On September 15, 2026 Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), ("Amplia" or the "Company"), and the Australia New Zealand Gynaecological Oncology Group (ANZGOG) reported that the clinical trial protocol for the planned PRROSE Phase 2 ovarian cancer study has been finalised, marking an important milestone toward study commencement.

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The ANZGOG and Amplia teams have worked collaboratively over the last three months to finalise the PRROSE trial protocol. With this completed, submission for ethics and site governance approvals will be undertaken, with site activation and patient recruitment planned before the end of 2026.

The PRROSE trial will explore the combination of Amplia’s FAK inhibitor, narmafotinib, in combination with standard-of-care chemotherapy, in women with high-grade serous ovarian cancer (HGSOC). The study will focus on patients whose tumours demonstrate a poor response to chemotherapy prior to planned interval debulking surgery, a group with a significant unmet medical need.

The study will be led by Dr Gwo Yaw Ho of Monash Health and Monash University and will be sponsored and coordinated by ANZGOG. Approximately 26 patients across selected clinical sites in Australia and New Zealand are expected to be enrolled into the trial.

Dr Chris Burns, CEO and Managing Director of Amplia, commented: "This is an important study for a patient population who currently have limited treatment options. We are grateful to the ANZGOG team, working closely with our clinical team at Amplia, for their diligent efforts to complete the trial protocol. We now look forward to finalising ethics submissions with the goal of opening trial sites before the end of the year."

Dr Gwo Yaw Ho, Lead Investigator, said: "Completion of the study protocol enables us to move towards evaluating this promising therapeutic approach in patients with high-grade serous ovarian cancer who are at increased risk of poor outcomes. We look forward to initiating the study and exploring the potential clinical benefit of combining narmafotinib with chemotherapy."

The PRROSE study was first announced in May 20261 and is designed to explore the potential role of FAK inhibition in improving outcomes for patients with ovarian cancer.

(Press release, Amplia Therapeutics, SEP 15, 2026, View Source [SID1234670856])

On September 15, 2026 Akeso, Inc. (9926.HK) reported the presentation of positive overall survival (OS) results from the randomized, double-blind, multicenter, registrational Phase III HARMONi-2 study (AK112-303) at the 2026 World Conference on Lung Cancer (WCLC), organized by the International Association for the Study of Lung Cancer (IASLC). The study evaluated the company’s first-in-class next-generation immuno-oncology therapy, ivonescimab, versus pembrolizumab as first-line treatment for patients with PD-L1-positive (PD-L1 TPS ≥1%) locally advanced or metastatic non-small cell lung cancer (NSCLC).

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Professor Caicun Zhou, Principal Investigator of HARMONi-2, IASLC President, and Director of the Department of Oncology at Shanghai East Hospital, delivered an oral presentation in the session titled "The Breakthrough Immunotherapy for Advanced NSCLC," where he shared the complete results of the study.

As of the data cutoff on August 20, 2026, the median follow-up was 36 months, and a total of 234 overall survival (OS) events had occurred. For this OS analysis, a prespecified O’Brien-Fleming spending function was used, with a one-sided alpha of 0.0141.

Results showed that, compared with pembrolizumab, first-line treatment with ivonescimab significantly prolonged OS in patients with PD-L1-positive advanced NSCLC. This finding met the prespecified statistical significance threshold and demonstrated clear clinical benefit. The overall survival benefit was generally consistent across prespecified subgroups, with particularly pronounced benefit observed in the PD-L1-high population.

1. Intention-to-Treat (ITT) Population: Median OS of 30.8 Months with Ivonescimab, 27% Reduction in Risk of Death, with a Significant and Widening Long-Term Survival Advantage

In the ITT population, ivonescimab monotherapy significantly prolonged OS versus pembrolizumab, with median OS of 30.8 months versus 22.6 months (HR=0.73; 95% CI: 0.57–0.95; P=0.009), corresponding to a 27% reduction in the risk of death.
Ivonescimab demonstrated a clear long-term survival advantage over pembrolizumab, which further widened with longer follow-up: 2-year OS rates were 57.9% versus 48.0%, and 3-year OS rates were 45.0% versus 33.1%.
After treatment discontinuation, 46.0% of patients in the pembrolizumab arm received subsequent systemic therapy, compared with 36.4% in the ivonescimab arm.
2. Overcoming Traditional Anti-VEGF Treatment Restrictions: No Significant Increase in Bleeding Risk Observed in High-Risk Squamous Patients

Squamous NSCLC patients accounted for 45.5% of the HARMONi-2 population, and non-squamous patients for 54.5%. Among squamous patients treated with ivonescimab, 72.2% had central tumors, 10.0% had tumor cavitation or necrosis, and 6.7% had tumors encasing major vessels.

These populations are traditionally considered contraindicated or high-risk for anti-VEGF therapies and have long lacked effective treatment options. However, no apparent increase in bleeding risk was observed with ivonescimab, and these patients showed favorable benefit.

3. Significant OS Benefit Across PD-L1 Expression Levels, with Outstanding Benefit in the TPS ≥50% Subgroup

In the PD-L1 TPS ≥50% subgroup, median OS was not reached (NR) with ivonescimab versus 23.2 months with pembrolizumab (HR=0.58; 95% CI: 0.38–0.89).
In the PD-L1 TPS 1–49% subgroup, median OS was 28.5 months with ivonescimab versus 22.1 months with pembrolizumab (HR=0.85; 95% CI: 0.61–1.18).
4. Consistent OS Benefit by Histology, with Greater Advantage in Squamous Cell Carcinoma

In the squamous cell carcinoma subgroup, median OS was 30.5 months with ivonescimab versus 19.3 months with pembrolizumab (HR=0.65; 95% CI: 0.45–0.95).
In the non-squamous subgroup, median OS was 33.6 months with ivonescimab versus 25.6 months with pembrolizumab (HR=0.79; 95% CI: 0.55–1.14).
5. Favorable Overall Safety Profile with No New Safety Signals; Safety Characteristics Generally Consistent Between Arms

In May 2024, a prespecified interim analysis of progression-free survival (PFS) assessed by the Independent Data Monitoring Committee (IDMC) confirmed that HARMONi-2 met its primary PFS endpoint with statistically significant and clinically meaningful results. Median PFS was 11.14 months with ivonescimab versus 5.82 months with pembrolizumab (HR=0.51, P<0.0001). This indication was approved in China in 2025.

HARMONi-2 is the first randomized, double-blind, controlled Phase III clinical study globally to demonstrate statistically significant positive OS and PFS results versus pembrolizumab.

An international multicenter Phase III clinical study evaluating ivonescimab monotherapy versus pembrolizumab as first-line treatment for PD-L1-high NSCLC (HARMONi-7/AK112-3007) is currently progressing efficiently.

To date, ivonescimab has consistently achieved dual-positive OS and PFS results across multiple Phase III head-to-head trials against PD-1/L1 therapies and continues to expand into major solid tumors beyond lung cancer. The synergistic antitumor effects of ivonescimab’s dual "immuno-oncology + anti-angiogenesis" mechanism continue to be validated in both clinical research and real-world settings. Ivonescimab has the potential to provide a more effective treatment option with a manageable safety profile for cancer patients worldwide and to drive continued progress in oncology care.

(Press release, Akeso Biopharma, SEP 15, 2026, View Source [SID1234670837])

On September 14, 2026 Curium reported that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for BEXLUTRY lutetium Lu 177 dotatate injection for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.

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BEXLUTRY is a radioligand therapy designed to deliver targeted radiation to GEP-NETs by binding to somatostatin receptors commonly expressed on these tumors. NETs originate from neuroendocrine cells, which are specialized cells widely dispersed throughout the body’s organs. The site of origin can vary because of the broad distribution of neuroendocrine cells. GEP-NETs represent 60-70% of NETs.

BEXLUTRY is a radioligand equivalent approved through the FDA’s 505(b)(2) pathway targeting LUTATHERA (lutetium Lu 177 dotatate), supported by published evidence and targeted bridging data that demonstrated a similar biological and chemical profile to a previously approved radiopharmaceutical therapy.

Renaud Dehareng, Curium’s Group Chief Executive Officer, said: "FDA approval of BEXLUTRY is a defining milestone for Curium as we expand our offering into oncology therapeutics. With over 100 years of experience in nuclear medicine and a long-standing commitment to the NET community, we are now bringing the full diagnosis-to-therapy capability needed to scale theranostics responsibly. For decades, Curium has earned trust in nuclear medicine through reliability, quality and day-in, day-out delivery. We are applying that same discipline and commitment to help eligible NET patients access radioligand therapy with confidence."

Mike Patterson, Curium’s North American Chief Executive Officer, said: "As the only vertically integrated, lutetium-based NETs therapy manufacturer, Curium is uniquely positioned to support a reliable supply of BEXLUTRY and help sites of care prepare for radioligand therapy delivery at scale. Today’s FDA approval brings us a step closer to advancing our ambition of aiming to improve the lives of up to 80% of patients with cancer. Our priority now is a high-quality launch supported by our end-to-end nuclear medicine infrastructure, designed to help ensure consistent delivery, predictable scheduling support for sites of care, and a dependable experience for patients receiving radioligand therapy."

BEXLUTRY is now available for prescribing physicians and patient use. Visit www.bexlutryhcp.com.

About BEXLUTRY

INDICATIONS AND USAGE

BEXLUTRYTM (lutetium Lu 177 dotatate injection) is indicated for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Risk From Radiation Exposure: BEXLUTRY contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. These risks of radiation associated with the use of BEXLUTRY are greater in pediatric patients than in adults.
Radiation can be detected in the urine for up to 30 days following BEXLUTRY administration. Minimize radiation exposure to patients, medical personnel, and household contacts during and after treatment with BEXLUTRY consistent with institutional good radiation safety practices, patient management procedures, Nuclear Regulatory Commission patient-release guidance, and instructions to the patient for follow-up radiation protection at home.
Myelosuppression: In NETTER-1, myelosuppression occurred more frequently in patients receiving lutetium Lu 177 dotatate injection with long-acting octreotide compared to patients receiving high-dose long-acting octreotide (all Grades/Grade 3 or 4): anemia (81%/0) versus (54%/1%); thrombocytopenia (53%/1%) versus (17%/0); and neutropenia (26%/3%) versus (11%/0). In NETTER-1, platelet nadir occurred at a median of 5.1 months following the first dose. Of the 59 patients who developed thrombocytopenia, 68% had platelet recovery to baseline or normal levels. The median time to platelet recovery was 2 months. Fifteen of the nineteen patients in whom platelet recovery was not documented had post-nadir platelet counts. Among these 15 patients, 5 improved to Grade 1, 9 to Grade 2, and 1 to Grade 3. Monitor blood cell counts. Withhold dose, reduce dose, or permanently discontinue BEXLUTRY based on the severity of myelosuppression.
Secondary Myelodysplastic Syndrome (MDS) and Leukemia: In NETTER-1, with a median follow-up time of 76 months in the main study, myelodysplastic syndrome (MDS) was reported in 2.3% of patients receiving lutetium Lu 177 dotatate injection with long-acting octreotide compared to no patients receiving high-dose long-acting octreotide.
In ERASMUS, 16 patients (2.0%) developed MDS and 4 (0.5%) developed acute leukemia. The median time to onset was 29 months (9 to 45 months) for MDS and 55 months (32 to 125 months) for acute leukemia.
Renal Toxicity: In ERASMUS, 8 patients (< 1%) developed renal failure 3 to 36 months following lutetium Lu 177 dotatate injection. Two of these patients had underlying renal impairment or risk factors for renal failure (e.g., diabetes or hypertension) and required dialysis.
Administer the recommended amino acid solution before, during and after BEXLUTRY to decrease the reabsorption of lutetium Lu 177 dotatate through the proximal tubules and decrease the radiation dose to the kidneys. Advise patients to hydrate and to urinate frequently before, on the day of, and the day after administration of BEXLUTRY.

Monitor serum creatinine and calculated creatinine clearance. Withhold dose, reduce dose, or permanently discontinue BEXLUTRY based on the severity of renal toxicity.

Patients with baseline renal impairment may be at increased risk of toxicity due to increased radiation exposure.

Hepatotoxicity: In ERASMUS, 2 patients (< 1%) were reported to have hepatic tumor hemorrhage, edema, or necrosis, with one patient experiencing intrahepatic congestion and cholestasis. Patients with hepatic metastasis may be at increased risk of hepatotoxicity due to radiation exposure.
Monitor transaminases, bilirubin, serum albumin, and international normalized ratio (INR) during treatment. Withhold dose, reduce dose, or permanently discontinue BEXLUTRY based on the severity of hepatotoxicity.

Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, occurred in patients treated with lutetium Lu 177 dotatate injection. Monitor patients closely for signs and symptoms of hypersensitivity reactions, including anaphylaxis, during and following BEXLUTRY administration for a minimum of 2 hours in a setting where cardiopulmonary resuscitation medication and equipment are available. Discontinue the infusion upon the first observation of any signs or symptoms consistent with a severe hypersensitivity reaction and initiate appropriate therapy.
Premedicate patients with a history of Grade 1 or 2 hypersensitivity reactions to BEXLUTRY before subsequent doses. Permanently discontinue BEXLUTRY in patients who experience Grade 3 or 4 hypersensitivity reactions.

Neuroendocrine Hormonal Crisis: Neuroendocrine hormonal crises, manifesting with flushing, diarrhea, bronchospasm and hypotension, occurred in < 1% of patients in ERASMUS and typically occurred during or within 24 hours following the initial lutetium Lu 177 dotatate injection dose. Two (< 1%) patients were reported to have hypercalcemia. Monitor patients for flushing, diarrhea, hypotension, bronchoconstriction or other signs and symptoms of tumor-related hormonal release. Administer intravenous somatostatin analogs, fluids, corticosteroids, and electrolytes as indicated.
Embryo-Fetal Toxicity: Based on its mechanism of action, BEXLUTRY can cause fetal harm when administered to a pregnant woman. Verify pregnancy status of females of reproductive potential prior to initiating BEXLUTRY. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with BEXLUTRY and for 7 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with BEXLUTRY and for 4 months after the last dose.
Risk of Infertility: BEXLUTRY may cause infertility in males and females. The recommended cumulative dose of 29.6 GBq of BEXLUTRY results in a radiation absorbed dose to the testes and ovaries within the range where temporary or permanent infertility can be expected following external beam radiotherapy.

ADVERSE REACTIONS

The most common Grade 3-4 adverse reactions (≥ 4% with a higher incidence in lutetium Lu 177 dotatate injection arm) reported in NETTER-1 were lymphopenia, increased GGT, vomiting, nausea, increased AST, increased ALT, hyperglycemia and hypokalemia.

With a median follow-up time of more than 4 years, the following rates of serious adverse reactions were reported in ERASMUS: myelodysplastic syndrome (2%), acute leukemia (1%), renal failure (2%), hypotension (1%), cardiac failure (2%), myocardial infarction (1%), and neuroendocrine hormonal crisis (1%).

DRUG INTERACTIONS

Somatostatin Analogs: Somatostatin and its analogs competitively bind to somatostatin receptors and may interfere with the efficacy of BEXLUTRY. Discontinue long-acting somatostatin analogs at least 4 weeks and short-acting octreotide at least 24 hours prior to each BEXLUTRY dose. Administer short- and long-acting octreotide during Bexlutry treatment as recommended.

Glucocorticoids: Glucocorticoids can induce down-regulation of subtype 2 somatostatin receptors (SSTR2). Avoid repeated administration of high doses of glucocorticoids during treatment with BEXLUTRY.

USE IN SPECIFIC POPULATIONS

Lactation

Advise women not to breastfeed during treatment with BEXLUTRY and for 2.5 months after the last dose.

Pediatric Use

Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine Tumors: The risks of radiation exposure associated with BEXLUTRY are greater in pediatric patients than in adult patients due to longer life expectancy. The safety and effectiveness of BEXLUTRY have not been established in pediatric patients younger than 12 years old with somatostatin receptor-positive GEP-NETs.

Pediatric use information is approved for Advanced Accelerator Applications USA INC’s LUTATHERA (lutetium Lu 177 dotatate) injection for intravenous use. However, due to Advanced Accelerator Applications USA Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

*LUTATHERA is a registered trademark of Advanced Accelerator Applications International SA.

Please see full Prescribing Information by clicking here or visit www.bexlutryhcp.com.

(Press release, Curium Pharma, SEP 14, 2026, View Source [SID1234673435])

On September 14, 2026 Sanofi and Cheplapharm, a European leader in well-established medicines, reported their intention to create a strategic partnership under which Cheplapharm would take over from Sanofi a selection of 20 mature medicines and three manufacturing sites worldwide. In return, Sanofi will receive a 26.4% equity stake in Cheplapharm, building on a collaboration that started in 2014.

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The partnership is based on a shared conviction: that innovative medicines and certain mature medicines have different needs and should benefit from operating models tailored to their specific manufacturing, regulatory and commercial requirements. Cheplapharm’s specialized expertise will ensure these medicines continue to meet patients’ needs throughout the next stage of their lifecycle.

"Our multi-year journey to simplify our mature portfolio has enabled us to focus on innovation while ensuring mature medicines continue to reach patients who need them. Cheplapharm has been a trusted partner for more than a decade and this transaction significantly builds on its prior acquisitions from Sanofi’s mature medicines portfolio. This new partnership, together with our equity stake in Cheplapharm, underscores our commitment to ensuring patients continue to benefit from today’s essential medicines while also pursuing tomorrow’s breakthroughs," said Thomas Grenier, Executive Vice President, General Medicines, Sanofi.

"This partnership marks a major milestone for Cheplapharm. Through this project, we are incorporating products that complement our extensive portfolio, as well as the expertise and manufacturing capabilities required to produce a flagship product, Lovenox/Clexane. This represents a long-term pharmaceutical and industrial commitment: to invest in our sites and their expertise, to preserve rare skills, and to ensure the long-term availability of these treatments for patients." "We are proud to pursue this ambition alongside Sanofi," said Edeltraud Lafer and Sebastian Braun, both Co-CEOs of Cheplapharm.

As part of the project, three manufacturing sites would be transferred to Cheplapharm: Csanyikvölgy in Hungary (c.400 employees), Jurong in Singapore (c.100 employees), and Ploërmel in France (c.65 employees). The teams would continue their activities with existing employment arrangements and collective agreements maintained. Sanofi and Cheplapharm will work closely together to ensure a smooth transition and continuity of supply in compliance with the highest manufacturing quality standards.

The commercial transfer of the medicine portfolio is planned to begin in the first quarter of 2027, followed by the transfer of the sites, subject to employee information and consultation procedures with employee representatives, regulatory approvals and customary closing conditions. The transaction is expected to be fully completed by the third quarter of 2027.

For Cheplapharm, this partnership represents an important step ensuring the continuity of its strategic growth. For Sanofi, it will enable the company to continue focusing its efforts on innovation, while supporting certain established medicines through the next stage of their lifecycle.

Financial considerations for Sanofi

The proposed transaction is not expected to have any impact on Sanofi’s financial guidance for 2026. The medicines being divested from Sanofi include Lovenox/Clexane (enoxaparin)1. Additional financial details are expected to be provided at a later stage.

(Press release, Sanofi, SEP 14, 2026, View Source [SID1234670925])

On September 14, 2026 GT Biopharma, Inc. (the "Company") entered into a Securities Purchase Agreement (the "Securities Purchase Agreement") with the purchasers identified therein (collectively, the "Purchasers") providing for the issuance and sale to the Purchasers of (i) up to 8,277.778 shares of the Company’s Series M 10% Convertible Preferred Stock (the "Preferred Stock"), (ii) warrants to purchase up to a number of shares of common stock of the Company (the "Common Stock") equal to 100% of the shares of the Company’s Common Stock issuable upon conversion of the shares of Preferred Stock (the "Common Warrants"), and (iii) warrants to purchase up to a number of shares of the Company’s Common Stock equal to the number of Greenshoe Conversion Shares (as defined in the Securities Purchase Agreement) issuable upon exercise of the Greenshoe Right (as defined below) (the "Vesting Warrants" and together with the Common Warrants, the "Warrants"), with an aggregate stated value of $8,277,778, for an aggregate purchase price of $7,450,000 (the "Offering").

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Pursuant to the Securities Purchase Agreement, each Purchaser may elect to purchase shares of Preferred Stock with an aggregate stated value of up to $33,333,333 (the "Greenshoe Rights") for an aggregate purchase price of $30,000,000, subject to adjustments, as further described in the Securities Purchase Agreement. Each Purchaser is entitled to exercise its respective Greenshoe Rights for an amount of Preferred Stock equal to the ratio of such Purchaser’s original subscription amount to the original aggregate subscription amount of all Purchasers.

Pursuant to the Certificate of Designation of Preferences, Rights and Limitations of Series M 10% Convertible Preferred Stock (the "Certificate of Designation"), and subject to certain ownership limitations, the Preferred Stock may be converted at any time at the option of the Purchasers into shares of the Company’s Common Stock at an initial conversion price of $6.10, subject to certain conditions, as further described in the Certificate of Designation. In addition, the holders of the Preferred Stock are entitled to receive cumulative dividends at the rate per share (as a percentage of the stated value per share) of 10% per annum until September 13, 2027, increasing to 12% per annum thereafter, payable quarterly on January 1, April 1, July 1 and October 1, beginning on the first such date after the date of issuance of the Preferred Stock and on each Conversion Date (as defined in the Certificate of Designation), with respect only to Preferred Stock being converted, in cash, shares of the Company’s Common Stock (subject to the Company’s satisfaction of the conditions set forth in the Certificate of Designation), or a combination thereof.

Pursuant to the Securities Purchase Agreement, each Purchaser will be issued (i) a Common Warrant, each to purchase up to a number of shares of the Company’s Common Stock equal to 100% of the Conversion Shares underlying the Preferred Shares issued to such Purchaser and (ii) a Vesting Warrant (the exercisability of which shall vest ratably from time to time in proportion to the Purchaser’s (or its permitted assigns’) exercise of such Purchaser’s Greenshoe Rights pursuant to Section 2.4 of the Securities Purchase Agreement), each to purchase up to a number of shares of the Company’s Common Stock equal to the number of Greenshoe Conversion Shares (as defined in the Securities Purchase Agreement) applicable to such Purchaser, in accordance with the Securities Purchase Agreement. The Common Warrants have an initial exercise price of $6.10 per share, are exercisable, subject to certain ownership limitations, immediately upon issuance and have a term of exercise equal to five years. The Vesting Warrants have an initial exercise price of $6.10 per share, are exercisable, subject to certain vesting and ownership limitations, and have a term of exercise equal to five years from the date that the applicable warrant shares vest.

The Preferred Shares and Warrants both have full ratchet price protection and are subject to other adjustments (including for reverse and forward splits, recapitalizations and similar transactions), as further described in the Certificate of Designation or the Warrants, as applicable. With respect to adjustments in connection with the exercise of Greenshoe Rights, in the first instance, there will not be a floor price; provided, however, if the Company receives written notice from The Nasdaq Stock Market that a floor price should be implemented, a floor price of $1.282 shall be set.

The securities in the Offering were offered privately pursuant to Rule 506(b) of Regulation D under the Securities Act of 1933, as amended.

Registration Rights Agreement

The Company and the Purchasers entered into a registration rights agreement (the "Registration Rights Agreement") pursuant to which the Company agreed to file a registration statement with the Securities and Exchange Commission (the "SEC") covering the public resale of the shares of Common Stock issuable upon conversion of the Preferred Stock and upon exercise of the Warrants. The Company has agreed to file a registration statement within thirty (30) days after the initial closing and after each closing of the exercise of a Greenshoe Right in accordance with the Securities Purchase Agreement, to become effective no later than sixty (60) days after the Closing Date (as defined in the Securities Purchase Agreement) or each Trigger Date (as defined in the Registration Rights Agreement), or in the event of a "full review" by the SEC, ninety (90) days after the Closing Date or each Trigger Date. If these deadlines are not met, the Company will be liable for partial liquidated damages of 1.5% of the subscription amount paid by each Purchaser pursuant to the Securities Purchase Agreement. Further, if the Company fails to pay such liquidated damages within seven days from the date payable, the Company will pay interest thereon at the prime rate plus 12% to each holder of the registerable securities.

Voting Agreement

Pursuant to the Securities Purchase Agreement, the Company agreed to hold a meeting of its stockholders at the earliest practical date after the execution of the Securities Purchase Agreement for the purpose of (i) obtaining shareholder approval for the issuance, in the aggregate, of more than 19.99% of the number of shares of the Company’s Common Stock outstanding on the date of the initial closing ("Shareholder Approval") and (ii) obtaining such shareholder approval as may be required to effect any necessary increase in authorized shares of Common Stock if the number of Underlying Shares (as defined the Securities Purchase Agreement) is greater than the number of authorized shares of Common Stock. In connection with the required Shareholder Approval, all of the Company’s officers and directors (each a "Voting Agreement Party") entered into a voting agreement (the "Voting Agreement") pursuant to which each Voting Agreement Party agreed to vote all shares of voting stock over which the Voting Agreement Party has voting control in favor of any proposal presented to the stockholders of the Company seeking the Shareholder Approval.

Lock-Up Agreement

Pursuant to the Securities Purchase Agreement, the Company and its directors and officers entered into lockup agreements (the "Lockup Agreements"), pursuant to which each officer and director agreed not to sell or transfer any securities of the Company held by them for a period commencing on the date of the Lockup Agreement until thirty (30) days after the later of (i) the Effective Date (as defined in the Securities Purchase Agreement) and (ii) the date that Shareholder Approval is obtained and deemed effective, subject to limited exceptions.

The foregoing descriptions of the terms of the Certificate of Designation, form of Common Warrant, form of Vesting Warrant, Securities Purchase Agreement, Registration Rights Agreement, Voting Agreement and Lockup Agreement are not intended to be complete and are qualified in their entirety by reference to such exhibits, which are filed herewith as Exhibits 3.1, 4.1, 4.2, 10.1, 10.2, 10.3 and 10.4, respectively, to this Current Report on Form 8-K and are incorporated by reference herein. Neither this current report on Form 8-K, nor the exhibits attached hereto, is an offer to sell or the solicitation of an offer to buy the securities described herein.

(Filing, GT Biopharma, SEP 14, 2026, View Source [SID1234670862])