Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.
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.
Fiscal Q2 results. SelectQuote reported fiscal Q2 revenue of $537.1 million, above our $520.0 million estimate, driven by stronger-than-expected Senior performance. Adj. EBITDA of $84.7 million exceeded our $82.0 million forecast, reflecting near-record 39% adj. EBITDA margins in Senior that more than offset pharmacy reimbursement pressure.
Medicare Advantage headwinds. Management cited pressure from a large national carrier’s decision to reduce strategic marketing spend across all channels. We believe this reflects a deliberate effort to moderate enrollment growth and protect plan profitability following above-trend member additions, rather than any deterioration in underlying demand.
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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.
MustGrow’s Canola Field Trials Demonstrate Clubroot Disease Suppression; Improved Canola Yield with Heathier Root Systems
MustGrow’s mustard-derived organic biocontrol technology TerraMGTM focuses on soil-borne disease and pest suppression, which has been shown to improve soil conditions, crop yields, and healthier root systems;
Clubroot is a soil-borne parasitic disease with devastating effects on canola production across the Canadian Prairies with no effective products currently registered for Clubroot suppression;
Field trial findings support TerraMGTM’s role as a sustainable product capable of suppressing Clubroot and promoting higher canola yields and root systems under various disease pressures;
MustGrow (via NexusBioAg) trialed approx. 100 acres over 2-year field program.
SASKATOON, Saskatchewan, Canada, February 3, 2026 – MustGrow Biologics Corp. (TSXV: MGRO; OTC: MGROF; FRA: 0C0) (the “Company” or “MustGrow“), is pleased to announce completion and results of its 2-year field trial program in the Canadian Prairies on approximately 100 acres of canola production. Field trial findings have demonstrated MustGrow’s TerraMGTM is a sustainable technology capable of suppressing clubroot parasitic disease (P. brassicae) (“Clubroot”) and promoting higher canola yields and root systems under various disease pressures.
Clubroot is a soil-borne parasitic disease that has had devastating effects on canola production across the Canadian Prairies with no effective products currently available for Clubroot suppression. Canola is Canada’s most valuable field crop, with 2025 production reaching approximately $14 billion (21.8 million tonnes at approximately $650/tonne)(1) and generating billions in annual export revenue. Without adequate treatment and management solutions, Clubroot continues to create major problems for Canadian canola farmers who need a solution.
TerraMGTM: MustGrow’s Answer to Clubroot
MustGrow is actively working towards registering its organic biocontrol product TerraMGTM through Health Canada’s Pest Management Regulatory Agency. TerraMGTM combats Clubroot through its mechanism, releasing naturally occurring isothiocyanates from mustard seed meal. Isothiocyanates are known to possess fungicidal and biocidal activity, suppressing a range of soil-borne pathogens, including Clubroot.
In MustGrow’s 2024 and 2025 field trials, conducted through its wholly-owned Canadian marketing and distribution business NexusBioAg, TerraMGTM-treated plots showed a significant reduction in resting spore concentrations of Clubroot relative to untreated controls. Visual assessments of canola root galls indicated reduced severity and incidence in treated plots. These findings support TerraMGTM’s role as a sustainable biocontrol capable of suppressing Clubroot inoculum and promoting higher canola yields and healthier root systems under various disease pressure.
In 2024, Clubroot spores were more prevalent due to a wetter growing season, and TerraMGTM performed exceptionally well with up to 95% reductions in Clubroot spores. Disease pressure was consistent throughout the season due to the wetter conditions. Yield benefits to the grower showed up to a 7 bushel/acre increase (19% increase over Canada’s 36 bushel/acre average production in 2024)(2), translating to a $91/acre increase in value to the farmer (at approximately $13/bushel average commodity price)(3).
In 2025, according to internal data, canola farmers experienced a relatively dry season and correspondingly less Clubroot disease prevalence than the much wetter 2024 season. Yield increase utilizing TerraMGTM demonstrated a 1-2 bushel/acre increase over the control, which was less impactful than 2024, with less Clubroot infestation in the fields to address.
Detrimental Disease with Limited Options for Farmers
The 15-20 year longevity of Clubroot’s highly resilient resting spores is a key element of Clubroot’s persistence and detrimental impact on canola. The parasitic disease induces gall formation on roots, disrupting water and nutrient uptake. Early infection with moderate to high spore loads can lead to 100% loss of canola crop. Infection at the early seedling stage can later result in wilting, stunting, yellowing and death of canola plants. In later crop stages, inflection may not necessarily show wilting, stunting or yellowing, but infected plants may ripen prematurely, resulting in shriveled seeds and negatively impacting yield, oil content, and quality.(4)
No effective products are currently registered for Clubroot suppression in canola. Current farming practices include extensive sanitation and equipment cleaning, long crop rotations (3-4 years between canola crops), and genetically-modified resistant canola varieties. While genetic resistance in commercial canola hybrids initially provided strong control, new mutated Clubroot pathotypes are now capable of overcoming resistance.(4)
These methods, while partially effective, are economically and logistically challenging. A biological, soil-active technology, like MustGrow’s TerraMGTM, capable of reducing resting spore loads could represent a significant breakthrough in sustainable Clubroot management for Canadian farmers.
MustGrow Biologics Corp. is a fully-integrated provider of innovative biological and regenerative agriculture solutions designed to support sustainable farming. The Company’s proprietary and third-party product lines offer eco-friendly alternatives to restricted or banned synthetic chemicals and fertilizers. In North America, MustGrow offers a portfolio of third-party crop nutrition solutions, including micronutrients, nitrogen stabilizers, biostimulants, adjuvants and foliar products. These products are synergistically distributed alongside MustGrow’s wholly-owned proprietary products and technologies that are derived from mustard and developed into organic biocontrol and biofertility products to help replace banned or restricted synthetic chemicals and fertilizers. Outside of North America, MustGrow is focused on collaborating with agriculture companies, such as Bayer AG in Europe, the Middle East and Africa, to commercialize MustGrow’s wholly-owned proprietary products and technologies. The Company is dedicated to driving shareholder value through the commercialization and expansion of its intellectual property portfolio of approximately 110 patents that are currently issued and pending, and the sales and distribution of its proprietary and third-party product lines through NexusBioAg. MustGrow is a publicly traded company (TSXV-MGRO) and has approximately 62.9 million common shares issued and outstanding and 77.0 million shares fully diluted. For further details, please visit www.mustgrow.ca.
Contact Information
Corey Giasson Director & CEO Phone: +1-306-668-2652 [email protected]
MustGrow Forward-Looking Statements
Certain statements included in this news release constitute “forward-looking statements” which involve known and unknown risks, uncertainties and other factors that may affect the results, performance or achievements of MustGrow.
Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”. Forward-looking statements in this news release, including statements about: the impact and significance of customer performance data and field testing, the increase in value of yields and the costs of such increase in value, if any, and are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow. Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include: those risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2024 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available on SEDAR+ at www.sedarplus.ca. Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.
Neither the TSXV, nor their Regulation Services Provider (as that term is defined in the policies of the TSXV), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.
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.
Phase 1b Data For Second Year After Transplantation Presented. Eledon presented data from its Phase 1b trial at the American Society of Transplant Surgeons (ASTS) meeting in January 2026. The presentation included data from 8 patients that had reached 24 months after transplantation, compared with 12 patients evaluated 12 months after transplantation presented in August 2025. These new data show a continued improvement in kidney function during the second year.
New Data Show Durability With Improvements. The 24-month data shows eGFR in tegoprubart patients continued to improve during months 12 to 24 after transplantation. The eGFR levels were restored to normal levels within 1 month after transplantation and were maintained for up to 2 years. Although this is a small number of patients, we see the result as consistent with prior data and our expectations for organ survival.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
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.
ORLANDO, Fla., Jan. 30, 2026 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ: NTRB) (NASDAQ: NTRBW) has provided an update to shareholders on the key milestones and discussions from this years Annual Shareholders Meeting, held on Jan 24, 2026 in Orlando, Florida. Details and highlights may be found below.
Addition of Two New Directors
Allesandro Puddu Alessandro Puddu is an Italian Chartered Accountant and Statutory Auditor with over 10 years of experience in audit, corporate advisory and financial reporting for industrial groups and listed companies.
He advises companies on tax and corporate matters, company valuations, extraordinary corporate transactions and IAS/IFRS reporting, including consolidated financial statements. He has supported the design and implementation of accounting and administrative procedures and regularly serves as statutory auditor and member of statutory boards of Italian companies.
He currently serves as Group Internal Auditor for a company listed on the STAR segment of the Italian Stock Exchange, overseeing internal control and audit activities, including those related to the Group’s United States subsidiaries. At the beginning of his career, he worked at PricewaterhouseCoopers as a Senior Auditor, reviewing Italian and multinational companies operating in various industrial sectors, including the pharmaceutical sector, and coordinating audit teams across multiple jurisdictions.
Alessandro Puddu is enrolled in the Italian Register of Chartered Accountants (Dottori Commercialisti), the Register of Statutory Auditors held by the Italian Ministry of Economy and Finance, and the Register of Crisis & Insolvency Practitioners, and holds a Master’s Degree in Economics and Management.
Viorica Carlig Viorica Carlig is a senior executive with over a decade of leadership experience across service-based companies. She currently provides executive and strategic oversight for multiple multinational organizations, leading operations, governance, compliance, budgeting, and growth initiatives in complex regulatory environments. With a background spanning business administration, law, and economics—including a Ph.D. in Economics—Viorica combines strong commercial judgment with rigorous operational and risk management expertise. Earlier in her career, she practiced commercial and corporate law as a member of the Bucharest Bar, advising companies on contracts, governance, and regulatory compliance. She is a multilingual leader experienced in managing diverse teams and stakeholders across Europe and beyond.
2025 AVERSA™ FENTANYL Development Summary
Strengthened collaboration with Kindeva for AVERSA™ FENTANYL through an exclusive product development partnership and long-term commitment based on shared development costs in exchange for milestone payments
Granted patent protecting its AVERSA™ abuse deterrent platform technology in Macao, a Special Administrative Region of the People’s Republic of China
Completed commercial manufacturing process scale-up with partner Kindeva for Aversa™ Fentanyl
Issued new US patent which further expands Nutriband’s intellectual property protection in the United States for its portfolio of abuse deterrent transdermal products
Held Type C meeting with US FDA to obtain feedback on the Chemistry, Manufacturing, and Controls plans for AVERSA™ FENTANYL through commercialization
Filed a new provisional patent application with the U.S. Patent and Trademark Office (USPTO) covering improved aversive formulations and coating application methods to enhance the abuse deterrent properties and further strengthen Nutriband’s intellectual property protection for its AVERSA™ technology
Initiated development of the worldwide commercial brand name and visual identity for AVERSA™ FENTANYL with Brand Institute, Inc.
2026 AVERSA™ FENTANYL Focus on Development Towards NDA Filing
File nonprovisional patent application to potentially extend patent protection of AVERSA™ technology-based products to 2046
Manufacture clinical supplies for the Human Abuse Liability (HAL) clinical trial
File Investigational New Drug (IND) application with the US FDA
Initiate Human Abuse Liability (HAL) clinical study
EarthVision Bio Purchase of Pocono Pharma
The full purchase price and closing for the proposed sale of our Pocono subsidiary has not been received as of the shareholder meeting on Jan 24, 2026. However, the Company is collecting on the agreed nonrefundable $10,000 USD weekly penalty and has so far collected $30,000 USD of payments to extend the closing date.
Company Complaint Filed with FINRA
The Company, has filed a complaint with the Financial Industry Regulatory Authority (FINRA) on behalf of our shareholders to look into suspected naked short selling. The information was collected and prepared with a specialist analyst in the area of naked short selling.
Warrant Expiration in 2026
The Company is reminding shareholders that the warrants issued in our uplisting to NASDAQ on October 1, 2021 will expire on October 1, 2026. Currently there are 91,0904 warrants set to expire with a strike price of $6.43 totaling $5,856,112 if exercised.
About AVERSA™ Abuse-Deterrent Transdermal Technology
Nutriband’s AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, including opioids and stimulant drugs, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.
About Nutriband Inc.
We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.
The Company’s website is www.nutriband.com. Any material contained in or derived from the Company’s websites or any other website is not part of this press release.
Forward-Looking Statements
Certain statements contained in this press release, including, without limitation, statements containing the words ‘’believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s periodic and current reports on Form 10-K, Forms 10-Q and 8-K and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.
TONMYA demonstrated significant reduction in fibromyalgia pain compared with placebo in the Phase 3 RESILIENT study
Unique sublingual formulation designed for bedtime dosing bypasses first-pass metabolism, optimizing parent-drug exposure during sleep and decreasing levels of the persistent active metabolite
Treatment was well tolerated with minimal effects on weight or blood pressure
CHATHAM, N.J., Jan. 30, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, presented data on TONMYA™, which was investigated as TNX-102 SL, at the 2026 Non-Opioid Pain Therapeutics Summit, on January 29, 2026, in Boston, Massachusetts. A copy of the Company’s presentation, titled “TNX-102 SL (Sublingual Cyclobenzaprine HCl): a Centrally Acting Non-Opioid Analgesic for the Treatment of Fibromyalgia,” is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.
“Fibromyalgia is a chronic pain disorder affecting more than 10 million adults in the U.S., with existing treatments often limited by tolerability and side effects,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The data presented at the Non-Opioid Pain Therapeutics Summit by our Chief Medical Officer, Gregory Sullivan, M.D. highlight TONMYA’S role as a centrally-acting, differentiated non-opioid treatment. TONMYA’S unique sublingual formulation is designed for bedtime administration and to bypass first-pass metabolism, resulting in a pharmacokinetic profile that favors parent-drug exposure during sleep while limiting daytime exposure to the active metabolite. Since fibromyalgia patients are commonly prescribed opioids off-label, there is a clear need for effective non-opioid alternatives.”
The data presented at the Summit come from RESILIENT, a 14-week randomized, double-blind, placebo-controlled Phase 3 trial at 34 U.S. sites, with 456 intent-to-treat participants who met the 2016 American College of Rheumatology criteria for fibromyalgia. Participants received TONMYA or placebo administered sublingually at bedtime. Treatment with TONMYA resulted in a statistically significant reduction in weekly average pain scores at Week 14 (p<0.0001) versus placebo, with an effect size of 0.38. The study also demonstrated significant improvements in key secondary endpoints, including sleep disturbance (p<0.001), fatigue (p<0.001), and the Symptoms (p<0.001) and Function (p=0.001) domains of the Fibromyalgia Impact Questionnaire-Revised (p<0.001 for both). TONMYA was well tolerated, with minimal impact on weight and blood pressure, and a rate of adverse event-related discontinuations of 6.1% on TONMYA vs. 3.5% on placebo. The most common adverse events were mild and self-limited oral cavity reactions that rarely led to study withdrawal.
“TONMYA’S sublingual formulation largely bypasses first-pass hepatic metabolism, which reduces formation of norcyclobenzaprine, the persistent active metabolite that we believe otherwise interferes with the duration of the treatment effect,” said Dr. Sullivan. “This results in a distinct pharmacokinetic profile compared to oral cyclobenzaprine, with greater relative bioavailability of the parent drug during sleep and reduced active metabolite exposure during daytime. Bedtime sublingual administration is also designed to target the non-restorative sleep that is central to fibromyalgia pathophysiology, translating to broad-spectrum activity across the core symptoms of fibromyalgia, including pain, sleep disturbance, and fatigue, with a favorable tolerability profile that may reduce the need for polypharmacy.”
TONMYA was approved on August 15, 2025, by the FDA for the treatment of fibromyalgia in adults. It is the first new prescription medicine approved for fibromyalgia in more than 15 years.
Tonix Pharmaceuticals Holding Corp.* Tonix is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix markets FDA-approved TONMYA™, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. TONMYA is the first new prescription medicine approved by the FDA for fibromyalgia in more than 15 years. TONMYA was investigated as TNX-102 SL. Tonix also markets two treatments for acute migraine in adults: Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray). Tonix’s development portfolio* is focused on central nervous system (CNS) disorders, immunology, immuno-oncology, rare disease and infectious disease. TNX-102 SL is being developed to treat acute stress reaction and acute stress disorder under an Investigator-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). TNX-102 SL is also in development for major depressive disorder. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a Phase 2- ready Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome and expected to start a potential pivotal Phase 2 study in 2026. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4800, a Phase 2- ready long-acting humanized monoclonal antibody for the seasonal prevention of Lyme disease. Finally, TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years, is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of high lethality infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md.
* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially as a result of a number of factors, including the ability of the Company to satisfy the conditions to the closing of the offering and the timing thereof, as well as those described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
INDICATION TONMYA is indicated for the treatment of fibromyalgia in adults.
CONTRAINDICATIONS TONMYA is contraindicated: In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected. With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.
During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure. In patients with hyperthyroidism.
WARNINGS AND PRECAUTIONS Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.
Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.
Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.
Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.
CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities. Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.
ADVERSE REACTIONS The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.
DRUG INTERACTIONS
MAO inhibitors: Life-threatening interactions may occur.
Other serotonergic drugs: Serotonin syndrome has been reported.
CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.
Tramadol: Seizure risk may be enhanced.
Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.
USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).
Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.
Pediatric use: The safety and effectiveness of TONMYA have not been established.
Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.
Please see additional safety information in the full Prescribing Information. To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Unicycive Announced FDA Acceptance Of The NDA. Unicycive announced FDA acceptance of its resubmission of the New Drug Application (NDA) for OLC (oxylanthanum citrate). The resubmitted application has been classified as a Class II complete response, with a six-month review period. June 29, 2026 is the new PDUFA date, the statutory date for the application to be answered. This is consistent with our expected timeframe for OLC approval and launch.
We See NDA Acceptance As A Significant Milestone. In June 2025, an FDA manufacturing inspection found compliance deficiencies at the facility of a contract manufacturer. This stopped the NDA approval process just weeks before the PDUFA (Prescription Drug User Fee Act) date of June 28, 2025. The review of the preclinical, clinical, safety, and manufacturing data had been completed. We believe this will result in prompt approval.
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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.
FDA assigns Prescription Drug User Fee Act (PDUFA) target date of June 29, 2026
Ended 2025 with unaudited cash position of $41.3M with expected runway into 2027
LOS ALTOS, Calif., Jan. 29, 2026 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for oxylanthanum carbonate (OLC), the Company’s investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The Agency has deemed the OLC resubmission to be a Class II complete response which has a six-month review period from the date of resubmission and set a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026.
“We are pleased that the agency has promptly accepted the resubmission of our NDA for OLC,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “We are advancing our commercial preparation activities in anticipation of a potential launch of OLC later this year, to help provide an important treatment option to patients with chronic kidney disease (CKD) on dialysis who continue to struggle with hyperphosphatemia.”
The NDA is supported by data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies as well as chemistry, manufacturing and controls (CMC) data. The FDA did not raise any concerns regarding OLC’s preclinical, clinical, or safety data included in the original NDA submission.
The Company ended 2025 with an unaudited position of $41.3 million in cash, cash equivalents, and short-term investments, which permits continued advancement of OLC commercial launch activities and a cash runway into 2027.
About Oxylanthanum Carbonate (OLC) OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden.
Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.
About Hyperphosphatemia Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). Annually there are over 450,000 individuals in the U.S. that require medication to control their phosphate levels.1 Uncontrolled hyperphosphatemia is strongly associated with increased death and hospitalization for CKD patients on dialysis. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.
1Flythe JE. Dialysis-Past, Present, and Future: A Kidney360 Perspectives Series. Kidney360. 2023 May 1;4(5):567-568. doi: 10.34067/KID.0000000000000145.
About Unicycive Therapeutics Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information about Unicycive, visit Unicycive.com and follow us on LinkedIn and X.
Forward-looking statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; our need to raise substantial additional capital in the future to fund our continuing operations and the development and commercialization of our current product candidates and future product candidates; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; risks related to delays in obtaining or failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; and our failure, or the failure of our third-party manufacturers, or their subcontractors, to comply with cGMPs or other applicable regulations, which could result in sanctions being imposed on us or the manufacturers, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any of which could adversely affect supplies of our product candidates and harm our business and results of operations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events 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.
Cardiff Made Two Significant Announcements. New data from the Phase 2 CRDF-004 trial testing onvansertib as a first line treatment for metastatic colorectal cancer was announced as expected. Patients in the high-dose onvansertib group showed a large benefit in overall response rates (ORR) and progression free survival (PFS). Separately, the CEO and CFO have left the company. Board Member Dr. Mani Mohindru was named Interim CEO.
Phase 2 Trial Design. As discussed in our January 5 report, CDRF-004 is a Phase 2 dose-finding trial testing two doses of onvansertib in combination with two standard-of-care (SOC) regimens against the standard of care regimens alone. It enrolled 110 patients with RAS-mutated metastatic colorectal cancer, mCRC. Its primary endpoint is objective response rate (ORR). Secondary endpoints include progression-free survival (PFS), duration of response (DOR) and safety. These endpoints were selected to guide the design of Phase 3.
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– Onvansertib added to FOLFIRI/bev first-line standard of care regimen showed dose-dependent improvement in overall response rates and durability trends as measured by progression-free survival in patients with RAS-mutated mCRC –
– Data support selection of 30 mg onvansertib dose for registrational program in first-line RAS-mutated mCRC –
– Data validate previously reported positive results from Phase 2 trial of onvansertib with FOLFIRI/bev in second-line mCRC bev-naïve patients, as published in the Journal of Clinical Oncology –
– Onvansertib continues to be safe and well-tolerated –
– Company expects to provide final data and registrational plans in first half of 2026 –
– Company to hold conference call today at 8:30 a.m. ET/5:30 a.m. PT –
SAN DIEGO, Jan. 27, 2026 (GLOBE NEWSWIRE) — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced a positive update from CRDF-004, a randomized dose-finding Phase 2 clinical trial evaluating onvansertib in combination with standard of care (SoC) regimens (FOLFIRI/bevacizumab (bev) or FOLFOX/bev) in patients with first-line (1L) RAS-mutated metastatic colorectal cancer (mCRC). In an intent-to-treat analysis, the clinical data show dose-dependent benefits across multiple efficacy measures in patients receiving onvansertib with FOLFIRI/bev compared to patients receiving either SoC regimen. In this trial, onvansertib with FOLFIRI/bev also performed better than onvansertib with FOLFOX/bev.
Based on these results, the Company has selected the 30 mg dose of onvansertib with FOLFIRI/bev to bring forward in a registrational trial in 1L patients with RAS-mutated mCRC. Cardiff Oncology plans to initiate a registrational program later this year pending finalization of the trial design in consultation with the FDA, in which the Company expects to compare onvansertib with FOLFIRI/bev to SoC regimens, FOLFIRI/bev or FOLFOX/bev.
“These data demonstrate promising enhanced benefits of onvansertib when combined with FOLFIRI/bev in RAS-mutated mCRC patients,” said Mani Mohindru, PhD, interim Chief Executive Officer. “We observed a consistent, dose-dependent treatment benefit across multiple measures of efficacy, including achieving statistical significance for PFS compared to SoC even with relatively small patient numbers. The 30 mg onvansertib–FOLFIRI/bev arm outperformed both SoC arms with no significant additive toxicity, supporting findings from our previous Phase 2 trial in second-line RAS-mutated mCRC. While we continue to review data from the ongoing trial, our plan is to rapidly move forward with the onvansertib 30 mg dose in combination with FOLFIRI/bev and we believe confirmatory data from a registrational trial has the potential to make this regimen a new SoC for 1L treatment of RAS-mutated mCRC.”
Bev=bevacizumab; BICR=Blinded Independent Central Review; CI=confidence interval; HR=hazard ratio; NR=not reached; Onv=onvansertib; ORR=objective response rate; PFS=progression-free survival; SoC=standard of care. aORR is confirmed responses bProgressive disease events were based on combined BICR and Investigator assessments due to very small number of events in BICR assessment. The earliest reported date was used for a conservative estimate. cSoC is the combination of the FOLFIRI/bev and FOLFOX/bev arms dPFS HR is the comparison of the onvansertib arm to FOLFIRI/bev ePFS HR is the comparison of the onvansertib arm to SoC fFisher’s exact test gLog-rank test
“There is a clear need for improved first-line treatment options for patients with mCRC, especially the half of those with RAS-mutated disease,” said Dr. J Randolph Hecht, MD, Professor of Clinical Medicine at the David Geffen School of Medicine at UCLA. “Unfortunately, first-line treatment for these patients hasn’t improved significantly for more than two decades. Onvansertib has a novel mechanism of action and these preliminary responses and PFS results in combination with FOLFIRI/bevacizumab are encouraging enough to test in a large Phase 3 trial. If such a trial were positive, it could become a new standard of care for these patients.”
Onvansertib in combination with both chemo/bev regimens was well-tolerated. There were no major or unexpected toxicities observed and no additive adverse events. Grade 3 or higher adverse events were infrequent, with neutropenia being the most common treatment-emergent adverse event across both the onvansertib combination and standard of care arms.
Conference Call and Webcast Cardiff Oncology will host a conference call and live webcast today, January 27, 2026 at 8:30 a.m. ET / 5:30 a.m. PT. Individuals interested in listening may do so by using the link in the “Events” section of the Company’s website. A replay will be available in the investor relations section on the Company’s website following the completion of the call.
CRDF-004 Trial Design The CRDF-004 Phase 2 trial was designed to evaluate two doses of onvansertib to identify the lowest maximally effective dose and to assess the safety, efficacy, and pharmacokinetics of onvansertib in combination with FOLFIRI/bevacizumab or FOLFOX/bevacizumab in first-line patients with KRAS- or NRAS-mutated metastatic colorectal cancer (mCRC). The trial’s endpoints include objective response rate (ORR), progression-free survival (PFS), duration of response, and safety.
For additional information about the trial, please visit www.clinicaltrials.gov (Trial ID: NCT06106308).
About Onvansertib Onvansertib is a highly specific, oral PLK1 inhibitor currently in mid-stage clinical development for RAS-mutated metastatic colorectal cancer. It is also being evaluated in multiple other cancers through investigator-initiated studies, including metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and chronic myelomonocytic leukemia (CMML). Promising monotherapy clinical results from an ongoing CMML trial were recently presented at the American Society of Hematology annual meeting in December 2025. CMML represents a rare disease with significant unmet need.
About Cardiff Oncology, Inc. Cardiff Oncology is a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology target with practice-changing potential. Our lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer (mCRC), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through ongoing investigator-initiated trials and has shown robust single agent clinical activity in hard-to-treat tumors. By targeting tumor vulnerabilities, we aim to overcome treatment resistance and deliver improved clinical outcomes for patients.
Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Cardiff Oncology’s expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology’s Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
SAN DIEGO, Jan. 27, 2026 (GLOBE NEWSWIRE) — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced a leadership transition designed to support the Company’s next phase of growth and advancement toward late-stage development and key clinical and corporate milestones.
Mani Mohindru, PhD, a member of Cardiff Oncology’s Board of Directors since 2021 and a seasoned biotech executive, has been appointed interim Chief Executive Officer, effective immediately. Mark Erlander, PhD, Chief Executive Officer, and James Levine, Chief Financial Officer, have stepped down from their respective roles.
As part of this transition, Ms. Brigitte Lindsay has been promoted to the role of Chief Accounting Officer, ensuring continuity within the finance function. She has been with the Company for more than 14 years and was most recently the Senior Vice President of Finance. The Company has initiated a search for a permanent Chief Executive Officer and Chief Financial Officer.
Cardiff Oncology’s lead product candidate, onvansertib, a highly specific, oral PLK1 inhibitor, is currently in mid-stage clinical development for RAS-mutated metastatic colorectal cancer (mCRC) and is also being evaluated as a single agent and in combinations across multiple additional cancers in investigator-initiated studies, including metastatic pancreatic ductal adenocarcinoma, small cell lung cancer, triple-negative breast cancer, and chronic myelomonocytic leukemia. The leadership transition reflects the Company’s focus on execution and clinical advancement as its programs mature.
“As Cardiff Oncology prepares for the next stage of clinical and corporate development, the Board concluded that this was the right moment to align executive and financial leadership with the Company’s evolving needs,” said Rodney S. Markin, MD, PhD, Chairman of the Board. “We want to express our sincere gratitude to Mark and Jamie for their significant contributions in guiding Cardiff to where it stands today—especially in the progress of our lead product candidate in first-line RAS-mutated mCRC, an area of high unmet need where there have not been any significant advancements in many years. Looking forward, we are confident in Dr. Mohindru’s ability to lead the Company at this key moment in onvansertib’s clinical development, as she brings a rare combination of deep scientific training, operational leadership, and capital markets expertise.”
“Cardiff Oncology has built a strong scientific and clinical foundation around PLK1 inhibition, with onvansertib demonstrating encouraging activity in a challenging to treat patient population,” said Mani Mohindru, PhD, interim Chief Executive Officer. “Given onvansertib’s activity in RAS-mutated mCRC as well as encouraging single agent data, there is potential to extend its benefit to other solid tumors and hematologic malignancies. I look forward to working closely with the Board and the team to sharpen our strategic priorities, advance our clinical programs, and thoughtfully position the Company for late-stage development while maintaining a disciplined approach to capital and execution.”
Dr. Mohindru is an experienced biotechnology executive with leadership experience spanning drug development, corporate strategy, and capital markets. She is the founder of Roshon Therapeutics, a private biotechnology company focused on developing novel therapies for cancer and inflammatory diseases, and currently serves on the Board of Directors of CytomX Therapeutics, Inc. (Nasdaq: CTMX). Previously, Dr. Mohindru served as Chief Executive Officer and Board Director of Novasenta and CereXis, and held senior leadership roles at public biotechnology companies including Cara Therapeutics, Inc. and Curis, Inc.
Earlier in her career, Dr. Mohindru was an equity research analyst covering the biotechnology sector at UBS, Credit Suisse, and ThinkEquity. She currently serves on the Executive Advisory Board of the CLP Institute at Northwestern University and the Scientific Investment Advisory Committee of the Gates Institute at the University of Colorado. Dr. Mohindru holds a PhD in Neurosciences from Northwestern University, as well as a BS in Human Biology and a Master’s degree in Biotechnology from the All India Institute of Medical Sciences in New Delhi, India.
About Cardiff Oncology, Inc. Cardiff Oncology is a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology target with practice-changing potential. Our lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer (mCRC), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through ongoing investigator-initiated trials and has shown robust single agent clinical activity in hard-to-treat tumors. By targeting tumor vulnerabilities, we aim to overcome treatment resistance and deliver improved clinical outcomes for patients.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Cardiff Oncology’s expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, our ability to conduct a successful search for and hire a permanent CEO and CFO, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology’s Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
STAFFORD, Texas, Jan. 27, 2026 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided additional updates on its cash burn rate and financing strategy.
The Company’s ATM financing vehicle allows the Company to sell its common stock directly into the trading market at market price. The amount raised through our ATM for 2025 exceeded the Company’s 2025 cash burn rate of approximately $9.5 million, leading to a year end cash balance of approximately $6 million as of December 31, 2025. Furthermore, the Company more than doubled its cash balance as of the close of business on January 23, 2026, to approximately $12.5 million, having raised approximately $7 million in the first three weeks of January 2026 through the ATM. The above preliminary financial figures are unaudited and are subject to change following completion of the Company’s financial audit for 2025.
CEO Snehal Patel commented, “Our financing strategy in January 2026 has been quite impressive so far without daily or constant use of the ATM. The current cash balance of $12.5 million could exceed the Company’s cash needs for all of 2026, given the $9.5 million annual burn rate in 2025 and the modest increase in cash needs over the $7 million annual burn rates in 2024 and 2023. We believe the Company’s lean structure and ongoing cost saving initiatives have been instrumental in this strategy, including the increasing number of patients entering the less expensive booster phase of Flamingo-01, due to less frequent site visits and vaccinations, and fewer more expensive site start-up costs.”
Mr. Patel further added, “While our cash burn rates in 2026 and 2027 are projected to increase, the expected ongoing use of the ATM to sustain or grow the current cash balance may reduce the likelihood of the Company doing a large near term financing in 2026 or 2027, though there can be no assurance of this. Since the follow-on offering in 2020, we primarily utilized the ATM with initially Jefferies and more recently H.C. Wainwright to fund the Company. Continued use of the ATM may provide a bridge to non-dilutive funding, such as strategic/licensing partnerships or debt/royalty financing vehicles, that would further fund FLAMINGO-01 and potential commercial launch activities.”
About FLAMINGO-01 Open Label Phase III Data
More than 1,000 patients have been screened with a current screen rate of approximately 600 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.
In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.
Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.
About GLSI-100 Phase IIb Study
In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:
80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.
About FLAMINGO-01 and GLSI-100
FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.
For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the “Contacts and Locations” section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.
About Greenwich LifeSciences, Inc.
Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company’s Twitter at https://twitter.com/GreenwichLS.
Forward-Looking Statement Disclaimer
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.
Data from eight participants continue to support safety and tolerability profile of tegoprubart
Mean eGFR increased over the measurement period, from 67.0 mL/min/1.73 m² at 12 months to 74.2 mL/min/1.73 m² at 24 months
IRVINE, Calif., Jan. 23, 2026 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced that it will present 24-month follow-up data from eight patients enrolled in the Phase 1b trial long-term extension evaluating tegoprubart in kidney transplantation at the American Society of Transplant Surgeons Winter Symposium, taking place January 23–25, 2026, in Scottsdale, Arizona.
There were no episodes of biopsy-proven acute rejection, graft loss, death, new-onset diabetes mellitus, or de novo donor-specific antibody formation during the study period. Mean estimated glomerular filtration rate (eGFR) increased over the measurement period, from 67.0 mL/min/1.73 m² at 12 months to 74.2 mL/min/1.73 m² at 24 months.
Details on the poster presentation are below:
Title: Long-Term Outcomes of a Phase 1, Single Arm Cohort of De Novo Kidney Transplant Recipients Treated with Tegoprubart, an Anti-CD40L Antibody, as the Core Immunosuppression Regimen Poster: #62 Session Title: Poster Session B Date: Friday, January 23, 2026, from 5:45 – 7:15 p.m. PT
Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, islet cell transplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.
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Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: our short operating history and shifts in our business strategy; our operating losses since inception; our need for additional funding to develop our lead drug candidate and our ability to secure additional funding on acceptable terms or at all; the impact of issuances of our common stock, including in the possibility of dilution or a decline in our stock price; our ability to successfully develop our product candidates; unfavorable global economic and financial market conditions; the regulatory environment of our business and our ability to obtain required regulatory approvals; results of non-clinical studies and clinical trials, and risks that non-clinical studies or early clinical trials may not be predictive of results of later-stage clinical trials; delays or difficulties in enrollment of patients in clinical trials; our ability to attract and retain our executives and key employees; legislation of the pharmaceutical and healthcare industries; cybersecurity and data privacy risks; the ability of our products to achieve marketing approval; competition in our industry; our ability to obtain insurance coverage; our dependence on contract research organizations; our ability to protect our intellectual property; public health crises; our ability to establish and maintain proper and effective internal control over financial reporting and other risks disclosed in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed with the Securities and Exchange Commission on November 14, 2025. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ materially from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.
MALVERN, Pa., Jan. 23, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (Nasdaq: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced the closing of its previously announced underwritten registered direct offering of 15,000,000 shares of its common stock at an offering price of $1.50 per share of common stock for net proceeds of $20.85 million, after deducting commissions and other estimated offering expenses payable by Ocugen. The financing was led by RTW Investments, with additional participation from new and existing investors.
Ocugen intends to use the net proceeds from the offering for general corporate purposes, capital expenditures, working capital, and general and administrative expenses and anticipates that the net proceeds will extend the company’s cash runway into the fourth quarter of 2026.
Oppenheimer & Co. acted as the sole book-running manager for the offering.
The offering was made pursuant to a shelf registration statement on Form S-3 (File No. 333-278774) previously filed with the Securities and Exchange Commission (the “SEC”) on April 18, 2024, which became effective on May 1, 2024. The offering was made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A prospectus supplement relating to and describing the terms of the offering has been filed with the SEC. Copies of the prospectus supplement and the accompanying base prospectus relating to the offering, may be obtained by visiting the SEC’s website at www.sec.gov or by contacting Oppenheimer & Co. Inc. Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, or by telephone at (212) 667-8055, or by email at [email protected].
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.
AboutOcugen,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.
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. Such forward-looking statements within this press release include, without limitation, statements regarding Ocugen’s expectations regarding the anticipated use of proceeds. 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, such as market and other conditions. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including the Company’s expected cash runway and various other factors. These and other risks and uncertainties are more fully described in our periodic filings with the 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 applicable law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, changed circumstances or otherwise, after the date of this press release.
