm.com


Wednesday, March 27, 2024

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.

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

Q4 miss. The company reported disappointing Q4 results with revenue of $41.0 million and adj. EBITDA of $2.3 million. Both figures were well below our estimates of $67.9 million and $6.4 million, respectively. The underperformance was largely driven by system changes that the company made to its Sell-side segment during the quarter.

Re-positioning for the future. During the quarter, the SSP underwent technological changes to enable it to process ad impressions using alternative IDs. This transformation was necessary for the company to prepare for the impending cookie deprecation, which Google is expected to implement later this year.


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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. 

Bit Digital (BTBT) – Potential Expansion of AI Contract

Posted on by cpereira@noblefcm.com


Wednesday, March 27, 2024

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

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

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

More GPUs. Yesterday, Bit Digital received a proposal from the Company’s existing customer in Bit Digital AI to expand the scope of its agreement. The proposal calls for an additional 2,048 GPUs, amounting to a total of 4,096 GPUs under the amended agreement. Management intends to accept the proposal, subject to agreement on certain terms and conditions.

Revenue Potential. The current contract before the potential upsize has an annualized revenue run-rate of $50 million. If the proposal is fully realized, the Company would be close to, or meet, its goal of $100 million of annualized revenue by the end of 2024, in our view. Recall, management noted an additional $60 million of capital would be needed to get to the $100 million target through acquiring the necessary GPUs, based on current market conditions.


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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. 

ZyVersa Therapeutics, Inc. (ZVSA) – FY23 Reported With Reiteration of Milestones For Kidney and Inflammasome Trials

Posted on by cpereira@noblefcm.com


Tuesday, March 26, 2024

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.

ZyVersa Reported FY2023. ZyVersa Reported a FY2023 loss of $106.2 million or $(108.97) per share, including write-downs of In-process Research and Development of $81.4 million and Goodwill of $11.9 million that were recorded with the reverse merger in December 2022. Excluding these items, the operating loss would have been $14.4 million. Cash on hand was $3.1 million on December 31, and does not include $2.7 million from warrant exercise reported during February 2024.

ZyVersa Has Made Progress Toward Starting VAR 200 Clinical Trials. ZyVersa announced the selection of a CRO and approval by an Institutional Review Board (IRB). These are steps required to start the Phase 2a clinical trial for VAR 200, its lead molecule for modulating cholesterol and lipid accumulation in the kidney that starts damage and declining function pathways. VAR 200 is expected to begin treating patients with diabetic kidney disease in 1H24.


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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. 

Bitcoin Depot (BTM) – A Set Up Year For Future Growth

Posted on by cpereira@noblefcm.com


Tuesday, March 26, 2024

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.

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

Q4 results. For Q4 the company reported $148.4 million in revenue, below our forecast of $157.0 million and roughly flat compared to the prior year period. Adj. EBITDA  for the quarter was $9.0 million, which was in line with our estimate. The softer than expected revenue was largely driven by the company’s redeployment of kiosks. Notably, we believe the company’s favorable redeployment efforts could improve operating results in the long-run.

Expansion strategy. Management highlighted franchising as a favorable option for expansion. Notably, franchising offers the company a less capital intensive method for expansion, which captures approximately 30%-50% of profits from licensed kiosks. Additionally, management views New York as a significant opportunity for growth, and is currently in the application process to obtain a license to operate in the state.


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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. 

DLH Holdings (DLHC) – Another CMOP Update

Posted on by cpereira@noblefcm.com


Tuesday, March 26, 2024

DLH delivers improved health and readiness solutions for federal programs through research, development, and innovative care processes. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,300 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to public health to improve the lives of millions. For more information, visit www.DLHcorp.com.

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

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

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

More Changes? The Veterans Administration appears to be making more changes to the Consolidated Mail Outpatient Pharmacy contract process. The procurements were set-aside for a service-disabled veteran owned small business as the prime contractor with each of the eight procurements being evaluated separately for 5-year contracts. On March 14th, the VA issued a notice for services for durations of up to three months.

Background. In an extended process, the VA is again seeking to complete a re-bid and award of the CMOP contracts. In January 2023 DLH and other parties submitted bids for the eight separately competed procurements pertaining to the program. Recall, DLH has operated under a series of “bridge” contracts since 2016. Most recently, the VA extended these contracts through April 30, 2024.


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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. 

One Stop Systems (OSS) – Reports Fourth Quarter and Fiscal Year Results

Posted on by cpereira@noblefcm.com


Monday, March 25, 2024

One Stop Systems, Inc. (OSS) designs and manufactures innovative AI Transportable edge computing modules and systems, including ruggedized servers, compute accelerators, expansion systems, flash storage arrays, and Ion Accelerator™ SAN, NAS, and data recording software for AI workflows. These products are used for AI data set capture, training, and large-scale inference in the defense, oil and gas, mining, autonomous vehicles, and rugged entertainment applications. OSS utilizes the power of PCI Express, the latest GPU accelerators and NVMe storage to build award-winning systems, including many industry firsts, for industrial OEMs and government customers. The company enables AI on the Fly® by bringing AI datacenter performance to ‘the edge,’ especially on mobile platforms, and by addressing the entire AI workflow, from high-speed data acquisition to deep learning, training, and inference. OSS products are available directly or through global distributors. For more information, go to www.onestopsystems.com.

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

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

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

A Transformational Year. 2023 was a transformational year for OSS. The low margin digital business went away, a new management team and Board members were installed, and the Company is now firmly focused on large and rapidly growing global markets driven by AI and ML.

4Q23 Results. Revenue totaled $13.2 million, slightly above our $13 million estimate, but down 28% y-o-y, reflecting the continued runoff of the Disguise business, which contributed $3.1 million of revenue in the year ago quarter. Gross margin, however, rose 640 basis points to 33.7%. OSS net loss was $277,560, or a loss of $0.01/sh in the quarter, compared to a net loss of $3.3 million, or a loss of $0.16/sh last year. Adjusted EPS was $0.01/sh compared to a net loss of $0.14/sh last year. We had forecasted a loss of $0.07/sh.


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Haynes International (HAYN) – Special Shareholder Meeting is Scheduled for April 16

Posted on by cpereira@noblefcm.com


Monday, March 25, 2024

Haynes International, Inc. is a leading developer, manufacturer and marketer of technologically advanced, nickel and cobalt-based high-performance alloys, primarily for use in the aerospace, industrial gas turbine and chemical processing industries.

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.

Special meeting of stockholders. Haynes International recently filed definitive proxy materials in anticipation of a special meeting of stockholders to vote on the company’s proposed merger with North American Stainless, Inc., a wholly owned subsidiary of Acerinox S.A. Acerinox is a leader in the manufacturing and distribution of stainless steel and high-performance alloys and will acquire all the outstanding shares of Haynes for $61.00 per share in an all-cash transaction. The special meeting of stockholders of Haynes International will be held virtually on Tuesday, April 16, 2024, at 9:30 am ET. Haynes stockholders of record as of the close on March 11 are entitled to vote the shares of Haynes International common stock held on the record date.

Closing is expected in the third calendar quarter. The waiting period under the Hart-Scott-Rodino Antitrust Improvements Act expired on March 18. Remaining closing conditions include approval of the merger under other applicable foreign investment laws and the adoption of the merger agreement by Haynes’ stockholders. The transaction is expected to close in the third calendar quarter of 2024.


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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.