GTBP GT Biopharma
GT Biopharma, Inc. is engages in the development and commercialization of novel immuno-oncology products. Its products include OXS-1550, OXS-1650, OXS-3550, OXS-4550, OXS-1750, OXS-1950, and OXS-2050. The company was founded in 1965 and is headquartered in Tampa, FL.
Company profile
Ticker
GTBP
Exchange
Website
CEO
Anthony Cataldo
Employees
Incorporated
Location
Fiscal year end
Industry (SIC)
Former names
OXIS INTERNATIONAL INC
SEC CIK
Corporate docs
IRS number
941620407
GTBP stock data
()
News
Benzinga's Top Ratings Upgrades, Downgrades For April 13, 2021
13 Apr 21
B. Riley FBR Initiates Coverage On GT Biopharma with Buy Rating, Announces Price Target of $21
13 Apr 21
GT Biopharma Announces Interim Results From GTB-3550 TriKE Monotherapy
12 Apr 21
51 Biggest Movers From Friday
12 Apr 21
12 Health Care Stocks Moving In Friday's Intraday Session
9 Apr 21
Press releases
Thinking about buying stock in Rigel Pharmaceuticals, Checkpoint Therapeutics, GT Biopharma, ICICI Bank, or Arbutus Biopharma?
13 Apr 21
GT Biopharma Announces GTB-3550 TriKE™ Monotherapy Rescues and Restores NK Cell Immune Surveillance in Relapsed/Refractory AML and MDS Cancer Patients
12 Apr 21
GT Biopharma Announces Enrollment Of Patient 10 in GTB-3550 TriKE™ Phase I/II Clinical Trial
8 Apr 21
Thinking about buying stock in Hyliion Holdings, BlackBerry, GT Biopharma, Seelos Therapeutics, or Oncternal Therapeutics?
7 Apr 21
GT Biopharma's TriKE™ Interim Clinical Trial Results Presented At Innate Killer Summit 2021
29 Mar 21
Investment data
Securities sold
Number of investors
Calendar
16 Apr 21
18 Apr 21
31 Dec 21
Financial summary
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Dec 20 | Sep 20 | Jun 20 | Mar 20 | |
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Diluted EPS |
Annual (USD) |
Dec 20 | Dec 19 | Dec 18 | Dec 17 | |
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Cost of revenue | |||||
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Diluted EPS |
Financial data from company earnings reports.
Cash burn rate (estimated) | Burn method: Change in cash | Burn method: Operating income/loss | Burn method: FCF (opex + capex) | Last Q | Avg 4Q | Last Q | Avg 4Q | Last Q | Avg 4Q |
---|---|---|---|---|---|---|
Cash on hand (at last report) | 5.3M | 5.3M | 5.3M | 5.3M | 5.3M | 5.3M |
Cash burn (monthly) | (positive/no burn) | (positive/no burn) | (positive/no burn) | 188.58K | 642.33K | 605.17K |
Cash used (since last report) | n/a | n/a | n/a | 680.17K | 2.32M | 2.18M |
Cash remaining | n/a | n/a | n/a | 4.62M | 2.98M | 3.11M |
Runway (months of cash) | n/a | n/a | n/a | 24.5 | 4.6 | 5.1 |
Recent insider trades
Date | Owner | Security | Transaction | Code | Indirect | 10b5-1 | $Price | #Shares | $Value | #Remaining |
---|---|---|---|---|---|---|---|---|---|---|
22 Dec 20 | Weldon Steven W | Common Stock | Sell | Dispose S | No | Yes | 0.4 | 47,978 | 19.19K | 3,720,000 |
21 Dec 20 | Weldon Steven W | Common Stock | Sell | Dispose S | No | Yes | 0.34 | 35,722 | 12.15K | 3,767,978 |
21 Dec 20 | Weldon Steven W | Common Stock | Sell | Dispose S | No | Yes | 0.33 | 50,000 | 16.5K | 3,803,700 |
21 Dec 20 | Weldon Steven W | Common Stock | Sell | Dispose S | No | Yes | 0.3 | 50,000 | 15K | 3,853,700 |
18 Dec 20 | Weldon Steven W | Common Stock | Sell | Dispose S | No | Yes | 0.3 | 50,000 | 15K | 3,903,700 |
17 Dec 20 | Weldon Steven W | Common Stock | Sell | Dispose S | No | Yes | 0.31 | 50,000 | 15.5K | 3,953,700 |
17 Dec 20 | Weldon Steven W | Common Stock | Sell | Dispose S | No | Yes | 0.3 | 50,000 | 15K | 4,003,700 |
16 Dec 20 | Weldon Steven W | Common Stock | Sell | Dispose S | No | Yes | 0.3 | 50,000 | 15K | 4,053,700 |
15 Dec 20 | Weldon Steven W | Common Stock | Sell | Dispose S | No | Yes | 0.32 | 50,000 | 16K | 4,103,700 |
15 Dec 20 | Weldon Steven W | Common Stock | Sell | Dispose S | No | Yes | 0.3 | 50,000 | 15K | 4,153,700 |
Institutional ownership Q4 2020
Data for the last complete 13F reporting period. To see the most recent changes to ownership, click the ownership history button above.
13F holders |
Current |
---|---|
Total holders | 0 |
Opened positions | 0 |
Closed positions | 0 |
Increased positions | 0 |
Reduced positions | 0 |
13F shares |
Current |
---|---|
Total value | 0 |
Total shares | 0 |
Total puts | 0 |
Total calls | 0 |
Total put/call ratio | – |
Largest owners |
Shares | Value |
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Financial report summary
?Risks
- Our business is at an early stage of development and we may not develop therapeutic products that can be commercialized.
- We have a history of operating losses and we expect to continue to incur losses for the foreseeable future and we may never generate revenue or achieve profitability.
- We will need additional capital to conduct our operations and develop our products, and our ability to obtain the necessary funding is uncertain.
- Research and Development Investment
- We have identified material weaknesses in our internal controls over financial reporting and have not yet remedied these weaknesses. If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common stock.
- Our intellectual property may be compromised.
- Claims that we infringe the intellectual property rights of others may prevent or delay our drug discovery and development efforts.
- We may desire, or be forced, to seek additional licenses to use intellectual property owned by third parties, and such licenses may not be available on commercially reasonable terms or at all.
- The patent protection covering some of our product candidates may be dependent on third parties, who may not effectively maintain that protection.
- We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time- consuming and unsuccessful.
- If we are unsuccessful in obtaining or maintaining patent protection for intellectual property in development, our business and competitive position would be harmed.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
- If we fail to meet our obligations under our license agreements, we may lose our rights to key technologies on which our business depends.
- We will have to hire additional executive officers and employees to operate our business. If we are unable to hire qualified personnel, we may not be able to implement our business strategy.
- We depend on key personnel for our continued operations and future success, and a loss of certain key personnel could significantly hinder our ability to move forward with our business plan.
- We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
- Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could cause our business to suffer.
- Our reliance on the activities of our non-employee consultants, research institutions and scientific contractors, whose activities are not wholly within our control, may lead to delays in development of our proposed products.
- It may take longer to complete our clinical trials than we project, or we may not be able to complete them at all.
- Clinical drug development is costly, time-consuming and uncertain, and we may suffer setbacks in our clinical development program that could harm our business.
- If we experience delays or difficulties in the enrollment of patients in clinical trials, those clinical trials could take longer than expected to complete and our receipt of necessary regulatory approvals could be delayed or prevented.
- We have limited clinical testing and regulatory capabilities, and human clinical trials are subject to extensive regulatory requirements, very expensive, time-consuming and difficult to design and implement. Our products may fail to achieve necessary safety and efficacy endpoints during clinical trials, which may limit our ability to generate revenues from therapeutic products.
- Obtaining regulatory approval even after clinical trials that are believed to be successful is an uncertain process.
- We will continue to be subject to extensive FDA regulation following any product approvals, and if we fail to comply with these regulations, we may suffer a significant setback in our business.
- Many of our business practices are subject to scrutiny and potential investigation by regulatory and government enforcement authorities, as well as to lawsuits brought by private citizens under federal and state laws. We could become subject to investigations, and our failure to comply with applicable law or an adverse decision in lawsuits may result in adverse consequences to us. If we fail to comply with U.S. healthcare laws, we could face substantial penalties and financial exposure, and our business, operations and financial condition could be adversely affected.
- We may not be successful in our efforts to build a pipeline of product candidates.
- Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.
- We may expend our limited resources to pursue a particular product candidate or indication that does not produce any commercially viable products and may fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
- Our products may be expensive to manufacture, and they may not be profitable if we are unable to control the costs to manufacture them.
- We currently lack manufacturing capabilities to produce our therapeutic product candidates at commercial-scale quantities and do not have an alternate manufacturing supply, which could negatively impact our ability to meet any future demand for the product.
- To be successful, our proposed products must be accepted by the healthcare community, which can be very slow to adopt or unreceptive to new technologies and products.
- Our business is based on novel technologies that are inherently expensive and risky and may not be understood by or accepted in the marketplace, which could adversely affect our future value.
- Our competition includes fully integrated biotechnology and pharmaceutical companies that have significant advantages over us.
- If competitors develop and market products that are more effective, safer or less expensive than our product candidates or offer other advantages, our commercial prospects will be limited.
- If we are unable to keep up with rapid technological changes in our field or compete effectively, we will be unable to operate profitably.
- We may not be able to obtain third-party patient reimbursement or favorable product pricing, which would reduce our ability to operate profitably.
- We may be subject to litigation that will be costly to defend or pursue and uncertain in its outcome.
- We are exposed to the risk of liability claims, for which we may not have adequate insurance.
- We could be subject to product liability lawsuits based on the use of our product candidates in clinical testing or, if obtained, following marketing approval and commercialization. If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to cease clinical testing or limit commercialization of our product candidates.
- We rely on third parties to conduct preclinical and clinical trials of our product candidates. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed.
- We currently have no marketing and sales force. If we are unable to establish effective marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, we may not be able to effectively market and sell our product candidates, if approved, or generate product revenues.
- Our business and operations would suffer in the event of system failures.
- Our operations are vulnerable to interruption by natural disasters, power loss, terrorist activity and other events beyond our control, the occurrence of which could materially harm our business.
- We have not held regular annual meetings in the past, and if we are required by the Delaware Court of Chancery to hold an annual meeting pursuant to Section 211(c) of the Delaware General Corporation Law, or the DGCL, it could result in the unanticipated expenditure of funds, time and other Company resources.
- There has been a limited public market for our common stock, and we do not know whether one will develop to provide you adequate liquidity. Furthermore, the trading price for our common stock, should an active trading market develop, may be volatile and could be subject to wide fluctuations in per-share price.
- Because our common stock may be deemed a low-priced “penny” stock, an investment in our common stock should be considered high- risk and subject to marketability restrictions.
- If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our stock, our stock price and trading volume could decline.
- Anti-takeover provisions may limit the ability of another party to acquire us, which could cause our stock price to decline.
- We do not currently or for the foreseeable future intend to pay dividends on our common stock.
Management Discussion
- During the year ended December 31, 2020 and 2019, we incurred $485 thousand and $1.7 million of research and development expenses, respectively. Research and development costs decreased due primarily to the reduction of employee, consultant and preclinical expenses. We anticipate our direct clinical and preclinical costs to increase significantly in 2021, totaling approximately $12 to $15 million, as we have initiated the Phase 1 clinical trial of our most advanced TriKe product candidate, GTB-3550 and anticipate entering Phase II in late second quarter of 2021.
- During the year ended December 31, 2020 and 2019, we incurred $6.3 million and $9.8 million of selling, general and administrative expenses, respectively. The decrease in selling, general and administrative expenses is primarily attributable the reduction of payroll and stock compensation expenses.
- For the year ended December 31, 2019, the Company entered into an Asset Purchase Agreement (the “Agreement”), pursuant to which the Company sold its rights, titles and interests, including associated patents, to the pharmaceutical product designated by the Company as GTB-004 (the “Product”). Under the Agreement, the Product was purchased by DAS Therapeutics, Inc. who the Company believes was well positioned to take over the clinical development of the Product including obtaining timely approval by the FDA.
Content analysis
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Positive | ||
Negative | ||
Uncertain | ||
Constraining | ||
Legalese | ||
Litigous | ||
Readability |
H.S. sophomore Avg
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New words:
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Removed:
accredited, accrue, accumulate, achieved, ADC, allogeneic, amending, Anemia, announce, antigenic, antitumor, apparent, ARL, background, bispecific, book, Buyer, capitalized, catalytic, clinically, Cogle, combine, combined, conform, consistently, construction, Contemporaneously, CR, created, crowd, Curr, Depreciation, destructive, diphtheria, discrimination, diseased, distinct, dividing, DNA, dozen, durable, elderly, eleven, encoding, enzymatic, erythropoietin, estate, executory, exempt, exhibited, expedite, fixed, Florida, fluctuated, GB, gene, glycoprotein, goodwill, greatly, Hematol, hidden, idea, IFN, immunotherapy, immunotoxin, individually, inflammation, inhibition, innovative, insured, integrity, internalization, internalize, investor, Kathleen, killed, leasehold, literature, lived, lytic, machinery, Malig, marketable, MCIT, membrane, methodology, mispairing, monitored, monospecific, mouse, multifactorial, myeloma, necessarily, neurology, objective, origin, origination, orphan, osteolytic, pain, partial, payload, peripheral, ph, pharmacokinetic, plant, plasma, population, potency, precursor, presence, pretreated, prevalent, preventing, printing, publicly, Raymond, real, receivable, recognizing, reconstituted, recoverable, refractory, Registrable, relief, remeasured, rent, Rep, repay, resistance, resistant, retail, reviewed, revised, scid, science, secured, selectivity, sensitive, sFv, shorter, signature, simultaneously, solubility, Southern, SPA, stated, Steven, sublicensing, substituted, taught, terminal, TetraKE, title, toxin, translocation, transplantation, treating, twelve, undergrad, undiscounted, unique, unmet, unrecognized, urine, utility, utilizing, VH, viewed, vitamin, VL, Washington
Financial reports
10-K
2020 FY
Annual report
16 Apr 21
NT 10-K
Notice of late annual filing
31 Mar 21
10-Q
2020 Q3
Quarterly report
13 Nov 20
10-Q/A
2020 Q2
Quarterly report (amended)
17 Aug 20
10-Q
2020 Q2
Quarterly report
14 Aug 20
10-Q
2020 Q1
Quarterly report
15 May 20
10-K
2019 FY
Annual report
27 Mar 20
10-Q
2019 Q3
Quarterly report
14 Nov 19
10-Q
2019 Q2
Quarterly report
14 Aug 19
10-Q
2019 Q1
Quarterly report
15 May 19
Current reports
8-K
Non-Reliance on Previously Issued Financial Statements or a Related Audit Report or Completed Interim Review
16 Apr 21
8-K
Unregistered Sales of Equity Securities
22 Feb 21
8-K
Unregistered Sales of Equity Securities
18 Feb 21
8-K
Unregistered Sales of Equity Securities
17 Feb 21
8-K
Entry into a Material Definitive Agreement
11 Feb 21
8-K
Entry into a Material Definitive Agreement
8 Feb 21
8-K
Entry into a Material Definitive Agreement
1 Feb 21
8-K
Departure of Directors or Certain Officers
19 Jan 21
8-K
Changes in Registrant's Certifying Accountant
31 Dec 20
8-K
Entry into a Material Definitive Agreement
28 Dec 20
Registration and prospectus
424B4
Prospectus supplement with pricing info
11 Feb 21
S-1/A
IPO registration (amended)
9 Feb 21
8-A12B
Registration of securities on exchange
8 Feb 21
S-1/A
IPO registration (amended)
8 Feb 21
S-1/A
IPO registration (amended)
2 Feb 21
S-1
IPO registration
11 Dec 20
424B3
Prospectus supplement
19 Nov 20
424B3
Prospectus supplement
9 Nov 20
424B3
Prospectus supplement
4 Nov 20
424B3
Prospectus supplement
7 Oct 20
Proxies
DEF 14C
Information statement
14 Jan 21
PRE 14C
Preliminary information
30 Dec 20
DEF 14C
Information statement
11 May 17
PRE 14C
Preliminary information
23 Mar 17
DEF 14C
Information statement
18 May 15
PRE 14C
Preliminary information
7 May 15
DEF 14A
Definitive proxy
13 Jul 11
PRE 14A
Preliminary proxy
30 Jun 11
DEF 14C
Information statement
19 Jan 11
PRE 14C
Preliminary information
6 Jan 11
Other
EFFECT
Notice of effectiveness
11 Feb 21
CORRESP
Correspondence with SEC
8 Feb 21
CORRESP
Correspondence with SEC
7 Feb 21
UPLOAD
Letter from SEC
15 Dec 20
EFFECT
Notice of effectiveness
29 Jul 20
CORRESP
Correspondence with SEC
23 Jul 20
UPLOAD
Letter from SEC
21 Jul 20
EFFECT
Notice of effectiveness
3 Oct 19
CORRESP
Correspondence with SEC
25 Sep 19
UPLOAD
Letter from SEC
19 Sep 19
Ownership
SC 13G/A
GT Biopharma / BRISTOL INVESTMENT FUND ownership change
16 Apr 21
SC 13G
GT Biopharma / BIGGER CAPITAL FUND L P ownership change
17 Feb 21
SC 13G/A
GT Biopharma / BRISTOL INVESTMENT FUND ownership change
8 Feb 21
SC 13G/A
GT Biopharma / ALPHA CAPITAL ANSTALT ownership change
5 Feb 21
4
GT Biopharma / Steven W Weldon ownership change
23 Dec 20
4
GT Biopharma / Steven W Weldon ownership change
18 Dec 20
4
GT Biopharma / Steven W Weldon ownership change
15 Dec 20
SC 13G
GT Biopharma / BRISTOL INVESTMENT FUND ownership change
10 Jun 20
4
GT Biopharma / Tony Cataldo ownership change
4 Jun 20
SC 13G/A
GT Biopharma / BRISTOL INVESTMENT FUND ownership change
18 May 20
Patents
APP
Utility
Use and Composition for Treating Myasthenia Gravis and Other Myasthenic Syndromes
19 Feb 20
The present invention describes the use of a 5HT3-antagonist, in combination with pyridostigmine, to facilitate the symptomatic treatment of mammalian subjects, and particularly humans, dogs, and cats, suffering from a myasthenic syndrome, notably myasthenia gravis, by providing a therapeutically effective pyridostigmine bromide daily dose without the typical adverse effects.
APP
Utility
Neostigmine Combination and Compositions
1 Jan 20
The present invention describes the use of a 5HT3-antagonist, in combination with neostigmine, to facilitate the treatment of a patient suffering from myasthenia gravis or other myasthenic syndromes by providing a therapeutically effective neostigmine bromide or methylsulfate daily dose that attenuates or even abrogates the dose-limiting gastrointestinal adverse effects of neostigmine.
APP
Utility
Composition of Matter and Use Thereof for Preventing and Treating Motion Sickness
4 Dec 19
Motion sickness in a mammalian subject, in particular, a human, may be prevented or treated by administering to a mammalian, a transdermal device system releasing oxybutynin or one of its enantiomers, such as (R)-oxybutynin.
Reddit threads
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Daily Discussion Thread - April 2nd, 2021
2 Apr 21
Daily Discussion Thread - April 1st, 2021
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Daily Discussion Thread - March 31st, 2021
31 Mar 21
IBM, yess 5pct div IBM Time in the Sun has finally arrived after 18 months
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Daily Discussion Thread - March 26th, 2021
26 Mar 21
Daily Discussion Thread - March 25th, 2021
25 Mar 21
Daily Discussion Thread - March 24th, 2021
24 Mar 21
Daily Discussion Thread - March 23rd, 2021
23 Mar 21
Followup to the Stock Scraper Analysis from yesterday (03/17/21)
18 Mar 21