Duyuru • May 16
Gt Biopharma Inc Announces First Patient Dosed in Phase 1 Trial of Gtb-5550, A B7-H3-Targeted Natural Killer (Nk) Cell Engager for Solid Tumors GT Biopharma, Inc. announced that the first patient was dosed in a Phase 1 dose escalation basket trial evaluating GTB-5550, its B7-H3-targeted natural killer (NK) cell engager for solid tumors expressing B7-H3. GTB-5550 is now the 3rd TriKE to enter the clinic and an expansion into a broader solid tumor opportunity, with the Phase 1 trial likely to focus on prostate cancer patients during the dose escalation phase. The company anticipates providing updates in the second half of 2026 as enrollment progresses through dose escalation cohorts. The Phase 1 trial with GTB-5550 will be the first nanobody TriKE tested with more patient-friendly subcutaneous dosing. The Phase 1a dose escalation portion of the trial will focus primarily on enrolling prostate cancer patients and evaluate up to 6 dose levels to identify the maximum tolerated dose. After the dose escalation phase, the Phase 1b expansion component will enroll patients with up to 7 different tumor types (castration-resistant prostate cancer, ovarian cancer, breast cancer, head and neck cancer, non-small cell lung cancer, pancreatic cancer, and bladder cancer) and further evaluate its safety, tolerability and preliminary anti-tumor activity. GTB-5550 will be administered by subcutaneous injection in the abdominal area for 5 consecutive days during Week 1 and Week 2 followed by 2 weeks of no treatment. One treatment cycle is 4 weeks in duration. Subsequent cycles receive treatment three times weekly for 2 weeks followed by 2 weeks of no treatment. A minimum of 2 cycles is planned, and patient-appropriate disease reassessment is performed after 2 cycles and every 8-12 weeks thereafter. Treatment may continue until disease progression, unacceptable toxicity, patient refusal, or treatment is no longer in the best interest of the patient. Patients are followed for 12 months to determine progression free survival and overall survival. More details can be found on clinicaltrials.gov with the identifier: NCT07541573. New Risk • May 14
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$13m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Shareholders have been substantially diluted in the past year (over 11x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$9.87m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$11m net loss in 3 years). New Risk • Apr 26
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.86m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$13m free cash flow). Shareholders have been substantially diluted in the past year (over 11x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$9.86m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$11m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Duyuru • Feb 04
GT Biopharma, Inc. Announces FDA Clearance of Investigational New Drug for GTB-5550 TriKE, B7-H3-Targeted Natural Killer Cell Engager for Solid Tumors Expressing B7-H3 GT Biopharma, Inc. announced FDA clearance of its IND application for GTB-5550, allowing the company to proceed with a Phase 1 clinical trial, which is anticipated to initiate in mid-2026. The company expects to commence enrollment of the Phase 1 basket trial in mid-2026. While the phase I trial is open to patients with common solid tumors that express B7-H3, in the dose-escalation component will prioritize enrollment for advanced prostate, ovarian, and pancreatic cancer patients who have failed standard therapies. Based on the encouraging trends we have seen from ongoing Phase 1 trial with GTB-5550 in AML patients, the company are even more enthusiastic about the potential benefits of GTB-5550 treatment in patients with solid tumors known to express B7-H3. The Phase 1 trial with GT B-5550 will be the first dual nanobody TriKE®? tested with more patient-friendly subcutaneous dosing. The Phase 1a dose escalation portion of the trial will test up to 6 dose levels to identify the maximum tolerated dose (MTD). After the dose escalation phase, the Phase 1b expansion component of the trial will then confirm the MTD identified in the Phase 1a trial in up to 7 different possible metastatic disease cohorts (castration-resistant prostate cancer, ovarian cancer, breast cancer, head and neck cancer, non-small cell lung cancer, pancreatic cancer, and bladder cancer) and further evaluate its safety, tolerability and preliminary anti-tumor activity. GTB-5550 will be administered by subcutaneous (SQ) injection in the abdominal area for 5 consecutive days during Week 1 and Week 2 followed by 2 weeks of no treatment. Treatment may continue until disease progression, unacceptable toxicity, patient refusal, or treatment is no longer in the best interest of the patient. Patients are followed for 12 months to determine progression free survival (PFS) and overall survival (OS). Duyuru • Jan 15
GT Biopharma, Inc. Announces IND Submission for GTB-5550 TriKE, B7-H3-Targeted Natural Killer Cell Engager for B7-H3 Expressing Solid Tumor Cancers GT Biopharma, Inc. announced the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) in December 2025 for GTB-5550 TriKE, a B7-H3-targeted natural killer (NK) cell engager for the treatment of B7-H3 expressing solid tumor cancers. The global market for B7-H3 expressed solid tumor cancers accounts for a portion of the estimated $362 billion global solid tumor cancers market (according to Data Bridge Market Research). B7-H3 expressing Solid tumor cancers are estimated to account for a significant portion of solid tumor cancers. GTB-5550 is a camelid (cam) anti-CD16/WT IL-15/cam anti-B7-H3 tri-specific natural killer (TriKE) cell engager, with a single chain recombinant TriKE comprised of three components joined by flexible linkers: 1) a nanobody arm that engages the CD16 activating receptor (camelid anti-CD16) on natural killer (NK) cells; 2) a wildtype IL-15 (WT IL-15) linker arm to drive NK cell proliferation, priming, and survival; and 3) a nanobody arm which specifically engages B7-H3 (camelid anti-B7-H 3) to target the antigen expressed on tumor cells. Based on supportive preclinical data, the planned Phase 1 trial with GTB-5550 will be the first dual nanobody TriKE®? tested with more patient-friendly subcutaneous dosing. GTB-5550 will been administered by subcutaneous (SQ) injection in the abdominal area for 5 consecutive days during Week 1 and Week 2 followed by 2 weeks of no treatment. One treatment cycle is 4 weeks in duration. A minimum of 2 cycles is planned, and patient-appropriate disease reassessment is performed after 2 cycles and every 8-12 weeks thereafter. Treatment may continue until disease progression, unacceptable toxicity, patient refusal, or treatment is no longer in the best interest of the patient. Patients are followed for 12 months to determine progression free survival (PFS) and overall survival (OS). Duyuru • Dec 12
GT Biopharma, Inc. Reports Continued Progress with Its Phase 1 Clinical Trial of GTB-3650 GT Biopharma, Inc. recently reported continued progress with its Phase 1 clinical trial of GTB-3650, which has now advanced into Cohort 4 at a dose level of 10µg/kg/day. The company is developing innovative immunotherapy treatments designed to combat some of the world's most challenging cancer types using its proprietary natural killer cell engager TriKE platform technology. The Phase 1 dose escalation study is evaluating GTB-3650 in patients battling relapsed or refractory blood cancers that express the CD33 protein, specifically acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). These represent some of the most difficult cancer cases to treat, involving patients whose disease either came back after initial therapy or never responded to conventional treatment options.GTB-3650 works by stimulating the patient's natural killer cells, a type of immune cell that naturally hunts down and destroys abnormal cells, to specifically target cancer cells. Patients receive the therapy through continuous infusions following a structured schedule: two weeks of treatment followed by two weeks of rest, repeating this cycle for up to four months based on how they respond. The six patients enrolled across Cohorts 1 through 3 have all been successfully treated with GTB-3650, demonstrating the therapy's tolerability at progressively higher dose levels. According to the company, the Cohort 4 dose level of 10µg/kg/day is more reflective of the potential clinical efficacy threshold based on positive trends observed across multiple immunological biomarkers and the complete absence of dose-limiting toxicities throughout all three completed cohorts. The Phase 1 first in human trial design calls for testing GTB-3650 in approximately 14 patients across seven cohorts, with two patients per cohort receiving progressively higher doses from 1.25µg/kg/day in Cohort 1 up to 100µg/kg/day in Cohort 7 if necessary. Beyond Cohort 4, three additional higher-dose cohorts remain available: Cohort 5 at 25µg/kg/day, Cohort 6 at 50µg/kg/day, and Cohort 7 at the maximum planned dose of 100µg/kg/day. The company plans to provide the next trial update in the first quarter of 2026.Beyond blood cancers, GT Biopharma is developing GTB-5550, which targets B7H3, a protein commonly found across various solid tumor types including breast, lung, ovarian, pancreatic, bladder, and prostate cancers. The company expects to submit its regulatory application to begin human trials of GTB-5550 in late December 2025 or January 2026.Both candidates utilize GT Biopharma's proprietary TriKE platform technology, which employs specialized antibody fragments originally found in camels and llamas. These molecules offer advantages over conventional antibodies due to their smaller size and greater stability. The company holds an exclusive worldwide license from the University of Minnesota for this technology. Duyuru • Oct 23
GT Biopharma, Inc. Provides Enrollment Update on GTB-3650 Phase 1 Trial in Patients with Relapsed or Refractory (r/r) CD33 Expressing Hematologic Malignancies GT Biopharma, Inc. announced successful completion of the Cohort 3 formal safety review with no safety or tolerability issues observed and advancement into Cohort 4 of its Phase 1 dose escalation trial evaluating GTB-3650 for the treatment of relapsed or refractory (r/r) CD33 Expressing hematologic malignancies. The six patients in Cohorts 1 through 3 have been successfully treated with GTB-3650 and the formal safety review of Cohort 3 showed no safety or tolerability issue observed. This has allowed progression to actively screening patients for Cohort 4. With a dose of 10 ug/kg/day, Cohort 4 is more reflective of the potential efficacy threshold. The Phase 1 trial protocol allows for three additional cohorts with much higher dose levels ranging from 25 ug/kg/day with Cohort 5, 50 ug/kg/day With Cohort 6 and 100 ug/kg/day for Cohort 7, if necessary. The company anticipates providing its next update on the trial in First Quarter 2026. The Phase 1 trial will evaluate of GTB-3650 in up to approximately 14 patients (two patients in each of seven cohorts), with doses ranging from 1.25 ug/kg/day in Cohort 1 to 100 ug/kg/day in Cohort 7. GTB-3650 is dosed in two-week blocks, two weeks on and two weeks off (defining a treatment cycle), for up to four months based on clinical benefit. The trial will assess safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells and clinical activity. Duyuru • Oct 10
GT Biopharma Provides Enrollment Update on GTB-3650 Phase 1 Trial in Patients with Relapsed or Refractory (r/r) CD33 Expressing Hematologic Malignancies GT Biopharma, Inc. announced that enrollment in the dose escalation cohorts of the Phase 1 trial, evaluating GTB-3650 for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies, is well on track. Enrollment in Cohorts 1 and 2 were successfully completed; both patients in Cohort 3 have now initiated treatment with no evidence of dose-limiting toxicities or safety concerns to date. The level of immune activation observed from multiple biomarkers in the first patient of Cohort 3 is consistent with the evidence of heightened immune activity in the first four patients from Cohorts 1 and 2. Assuming Cohort 3 is completed with no new safety findings, the trial will continue to dose-escalate into the higher ranges of GTB-3650 anticipated to be necessary to translate heightened immune activation into clinically meaningful evidence of therapeutic activity. Initiation of dosing in Cohort 4 is planned by year-end 2025 and additional data updates are anticipated in first quarter 2026. The Phase 1 protocol allows evaluation of GTB-3650 in up to approximately 14 patients (two patients in each of seven cohorts), with doses ranging from 1.25ug/kg/day in Cohort 1 to 100ug/kg/day in cohort 7. GTB-3650 will be dosed in two-week blocks, two weeks on and two weeks off (defining a treatment cycle), for up to four months based on clinical benefit. The trial will assess safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells and clinical activity. New Risk • Oct 08
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 19% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$10m free cash flow). Share price has been highly volatile over the past 3 months (19% average weekly change). Shareholders have been substantially diluted in the past year (59% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$2.67m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$5.0m net loss in 3 years). New Risk • Aug 15
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$10m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$10m free cash flow). Shareholders have been substantially diluted in the past year (41% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$4.56m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$5.0m net loss in 3 years). Share price has been volatile over the past 3 months (15% average weekly change). Duyuru • Aug 12
GT Biopharma Advances into Cohort 3 of GTB-3650 Phase 1 Trial Following Safety Review of Cohort 2 GT Biopharma, Inc. announced initiation of dosing in Cohort 3 of its Phase 1 dose escalation trial evaluating GTB-3650 for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies. The Phase 1 dose escalation trial is evaluating GTB-3650, GT Biopharma's second-generation TriKE, for the treatment of relapsed and refractory (r/®? CD33 expressing hematologic Malignancies. Cohorts 1 and 2 have now both been successfully completed and following the formal safety reviews, no safety or tolerability issues have been observed. This has allowed initiation of dosing in cohort 3, with the first patient now having completed the first week of cycle 1. Patients from Cohort 1 and Cohort 2 have shown encouraging early results indicative of GTB-3650's ability to activate endogenous NK cells and induce NK cell expansion. Data from multiple blood biomarker assays from the first four patients show heightened immune activity. GT Biopharma plans on releasing initial Phase 1 results later in 2025 following completion of additional dose cohorts. The trial plans to evaluate GTB-3650 in up to approximately 14 patients (seven cohorts) and GTB-3650 will be dosed in two-week blocks, two weeks on and two weeks off (defining a treatment cycle), for up to four months based on clinical benefit. The trial will assess safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells and clinical activity. Board Change • Jul 01
High number of new and inexperienced directors There are 4 new directors who have joined the board in the last 3 years. The company's board is composed of: 4 new directors. 1 experienced director. No highly experienced directors. CEO & Executive Chairman Michael Breen is the most experienced director on the board, commencing their role in 2021. The company’s lack of experienced directors is considered a risk according to the Simply Wall St Risk Model. New Risk • Jun 15
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 46% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Negative equity (-US$980k). Shareholders have been substantially diluted in the past year (46% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$8.94m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$6.6m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Duyuru • Jun 13
GT Biopharma, Inc Appoints David C. Mun-Gavin to Its Board of Directors GT Biopharma, Inc. announced the appointment of David C. Mun-Gavin to its Board of Directors. Mr. Mun-Gavin has several decades of executive leadership experience at the very highest levels. He has served as the Client Director, International Private Banking Division, of several global private banks. The global institutions where Mr. Mun-Gavin has worked include Credit Suisse, Swiss Bank Corporation Investment Banking Ltd., and Bankers Trust International Limited. Mr. Mun-Gavin has also served in other management roles, including several years as CEO of the Vanol Group, an international oil trading company. Mr. Mun-Gavin is a qualified Chartered Accountant (SA) and worked for Goldby, Compton and Mackelvie during his accountancy career. Duyuru • Jun 02
GT Biopharma, Inc., Annual General Meeting, Jul 24, 2025 GT Biopharma, Inc., Annual General Meeting, Jul 24, 2025. Location: 1900 avenue of the stars, suite 2700, los angeles, california 90067, United States Duyuru • May 28
GT Biopharma, Inc. announced that it has received $5.95 million in funding On May 27, 2025, GT Biopharma, Inc., closed the transaction. The company has raised $5,950,000 from 9 investors pursuant to regulation D. Duyuru • May 20
Gt Biopharma Advances GTB-3650 Phase 1 Trial to Cohort 2 Following Successful Initial Human Dosing and Evidence of Early Immune Activation Signals GT Biopharma, Inc. announced successful completion of dosing in Cohort 1 and subsequent initiation of dosing in Cohort 2 of its Phase 1 dose escalation trial evaluating GTB-3650 for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies. Cohort 1 has been successfully completed with patients having undergone the first and second dosing cycles. Following the formal safety review, no safety or tolerability issues were observed, allowing the company to move forward with Cohort 2, with the first patient now having been treated with the first dose cycle. Based on multiple assays of various blood biomarkers, both patients in Cohort 1 have shown early evidence of increased immunologic activity, supporting GTB-3650's ability to activate endogenous NK cells and induce NK cell expansion. The company plans on releasing more detailed results later in 2025 following enrollment and completion of additional dose cohorts. The trial plans to evaluate GTB-3650 in up to approximately 14 patients (seven cohorts) and GTB-3650 will be dosed in two-week blocks, two weeks on and two weeks off, for up to four months based on clinical benefit. The trial will assess safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells and clinical activity. Duyuru • May 13
GT Biopharma, Inc. announced that it expects to receive $5.45 million in funding GT Biopharma, Inc. announced that it has entered into a Securities Purchase Agreement with the purchasers identified therein providing for the issuance and sale to the Purchasers of up to 6,056 shares of the Company’s Series L 10% Convertible Preferred Stock, warrants to purchase up to a number of shares of common stock of the Company equal to 100% of the shares of the Company’s Common Stock issuable upon conversion of the shares of Preferred Stock and warrants to purchase up to a number of shares of Company’s Common Stock equal to the number of Greenshoe Conversion Shares issuable upon exercise of the Greenshoe Right with an aggregate stated value of $6,055,555.56, for an aggregate gross proceeds of $5,450,000 on May 12, 2025. Pursuant to the Securities Purchase Agreement, each Purchaser may elect to purchase shares of Preferred Stock with an aggregate stated value of up to $22,000,000 for an aggregate purchase price of $19,800,000, 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 designating the Preferred Stock 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 $2.043, 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 of 10% per annum until May 11, 2026, increasing to 12% per annum thereafter, payable quarterly on January 1, April 1, July 1 and October 1, beginning on the first date after the date of issuance of the Preferred Stock and on each Conversion Date, in cash, shares of the Company’s Common Stock, or a combination thereof. The securities in the Offering were offered privately pursuant to Rule 506(b) of Regulation D under the Securities Act of 1933, as amended. Duyuru • Mar 08
GT Biopharma, Inc. announced that it has received $1.280358 million in funding On March 7, 2025, GT Biopharma, Inc. closed the transaction. The transaction included participation from six investors. The company paid $70,000 as sales commissions. Duyuru • Feb 24
GT Biopharma, Inc. has withdrawn its Follow-on Equity Offering. GT Biopharma, Inc. has withdrawn its Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 3,361,344
Price\Range: $2.38
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 3,361,344
Security Name: Common Warrants
Security Type: Equity Warrant
Securities Offered: 3,361,344 New Risk • Feb 24
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$13m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$13m free cash flow). Share price has been highly volatile over the past 3 months (22% average weekly change). Negative equity (-US$1.7m). Shareholders have been substantially diluted in the past year (62% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$4.80m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$14m net loss in 3 years). Duyuru • Jan 27
GT Biopharma, Inc. Announces First Patient Dosed in Phase 1 Trial of GTB-3650, Second-Generation TriKE for the Treatment of Hematologic Malignancies GT Biopharma, Inc. announced that the first patient was dosed in a Phase 1 trial evaluating GTB-3650, its second-generation TriKE, for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies. GTB-3650 is GT Biopharma's wholly owned second-generation TriKE. It utilizes camid nanobody technology, with the potential to improve potency and enhance binding affinity. The Phase 1 dose escalation study will evaluate GTB-3650 in up to approximately 14 patients (seven cohorts) with relapsed or refractory®? CD33 expressing hematologic Malignancies, including refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). GTB-3650 will be dosed in two-week blocks, two weeks on and two weeks off, for up to four months based on clinical benefit. The trial will assess safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells and clinical activity. Duyuru • Dec 24
GT Biopharma, Inc. has filed a Follow-on Equity Offering. GT Biopharma, Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant New Risk • Dec 24
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 21% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$12m free cash flow). Share price has been highly volatile over the past 3 months (21% average weekly change). Earnings are forecast to decline by an average of 2.8% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (62% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$3.90m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$14m net loss in 3 years). New Risk • Dec 02
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 2.8% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$12m free cash flow). Earnings are forecast to decline by an average of 2.8% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (62% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$6.26m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$14m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Duyuru • Nov 28
GT Biopharma Receives Nasdaq Notification Regarding Listing Rule 5550(b)(1) On November 21, 2024, GT Biopharma, Inc. received a letter (the Letter") from the Nasdaq Listing Qualifications Staff (the Staff") of The Nasdaq Stock Market LLC (Nasdaq") notifying the Company that its amount of stockholders' equity has fallen below the $2,500,000 required minimum for continued listing set in Nasdaq Listing Rule 5550(b)(1). Nasdaq's determination was based upon the Company's stockholders' equity as reported in the Company's Quarterly Report on Form 10-Q for the period ended September 30, 2024. The Letter also noted that the Company does not meet the alternatives of market value of listed securities or net income from continuing operations, and therefore, the Company no longer complies with Nasdaq's Listing Rules. This Letter has no immediate effect on the listing of the Company's common stock, and its common stock will continue to trade on The Nasdaq Capital Market under the symbol GTBP" at this time. Under Nasdaq Listing Rules, the Company has until January 6, 2025 to provide Nasdaq with a plan to achieve and sustain compliance. If Nasdaq accepts the Company's plan to regain compliance, Nasdaq may grant an extension of up to 180 calendar days from the date of the Letter to evidence compliance. If Nasdaq does not accept the Company's plan to regain compliance, the Company will have the opportunity to appeal the decision to a Nasdaq Hearings Panel. The Company intends to submit to Nasdaq, within the requisite time period, a plan to regain compliance with Listing Rule 5550(b)(1). There can be no assurance that Nasdaq will accept the Company's plan, that the Company will be able to regain compliance with Listing Rule 5550(b)(1) or that the Company will be able meet the continued listing requirements during any compliance period that may be granted by Nasdaq. Duyuru • Jun 27
GT Biopharma, Inc. Announces FDA Clearance of Investigational New Drug (IND) Application for GTB-3650, an NK Cell Engager for Treatment of CD33+ Leukemia GT Biopharma, Inc. announced FDA clearance of its IND application for GTB-3650, allowing the company to proceed with a Phase 1 clinical trial, which is anticipated to start in second half of 2024. The Phase 1 dose escalation study will evaluate GTB-3650 in up to six cohorts of adult patients with relapsed or refractory (r/r) CD33 expressing hematologic malignancies, including acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). GTB-3650 will be dosed in two-week blocks, two weeks on and two weeks off for up to four months based on clinical benefit. The trial will assess safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells and clinical activity. Camelid antibodies are single domain antibodies (sdAbs) from the Camelidae family of mammals that include llamas, camels, and alpacas. These animals produce two main types of antibodies. One type of antibody camelids produce is the conventional antibody that is made up of two heavy chains and two light chains. They also produce another type of antibody that is made up of only two heavy chains and no light chain. This is known as heavy chain IgG (hcIgG). While these antibodies do not contain the CH1 region, they retain an antigen binding domain called the VHH region. VHH antibodies, also known as single domain antibodies, contain only the VHH region from the camelid antibody. Camelid antibodies have key characteristics, which include high affinity and specificity (equivalent to conventional antibodies), high thermostability, good solubility and strictly monomeric behavior, small size, relatively low production cost, ease of genetic engineering, format flexibility or modularity, low immunogenicity, and a higher penetration rate into tissues. Duyuru • Jun 10
GT Biopharma, Inc. Announces CFO Changes On June 3, 2024, Manu Ohri’s employment as Chief Financial Officer at GT Biopharma, Inc. was terminated. In connection with Mr. Ohri’s termination, on June 3, 2024, the Company has appointed Alan L. Urban as the Company’s Chief Financial Officer. Mr. Urban, age 55, has previously served as a member of the Board of Directors of the Company from June 2022 to May 2023; as Chief Financial Officer for SRAX, Inc., a financial technology company, from March 2023 to July 2023; as Chief Financial Officer for Creek Road Miners, Inc. a cryptocurrency mining company, from November 2021 to March 2023; and as Chief Financial Officer and Secretary for Research Solutions, Inc. a SaaS and content provider in the scientific, technical and medical information space, from October 2011 to October 2021. Earlier in his career, Mr. Urban served as Chief Financial Officer and Senior Vice President of Finance and Accounting for ReachLocal, Inc., an internet marketing company; and as Vice President of Finance and Treasurer for Infotrieve, Inc., a content provider in the scientific, technical and medical information space. He has been a Certified Public Accountant (currently inactive) since 1998. Mr. Urban received a B.S. in Business, with a concentration in Accounting Theory and Practice, from California State University, Northridge. New Risk • May 26
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 73% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (46% average weekly change). Shareholders have been substantially diluted in the past year (73% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$7.94m market cap). Duyuru • May 22
GT Biopharma, Inc. has filed a Follow-on Equity Offering in the amount of $3.219 million. GT Biopharma, Inc. has filed a Follow-on Equity Offering in the amount of $3.219 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 740,000
Price\Range: $4.35
Transaction Features: Registered Direct Offering New Risk • May 17
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$10m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$10m free cash flow). Revenue is less than US$1m. Market cap is less than US$10m (US$4.51m market cap). Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (11% increase in shares outstanding). Duyuru • May 01
GT Biopharma, Inc., Annual General Meeting, Jun 25, 2024 GT Biopharma, Inc., Annual General Meeting, Jun 25, 2024, at 11:00 Pacific Standard Time. Agenda: To elect four directors to serve until the 2025 annual meeting of stockholders or until their successors are duly elected and qualified; to ratify the appointment of Weinberg & Company, P.A. as the Company’s independent accountants for the fiscal year ending December 31, 2024; to hold an advisory vote on executive compensation; and to transact other business properly presented at the meeting or any postponement or adjournment thereof. New Risk • Feb 14
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 10% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 56% per year for the foreseeable future. Revenue is less than US$1m. Market cap is less than US$10m (US$5.21m market cap). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$15m net loss next year). Share price has been volatile over the past 3 months (10% average weekly change). Shareholders have been diluted in the past year (27% increase in shares outstanding). Duyuru • Feb 02
GT Biopharma Announces 1 for 30 Reverse Stock Split to Regain Compliance with the Minimum Bid Price Requirement for Continued Listing on The Nasdaq Capital Market GT Biopharma, Inc. announced that it will conduct a reverse stock split of its outstanding shares of common stock at a ratio of 1-for-30. The reverse stock split will become effective at 5:00 p.m. Eastern time, on February 2, 2024. The Company’s common stock will continue to be traded on the Nasdaq Capital Market under the symbol ‘GTBP’ and will begin trading on a post-split basis at the market open on February 5, 2024. The reverse stock split is part of the Company’s plan to regain compliance with the Minimum Bid Price Requirement of $1.00 per share for continued listing on The Nasdaq Capital Market. Duyuru • Dec 04
GT Biopharma Announces IND Submission for GTB-3650 for Treatment of CD33+ Leukemia GT Biopharma, Inc. announced the submission of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for the development of GTB-3650, a 2nd generation antibody TriKE for the treatment of patients with CD33+ leukemia, including relapsed/refractory acute myelogenous leukemia (AML) and high-risk myelodysplastic syndrome (MDS). Duyuru • Nov 07
GT Biopharma, Inc. Presents Positive Preclinical Data for GTB-5550, a Novel TriKE(R) Molecule for Targeted Prostate Cancer Treatment During the Society for Immunotherapy of Cancer (SITC) 2023 Annual Meeting GT Biopharma, Inc. announced positive preclinical data in highlighting GTB-5550's potential in prostate cancer. Martin Felices, PhD, Associate Professor of Medicine at the University of Minnesota, presented these data on Saturday, November 4th at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2023, which is being held in San Diego, California November. Natural killer (NK) cells are being increasingly explored in clinical trials due to their safety profile and ability to mediate tumor killing without prior priming. However, lack of antigen-specific targeting, decreased numbers, and suppressive signals from the tumor microenvironment (TME) of Prostate Cancer (PCa), can negatively impact NK cell efficacy. GTB-5550 was specifically designed as a novel tri-specific killer engager (TriKE(R)) molecule with three components: an arm that engages with CD16, an activating receptor of NK cells, an arm that binds to tumor antigens expressed in prostate cancer (PSMA or B7H3), and an interleukin (IL)-15 moiety that is essential for NK cell survival, proliferation, priming and motility. ey findings demonstrated that normal donor and prostate cancer patient NK cells displayed better, specific, degranulation against prostate cancer cell lines in the presence of PSMA or B7H3 TriKEs. NK cell cytotoxicity was also improved, even in the presence of enzalutamide resistant lines, hypoxia, or MDSCs. The TriKE molecules displayed improved tumor control, compared to IL-15 control or no treatment, in xenogeneic models of prostate cancer. Duyuru • Aug 23
Nasdaq Listing Qualifications Department Determines the GT Biopharma's Eligibility for an Additional 180 Calendar Day Period, or Until February 20, 2024, to Regain Compliance On August 22, 2023, GT Biopharma, Inc. (the ‘Company’) received notice from the Nasdaq Listing Qualifications Department (the ‘Staff’) of the Nasdaq Stock Market LLC (‘Nasdaq’) advising that the Staff determined the Company is eligible for an additional 180 calendar day period, or until February 20, 2024, to regain compliance with its minimum bid price requirement rule under Rule 5550(a)(2) (the ‘Minimum Bid Price Requirement’) pursuant to the Nasdaq Listing Rule 5810(c)(3)(A). The notification has no immediate effect on the listing of the Company’s common stock, and its common stock will continue to trade on The Nasdaq Capital Market under the symbol ‘GTBP’ at this time. The Company has a period of an additional 180 calendar days, or until February 20, 2024, to regain compliance with the Minimum Bid Price Requirement. If at any time before February 20, 2024, the bid price of the Company’s common stock closes at $1.00 per share or more for a minimum of 10 consecutive business days, the Staff will provide written confirmation that the Company has achieved compliance and the matter will be closed. There can be no assurance that the Company will be able to regain compliance with the Minimum Bid Price Requirement or will otherwise be in compliance with other Nasdaq Listing Rules. However, the Company intends to actively monitor the closing bid price for its common stock and will consider available options to resolve the deficiency and regain compliance with the Minimum Bid Price Requirement, including initiating a reverse stock split. If the Company chooses to implement a reverse stock split, must complete the reverse stock split no later than 10 business days prior to the expiration date of the additional compliance period on February 20, 2024 in order to timely regain compliance. New Risk • Aug 07
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 52% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 52% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$123m net loss in 3 years). Share price has been volatile over the past 3 months (15% average weekly change). Shareholders have been diluted in the past year (23% increase in shares outstanding). Market cap is less than US$100m (US$10.5m market cap). New Risk • Aug 02
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.81m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Revenue is less than US$1m. Market cap is less than US$10m (US$9.81m market cap). Minor Risks Share price has been volatile over the past 3 months (15% average weekly change). Shareholders have been diluted in the past year (23% increase in shares outstanding). Duyuru • May 06
GT Biopharma, Inc. Announces Board Changes GT Biopharma, Inc. has named Charles J. Casamento to fill a vacant seat on the Board and to serve as a member of the Audit Committee of the Board, the Compensation Committee of the Board and the Nominating and Corporate Governance Committee of the Board as of May 1, 2023. Concurrently, Alan Urban resigned as a member of the Board of Directors in order to pursue new career endeavors. Mr. Casamento is currently executive director and principal of The Sage Group, a healthcare advisory group specializing in mergers, acquisitions, and partnerships between biotechnology companies and pharmaceutical companies, since 2007. Mr. Casamentos career in healthcare spans more than 35 years, where he was a founder or had held senior management roles at various biopharmaceutical companies including Osteologix Inc., Questcor Pharmaceuticals, Inc., RiboGene, Inc., Interneuron Pharmaceuticals (Indevus), Genzyme Corporation, amongst other companies. Mr. Casamento also serves on the board of directors of the following NASDAQ listed companies: Eton Pharmaceuticals, Inc., First Wave Biopharma, Inc., PaxMedica, Inc., and Relmada Therapeutics, Inc. During his career he has served on the boards of fourteen Biotech/Pharma companies and has also been a director and vice chairman of The Catholic Medical Missions Board, a large not-for-profit organization providing health care services to third world countries. He has served as a guest lecturer at Fordham University and is on the Science Council of Fordham University. He holds a bachelors degree in Pharmacy from Fordham University and an MBA from Iona University and was originally licensed to practice pharmacy in the states of New York and New Jersey. Mr. Casamentos significant experience in the biotechnology sector make him a valuable addition to the Board. Duyuru • Dec 16
Gt Biopharma Names Dr. Jeff Miller as Consulting Chief Medical Officer GT Biopharma, Inc. named Dr. Jeff Miller,renowned NK Cell Cancer Specialist as Consulting Chief Medical Officer. Dr. Miller is currently Professor of Medicine at the University of Minnesot and is the Deputy Director of the University of Minnesota'sMasonic Comprehensive Cancer Center. Dr. Miller has more than 25 years of experience studying the biology of NK cells, and other immune effector cells and their use in clinical immunotherapy with over 300 peer- reviewed publications. Dr. Miller is a board certified physician specializing in hematological oncology. Dr. Miller is a member of numerous medical societies such as the American Society of Hematology, the American Association of Immunologists, and has been a member of the American Society of Clinical Investigation since 1999. Dr. Miller serves on the editorial board for Transplantation and Cell Therapy and is a reviewer for a number of journals and NIH grants.Dr. Miller's current discovery and research themes in the Miller Laboratory include: NK cells and their receptors after hematopoietic cell transplantation CMV induce adaptive NK cells exhibit enhanced function through CD16 Induction of NK cells antigen specificity through CD16 targeting Preserving and enhancing NK cell function through antibody dependent cellular cytotoxicity (ADCC). Duyuru • Dec 15
GT Biopharma, Inc. Announces Gregory Berk, President of Research & Development and Chief Medical Officer, Is no Longer Employee GT Biopharma, Inc. announced that effective December 8, 2022, Dr. Gregory Berk, President of Research & Development and Chief Medical Officer, is no longer employed by the Registrant. Price Target Changed • Nov 16
Price target decreased to US$4.00 Down from US$14.00, the current price target is an average from 2 analysts. New target price is 98% above last closing price of US$2.02. Stock is down 60% over the past year. The company is forecast to post a net loss per share of US$0.64 next year compared to a net loss per share of US$2.06 last year. Board Change • Nov 16
High number of new and inexperienced directors There are 7 new directors who have joined the board in the last 3 years. The company's board is composed of: 7 new directors. 3 experienced directors. No highly experienced directors. Consulting Chief Scientific Officer & Scientific Advisor Jeff Miller is the most experienced director on the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Duyuru • Aug 31
Gt Biopharma, Inc. Affirms Manufacturing Timeline for Lead Investigational Asset GTB-3650 GT Biopharma, Inc. announced entering into a Settlement and Investment Agreement (the “Agreement”) with its contract manufacturing partner Cytovance Biologics. The signed Agreement, covers all work required to facilitate the registration of an investigational new drug (IND) filing with the U.S. Food and Drug Administration (“FDA”) of its lead investigational asset GTB-3650. GTB-3650 is the Company's lead second-generation Tri-Specific Killer Engager TriKE® program currently in preclinical development for the treatment of relapsed/refractory acute myelogenous leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The Company previously announced that its second generation TriKE, GTB-3650, will supplant GTB-3550. The MSA with Cytovance covers all changes to scope of work in order to advance GTB-3650 forward. In consideration for this scope of work payments to Cytovance will be in the form of cash and stock but limited to no more than 4.9% of GTB’s total shares outstanding. The Company now expects to file its investigational new drug (“IND”) application with the FDA for its GTB-3650 product no later than March 31, 2023, and to file its IND application with the FDA for its GTB-5550 product no later than June 30, 2023. Therapeutic and commercial advantages of GTB-3650 compared to GTB-3550 include: GTB-3650 is based on second generation camelid single-domain antibody technology that holds several advantages over traditional IgG monoclonal antibodies; Improved potency and enhanced binding affinity; Similar preclinical safety profile; Proprietary patented molecule, which unlike GTB-3550, is wholly owned by GT Biopharma. Duyuru • Jun 26
GT Biopharma, Inc.(NasdaqCM:GTBP) dropped from Russell 3000E Index GT Biopharma, Inc.(NasdaqCM:GTBP) dropped from Russell 3000E Index Duyuru • Jun 11
GT Biopharma, Inc. Appoints Alan L. Urban to Fill Vacant Seat on Board Effective June 9, 2022, the Board of Directors of GT Biopharma, Inc. appointed Alan L. Urban to fill a vacant seat on the Board and to serve as a member of the Audit Committee of the Board. The Board determined that Mr. Urban qualifies as an independent director as that term is defined in the applicable rules for companies traded on The NASDAQ Stock Market. Mr. Urban, age 53, has over 25 years of experience in corporate finance and accounting. Mr. Urban has previously served in numerous senior management positions, including: Chief Financial Officer of Research Solutions from 2011 through 2021; Chief Financial Officer of ReachLocal from 2007 to 2009, an internet marketing company that ranked #1 on Deloitte’s Tech Fast 500 List; Chief Financial Officer of a leading online poker company from 2005 to 2006; and Vice President of Finance and Treasurer for Infotrieve from 2000 to 2004. Mr. Urban has also held positions as an audit and tax manager in public accounting, and as an internal auditor. He holds a B.S. in Business, with a concentration in Accounting Theory and Practice, from California State University, Northridge and has been a Certified Public Accountant (currently inactive) since 1998. Mr. Urban’s significant experience as a member of senior management of public reporting companies make him a valuable addition to the Board. Duyuru • May 02
GT Biopharma, Inc., Annual General Meeting, Jun 08, 2022 GT Biopharma, Inc., Annual General Meeting, Jun 08, 2022, at 11:00 Pacific Standard Time. Agenda: To consider and elect three directors to serve until the 2023 annual meeting of stockholders or until their successors are duly elected and qualified; to consider and ratify the appointment of Weinberg & Company, P.A. as the Company’s independent accountants for the fiscal year ending December 31, 2022; to adopt the GT Biopharma, Inc. 2022 Omnibus Incentive Plan authorizing the issuance of up to 5,000,000 shares of common stock pursuant to awards granted thereunder; to consider and approve an amendment to the restated certificate of incorporation to decrease the authorized number of shares of common stock from 750,000,000 to 250,000,000; to hold an advisory vote on executive compensation; to hold an advisory vote on the frequency of the advisory vote on executive compensation; and to transact other business properly presented at the meeting or any postponement or adjournment thereof. Price Target Changed • Apr 27
Price target decreased to US$17.33 Down from US$23.67, the current price target is an average from 3 analysts. New target price is 699% above last closing price of US$2.17. Stock is down 82% over the past year. The company is forecast to post a net loss per share of US$1.25 next year compared to a net loss per share of US$2.06 last year. Board Change • Apr 27
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. 3 experienced directors. No highly experienced directors. Consulting Chief Scientific Officer & Scientific Advisor Jeff Miller is the most experienced director on the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Duyuru • Mar 10
GT Biopharma, Inc. Announces CEO Changes Effective March 2, 2022, the GT Biopharma, Inc. (Registrant) appointed Michael Breen as the Registrant's Interim Chief Executive Officer with an increase in his annual base compensation to $515,000. Gregory Berk, M.D. ceased serving as the Registrant's Interim Chief Executive Officer, but will continue to serve as the Registrant's President of Research & Development and Chief Medical Officer, with a cost-of-living increase in his annual base compensation to $437,750. Duyuru • Feb 19
GT Biopharma, Inc Appoints Manu Ohri as Chief Financial Officer GT Biopharma, Inc. announced the appointment of Manu Ohri, who joins the Company as its Chief Financial Officer (CFO) effective immediately. Mr. Ohri, an accomplished accounting and finance executive brings to GT Biopharma over 25 years of management, finance and public accounting experience in working with Board of Directors, capital markets, independent auditors and attorneys. Mr. Ohri, served as CFO for multiple public companies began his career in public accounting as an auditor for PricewaterhouseCoopers and subsequently for Deloitte & Touche in excess of seven years. He is a licensed CPA and received his MBA with a concentration in Accounting and Finance from the University of Detroit. Price Target Changed • Feb 09
Price target decreased to US$17.33 Down from US$23.67, the current price target is an average from 3 analysts. New target price is 537% above last closing price of US$2.72. Stock is down 64% over the past year. The company is forecast to post a net loss per share of US$1.65 next year compared to a net loss per share of US$6.45 last year. Duyuru • Dec 09
GT Biopharma Demonstrates Novel B7-H3 Targeting Dual Camelid Nanobody BiKE and GTB-5550 Induce NK Cell Activation Against Broad Spectrum of Tumors at ESMO IO Congress 2021 GT Biopharma, Inc. announced that the Company's mini-poster presentation abstract is now broadly available on the European Society for Medical Oncology ("ESMO") Immuno-Oncology ("IO") Congress 2021 abstracts webpage. The congress is being held from December 8-11, 2021, in Geneva Switzerland. The study was conducted by Dr. Jeff Miller's lab, University of Minnesota where functional assays were conducted with various ovarian, prostate, and hematologic malignancy cell lines with varying levels of B7H3 expression from none to very high levels. Dr. Miller's lab previously showed that dual camelid nanobody tri-specific killer engager (TriKE) (GTB-5550) specifically bound B7-H3 on PC3/C4-2 prostate cancer (PCa) cells and activated peripheral blood (PB) NK cells. The company has since developed a dual camelid bispecific killer engager (BiKE) targeting B7-H3 and show that both GTB-5550, which harbors wild-type IL-15, and BiKE display broad activity against B7-H3-expressing tumors. Compared to monomeric IL-15, GTB-5550 shows CD16-dependent metabolic activation of NK cells. Presentation highlights from the mini-poster titled, "Novel B7-H3 Targeting Dual-Nanobody NK Cell Engagers Display Robust Activity" include: Study Background: BiKE and GTB-5550 were manufactured in a mammalian expression system and purified from supernatants. Models were used to evaluate how the BiKE and GTB-5550 induce NK cell degranulation (CD107a) and interferon gamma production through a variety of cell lines including PCa cells harboring enzalutamide resistance with divergent mechanisms including 22RV1 (androgen ligand-independent AR-V7 splice variant) as well as a spontaneously resistant LNCaP model (AR hyper activation), as well as a CREB5 overexpressing (epithelial to mesenchymal transition) LNCaP model. Metabolic stimulation was measured in NK-92 cell lines. PB NK cells were robustly activated, compared to controls, when treated with GTB-5550 or BiKE and cultured with enzalutamide resistant PCa, osteosarcoma (U2OS, SaOS2), rhabdomyosarcoma (RH30), ovarian carcinoma (MA148, OVCAR8), AML (MV4;11, THP-1) and multiple myeloma (MM1S) cell lines. GTB-5550 was approximately 2 times more potent than NCI IL-15 in terms of metabolic stimulation of CD16+ NK-92 cells, but not CD16- NK-92 cells. Spheroid killing assays and deeper metabolic analyses are in progress. Results of the Study: The data demonstrated that the novel dual camelid nanobody BiKE and GTB-5550 induce NK cell activation against a broad spectrum of tumors expressing B7-H3. Furthermore, B7-H3 is expressed at high levels on prostate cancer cell lines demonstrating enzalutamide resistance, thus inducing efficient targeting of these therapy PCa refractory lines. This B7-H3 targeting NK platform demonstrates broad translational potential. GMP production of GTB-5550 has been initiated. ESMO IO 2021 presentation details: -Poster Display Title (#126P): Novel B7-H3 targeting dual nanobody NK cell engagers display robust activity against a broad spectrum of solid and hematologic malignancies GTB-5550 TriKE® product candidate is being developed for the treatment of B7H3+ solid tumor cancers. GTB-5550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-B7H3 antibodies and human IL-15. GTB-3650 is the Company's lead second-generation Tri-Specific Killer Engager TriKE® program currently in preclinical development for the treatment of relapsed/refractory acute myelogenous leukemia (AML) and high-risk myelodysplastic syndrome (MDS). Price Target Changed • Nov 17
Price target increased to US$25.33 Up from US$23.67, the current price target is an average from 3 analysts. New target price is 407% above last closing price of US$5.00. Stock is up 59% over the past year. The company is forecast to post a net loss per share of US$1.63 next year compared to a net loss per share of US$6.45 last year. Board Change • Nov 17
High number of new and inexperienced directors There are 7 new directors who have joined the board in the last 3 years. The company's board is composed of: 7 new directors. 3 experienced directors. No highly experienced directors. Scientific Advisor Daniel Vallera is the most experienced director on the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Duyuru • Sep 17
GT Biopharma Announces Updated Positive Safety Data from Phase 1 GTB-3550 Monotherapy Trike Trial an Investigational Immunotherapy for Refractory Cancers to Be Presented At ESMO Congress 2021 GT Biopharma, Inc. a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer cell engager, TriKE protein biologic technology platform, announced that Jeffrey Miller, MD, University of Minnesota Medical School, Professor of Medicine, Division of Hematology, Oncology and Transportation will present a mini-oral presentation at the European Society for Medical Oncology Congress 2021 to be held virtually September 16-21. The mini-oral presentation will present updated positive Phase 1 safety data, progress, and preclinical data going beyond hematologic malignancies to solid tumors of a Phase 1 GTB-3550 TriKE trial. The Tri-Specific Killer Engager TriKE program is currently in pre-clinical and clinical development for the treatment of relapsed/refractory acute myelogenous leukemia and high-risk myelodysplastic syndrome with solid tumor TriKE commercial manufacturing and IND enabling studies in progress. Therapeutic and commercial advantages of GTB-3650 compared to GTB-3550 include: Based on second generation camelid single-domain antibody technology that holds several advantages over traditional IgG monoclonal antibodies; Improved potency and enhanced binding affinity; Similar preclinical safety profile; Commercial manufacturing capabilities through arrangement with Cytovance; Proprietary patented molecule, which unlike GTB-3550, is wholly owned by GT Biopharma; Camelid antibodies are single domain antibodies from the Camelidae family of mammals that include llamas, camels, and alpacas. These animals produce 2 main types of antibodies. One type of antibody camelids produce is the conventional antibody that is made up of 2 heavy chains and 2 light chains. They also produce another type of antibody that is made up of only 2 heavy chains and no light chain. This is known as heavy chain IgG. While these antibodies do not contain the CH1 region, they retain an antigen binding domain called the VHH region. VHH antibodies, also known as single domain antibodies, contain only the VHH region from the camelid antibody. Camelid antibodies have key characteristics, which include high affinity and specificity, high thermostability, good solubility and strictly monomeric behavior, small size, relatively low production cost, ease of genetic engineering, format flexibility or modularity, low immunogenicity, and a higher penetration rate into tissues. GTB-3650 is the Company's lead second-generation Tri-Specific Killer Engager TriKE program currently in preclinical development for the treatment of relapsed/refractory acute myelogenous leukemia and high-risk myelodysplastic syndrome. Duyuru • Sep 14
GT Biopharma, Inc. Advances GTB-3650, a Second-Generation Tri-Specific Killer Engager -TriKE®, Into IND-Enabling Studies GT Biopharma, Inc. announced the advancement of GTB-3650 into IND-enabling studies, with which it plans to supplant the ongoing Phase 1 program with GTB-3550. Therapeutic and commercial advantages of GTB-3650 compared to GTB-3550 include: Based on second generation camelid single-domain antibody technology that holds several advantages over traditional IgG monoclonal antibodies; Improved potency and enhanced binding affinity; Similar preclinical safety profile; Commercial manufacturing capabilities through arrangement with Cytovance; Proprietary patented molecule, which unlike GTB-3550, is wholly owned by GT Biopharma. About Camelid Antibodies: Camelid antibodies are single domain antibodies (sdAbs) from the Camelidae family of mammals that include llamas, camels, and alpacas. These animals produce 2 main types of antibodies. One type of antibody camelids produce is the conventional antibody that is made up of 2 heavy chains and 2 light chains. They also produce another type of antibody that is made up of only 2 heavy chains and no light chain. This is known as heavy chain IgG (hcIgG). While these antibodies do not contain the CH1 region, they retain an antigen binding domain called the VHH region. VHH antibodies, also known as single domain antibodies, contain only the VHH region from the camelid antibody. Camelid antibodies have key characteristics, which include high affinity and specificity (equivalent to conventional antibodies), high thermostability, good solubility and strictly monomeric behavior, small size, relatively low production cost, ease of genetic engineering, format flexibility or modularity, low immunogenicity, and a higher penetration rate into tissues. About GTB-3650: GTB-3650 is the Company's lead second-generation Tri-Specific Killer Engager TriKE® program currently in preclinical development for the treatment of relapsed/refractory acute myelogenous leukemia (AML) and high-risk myelodysplastic syndrome (MDS). Duyuru • Aug 18
GT Biopharma, Inc. announced delayed 10-Q filing On 08/17/2021, GT Biopharma, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Duyuru • Aug 14
GT Biopharma Provides Second Quarter 2021 Business Update GT Biopharma, Inc. provided a general business update of events in the second quarter ending June 30, 2021. Clinical Highlights: Reported Positive, Interim Data Results from First-in-Human GTB-3550 TriKE Phase I Clinical Trial for the Treatment of Refractory/Relapsed Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndromes (MDS): In June 2021, GT Biopharma and Dr. Jeffrey S. Miller presented positive, interim results from the Phase I dose-escalation portion of the Phase I/II dose expansion clinical trial of GTB-3550 TriKE at the 2021 Raymond James Human Health Innovation Conference. Results demonstrated that 57% of patients achieved significant reduction in AML/MDS cancer cell burden, with one patient reaching up to 63.7% reduction in bone marrow blast levels. Across all patients, treatment of GTB-3550 TriKE was well tolerated and no signs of cytokine release syndrome (CRS) were detected. This portion of the Phase I/II dose expansion trial is focused on determining the recommended Phase II dose, the maximum tolerated dose (MTD), optimal dose schedule, safety and tolerability of GTB-3550 TriKE administration. The Phase I safety study is expected to complete later this fall and the Company has scheduled an interim data publication for September 16-21, 2021 at the European Society for Medical Oncology Conference to be held in Paris, France. Price Target Changed • Jul 01
Price target increased to US$25.33 Up from US$23.67, the current price target is an average from 3 analysts. New target price is 63% above last closing price of US$15.50. Stock is up 529% over the past year. Duyuru • Jun 24
GT Biopharma Announces Interim GTB-3550 Trike Monotherapy Clinical Trial Results GT Biopharma, Inc. announced Jeffrey S. Miller, M.D., Deputy Director of the Masonic Cancer Center and Consulting Chief Scientific Officer, provided an update concerning GTB-3550 TriKE™ monotherapy clinical trial interim results at the 2021 Raymond James Health Innovation Conference. Highlights to date from patients treated with GTB-3550 TriKE™ monotherapy in the dose escalation Phase 1 clinical trial for the treatment of high-risk MDS and refractory/relapsed AML: 57% of patients experienced significant reduction in AML/MDS cancer cell burden when treated with doses of GTB-3550 ranging from 25mcg/kg/day to 150mcg/kg/day. Up to 63.7% reduction in bone marrow blast levels observed in some patients. GTB-3550 was well tolerated by all patients with no cytokine release syndrome observed. Restoration of patient's endogenous NK cell function, proliferation and immune surveillance observed in all patients – No progenitor-derived or autologous/allogenic cell therapy required. The on-going Phase 1 clinical trial of GTB-3550 TriKE™ monotherapy is focused on evaluating safety, and the determination of the recommended Phase 2 dose (RP2D), dose schedule and the maximum tolerated dose (MTD). Additional information is being collected concerning anti-tumor activity against CD33+ acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) cancer cells, and restoration of the patient's exhausted/inhibited endogenous NK cell population. To date, 11 patients have completed treatment in the GTB-3550 Phase 1 clinical trial. Patient 5, Patient 7, Patient 9, Patient 11 experienced 33%, 61%, 63% and 50% reduction in CD33+ AML/MDS bone marrow blast levels, respectively. The Phase 1 safety part of the study is expected to conclude in late August 2021 with data publication currently scheduled for end of September 2021. Duyuru • May 13
GT Biopharma, Inc. Announces Update on the Commencement of the GTB-3550 Trike Monotherapy Phase 2 Clinical Trial and Solid Tumor Trike Product Candidates GT Biopharma, Inc. provided an update concerning the commencement of the GTB-3550 TriKE monotherapy Phase 2 clinical trial, and certain of its solid tumor targeting TriKE product candidates. Highlights to date from patients treated with GTB-3550 TriKE in the dose escalation Phase 1 clinical trial for the treatment of high-risk myelodysplastic syndromes (MDS) and refractory/relapsed acute myeloid leukemia (AML): Up to 63.7% Reduction in Bone Marrow Blast Levels seen in some patients. Restoration of Patient's Endogenous NK Cell Function, Proliferation and Immune Surveillance. No Progenitor-derived or Autologous/Allogenic Cell Therapy Required. No Cytokine Release Syndrome Observed. While the design of the Phase 1 part of the GTB-3550 clinical trial was focused on evaluating safety, indications of anti-tumor activity during Phase 1 have resulted in a refocusing of the Phase 2 design of the clinical trial towards enhancing efficacy, durability of the clinical response, and overall survival with the goal to seek accelerated approval from FDA. The company intends to enroll patients with CD33 expression =50% in two independent cohorts (higher-risk myelodysplastic syndrome and acute myeloid leukemia); treat patients with two cycles of GTB-3550 therapy with a rest period between cycles as opposed to the single-cycle used during Phase 1; enroll patients with fewer prior treatment lines; and, evaluate the potential use of minimal residual disease (MRD) based endpoints that may allow for accelerated approval. Solid tumor cancers present a significantly larger market opportunity than hematologic cancer indications, and represent the majority of new cancer diagnoses annually. The Company is presently advancing three TriKE product candidates in GMP manufacturing and early clinical development. These solid tumor TriKE product candidates will target cancers expressing HER2 (GTB-6550), PD-L1 (GTB-4550) and B7H3 (GTB-5550), and will be evaluated for the treatment of multiple cancers such as breast, lung, gastric, colorectal and ovarian. Duyuru • Apr 02
GT Biopharma, Inc. announced delayed annual 10-K filing On 03/31/2021, GT Biopharma, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Duyuru • Mar 18
GT Biopharma, Inc. Updates Interim GTB-3550 Trike™ Clinical Trial Results GT Biopharma, Inc. announced updated interim Phase I/II clinical trial results for the Company's lead therapeutic candidate, GTB-3550, being evaluated for the treatment of high-risk myelodysplastic syndromes (MDS) and refractory/relapsed acute myeloid leukemia (AML). To date, 9 patients have been enrolled in the Phase I/II Expansion clinical trial. Patients enrolled early in the Study (patients 1-4) were treated with doses of GTB-3550 below the anticipated therapeutic dose (RP2D) and maximum tolerated dose (MTD) to address possible safety concerns. All patients treated at the lower doses exhibited no signs of toxicity, and did not experience any Grade of Cytokine Release Syndrome (CRS). Patients 5-9 were treated with increasing doses of GTB-3550 (25mcg/kg/day, 50mcg/kg/day and 100mcg/kg/day, respectively). Three of the five patients (60%) experienced reduction in bone marrow blasts with two patients (one patient treated at the 50mcg/kg/day dose level and one patient treated at the 100mcg/kg/day dose level) experiencing significant reductions in bone marrow blast levels. As previously reported, Patient 7 treated at the 50mcg/kg/day dose level achieved a 61.7% reduction in bone marrow blast levels from 12% before therapy to 4.6% after GTB-3550 therapy. Patient 9 treated at the 100mcg/kg/day dose level achieved a 63.7% reduction in bone marrow blast levels from 22% before therapy to 8% after therapy. All patients treated at these higher doses of GTB-3550 did not experience any Grade of Cytokine Release Syndrome (CRS). All patients treated to date with GTB-3550 TriKE displayed no signs of any Grade of cytokine release syndrome (CRS). Of particular note, GTB-3550 is currently being administered to patients at doses significantly higher than the reported MTD (Maximum Tolerated Dose) for continuous infusion of recombinant human IL-15 (Interleukin-15) (Waldmann, TA et al, Clin Cancer Res. (2019) 25:4945–54). GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies, and a modified form of IL-15. Correlative studies have shown reproducible endogenous ("native") NK cell activity in all patients. NK cell activation increases early during treatment. This finding correlated with an increase proportion and absolute number of NK cells during treatment. Targeted delivery of IL-15 to NK cells via GTB-3550 TriKE showed preferential proliferation of NK cells and significantly less effect on CD8+ and CD4+ T-cells. company also observed no CD16 shedding by patients' NK cells, and saw enhanced HL-60 AML target cell killing. This data indicates GTB-3550 TriKE™ rescues the patient's exhausted/inhibited endogenous NK cells resulting in their activation, proliferation and persistence. Duyuru • Mar 09
GT Biopharma, Inc. Announces Preclinical Results For Its ROR1 TriKE™ As A Treatment For Prostate Cancer GT Biopharma, Inc. announced preclinical results for its ROR1 TriKE™ product candidate as a prospective therapy for the treatment of prostate cancer. Tyrosine kinase transmembrane receptor ROR1 has recently been shown to be overexpressed on certain cancer cells, and appears to play a functional role in promoting migration/invasion and influencing the metastatic potential of various solid tumor cancers. Targeting ROR1 on cancer cells with TriKE™ and redirecting NK cells to attack and kill cancer cells expressing ROR1, could result in a therapeutic treatment that limits the metastatic potential and invasiveness of certain solid tumor cancers. The ROR1 TriKE™ was evaluated in several preclinical models of prostate cancer, and was found to be effective at promoting NK cell killing of multiple prostate cancer cells including LnCAP, C4-2, PC-3, DU-145, VCaP and 22RV1. Significant NK cell activation and interferon gamma (IFN?) production was also observed as a result of TriKE™ engagement and activation of the NK cell. Duyuru • Mar 05
GT Biopharma, Inc. Adds University of Wisconsin--Madison Carbone Cancer Center as Second Site in Ongoing Phase 1/2 Clinical Trial of GTB-3550 TriKE, a Novel NK Cell Therapeutic Cancer Treatment GT Biopharma, Inc. target-directed Natural Killer (NK) cell engager immunotherapy protein biologic platform technology: TriKE for cancer and infectious diseases, announced the addition of a new clinical trial site for its ongoing GTB-3550 TriKE™ multicenter Phase I/II trial (ClinicalTrials.govNCT03214666). The University of Wisconsin – Madison Carbone Cancer Center will serve as the second site for this program. UM's Masonic Cancer Center is the initial site of the GTB-3550 TriKE™ Phase 1/2 trial. GTB-3550 TriKE is being evaluated in patients age 18 and older with CD33+ malignancies (primary induction failure or relapsed acute myeloid leukemia [AML] with failure of one reinduction attempt, or high-risk myelodysplastic syndromes [MDS] progressed on two lines of therapy). The primary endpoint is to identify the maximum tolerated dose and safety of GTB-3550 TriKE therapy. Correlative objectives include the number, phenotype, activation status and function of NK cells and T cells. Interim results presented at the American Society of Hematology meeting on December 5, 2020 demonstrates GTB-3550 TriKE™ reduces bone marrow blast levels in AML and MDS patients with reported no toxicities, and improves NK cell function and proliferation. Duyuru • Feb 19
Gt Biopharma, Inc. Sign an Expanded GMP Manufacturing Agreement with Cytovance Biologics GT Biopharma, Inc. announced it has signed an expanded GMP manufacturing agreement with Cytovance Biologics for the manufacture of all TriKEs™. Previously, the lead candidate GTB-3550 TriKE™ was manufactured at the University of Minnesota's GMP manufacturing center, following its invention and development at the institution by GT Biopharma's Consulting Chief Medical Officer, Jeffrey S. Miller, M.D. GTB-3550 TriKE™ is the Company's first TriKE™ product candidate being initially developed for the treatment of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and other CD33+ hematopoietic malignancies. GTB-3550 TriKE™ is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15. The natural killer (NK) cell stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill cancer cells and amplify the body's native immune system's NK cells. Patients with CD33+ malignancies (primary induction failure or relapsed AML with failure of one reinduction attempt or high-risk MDS progressed on two lines of therapy) age 18 and older are eligible (NCT03214666). The primary endpoint is to identify the maximum tolerated dose (MTD) of GTB-3550 TriKE™. Correlative objectives include the number, phenotype, activation status and function of NK cells and T cells. Interim results presented at the American Society of Hematology meeting December 5, 2020 demonstrates GTB-3550 TriKE™ reduces bone marrow blast levels in AML and MDS patients with reported no toxicities, and improves NK cell function and proliferation. Duyuru • Feb 13
GT Biopharma, Inc. has completed a Composite Units Offering in the amount of $23.65 million. GT Biopharma, Inc. has completed a Composite Units Offering in the amount of $23.65 million.
Security Name: Units
Security Type: Equity/Derivative Unit
Securities Offered: 4,300,000
Price\Range: $5.5
Discount Per Security: $0.44
Security Name: Pre-Funded Units
Security Type: Equity/Derivative Unit
Price\Range: $5.499
Discount Per Security: $0.4399 Duyuru • Jan 20
GT Biopharma, Inc. Announces Board Changes On January 13, 2021, the Board of Directors of GT Biopharma, Inc. approved the appointment of Michael Breen and Rajesh Shrotriya to each serve as directors of the Company. Mr. Breen will chair the Audit Committee and be a member of the Nominating Committee. Dr. Shrotriya will be a member of the Audit Committee and the Nominating Committee. Duyuru • Jan 13
GT Biopharma Announces Eighth Patient Begins Treatment of GTB-3550 GT Biopharma, Inc. announced the continuation of enrollment with patient 8 in its GTB-3550 clinical trial following the conclusion of a 30-day Covid-19 related pause in enrolling patients in all clinical trials currently being conducted at the University of Minnesota'sMasonic Cancer Center. Patients with CD33+ malignancies (primary induction failure or relapsed AML with failure of one reinduction attempt or high-risk MDS progressed on two lines of therapy) age 18 and older are eligible to participate in the GTB-3550 TriKE™ clinical trial (NCT03214666). The primary endpoint of the Study is to identify the maximum tolerated dose (MTD) of GTB-3550 TriKE. Correlative objectives include the number, phenotype, activation status and function of NK cells and T cells. The GTB-3550 TriKE clinical trial commenced patient enrollment in February 2020 for the treatment of relapsed/refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (HR-MDS). To date, seven patients have been enrolled in the clinical trial; two patients treated at 5 mcg/kg/day, two patients treated at 10 mcg/kg/day, two patients at 25 mcg/kg/day, and one patient treated at 50 mcg/kg/day. All seven patients have completed therapy. The results to date have been positive and the company continues to expand the enrollment. High-risk myelodysplastic syndromes (HR-MDS) patient had failed hypomethylating agent and Luspatercept therapies prior to being treated with GTB-3550 at 50mcg/kg/day (three consecutive 96-hour continuous infusions). The patient achieved bone marrow blast level reduction from 12% before GTB-3550 therapy to 4.6% post GTB-3550 therapy determined by morphological assessment (61.7% reduction in cancer cells), and had stable hematologic parameters including normal platelet counts throughout therapy. Following this single course of GTB-3550 therapy and the significant reduction in bone marrow blast levels, the patient demonstrated clinical benefit from GTB-3550 therapy, and qualified for and has received a hematopoietic stem cell transplant (HSCT). The only treatment with curative intent for a majority of elderly HR-MDS or relapsed/refractory AML patients is allogeneic hematopoietic stem cell transplant (HSCT). GTB-3550 TriKE therapy represents a novel, low intensity therapeutic option which has the potential to increase HSCT eligibility for elderly HR-MDS and relapsed/refractory AML patients. Two patients with relapsed/refractory acute myeloid leukemia who has previously failed prior therapies prior to being treated with GTB-3550; one patient treated at 5mcg/kg/day achieved stable disease and another patient treated at 25mcg/kg/day experienced a 33% reduction in bone marrow blast levels. No signs of clinical immune activation, and no dose limiting toxicity such as cytokine release syndrome (CRS) or serious adverse events (SAEs) or fevers, tachycardia or constitutional symptoms have been observed in any patient treated to date with GTB-3550 TriKE. Correlative studies also showed no shedding of CD16 from patient's NK cells, and potent NK cell activation, proliferation and target cell killing without the need for supplemental autologous NK cell therapy. Targeted delivery of IL-15 to NK cells via GTB-3550 TriKE therapy showed preferential proliferation of NK cells, significantly less effect on CD8+ T-cells, and no observed toxicity at 25x the previous reported MTD for continuous infusion of recombinant human IL-15. GTB-3550 TriKE is a single-chain, tri-specific scFv.recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies. Duyuru • Dec 19
Gt Biopharma, Inc. and Cytovance Reaches Agreement for License Rights to Use Certain Bacterial and Mammalian Cell Lines and for GMP Manufacturing Services Performed to Date Regarding the Company's Trike™ Product Candidates GT Biopharma, Inc. announced that Cytovance have reached an agreement for license rights to use certain bacterial and mammalian cell lines and for GMP manufacturing services performed to date regarding the Company's TriKE™ product candidates. Under the terms of the partnership agreement entered into between the companies, Cytovance is the exclusive GMP manufacture for three of the Company's TriKE™ therapeutic product candidates. Cytovance will manufacture TriKE™ in accordance with GMP using Cytovance's proprietary Keystone® bacterial or mammalian expression systems. Subject to the completion of certain milestones by Cytovance, GT Biopharma has the option to pay Cytovance up to $6 million for licenses to use certain of Cytovance's bacterial and mammalian cell lines and for manufacturing services performed in either cash or in shares of the Company's common stock valued at the time Cytovance achieves each of several milestones over the next 12 months. Duyuru • Nov 20
Dr. Greg Berk, M.D. Joins Board of Directors of GT Biopharma, Inc GT Biopharma, Inc. announced Dr. Greg Berk, M.D. has joined the Company's Board of Directors. Dr. Greg Berk is an Independent Director of the Company. Dr. Berk is a senior oncology drug development consultant. Dr. Berk previously served as Chief Medical Officer at Verastem. Dr. Berk was President, Chief Medical Officer, and Board Member of Sideris Pharmaceuticals. From May 2012 until January 2014, Dr. Berk was Chief Medical Officer of BIND Therapeutics. Duyuru • Nov 19
GT Biopharma, Inc. Appoints Michael Handelman as Chief Financial Officer GT Biopharma, Inc. announced Michael Handelman, CPA has been appointed Chief Financial Officer of the company. Prior to joining the company, Mr. Handelman served as Chief Financial Officer of Iovance Biotherapeutics, Inc. (IOVA), from February 2011 until June 2015 and was a member of the Iovance's Board of Directors from February 2013 until May 2013. Mr. Handelman became a Director of GoooGreen, Inc. in August 2020 and Chairman of the Board of Directors and Secretary in September 2020. He has served as Chief Financial Officer of Clickstream Corporation since October 2015. Mr. Handelman served as the Chief Financial Officer and as a financial management consultant of Oxis International, Inc. from August 2009 until October 2011. From November 2004 to July 2009, Mr. Handelman served as Chief Financial Officer and Chief Operating Officer of TechnoConcepts, Inc. Duyuru • Oct 14
GT Biopharma, Inc. Announces Advisory Board Appointments GT Biopharma, Inc., an immuno-oncology company focused on innovative therapies based on the Company's proprietary NK cell engager (TriKE(TM)) technology announced Dr. Samir Taneja and Dr. Philip Werthman have joined the Company's Scientific and Medical Advisory Board. Dr. Samir Taneja, M.D. is the James M. and Janet Riha Neissa Professor of Urologic Oncology and a Professor of Urology, Radiology and Biomedical Engineering at the New York University Grossman School of Medicine. Dr. Taneja additionally serves as Vice Chair of Urology and Director of the Division of Urologic Oncology in the School of Medicine, Director of the GU Oncology Program of the Perlmutter Cancer Center, and Co-Director of the Smilow Comprehensive Prostate Cancer Center at NYU Langone Health. Dr. Philip Werthman, M.D., MMH is director of the Center for Male Reproductive Medicine, and former assistant clinical professor of urology at the University of Southern California School of Medicine. Dr. Werthman received his medical degree from Hahnemann University School of Medicine in Philadelphia, graduating valedictorian. Dr. Werthman completed his residency and fellowship in urology at the University of California, Los Angeles (UCLA). Duyuru • Sep 24
GT Biopharma, Inc. announced that it has received $0.25 million in funding GT Biopharma, Inc. (OTCPK:GTBP) announced that it has entered into a securities purchase agreement with two purchasers on September 16, 2020. The company issued 10% senior convertible debentures for gross proceeds of $250,000. The debentures issued in the transaction are convertible into common stock of the company at a price of $0.20 per share. The shares have a pr value of $0.001 per share. The company will issue securities pursuant to Regulation D. Duyuru • Jul 24
GT Biopharma, Inc. announced that it has received $5.607 million in funding On July 23, 2020, GT Biopharma, Inc. (OTCPK:GTBP) closed the transaction. The company has amended the terms of the transaction and has raised $5,607,000. The company has raised $3,190,000 in its second tranche. The transaction included participation from eighteen investors. Duyuru • Jun 16
GT Biopharma, Inc. announced that it expects to receive $2.417 million in funding GT Biopharma, Inc. (OTCPK:GTBP) announced that it will receive $2,417,000 in funding on April 20, 2020. The company will issue convertible debt in the transaction. The company will issue securities pursuant to exemption provided under Regulation D.