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 2 BESTOW Trial Data Reported. On Thursday evening, November 6, the results of the Phase 2 BESTOW trial in kidney transplant patients were presented. The trial did not meet its primary endpoint of tegoprubart superiority to the control arm but showed improvements in several important endpoints. We believe tegoprubart performed well and that the sharp decline in stock price is unwarranted.
Design Of The Phase 2 BESTOW Trial. The trial enrolled 126 patients into and randomized them into two arms. The first received tegoprubart and the second received tacrolimus, the standard of care, as a control arm. The primary endpoint was a difference in eGFR, a measure of kidney filtration and function. Additional endpoints reported were for the iBOX composite and measures of adverse events.
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Net income of $5.9 million and $11.2 million for the three and nine months ended September 30, 2025, respectively
Full-year revenue guidance revised to $115-118 million (from $118 – $128 million previously) due to delayed Etorel® (Nintedanib) rollout and government procurement-related uncertainty
Q3 2025 vs Q3 2024 Highlights
Quarterly revenue of $30.6 million, up 20% year-over-year, driven by ETUARY® growth and contributions from sales of Etorel® and Contiva®.
GAAP net income doubled to $5.9 million and adjusted net income rose to $8.8 million, reflecting commercial execution and disciplined cost control.
Operating income increased 64% to $6.9 million, as operating expenses grew at a slower pace than revenue.
Basic EPS improved to $0.04, compared to $0.01 year-over-year.
Nine-Month 2025 Highlights
Revenue of $79.4 million, moderately above the prior-year period, supported by steady Q3 growth of Etorel® and Contiva®, after earlier supply chain and distribution delays related to new product launches.
Basic EPS down from $0.14 to $0.08, reflecting higher operating expenses related to the dual product launches in the first half of 2025, partially offset by the strong Q3 profit recovery.
$80.3 million in cash, cash equivalents, and short and long-term deposits, up 57% year-to-date, as of Sept 30, 2025.
Business Update
Hydronidone New Drug Application (NDA) progressing in China, with Priority Review discussions ongoing and targeted submission following completion of regulatory interactions.
Completed patient enrollment in the 52-week Phase 3 pirfenidone pneumoconiosis (PD) trial (272 patients, 18 sites).
Plan to initiate an adaptive Phase 2/3 trial of pirfenidone in oncology-related pulmonary complications (RILI/immune-related pneumonitis) in Q4 2025.
U.S. MASH IND anticipated timeline adjusted to 2026 to allow for (i) the incorporation of the complete Phase 2 and 3 CHB-associated liver fibrosis clinical data from China; and (ii) planning and expected initiation of a hepatic impairment study under the existing U.S. IND to further inform safety, dose optimization, and regulatory discussions.
SAN DIEGO, Nov. 07, 2025 (GLOBE NEWSWIRE) — Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced financial results for the third quarter ended September 30, 2025 and provided a business update.
“Following the positive results from our pivotal Phase 3 trial in the PRC evaluating Hydronidone for the treatment of CHB-associated liver fibrosis, we are working diligently toward our NDA submission and are leveraging Hydronidone’s Breakthrough Therapy designation to bring this much-needed therapy to patients in China,” said Ping Zhang, Executive Chairman and Interim Chief Executive Officer of Gyre Therapeutics. “With enrollment now completed in our 52-week Phase 3 trial of pirfenidone for the treatment of pneumoconiosis, we continue to advance our pipeline in China. We are also preparing for U.S. clinical activities and expect to file the U.S. IND for Hydronidone for the treatment of MASH-associated liver fibrosis in 2026, supported by the translation and regulatory-quality review of our China Phase 2 and Phase 3 trial data and an upcoming hepatic impairment study.”
Third Quarter Business Highlights and Upcoming Milestones
Commercial Portfolio
ETUARY® (pirfenidone): Generated $27.7 million in sales of ETUARY® for the quarter ended September 30, 2025, compared to $25.3 million for the same period in 2024.
Etorel® (nintedanib ethanesulfonate soft capsules): Generated $1.5 million in sales of Etorel® for the quarter ended September 30, 2025, the first full quarter of launch.
Contiva® (avatrombopag maleate tablets): Generated $1.2 million in sales of Contiva® for the quarter ended September 30, 2025.
Pipeline Development Updates
Hydronidone:
New Drug Application (NDA) in China:
Building on the positive Phase 3 trial results, Gyre Pharmaceuticals is actively engaging with China’s National Medical Products Administration (NMPA) to confirm Priority Review eligibility for Hydronidone’s New Drug Application (NDA).
The Company remains on track to advance regulatory filing activities and intends to proceed with the NDA submission for Hydronidone in China upon completion of ongoing regulatory interactions and resolution of any outstanding requirements.
Hydronidone U.S. IND Timing Update:
The anticipated timeline for submitting the U.S. IND for Hydronidone for the treatment of MASH-associated liver fibrosis has been adjusted due to the delayed availability of the full Phase 3 trial data set from the completed trial of Hydronidone for the treatment of CHB-associated liver fibrosis in China. The Phase 2 and Phase 3 trial data form the core clinical safety package supporting the U.S. program, and the translation and regulatory-quality review of the Clinical Study Reports are currently in progress.
In parallel, Gyre plans to conduct a hepatic impairment study in U.S. subjects under its active U.S. IND. In light of the shifting market dynamics in the MASH landscape, this study is expected to help determine dose selection and appropriate enrollment criteria in populations with reduced hepatic function, thereby supporting a more robust Phase 2 development strategy.
With these activities underway, Gyre expects to file the U.S. IND for Hydronidone for the treatment of MASH-associated liver fibrosis in 2026, and, subject to U.S. IND clearance, initiate a Phase 2 trial.
Pirfenidone Development and Indication Expansion:
In the third quarter of 2025, Gyre Pharmaceuticals completed patient enrollment in the 52-week Phase 3 clinical trial evaluating pirfenidone for the treatment of pneumoconiosis. The multicenter, randomized, double-blind, placebo-controlled trial enrolled 272 patients across 18 clinical research centers in China. The trial is designed to evaluate the efficacy and safety of 52 weeks of pirfenidone treatment in patients with pneumoconiosis, a chronic occupational lung disease characterized by progressive pulmonary fibrosis.
Following the NMPA’s approval in March 2025 of Gyre Pharmaceuticals’ clinical trial application for pirfenidone in oncology-related pulmonary complications, Gyre Pharmaceuticals plans to initiate an adaptive Phase 2/3 trial in the fourth quarter of 2025 in the PRC, targeting radiation-induced lung injury (RILI) including cases complicated by immune-related pneumonitis across leading oncology centers.
Financial Results
Cash Position
As of September 30, 2025, Gyre held $40.4 million in cash and cash equivalents, $19.6 million in short-term bank deposits, and $20.3 million in long-term certificates of deposit, totaling $80.3 million.
Financial Results for the Three Months Ended September 30, 2025
Revenues: Revenues for the three months ended September 30, 2025 were $30.6 million, compared to $25.5 million for the same period in 2024. The $5.1 million increase was primarily due to $1.5 million from Etorel® sales, $1.2 million from Contiva® sales and a $2.4 million increase in revenue from ETUARY® sales. The increase in ETUARY® sales was mainly driven by a shift in marketing focus in the third quarter. We continue to anticipate revenue growth over the remainder of the year, driven by the growth of ETUARY® sales and supplemented by the commercialization of Etorel® and Contiva® in 2025.
Cost of Revenues: For the three months ended September 30, 2025, cost of revenues was $1.6 million, compared to $1.0 million for the same period in 2024. The $0.6 million increase was primarily attributable to a $0.2 million increase in the costs associated with Contiva® and Etorel®, in line with the corresponding increase in their sales, and a $0.5 million increase in costs associated with ETUARY® due to the higher sales and increased production costs for the product batch related to such sales, partially offset by a $0.1 million decrease in costs associated with generic drugs due to the decrease of sales.
Selling and Marketing Expense: For the three months ended September 30, 2025, selling and marketing expense was $15.3 million, compared to $13.7 million for the same period in 2024. The $1.6 million increase was primarily attributable to a $0.5 million increase in payroll costs, driven by higher headcount and an increase of sales in the three months ended September 30, 2025 and a $1.1 million increase in promotion and conference expenses.
Research and Development Expense: For the three months ended September 30, 2025, research and development expense was $2.4 million, compared to $2.8 million for the same period in 2024. The decrease was primarily attributable to a $0.4 million decrease in clinical trial costs resulting from the completion of the Phase 3 trial of Hydronidone in the second quarter of 2025, and a $0.2 million decrease in pre-clinical research expenses, partially offset by $0.2 million increase in staff costs.
General and Administrative Expense: For the three months ended September 30, 2025, general and administrative expense was $4.3 million, compared to $3.8 million for the same period in 2024. The $0.5 million increase was primarily driven by a $1.1 million increase in functional and administrative department’s personnel and stock compensation costs and a $0.2 million increase in miscellaneous expenses, partially offset by a $0.8 million decrease in professional fees.
Income from Operations: For the three months ended September 30, 2025, income from operations was $6.9 million, compared to $4.2 million for the same period in 2024. The $2.7 million increase was primarily driven by a $5.1 million increase in revenue, partially offset by a $2.4 million increase in total operating expenses.
Net Income: For the three months ended September 30, 2025, net income was $5.9 million, compared to $2.9 million for the same period in 2024. The increase was primarily driven by an increase in revenue of $5.1 million and an increase in other income of $0.8 million, partially offset by an increase in operating expenses of $2.4 million and an increase in income tax expense of $0.6 million.
Non-GAAP Adjusted Net Income: For the three months ended September 30, 2025, non-GAAP adjusted net income was $8.8 million, compared to $4.4 million for the same period in 2024. The increase was primarily driven by an increase in revenue of $5.1 million and an increase in other income of $0.8 million, partially offset by an increase in operating expenses of $1.5 million.
Financial Results for the Nine Months Ended September 30, 2025
Revenues: Revenues for the nine months ended September 30, 2025 were $79.4 million, compared to $77.9 million for the same period in 2024. The $1.5 million increase was primarily driven by the increase in new product sales of Contiva® by $3.0 million and Etorel® by $3.1 million, partially offset by a $4.4 million decline in ETUARY® sales and a $0.2 million decrease in generic drug revenue. The decrease in ETUARY® sales was primarily due to the allocation of marketing resources towards the launches of two new products during the first half of the year. In the third quarter, Gyre refocused marketing efforts on ETUARY® in response to market uncertainties related to Etorel® and Contiva®, both of which were included in the latest national volume-based procurement catalog. For the three months ended September 30, 2025, Gyre recorded an increase in ETUARY® sales compared to the same period in 2024, and Gyre expects ETUARY® sales will continue to grow in the three months ended December 31, 2025 compared to the same period in 2024.
We revised our full-year revenue guidance (see “Revised Full Year 2025 Financial Guidance” section below) primarily due to lower-than-expected sales of Contiva® and Etorel® relative to internal budget expectations. While both products continue to expand their commercial presence, initial rollout challenges and external market dynamics have resulted in lower than-expected sales.
For Etorel®, early-year supply chain and distribution delays moderated launch uptake, and uncertainty related to government volume-based procurement led customers to cautious purchasing behavior. While the underlying demand has started to improve, current performance remains below our original expectations for the year.
Cost of Revenues: For the nine months ended September 30, 2025, cost of revenues was $3.7 million, compared to $2.7 million for the same period in 2024. The $1.0 million increase was primarily driven by a $0.1 million increase in stock-based compensation and a $0.4 million increase in the costs of Etorel® and Contiva®, in line with the corresponding increase in their sales, as well as a $0.8 million increase in ETUARY®’s cost due to the higher plant, property and equipment depreciation from a plant renovation in 2025, partially offset by a $0.3 million decrease in costs related to generic drugs due to the decrease of sales.
Selling and Marketing Expense: For the nine months ended September 30, 2025, selling and marketing expense was $41.4 million, compared to $40.7 million for the same period in 2024. The $0.7 million increase was primarily driven by a $0.9 million increase in conference expenses and a $0.1 million increase in stock compensation costs, partially offset by a $0.3 million reduction in staff costs.
Research and Development Expense: For the nine months ended September 30, 2025, research and development expense was $8.9 million, compared to $8.3 million for the same period in 2024. The $0.6 million increase was primarily attributable to a $1.0 million increase in clinical trial costs, primarily as a result of data analysis costs for Hydronidone in the first half of 2025. This increase was offset by a $0.2 million decrease in materials and utilities expenses and a $0.2 million decrease in pre-clinical research expenses.
General and Administrative Expense: For the nine months ended September 30, 2025, general and administrative expense was $14.1 million, compared to $10.6 million for the same period in 2024. The $3.5 million increase was primarily driven by a $2.8 million increase in functional and administrative department’s personnel and stock compensation costs and a $0.9 million increase in miscellaneous expense, mainly due to the increase in expenses related to Gyre Pharmaceuticals’ annual employee appreciation event, partially offset by a $0.2 million decrease in professional fees.
Income from Operations: For the nine months ended September 30, 2025, income from operations was $11.4 million, compared to $15.5 million for the same period in 2024. The $4.1 million decrease was primarily driven by a $5.6 million increase in total operating expenses, partially offset by a $1.5 million increase in revenue.
Net Income: For the nine months ended September 30, 2025, net income was $11.2 million, compared to $17.3 million for the same period in 2024. The decrease was primarily driven by the increase in operating expenses of $5.6 million and decrease in change in fair value of warrant liability of $4.5 million, partially offset by an increase in revenue of $1.5 million, an increase in other income of $0.7 million, and a decrease of income tax expense of $1.9 million.
Non-GAAP Adjusted Net Income: For the nine months ended September 30, 2025, non-GAAP adjusted net income was $14.6 million, compared to $15.7 million for the same period in 2024. The decrease was primarily driven by the increase in operating expenses of $3.3 million, partially offset by an increase in revenue of $1.5 million and an increase in other income of $0.7 million.
Revised Full Year 2025 Financial Guidance
Full-year revenue guidance revised from $118–128 million to $115–118 million, reflecting slower-than-expected commercialization of Etorel® (nintedanib) due to early supply chain and distribution challenges, as well as increased market uncertainty related to China’s centralized procurement policy leading to more cautious purchasing behavior in the second half of the year, partially offset by stronger-than-expected ETUARY® sales.
Please note that the revenue guidance assumes a constant foreign currency rate and no significant economic disruption or downturn.
Use of Non-GAAP Financial Measures by Gyre Therapeutics, Inc.
Gyre reports financial results in accordance with accounting principles generally accepted in the United States (“GAAP”). This release presents the financial measure “adjusted net income,” which is not calculated in accordance with GAAP. The most directly comparable GAAP measure for this non-GAAP financial measure is “net income.” Adjusted net income presents Gyre’s results of operations after excluding gain from change in fair value of warrants, stock-based compensation, and provision for income taxes. This is meant to supplement, and not substitute, Gyre’s financial information presented in accordance with GAAP. Adjusted net income as defined by Gyre may not be comparable to similar non-GAAP measures presented by other companies. Management believes that presenting adjusted net income provides investors with additional useful information in evaluating the Gyre’s performance and valuation. See the reconciliation of adjusted net income to net income in the section titled “Reconciliation of GAAP to Non-GAAP Financial Measures” below.
About Gyre Pharmaceuticals
Gyre Pharmaceuticals is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY® (pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share (2024 net sales of $105.8 million). In addition, Gyre Pharmaceuticals’ pipeline includes Hydronidone, a structural analogue of pirfenidone, which demonstrated statistically significant fibrosis regression after 52 weeks of treatment in a pivotal Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC. Hydronidone received Breakthrough Therapy designation by the NMPA Center for Drug Evaluation in March 2021. Gyre Pharmaceuticals is also developing treatments for PD, RILI with or without immune-related pneumonitis, COPD, PAH and ALF/ACLF. In October 2023, Gyre Therapeutics acquired an indirect majority interest of 65.2% in Gyre Pharmaceuticals. In the third quarter of 2025, this indirect interest was increased from 65.2% to 69.7% through the increased capital contribution from BJContinent Pharmaceuticals Limited to Gyre Pharmaceuticals.
About Gyre Therapeutics
Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of Hydronidone for liver fibrosis, including MASH, in the United States Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the People’s Republic of China, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY®, and development programs for F573, F528, and F230.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: the expectations regarding Gyre’s research and development efforts, timing of expected clinical readouts, including the anticipated timing of the submission of Gyre’s U.S. IND for Hydronidone for the treatment of MASH-associated liver fibrosis, a hepatic impairment study of Hydronidone in U.S. subjects under Gyre’s active IND, the initiation of Gyre’s Phase 2/3 trial in the PRC for pirfenidone capsules for the treatment of RILI, including cases complicated by immune-related pneumonitis, the filing of an NDA with the NMPA and timing for potential commercial approval for Hydronidone for the treatment of CHB-associated liver fibrosis and trial design of Gyre’s Phase 3 clinical trial evaluating pirfenidone for the treatment of pneumoconiosis, the expectations regarding commercial revenues from the sales of Etorel® and Contiva® maleate tablets, interactions with regulators, expectations regarding future product sales, Gyre’s ability to meet its expected revenue guidance and Gyre’s financial position and cash resources. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital; supply chain and distribution delays and challenges. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025 and in other filings with the Securities and Exchange Commission.
Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
For Investors: David Zhang Gyre Therapeutics david.zhang@gyretx.com
Data from patients who remained on tegoprubart for a year post transplant showed an overall mean 12-month estimated glomerular filtration rate (eGFR) of approximately 69 mL/min/1.73 m²
Tegoprubart demonstrated a favorable safety and tolerability profile, substantially reducing the metabolic, neurologic, and cardiovascular toxicities commonly associated with tacrolimus
Supports advancement into Phase 3 development as a potential new standard for the prevention of kidney transplant rejection
Conference call to be held Friday, November 7 at 8:00 a.m. ET
IRVINE, Calif., Nov. 06, 2025 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced results from its Phase 2 BESTOW trial evaluating tegoprubart for the prevention of organ rejection in patients receiving a de novo kidney transplant. Results from the Phase 2 BESTOW clinical trial were presented today as a late breaking oral presentation titled “Efficacy and Safety of Tegoprubart for the Prevention of Rejection in Kidney Transplantation: Results from the Phase 2 BESTOW Trial,” at the American Society of Nephrology’s Kidney Week 2025 Annual Meeting in Houston, TX.
“The Phase 2 BESTOW data results demonstrate tegoprubart’s potential to maintain excellent kidney function while reducing the chronic metabolic, neurologic, and cardiovascular toxicities that burden patients on tacrolimus,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “By pairing strong immunosuppressive efficacy with a differentiated safety profile, including dramatically lower rates of new-onset diabetes, tremor, and dialysis-requiring delayed graft function, tegoprubart represents a promising next-generation option for kidney transplant immunosuppression as we advance into Phase 3.”
“There remains a significant unmet need for safer alternatives to traditional tacrolimus-based immunosuppression regimens—options that can reduce harmful side effects without compromising efficacy. The Phase 2 results presented at ASN Kidney Week highlight the potential of tegoprubart to deliver strong graft function after kidney transplantation, while avoiding the long-term toxicities often associated with current standard of care,” said Andrew Adams, M.D., Ph.D., Professor of Surgery and Chief, Division of Transplantation, John S. Najarian Surgical Chair in Clinical Transplantation, Department of Surgery, University of Minnesota. “It’s been more than a decade since we’ve seen true innovation in transplant immunosuppression. These data offer real hope that patients may soon have a transformative therapy that improves their health outcomes and overall quality of life.”
Study Design
The 12-month, randomized, head-to-head, Phase 2 study enrolled 127 kidney transplant recipients (63 receiving tegoprubart and 64 receiving tacrolimus) across 44 global sites. The study directly compared tegoprubart-based immunosuppression with a tacrolimus-based regimen. All patients also received rabbit antithymocyte globulin (rATG) induction and maintenance therapy with mycophenolate mofetil (MMF/MPA) and corticosteroids.
The study’s primary efficacy endpoint was the change in eGFR at 12 months post-transplant. Secondary endpoints included biopsy-proven acute rejection (BPAR), patient and graft survival, composite efficacy failure, iBox score, donor-specific antibodies (DSAs), delayed graft function (DGF), and new-onset diabetes after transplantation (NODAT).
Safety Results
Safety findings underscore tegoprubart’s potential to maintain effective immunosuppression while minimizing the metabolic, neurologic, and cardiovascular toxicities characteristic of tacrolimus-based therapy.
Metabolic effects: New-onset diabetes developed in approximately 1 in 6 patients receiving tacrolimus versus 1 in 47 receiving tegoprubart.
Neurologic effects: Tremor was markedly higher in the tacrolimus group (25.0% vs. 1.6%).
Cardiovascular effects: Hypertension (15.9% vs. 25.0%), hypertensive crisis (1.6% vs. 7.8%), and heart failure (0% vs. 4.7%) all favored tegoprubart.
Renal recovery: Delayed graft function occurred less often with tegoprubart and required shorter dialysis (14.3% vs. 25.0%; 4.6 days vs. 6.1 days), suggesting potential reductions of 115 days on dialysis post-transplant per 100 deceased donor kidney recipients on tegoprubart vs. tacrolimus.
Infections: Sepsis or bacteremia occurred more frequently in the tacrolimus arm (17.2% vs. 4.8%). Viral infection rates (CMV, BK, EBV, fungal) were similar across groups, with no cases of Post-Transplant Lymphoproliferative Disorder (PTLD) or Progressive Multifocal Leukoencephalopathy (PML).
Overall rates of serious adverse events were comparable between treatment arms.
Efficacy Results
eGFR on tegoprubart treatment was 69 mL/min/1.73 m² (n=51) at 12 months vs. 66 mL/min/1.73 m² for tacrolimus (n=56). Although the primary endpoint did not reach statistical significance, tegoprubart maintained strong renal function, delivering what the Company believes is the highest mean eGFR level reported to date in kidney transplant clinical trials evaluating rejection prevention.
Subgroup analyses demonstrated higher eGFRs in nearly all tegoprubart subgroups compared with tacrolimus, particularly among living-related donor recipients (~72 mL/min/1.73 m² vs. 62 mL/min/1.73 m²) and high Kidney Donor Profile Index (KDPI > 35) transplants (~62 mL/min/1.73 m² vs. 53 mL/min/1.73 m²).
In the deceased donor subgroup, tegoprubart achieved a mean eGFR of approximately 68 mL/min/1.73 m² at 12 months.
The efficacy failure composite endpoint, comprising death, graft loss and biopsy proven acute rejection, is the approval endpoint currently recognized by the U.S. Food and Drug Administration. Efficacy failure composite endpoint was 22% in the tegoprubart group vs. 17% in the tacrolimus group, demonstrating non-inferiority for tegoprubart vs. tacrolimus, using a 20% non-inferiority margin. The Company believes these results, if replicated in a Phase 3 study, would be sufficient to support tegoprubart’s approvability.
The rate of acute rejection in all biopsies was 20.6% in the tegoprubart group compared with 14.1% in the tacrolimus group.
Among patients in the tegoprubart group who experienced acute rejection and remained on treatment through month 12, mean eGFR was 73 mL/min/1.73 m², compared with 50 mL/min/1.73 m² in those who switched to tacrolimus.
There was 1 case of donor-specific antibodies (DSA) in the tegoprubart arm vs. 2 in the tacrolimus arm.
Next Steps
Based on these results, Eledon plans to advance tegoprubart into Phase 3 development following discussions with regulators on study design and data requirements. Insights from the Phase 2 BESTOW data set and the ongoing long-term extension study will be incorporated to optimize the Phase 3 protocol and strengthen the regulatory package.
Estimated cash, cash equivalents and short-term investments totaled approximately $93.4 million as of September 30, 2025. The company expects current cash, cash equivalents and short-term investments to fund operations to late 2026.
Conference Call
Eledon will hold a conference call on November 7, 2025, at 8:00 a.m. Eastern Time to discuss the Phase 2 BESTOW trial results presented at Kidney Week. The dial-in numbers are 1-800-717-1738 for domestic callers and 1-646-307-1865 for international callers. The conference ID is 92427. A live webcast of the conference call will be available on the Investor Relations section of the Company’s website at www.eledon.com. The webcast will be archived on the website following the completion of the call and a copy of the presentation for the conference call will be posted on the Company’s website at https://ir.eledon.com/investor-relations prior to the conference call.
Full details of the oral presentation are below:
Title: Efficacy and Safety of Tegoprubart for the Prevention of Rejection in Kidney Transplantation: Results from the Phase 2 BESTOW Trial Session Title: Late-Breaking Research Orals – 1 Presenter: Andrew Adams, M.D., Ph.D., Professor of Surgery and Chief Division of Transplantation, John S. Najarian Surgical Chair in Clinical Transplantation, Department of Surgery, University of Minnesota Session Date and Time: November 6, 2025, from 4:30 p.m. to 6:00 p.m. CT
Eledon is also conducting an ongoing open label Phase 1b study (NCT05027906) and a long-term safety and efficacy extension study (NCT06126380) to evaluate tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant. Participants who complete 12 months of treatment in the Phase 1b and Phase 2 BESTOW trials are eligible to enroll into the long-term extension study.
About Eledon Pharmaceuticals and tegoprubart
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, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.
Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter
Statement Regarding Preliminary Financial Information
The cash, cash equivalents and short-term investments presented in this press release is unaudited and preliminary and is subject to completion of financial closing procedures, including the completion of management’s review. The preliminary financial information is based on information currently available to management, and may vary from the amounts that will be reported in Eledon’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 that the Company will file with the U.S. Securities and Exchange Commission.
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 ongoing, planned and future clinical trials, the development of product candidates, expected or future results of tegoprubart trials and its ability to prevent rejection in connection with kidney transplantation, submissions to regulators, our expected cash, cash equivalents and short-term investments 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: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and uncertainties relating to the completion of our quarter-end closing procedures for our financial statements for the quarter ended September 30, 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 significantly 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.
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.
Mixed Fiscal Q1 results. SelectQuote reported Q1 revenue of $328.8 million, above our estimate of $310.0 million. Adj. EBITDA loss of $32.1 million was slightly wider than expected due to temporary pharmacy reimbursement headwinds. Overall, results showed resilient topline growth despite short-term margin pressure, reflecting solid execution across Healthcare Services and Senior segments in a seasonally lighter quarter.
Healthcare Services headwind. Lower reimbursement rates from one pharmacy benefit manager impacted both revenue and margins in Healthcare Services in the quarter. The reimbursement adjustment, tied to the PBM’s calendar-year 2025 pricing update, will continue through fiscal Q2, when management expects segment adj. EBITDA to reach breakeven before normalizing in the second half.
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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.
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.
Ocugen Reports 3Q25 With Milestones For FY2026. Ocugen reported a 3Q25 loss of $20.1 million or $(0.07) per share and gave updates on its clinical programs. Importantly, all three clinical trials are meeting or beating our expectations for progress toward the BLA filings. We continue to expect “3 filings in 3 years”, with the first approval in mid-2027.
OCU400 Expected To Start Rolling BLA Filing In 1H26. OCU400 received RMAT designation from the FDA, allowing portions of the BLA to be submitted as they are completed rather than waiting to submit the entire BLA at once. The non-clinical portions are planned for submission in early 2026, with clinical trial data submitted in 4Q26. This should start the FDA review earlier and allow for approval in mid-2027.
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.
Eli Lilly & Co. and Novo Nordisk A/S have reached a sweeping agreement with the Trump administration to cut the prices of their blockbuster obesity drugs in exchange for tariff relief and expanded Medicare access — a move poised to reshape both the weight-loss market and broader healthcare policy in the U.S.
Under the deal, the two pharmaceutical giants will lower prices on their popular medications, Zepbound and Wegovy, bringing the monthly cost for eligible Medicare and Medicaid patients with obesity and related conditions down to roughly $245, with co-pays for Medicare users capped near $50. Both companies will also offer discounted direct-purchase programs: Eli Lilly will sell Zepbound’s lowest dose for about $299 a month via its LillyDirect platform, while Novo Nordisk’s Wegovy will be available at $499 through NovoCare. That’s less than half their current U.S. list prices, which exceed $1,000 per month.
In return, the companies receive a three-year exemption from new import tariffs on pharmaceutical products and fast-track regulatory reviews for upcoming weight-loss pills, which could reach the market next year at introductory prices near $149 per month. Both Lilly and Novo have pledged to manufacture these new products in the U.S., aligning with the administration’s push to onshore critical drug production.
The timing of the announcement, coming just days after midterm election losses for the Republican Party, underscores the political weight behind lowering healthcare costs. The White House framed the move as part of a broader effort to ease cost-of-living pressures, a theme that has dominated recent public sentiment.
For the pharmaceutical industry, the agreement signals a new era of negotiation — one in which pricing concessions may secure favorable trade treatment and regulatory acceleration. Rival firms including Pfizer, AstraZeneca, and Germany’s Merck KGaA have reportedly pursued similar arrangements to avoid heavier restrictions or penalties.
The deal also reflects growing momentum toward allowing Medicare coverage for anti-obesity drugs — something long prohibited under federal law. Beginning next year, patients with qualifying health conditions such as prediabetes or heart failure will gain access to these treatments under government plans, marking a significant policy shift that could expand the addressable market for weight-loss medications to millions of new patients.
From an investment standpoint, the move could reverberate across healthcare and biotech stocks. Large-cap players like Lilly and Novo may face slimmer margins on price-controlled drugs but stand to gain from much higher volume and broader insurance access. Small-cap biotech firms developing next-generation metabolic or appetite-control treatments could benefit from renewed investor attention and potential partnership opportunities as major pharmaceutical companies look to diversify pipelines and defend market share.
While the announcement temporarily weighed on Lilly’s shares and lifted Novo’s, analysts expect the broader obesity-drug market to continue expanding rapidly — particularly if upcoming oral treatments deliver similar efficacy at lower costs. For investors, the balance between pricing pressure and explosive demand could define one of the most lucrative — and politically charged — healthcare themes heading into 2026.
Phase 2/3 OCU410ST GARDian3 pivotal confirmatory trial is progressing toward 1H 2027 Biologics License Application (BLA) filing with 50% enrollment completed to date
European Medicines Agency (EMA) provided acceptability of a single U.S.-based trial for submission of a Marketing Authorization Application (MAA)
Executed licensing agreement with Kwangdong Pharmaceutical for exclusive rights in South Korea to OCU400
Sales milestones of $1.5 million for every $15 million of sales in South Korea, projected to reach $180 million or more in first 10 years of commercialization and royalties equaling 25% of net sales
Closed $20 million registered direct offering of common stock and accompanying premium warrants
The Company will receive $30 million of additional gross proceeds if the warrants are exercised in full
MALVERN, Pa., Nov. 05, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today reported third quarter 2025 financial results along with a general business update.
“With two late-stage modifier gene therapies on track to meet 2026 and 2027 BLA/MAA filings, it’s remarkable to look back and recognize we only began dosing the first patient in the Phase 1/2 OCU400 clinical trial in 2022,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “The OCU410ST Phase 2/3 GARDian3 pivotal confirmatory trial is following close behind the OCU400 Phase 3 liMeLiGhT clinical trial, and with 50% enrollment completed to date, we believe recruitment will be completed in the first quarter of 2026. This progress not only reinforces our commitment to file three BLAs in the next three years, but it also brings us closer to addressing the incredible unmet medical needs that exist for patients facing vision loss.”
In September, Ocugen announced its exclusive licensing agreement with Kwangdong Pharmaceutical Co., Ltd. (Kwangdong) for the rights to OCU400 in South Korea. Under the agreement, the Company will receive up to $7.5 million in upfront and development milestone payments, plus sales milestones of $1.5 million for every $15 million of sales in South Korea, projected to reach $180 million or more in the first 10 years of commercialization. The Company will also earn a 25% royalty on net sales generated by Kwangdong and will be responsible for manufacturing and supplying OCU400. A regional approach preserves Ocugen’s rights to larger geographies to maximize total patient reach while also generating a potential return for shareholders.
Enrollment in the OCU400 Phase 3 liMeliGhT clinical trial is nearing completion, and the program remains on track for BLA and MAA submissions in 2026. This is the only known broad retinitis pigmentosa (RP) gene-agnostic trial to address multiple genetic mutations and multiple disease pathways with a single therapeutic approach. There are approximately 300,000 people in the U.S. and Europe combined living with RP, which affects greater than 100 genes. Ocugen’s gene-agnostic approach has the potential to treat multiple gene mutations associated with RP with a one-time subretinal injection.
The Phase 2/3 GARDian3 pivotal confirmatory trial for OCU410ST for Stargardt disease is well underway and in August the Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA provided acceptability of a single U.S.-based trial for submission of an MAA. Stargardt disease affects approximately 100,000 people in the U.S. and Europe combined, and approximately 1 million globally. Currently, there is no FDA-approved treatment available for Stargardt disease.
Also in August, Ocugen closed a registered direct offering pursuant to a securities purchase agreement with Janus Henderson Investors for the purchase and sale of 20,000,000 shares of common stock and warrants to purchase up to an aggregate of 20,000,000 shares of common stock at a purchase price of $1.00 per share and accompanying warrant at a premium exercise price of $1.50 per share. The gross proceeds to the Company were approximately $20 million, which Ocugen anticipates will extend the Company’s cash runway into the second quarter of 2026. The Company will receive $30 million of additional gross proceeds if the warrants are exercised in full extending runway into 2027.
“We will continue to pursue financing opportunities along with strategic business development to fund the Company into commercialization,” said Dr. Musunuri. “We have engaged with potential funding and business partners during various investor and global conferences. I look forward to additional substantive conversations between now and the end of the year.”
Upcoming inflection points for Ocugen’s novel modifier gene therapy platform include OCU410 (Geographic Atrophy) Phase 2 full data release expected in the first quarter of 2026, OCU410ST (Stargardt disease) interim data on 50% of patients at eight months of treatment expected mid-year 2026, and OCU400 (RP) Phase 3 top line data expected in the fourth quarter of 2026. The Company looks forward to providing the market and key stakeholders with near-term catalysts supporting Ocugen’s strong path forward.
OCU400 – Enrollment in the Phase 3 liMeliGhT clinical trial is nearing completion. The Company secured an exclusive licensing agreement with Kwangdong for rights to OCU400 in South Korea and will continue to pursue regional partnerships. Intend to initiate BLA rolling submission in the first half of 2026 and release Phase 3 top-line data in the fourth quarter of 2026.
OCU410ST – Pivotal confirmatory Phase 2/3 trial is ahead of schedule. CHMP of the EMA provided acceptability of a single U.S.-based trial for submission of an MAA. Intend to release interim data (50% of patients at 8 months of treatment) mid-year 2026.
OCU410 – Intend to release full data from the Phase 2 clinical trial in the first quarter of 2026 and begin Phase 3 in 2026.
Ophthalmic Biologic Product
OCU200 – Intend to complete enrollment in the Phase 1 clinical trial in 4Q 2025.
Third Quarter 2025 Financial Results
With the recent $20 million financing in the third quarter, we expect our current cash position provides sufficient runway to operate through 2Q 2026.
The Company’s cash, cash equivalents and restricted cash totaled $32.9 million as of September 30, 2025, compared to $58.8 million as of December 31, 2024.
Total operating expenses for the three months ended September 30, 2025 were $19.4 million and included research and development expenses of $11.2 million and general and administrative expenses of $8.2 million. This compares to total operating expenses for the three months ended September 30, 2024 of $14.4 million that included research and development expenses of $8.1 million and general and administrative expenses of $6.3 million.
Conference Call and Webcast Details
Ocugen has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the financial results and recent business highlights. Ocugen’s senior management team will host the call, which will be open to all listeners. There will also be a question-and-answer session following the prepared remarks.
Attendees are invited to participate on the call or webcast using the following details:
Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers Conference ID: 3029428 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, including, but not limited to, strategy, business plans and objectives for Ocugen’s clinical programs, plans and timelines for the preclinical and clinical development of Ocugen’s product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, the ability to initiate new clinical programs, Ocugen’s financial condition and expected cash runway into the second quarter of 2026, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines,and Ocugen’s projections under its license agreement with Kwangdong Pharmaceutical Co., Ltd., 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, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our annual and 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.
Atlanta, GA – November 4, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies for infectious diseases and cancer, today announced that it will report its financial results for the quarter ended September 30, 2025, after the close of U.S. markets on Thursday, November 13, 2025. Following the release, management will host a live conference call and audio webcast at 4:30 p.m. ET to review results and provide a business update.
Conference Call Details
To access the live conference call, participants may register in advance here (https://edge.media-server.com/mmc/p/u86rmdmb/). The live audio webcast of the call will be available via the “Events & Presentations” section of the Company’s Investor Relations website at www.geovax.com/investors. To participate via telephone, please register using the link above; registrants will receive a confirmation email with dial-in information, a unique passcode, and access instructions. Although registration is not required, participants are encouraged to join ten minutes prior to the scheduled start. An archive of the webcast will be available on the Company’s website approximately two hours after the conclusion of the call and will remain available for at least 90 days.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) 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, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Planning to initiate an open-label Phase 2 study of TNX-1500 under an investigator-initiated IND to evaluate safety and activity in the first half of 2026
Novel immunomodulatory regimen designed to reduce calcineurin inhibitor exposure and improve outcomes
Dimeric Fc-modified mAb TNX-1500 selectively targets cell-associated CD40L with once-monthly dosing
CHATHAM, N.J., Nov. 04, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated, commercial biotechnology company, today announced a collaboration with Massachusetts General Hospital (MGH), a founding member of Mass General Brigham (MGB) to conduct a Phase 2 clinical trial evaluating monoclonal antibody (mAb) TNX-1500 in kidney transplant recipients. The investigator-initiated study will be led by Ayman Al Jurdi, M.D., at MGH and is designed to assess the safety, tolerability and activity of Fc-modified anti-CD40L mAb TNX-1500 in preventing kidney transplant rejection while significantly minimizing the dose of conventional immunosuppressive drugs, which are associated with infection, cancer, cardiovascular side effects and various metabolic derangements. The CD40 ligand (CD40L) is also known as CD154. Study initiation is contingent on institutional review board (IRB) approval and FDA clearance of an investigator-initiated investigational new drug application (IND).
“TNX-1500 represents a differentiated approach that is designed to block the function of cell-associated CD40L,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Collaborating with MGH, one of the nation’s leading transplant research centers, allows us to advance this promising candidate in patients who need safer therapies with better long-term outcomes. The Fc-modified TNX-1500 has shown activity and has been well tolerated in animals1,2 and in a Phase 1 pharmacodynamic (PD) and pharmacokinetic (PK) study that supports monthly dosing. Ultimately, our goal is to establish TNX-1500 as a monotherapy, with the potential to transform the landscape of organ transplant management.”
“The ability to modulate the immune system without the toxicities associated with prolonged standard dose CNIs is one of the most pressing unmet needs in transplantation,” said Ayman Al Jurdi, M.D., Principal Investigator at MGH. “Studying TNX-1500 in this Phase II trial will allow us to explore its potential to improve long-term outcomes for kidney transplant recipients.”
Pending IRB approval and IND clearance, the open-label, single-center study will enroll five adult kidney transplant recipients at MGH. Patients will receive induction therapy with anti-thymocyte globulin, TNX-1500, tacrolimus, and corticosteroids. The corticosteroids will be tapered and discontinued by Day 33 post-transplant. TNX-1500 will be continued for 12 months (to the primary endpoint) with an option to continue treatment beyond 12 months. Tacrolimus at standard dose will be continued for six months, at which point tacrolimus will be decreased to low dose with the expectation of discontinuing tacrolimus after 12 months. The primary endpoint is the incidence of adverse and serious adverse events at 12 months. Secondary endpoints include graft survival, renal function, biopsy-proven acute rejection, and incidence of donor-specific antibodies. The study is expected to be initiated in the first half of 2026.
About TNX-1500
TNX-1500 (Fc-modified humanized anti-CD40L mAb) is a humanized monoclonal antibody that interacts with the CD40-ligand (CD40L), also known as CD154. TNX-1500 is being developed for the prevention of allograft and xenograft rejection, for the prevention of graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation (HCT) and for the treatment of autoimmune diseases. The first-in-human Phase 1 PD/PK study of TNX-1500 was completed and topline reported in first quarter 2025 to support dosing in a planned Phase 2 trial in kidney transplant recipients. The primary objective of the Phase 1 trial was to assess the safety, tolerability, PD and PK of single-dose intravenous (i.v.) TNX-1500 at 3 mg/kg, 10 mg/kg, and 30 mg/kg. Two published articles in the peer-reviewed American Journal of Transplantation demonstrate TNX-1500 prevents rejection, prolongs survival and preserves graft function as a single agent or in combination with other drugs in animal renal and heart allografts.1,2
1Lassiter G, et al. Am J Transplant. 2023;23(8):1171-1181. 2Miura S, et al. Am J Transplant. 2023;23(8):1182-1193.
Tonix Pharmaceuticals Holding Corp.
Tonix Pharmaceuticals is a fully-integrated commercial biotechnology company with marketed products and a pipeline of development candidates. Tonix has received FDA approval for Tonmya™ (cyclobenzaprine HCl sublingual tablets), a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. This marks the first approval for a new prescription medicine for fibromyalgia in more than 15 years. Tonix also markets two treatments for acute migraine in adults. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, immunology, immuno-oncology, rare disease and infectious disease. TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is being developed to treat acute stress reaction and acute stress disorder under a Physician-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 rare disease portfolio includes TNX-2900, intranasal potentiated oxytocin with magnesium, in development for Prader-Willi syndrome. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4800, a 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 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.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize Tonmya and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
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.
Relocations Strengthen Ties to Georgia’s Bio-Ecosystem and Position GeoVax for Late-Stage Development and Market Readiness
Atlanta, GA – November 3, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and multi-antigen vaccines against cancers and infectious diseases, today announced relocations of its corporate headquarters and laboratory operations to new facilities in the Atlanta metropolitan area. The moves, scheduled for fourth quarter of 2025, will support GeoVax’s continued growth, expanding pipeline, and preparation for product commercialization.
GeoVax’s laboratory group is relocating to Science Square / Portal Innovations, located in midtown Atlanta. This state-of-the-art facility will provide the Company’s R&D team with expanded access to modern laboratories and collaborative research environments designed to accelerate innovation and development activities.
The Company’s new corporate headquarters will be located at 1955 Lake Park Drive in Smyrna, Georgia, establishing a new hub for corporate operations and leadership activities.
“These moves reflect a significant milestone in GeoVax’s evolution,” said David Dodd, Chairman and Chief Executive Officer of GeoVax. “By placing members of our R&D team in one of the most dynamic bio-research ecosystems in the Southeast, and by expanding our administrative base, we are positioning GeoVax for an accelerated next stage of growth. These facilities will support our broad and advancing pipeline, which includes our promising GEO-MVA program and multiple clinical trials in cancer therapy and infectious disease vaccines.”
“We are incredibly excited for GeoVax to join Portal Atlanta at Science Square Labs,” said Eddie Lai, Director of Business Development, Atlanta Portal Innovations. “GeoVax brings a strong legacy of innovation rooted in the Southeast to the Portal Innovations ecosystem that includes 100+ innovative companies utilizing our sites across the country. As an innovation engine, Portal Innovations supports scientific companies including life sciences and biotech in all stages of development in both R&D and administrative capabilities, and GeoVax is a perfect addition to our growth right here in Atlanta.”
The relocations underscore GeoVax’s trajectory as a company focused on long-term growth, scientific advancement, and future commercialization opportunities. As the Company builds momentum with a deepening pipeline and strategic partnerships, its enhanced infrastructure will provide a strong foundation to meet global healthcare needs.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) 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, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Business, regulatory and clinical updates will be provided
CAMBRIDGE, Mass., Nov. 3, 2025 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that it will host an investor update meeting on December 8, 2025 at 8:30 a.m. Eastern Time.
The Company plans to provide status updates about its near-term milestones and objectives:
Phase 3 PARAGON study initiation (ALS)
Notice of Compliance with conditions (NOC/c) submission in Canada
Status of the binding term sheet executed in December 2024
RoAD Phase 2 program (Alzheimer’s disease)
Investors interested in attending the webinar are invited to register here.
About NeuroSense
NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense’s strategy is to develop combined therapies targeting multiple pathways associated with these diseases.
For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.
Forward-Looking Statements
This press release contains “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 NeuroSense Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the timing of regulatory filings, meetings and regulatory decisions. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the uncertainty regarding outcomes and the timing of current and future clinical trials; timing for reporting data; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 7, 2025 and NeuroSense’s subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.
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 3 Data To Be Presented At A Medical Meeting. Presentation of data from the Hydronidone Phase 3 trial is scheduled for Friday, November 7,2025 at the The Liver Meeting, the annual conference of the American Association for the Study of Liver Disease (AASLD). This presentation is expected to give detailed clinical data on the actions Hydronidone in liver fibrosis associated with chronic hepatitis B infection. We see this indication as proof of concept as well as a revenue opportunity.
We Expect Additional Clinical Trial Details To Be Presented. The Phase 3 trial met its primary endpoint of regression of liver fibrosis, with treated patients showing a regression rate of 52.85% compared with a placebo patient rate of 29.84% (p=0.0002). This reduction compared with placebo is both statistically significant and clinically meaningful. An important secondary endpoint, reduction in inflammation, also showed meaningful improvement.
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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.
Investment by Directors and Management demonstrates confidence in the Company
Potential for an additional $1.8million upon the exercise in full of warrants
BOTHELL, Wash., Oct. 30, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (the “Company” or “Cocrystal”) announces the completion of a private placement of units priced at-the-market under Nasdaq rules with 743,024 shares of its common stock at a purchase price of $1.39 per unit for proceeds of $1.03 million and unregistered warrants to purchase up to 1,486,048 shares of common stock at an exercise price of $1.24 per share. The warrants are exercisable upon issuance and will expire in 27 months.
The four Investors in the private placement are Cocrystal Directors Phillip Frost, M.D., who co-founded the Company and serves as Chairman and CEO of OPKO Health, Inc., Fred Hassan, who is Chairman of the investment firm Caret Group and Director of the private equity firm Warburg Pincus and Richard Pfenniger, and Cocrystal co-CEO and CFO James Martin.
“It’s gratifying to join these distinguished board members, who are respected industry veterans, in a shared our commitment to advancing Cocrystal’s mission of addressing the global need for novel antiviral therapies,” said Mr. Martin. “These investments have strengthened our balance sheet as we approach key milestones in our antiviral clinical programs.”
The potential additional proceeds to the Company from the warrants, if fully exercised on a cash basis, will be approximately $1.83 million. No assurance can be given that any of these warrants will be exercised. The Company intends to use the net proceeds from this offering to support its clinical development programs, for working capital and general corporate purposes.
The unregistered securities described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and Regulation D promulgated thereunder and have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the unregistered shares and shares of common stock issuable upon exercise of the warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company that addresses significant unmet needs by developing innovative antiviral treatments for challenging diseases including influenza, viral gastroenteritis, COVID, and hepatitis. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create viable antiviral drugs.
