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.
1Q25 Had Lower Expenses Than We Projected. Eledon reported a loss of $6.5 million or $(0.08) per share, including a gain of $10.1 million related to fair value of warrant liabilities. Without this one-time item, the loss would have been $16.6 million or $(0.21) per share, as Research and Development expense increased less from the previous quarters than we anticipated. We expect R&D to be relatively steady as the Phase 1b and Phase 2 BESTOW trials conclude later in FY2025. Cash on March 31, 2025, was $124.9 million.
Phase 1b Trial Data Expected Mid-Year. The Phase 1b open-label trial is testing an anti-rejection regimen using tegoprubart in kidney transplantation. We see this as important data, since the Phase 2 BESTOW trial is testing this regimen against the standard regimen with tacrolimus. Since historical data for the tacrolimus regimen has been published, we believe the Phase 1b data has some predictive value for the Phase 2 BESTROW trial.
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Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
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.
Fourth Quarter Included New Data On Norovirus Variants. Cocrystal reported a 1Q25 loss of $2.3 million or $(0.23) per share. During the quarter the company announced Phase 1 results from its CDI-988 study in norovirus. Importantly, preclinical data showed efficacy against new norovirus variants. We believe this provides additional support to Cocrystal’s method of targeting highly-conserved viral replication enzymes to make effective drugs against both current and future variants. Cash on March 31, 2025 was $6.9 million.
CDI-988 Activity Includes New Variant Strains. CDI-988 is a protease inhibitor in development for norovirus and corona virus. CDI-988 has shown activity against multiple strains, with new preclinical data in April 2025 showing efficacy against the GII.17 and GII.4 strains that have recently been most prevalent. Results from the Phase 1 high-dose cohort in healthy subjects is expected to be announced in 2Q2025. A human challenge trial is planned for later in FY2025 to evaluate CDI-988 for treatment and prophylaxis against norovirus.
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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.
Counting Down To The OLC PDUFA Date. Unicycive reported a 1Q25 loss of $21.2 million or $(0.61) per share, consistent with our estimates. We continue to expect approval of OLC (oxylanthanum carbonate) around its PDUFA date of June 28, followed by its launch later in the year. The company had $19.8 million in cash on March 31, 2025.
OLC Reduces Pill Burden To Improve Compliance. OLC is Unicycive proprietary formulation of lanthanum carbonate. It was developed to reduce serum phosphate levels in renal dialysis patients with only two small pills per day. We expect OLC to compete against Fosrenol (from Shire), the approved formulation of lanthanum, that requires chewing 3 to 6 large pills each day. This difference makes patient compliance easier.
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Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-15001 which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.
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.
1Q25 Reported With Product Updates. Tonix reported a 1Q25 loss of $16.8 million or $(2.84) per share, a smaller loss than we had estimated. Product sales were $2.4 million, slightly lower than the $2.6 million in 4Q24. Gross margins were 61%, an improvement over the 54% seen in 4Q24. TNX-102 SL has a PDUFA date of August 15, and preparations continue for launch in 4Q25. Cash on hand on March 31 was $131.7 million.
Anticipation Builds For TNX-102 SL PDUFA Date. We believe the two Phase 3 trials support product approval for TNX-102 SL in its fibromyalgia indication. As we have described in previous Research Notes, fibromyalgia is currently treated with a combination of pain relievers (opioid and neurological), antidepressants, and insomnia drugs. TNX-102 SL could become the first drug to relieve all major symptoms without side effects from each class of drug.
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CHICAGO, May 13, 2025 (GLOBE NEWSWIRE) — GoHealth, Inc. (NASDAQ: GOCO) (“GoHealth” or the “Company”), a leading health insurance marketplace and Medicare-focused digital health company, today announced financial results for the three months ended March 31, 2025.
First Quarter Highlights
First quarter 2025 net revenues of $221.0 million, a 19.1% increase compared to $185.6 million in the prior year period.
First quarter 2025 net loss of $9.8 million, a 54.2% improvement compared to a net loss of $21.3 million in the prior year period.
First quarter 2025 Adjusted EBITDA1 of $42.1 million, a 56.4% increase compared to $26.9 million in the prior year period.
First quarter 2025 Submissions2 were 303,026, a 40.2% increase compared to 216,148 Submissions in the prior year period, primarily driven by strong contributions from GoHealth’s internal captive agents.
First quarter 2025 Direct Operating Cost per Submission3 was $522, an 18.4% improvement compared to $640 in the prior year period.
Launched GoHealth Protect, a suite of products offered to cover unexpected life events, with the expansion into guaranteed acceptance life insurance as the inaugural product.
“Our achievements in the first quarter demonstrate substantial progress in key financial metrics, including revenue, Adjusted EBITDA, margin enhancement, and capital efficiency,” said Vijay Kotte, CEO of GoHealth. “We are continuously refining our platform, tools, product offerings and technology to provide consumers with a more personalized and higher-quality experience as they navigate complex coverage options. We believe these investments are not only elevating the consumer journey but also driving better outcomes across our business. With the recent launch of GoHealth Protect, we are diversifying our product offerings with a curated marketplace of coverage options. By expanding into guaranteed acceptance life insurance, we seek to extend the value of customer relationships, bolster unit economics, and further our mission of delivering peace of mind to consumers.”
“We delivered strong year-over-year growth, reduced customer acquisition costs, and improved operating leverage. At the same time, we continued to invest selectively in high-return initiatives, including the launch of our GoHealth Protect life insurance,” said Brendan Shanahan, CFO of GoHealth. “As this new offering scales, we expect it to enhance our ability to generate cash flow throughout the year while driving down acquisition costs across the business. A combination of disciplined execution and smart investment will position us well for continued momentum in the quarters ahead.”
(1)
Adjusted EBITDA is a non-GAAP measure. For a definition of Adjusted EBITDA and a reconciliation to the most comparable GAAP measure, please see below.
(2)
Number of Submissions is an operating metric. For a definition of Submissions, please see below.
(3)
Direct Operating Cost per Submission is an operating metric. For a definition of Direct Operating Cost per Submission and an explanation of its calculation, please see below.
Conference Call Details
The Company will host a conference call today, Tuesday, May 13, 2025 at 8:00 a.m. (ET) to discuss its financial results. A live audio webcast of the conference call will be available via GoHealth’s Investor Relations website, https://investors.gohealth.com/. A replay of the call will be available via webcast for on-demand listening shortly after the completion of the call.
About GoHealth, Inc.
GoHealth is a leading health insurance marketplace and Medicare-focused digital health company whose purpose is to compassionately ensure consumers’ peace of mind when making healthcare decisions so they can focus on living life. For many of these consumers, enrolling in a health insurance plan is confusing and difficult, and seemingly small differences between health plans may lead to significant out-of-pocket costs or lack of access to critical providers and medicines. GoHealth’s proprietary technology platform leverages modern machine-learning algorithms, powered by over two decades of insurance purchasing behavior, to reimagine the process of matching a health plan to a consumer’s specific needs. Its unbiased, technology-driven marketplace coupled with highly skilled licensed agents has facilitated the enrollment of millions of consumers in Medicare plans since GoHealth’s inception. For more information, visit https://www.gohealth.com.
Investor Relations:
John Shave
JShave@gohealth.com
Media Relations:
Pressinquiries@gohealth.com
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These forward-looking statements are made in reliance upon the safe harbor provision of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release may be forward-looking statements. Statements regarding our future results of operations and financial position, business strategy and plans and objectives of management for future operations, including, among others, statements regarding our expected growth, future capital expenditures, debt service obligations, adoption and use of artificial intelligence technologies, the impact on our business from regulatory changes, the impact on our business from the acquisition of e-TeleQuote Insurance, Inc. (“e-TeleQuote”) and our ability to successfully integrate e-TeleQuote’s operations, technologies and employees into our business, are forward-looking statements.
In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “aims,” “expects,” “plans,” “anticipates,” “could,” “intends,” “targets,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” “likely,” “future” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this press release are only predictions, projections and other statements about future events that are based on current expectations and assumptions. Accordingly, we caution you that any such forward-looking statements are not guarantees of future performance and are subject to risks, assumptions and uncertainties that are difficult to predict. Although we believe that the expectations reflected in these forward-looking statements are reasonable as of the date made, actual results may prove to be materially different from the results expressed or implied by the forward-looking statements.
These forward-looking statements speak only as of the date of this press release and are subject to a number of important factors that could cause actual results to differ materially from those in the forward-looking statements, including the factors described in the sections titled “Summary Risk Factors,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (“2024 Annual Report on Form 10-K”), our forthcoming Quarterly Report on Form 10-Q for the first quarter ended March 31, 2025 (“Q1 2025 Quarterly Report on Form 10-Q”) and in our other filings with the Securities and Exchange Commission. The factors described in our 2024 Annual Report on Form 10-K and our forthcoming Q1 2025 Quarterly Report on Form 10-Q should not be construed as exhaustive and should be read together with the other cautionary statements included in this press release, as well as the cautionary statements and other risk factors set forth in our other filings with the Securities and Exchange Commission.
You should read this press release and the documents that we reference in this press release completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
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.
1Q25 Reported With Product Launch and Clinical Trial Updates. Gyre reported Net Income of $3.7 million with Net Income Attributable to Common Shareholders of $2.7 million or $(0.03) per share. Data analysis for the Phase 3 Hydronidone trial in CHB-ALF (chronic hepatitis B-associated liver fibrosis) is ongoing, with a data announcement expected during 2Q25. The company also launched avatrombopag in China and plans to launch nintedanib during 2Q25. The cash balance on March 31, 2025 was $51.3 million.
Product Sales Declined But Gross Margin Was As Expected. Product sales were $22.1 million, a decline from $27.8 million in 4Q24. The decline in sales of Etuary, its drug for ITP, was attributed to the economic conditions in China and the shift in marketing resources away from Etuary and toward the new products, nintedanib and avatrombopag. Gross Margin of 96% was as we expected despite lower product volume.
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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.
Clinical Programs Meet Or Beat Expected Timeframes. Ocugen reported a 1Q25 loss of $15.4 million or $(0.05) per share, consistent with our estimates. The company’s three clinical trial continue to progress on schedule, with the first BLA application expected in mid-2026. Its fourth product, OCU200, initiated Phase 1 patient treatment during the quarter. Cash balance on March 31 was $38.1 million, projected to fund operations through early FY2026.
OCU400 Trial Continues To Lead The Way. The OCU400 liMeliGhT (pronounced “Limelight”) Phase 3 trial in RP continues to enroll patients, with completion expected around YE2025. The study enrolls patients over 5 years of age with any combination of over 100 mutations that cause RP. These patients are at stages ranging from early to advanced RP.
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Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
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Moving Forward. MariMed brands continue to capture more share across the markets served. The Company expanded into 70 new storefronts in the quarter. Although MariMed’s brands are already top sellers in their markets, we believe there is a significant opportunity to seize additional market share.
1Q25. Revenue in the first quarter of 2025 of $38 million was virtually unchanged from the first quarter of 2024. We had projected $38.8 million. Adjusted EBITDA was $2.56 million, down from $4.66 million last year. Reported net loss was $5.4 million, or $0.01/sh, compared to a net loss of $1.3 million, or breakeven, last year.
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Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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First Quarter Was Highlighted By The Collaboration With Abbott. Cadrenal Therapeutics reported a 1Q25 loss of $3.8 million or $(2.09) per share. An important development during the quarter was an agreement with Abbott to develop tecarfarin in LVADs (Left Ventricular Assist Devices). As planned, the company held a meeting with the FDA to discuss the next steps for clinical development of tecarfarin, its anticoagulant. Cash on March 31, 2025 was $7.3 million.
Meeting For Clinical Development Guidance Held With FDA. Cadrenal and the FDA held a meeting to discuss plans to conduct clinical trials to support an application for tecarfarin approval. The FDA gave guidance on the design and data requirements. Cadrenal plans to use the information to plan the final study design then submit it to the FDA for review and feedback.
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MALVERN, Pa., May 02, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that it will host a conference call and live webcast to discuss the Company’s first quarter 2025 financial results and provide a business update at 8:30 a.m. ET on Friday, May 9, 2025.
Ocugen will issue a pre-market earnings announcement on the same day. Attendees are invited to participate on 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: 1773288 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 pioneering biotechnology leader in gene therapies for blindness diseases. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Unlike traditional gene therapies and gene editing, Ocugen’s modifier gene therapies address the entire disease—complex diseases that are potentially caused by imbalances in multiple gene networks. Currently we have programs in development for inherited retinal diseases and blindness diseases affecting millions across the globe, including retinitis pigmentosa, Stargardt disease, and geographic atrophy—late stage dry age-related macular degeneration. Discover more at www.ocugen.com and follow us on X 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.
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.
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.
First Quarter Included Contract Revenues. GeoVax reported a 1Q25 loss of $5.4 million or $(0.45) per share, a smaller loss than we had expected. The quarter included $1.6 million in Contract Revenue from the BARDA contract in preparation for the Phase 2 trial. Since the contract was cancelled on April 11, 2025, the 2Q25 results will include some final contract work. Cash on March 31, 2025, was $7.4 million.
CM04S1 Continues Development With Focus On Immunocompromised Patients. The current focus of CM04S1 development is in immunocompromised patients, a population estimated at 40 million patients in the US alone. Data from the Phase 1 and Phase 2 clinical trials for CM04S1 was presented at the 25th World Vaccine Congress. The two Phase 2 trials in chronic lymphocytic leukemia and stem cell transplants continue to enroll patients, while the Phase 2 Healthy Adult Booster trial is expected to report data during 2Q25.
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Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Fiscal Year 2025 Reported. Nutriband reported its financial results for FY2025, ended January 31, 2025, with a 4Q25 loss of $5.5 million or ($0.50) per share and a loss of $10.5 million or $(0.99) per share. Preparations for the abuse-deterrence clinical testing continue, with an NDA expected toward 4Q25 or early 2026. As of January 31, 2025, the cash balance was $4.3 million.
Revenue For The Pocono Pharmaceutical Division Met Expectations. The Pocono Pharmaceutical division revenue for FY2025 was $2.1 million, with 4Q25 consistent with previous quarters. Gross margin improved in 4Q25 to 45% of sales, the highest level of the year. Nutriband has extended its contract manufacturing collaboration with KT tape, the kinesiology tape company, with modest growth in our projections for FY2026.
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