On March 28, 2022 GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager, TriKE platform, reported fourth quarter and full-year 2021 results for the period ended December 31, 2021 (Press release, GT Biopharma, MAR 28, 2022, View Source [SID1234611071]).

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"We’re excited for GTB-3650’s prospects in the new year as we advance the Company’s second-generation Tri-specific NK cell engager (TriKE) technology into an IND-enabling study. The development of GTB-3650, our lead-asset second generation nanobody TriKE has been significantly de-risked, propelled by GTB-3550 predecessor data published in 2021 including: positive first-in-human Phase 1 data; and in-vivo animal model data, conducted in combination with a bispecific killer cell engager asset," said Michael Breen, Executive Chairman and Interim Chief Executive Officer. "Our optimism continues to rise as these proof-of-concept data demonstrate a well-tolerated safety profile and strong NK cell activation against a broad range of tumors. In total, the Company’s TriKE nanobody platform, a rich platform technology, has demonstrated broad utility. We are confident in our ability to develop these assets as a monotherapy, as a combination therapy with conventional chemotherapy, or in combination with other potential joint commercialization technologies."

Quarterly Highlights
The Company presented pre-clinical TriKE data in an oral poster-presentation both virtually and in-person at ESMO (Free ESMO Whitepaper) Targeted Anticancer Therapies (TAT) Congress, March 7–8, 2022.
The pre-clinical evidence suggests, despite the difference in circulating immune cells of Stage IVB NSCLC patients, mesothelin-targeted TriKE can work alongside current standard of care and provide benefit even in the hypoxic environment of a solid tumor.
Dr. Jeffrey Miller, GT Biopharma consultant Chief Scientific Officer, also participated in an oral poster-presentation session at the European Society for Medical Oncology Immuno-Oncology (ESMO IO) Congress, December 8–11, 2021.
The presentation highlighted the broad activity of GTB-5550, which harbors wild-type IL-15 in combination with TriKE against B7-H3-expressing tumors.
Upcoming Conference Participation
GT Biopharma will participate in poster-presentation sessions at the following upcoming medical conferences:
EBMT Abstract AS_EBMT-2022-00508, "A Tri-specific Killer Engager (TriKE) against B7-H3 enhances NK cell mediated killing of multiple myeloma"
AACR Abstract 3435, "GTB-5550 (cam16-IL15-camB7H3) Tri-specific Killer Engager (TriKE) drives natural killer cell activation and antibody dependent cellular cytotoxicity against head and neck squamous cell carcinomas"
Fourth Quarter and Year End 2021 Financial Summary
Cash Position: The Company had total cash, cash equivalents and short-term investments of $32.0 million as of December 31, 2021, compared to $5.3 million as of December 30, 2020. This is expected to provide ample runway to fund operations into 2023 including Phase 1 clinical development of its lead products GTB-3650 and GTB-5550.

Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2021 were $6.3 million compared to $233,000 in the same quarter a year ago. R&D expenses for the year-ending December 31, 2021, were $9.6 million compared to $485,000 in the year ended December 31, 2020. Research and development expenses increased primarily due to the admittance of additional patients into the Phase 1 GTB-3550 clinical trial and the continued development and production of our most advanced TriKE product candidates GTB-3650 and GTB-5550.

General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2021 were $11.8 million compared to $2.0 million in the same quarter a year-ago. G&A expenses for the year ending December 31, 2021, were $47.9 million compared to $6.3 million for the year ending December 31, 2020. The increase in general and administrative expenses was primarily attributable to the increase in stock-based compensation and expenses incurred in support of our planned growth and new public company compliance initiatives. For the year ended December 31, 2021, we incurred $33.9 million of stock-based compensation expense as compared to $269,000 in stock-based compensation expense for the year ended December 31, 2020.

Net Loss: For the fourth quarter of 2021, the Company reported a net loss of $18.0 million, compared to a net loss of $6.3 million in the same quarter a year ago. For the year ended December 31, 2021, the Company reported a net loss of $58.0 million compared to a net loss of $28.3 million for the year ending December 31, 2020.

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 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.

On March 28, 2022 Nimbus Therapeutics, a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, reported that it will present preclinical data from its Casitas B-lineage lymphoma b (Cbl-b) program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting, being held April 8-13, 2022 in New Orleans, LA (Press release, Nimbus Therapeutics, MAR 28, 2022, View Source [SID1234611035]).

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Cbl-b is validated as an immuno-oncology target; the enzyme catalyzes the ubiquitination of substrate proteins to regulate multiple signaling events in a variety of cell types, including immune cells. Nimbus undertook a structure-based drug design approach to identify NTX-801, a Cbl-b inhibitor. In an in vivo PD model, NTX-801 was observed to enhance cytokine responses. In a syngeneic mouse model, NTX-801 demonstrated tumor growth inhibitory activity.

Details of the AACR (Free AACR Whitepaper) presentation are as follows:

Abstract Control Number: 4649
Abstract Title: Discovery of NTX-801, a potent Cbl-b inhibitor with antitumor activity in syngeneic models
Session Title: Preclinical Immunotherapy

On March 28, 2022 Oasmia Pharmaceutical AB, an oncology-focused specialty pharmaceutical company, reported its new name, Vivesto AB, has been registered with the Swedish Companies Registration Office. As a result of the name change, the company will also change the name and short name (ticker) of its share and paid subscribed shares ("BTA") (Press release, Oasmia, MAR 28, 2022, View Source [SID1234611057]).

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The new name, Vivesto AB, which was approved at the Extraordinary General Meeting on 21 February 2022, reflects the company’s commitment to improve survival and quality of life for patients with cancer through investment in R&D and innovation and marks the end of a turn-around period for the company culminating in the recent successful financing which now provides ample funding for the future operations including key clinical trials.

François Martelet, CEO, said: "We are excited to start a new chapter for Vivesto with the recent completion of the rights issue, which created solid foundations that will enable us to continue to achieve our strategic goals by funding existing operations and clinical trials of our lead products in the next 18-24 months. We are now fully focused on making our ‘string of pearls’ strategy a reality by adding promising and innovative oncology programs to our pipeline through in-licensing and M&A. Our new identity encapsulates our mission to support life through a diversified portfolio of cancer therapies, and we have built a powerful platform for future growth."

Change of name and short name (ticker)
The name of the share on Nasdaq Stockholm will change from Oasmia Pharmaceutical AB to Vivesto AB and its ticker from OASM to VIVE. The name of the BTA will change from Oasmia Pharmaceutical AB BTA to Vivesto AB BTA and its short name OASM BTA to VIVE BTA.

The ISIN code of the company’s share and BTA will remain unchanged. The last day for trading with the current tickers is today, 28 March 2022. The first day for trading with the new tickers will be on 29 March 2022.

This is an administrative matter. Shareholders therefore do not need to take any action.

The Company worked with the Brand Institute to develop its new identity. Vivesto was ranked highly for brand recognition and relevance by patients, medical professionals and investors surveyed in Europe, the US and Sweden.

On March 28, 2022 Avera Health (Avera), an integrated regional health care system that serves 300 locations across the Upper Midwest, and Theralink Technologies (OTC: THER) ("Theralink" or the "Company"), a precision medicine company with a novel phosphoprotein-based assay for breast cancer reported a strategic collaboration to advance comprehensive molecular profiling, enabling Avera Health’s providers and patients to benefit from data-driven insights that inform targeted cancer treatments (Press release, Avera Pharmaceuticals, MAR 28, 2022, View Source [SID1234611072]).

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Avera has a long-standing history of leading the way in precision oncology with patients’ tumors being genetically sequenced to guide individualized cancer care. Theralink, with its patented protein and phosphoprotein biomarker platform and lab developed test, is the only commercially available assay for clinical use that measures the tumor cell levels of activated proteins, which are the primary targets of most FDA-approved therapies and biopharmaceutical investigational drugs.

Theralink will provide key patient-specific information about which drug targets are activated and "in use" in each patient tumor sample. This information, coupled with the genomics findings, will provide a comprehensive molecular profile for all Avera oncology patients by way of a multiomic report used for physician treatment decisions.

"Avera has been a cancer care leader in our region for many years. Avera Cancer Institute is focused on actionable insights for our physicians and patients to make treatment decisions that are personalized," said Casey Williams, Chief Scientific Officer and Executive Director of Cancer Research. "We understand the role this innovative approach plays in generating better health outcomes for our patients, and Theralink will play a key role in that process."

"We believe that the Theralink protein/phosphoprotein data, combined with the next generation sequencing data, may give Avera Cancer Institute the most cutting edge and best precision oncology data in the world, potentially creating a step change in cancer care," said Mick Ruxin, M.D., President & CEO of Theralink. He went on to say, "It is gratifying to know that a large, prestigious, midwest cancer program, Avera Health, has realized the significant potential value of our Theralink assay for their cancer patients." Dr. Ruxin continued, "We expect great results from working with Avera and their patients in our goal to decrease the morbidity and mortality of cancer patients."

As part of this collaboration, Avera will assist Theralink Technologies in validating new clinical assays for additional tumors (such as GYN, Head and Neck, GI, Lung, Kidney, Liver and Prostate) through retrospective case analysis and population-based data. This may bring new capability and insights to precision oncology care and allow for the Theralink assay to become a pan-tumor assay.

On March 28, 2022 Nuvo Pharmaceuticals Inc. (TSX:MRV; OTCQX:MRVFF) d/b/a Miravo Healthcare (Miravo or the Company), a Canadian-focused healthcare company with global reach and a diversified portfolio of commercial products, reported its financial and operational results for the three months and year ended December 31, 2021 (Press release, Nuvo Pharmaceuticals, MAR 28, 2022, View Source [SID1234611036]). For further details on the results, please refer to Miravo’s Management, Discussion and Analysis (MD&A) and Consolidated Financial Statements for the three months and year ended December 31, 2021 which are available on the Company’s website (www.miravohealthcare.com). All figures are in Canadian dollars, unless otherwise noted.

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Key Developments Three months ended December 31, 2021 include the following:
• Total revenue was $17.7 million, an increase of 2% compared to $17.3 million for the three months ended December 31, 2020. Adjusted total revenue(1) was $17.8 million, an increase of 3% compared to $17.3 million for the three months ended December 31, 2020.
• Net loss was $5.6 million compared to net income of $2.4 million for the three months ended December 31, 2020. Adjusted EBITDA(1) was $3.4 million, a decrease of 46% compared to $6.2 million for the three months ended December 31, 2020.
• Revenue related to Blexten, Cambia and Suvexx was $8.8 million, an increase of 30% compared to revenue of $6.8 million for the three months ended December 31, 2020. Total Canadian prescriptions of Blexten, Cambia and Suvexx increased by 20%, 3% and 80%, respectively compared to the three months ended December 31, 2020.
• The Company repaid $3.1 million (US$2.5 million) of the Amortization Loan to Deerfield Management Company, L.P. (Deerfield).
• As at December 31, 2021, cash and cash equivalents were $30.9 million. Year ended December 31, 2021 include the following:
• Total revenue was $68.9 million, a decrease of 7% compared to $73.8 million for the year ended December 31, 2020. Adjusted total revenue(1) was $69.4 million, a decrease of 2% compared to $71.0 million for the year ended December 31, 2020.
• Net loss was $32.2 million compared to net loss of $4.1 million for the year ended December 31, 2020. Adjusted EBITDA(1) was $22.2 million, a decrease of 22% compared to $28.4 million for the year ended December 31, 2020. • Revenue related to Blexten, Cambia and Suvexx was $32.3 million, an increase of 27% compared to revenue of $25.5 million for the year ended December 31, 2020. Canadian prescriptions of Blexten and Cambia increased by 21% and 8%, respectively compared to the year ended December 31, 2020.
• The Company repaid $13.4 million (US$10.8 million) of the Amortization Loan to Deerfield. (1) Non-IFRS financial measure. These measures are not recognized under IFRS and do not have standardized meanings prescribed by IFRS. See the Non-IFRS Measures section for definitions, reconciliations and the basis of presentation of the Company’s non-IFRS measures. Business Update
• In February 2022, the United States District Court for the District of New Jersey granted a motion for summary judgment filed by Dr. Reddy’s Laboratories Inc. (Dr. Reddy’s). As a result, the asserted claims of Nuvo Pharmaceuticals (Ireland) DAC’s (Miravo Ireland) U.S. Patent Nos. 8,858,996 (the ‘996 Patent) and 9,161,920 (the ‘920 Patent) related to Vimovo in the U.S. were found to be invalid. Miravo Ireland and its partner are not planning on appealing this decision.
• In February 2022, Blexten for pediatric use in patients 4 years of age and older* was commercially launched in Canada by. The pediatric use includes two new dosage formats; a 2.5mg/mL oral solution and a 10mg orodispersible tablet (quick melt) for the treatment of the symptoms of seasonal allergic rhinitis and chronic spontaneous urticaria (such as itchiness and hives). The pediatric formats will be available to patients with a prescription from their healthcare provider.
• In October 2021, Resultz was commercially launched in the U.S. market by The Mentholatum Company. Resultz is marketed in the U.S. under the brand name Mentholatum Kids Headlice Removal Kit. The Company’s Irish subsidiary, Miravo Ireland receives revenue from the supply of finished product to The Mentholatum Company.

* Blexten (bilastine) is indicated for the symptomatic relief of nasal and non-nasal symptoms of seasonal allergic rhinitis and chronic spontaneous urticaria (e.g. pruritus and hives) in patients 4 years of age and older with a body weight of at least 16 kg.

"Our key promoted brands have demonstrated continued strong performance with Blexten, Cambia, Suvexx and NeoVisc achieving year-over-year gains in prescription and revenue growth despite COVID-19 pandemic related headwinds. We are encouraged by the increasing numbers of in-person patient visits at healthcare providers and anticipate a return to pre-pandemic levels over the coming quarters," said Jesse Ledger, Miravo’s President & CEO. "Our product portfolio has continued to expand with the approval and subsequent launch of the pediatric formats of Blexten in Canada; and our EU and South Korean marketing authorization applications for Suvexx continue to move through the review process in their respective territories." 2021 and Fourth Quarter Financial Results Adjusted total revenue was $69.4 million for the year ended December 31, 2021 compared to $71.0 million for the year ended December 31, 2020.

The $1.6 million decrease in adjusted total revenue in the current year was primarily attributable to a decrease of $6.7 million of revenue from the Licensing and Royalty Business segment and a decrease in revenue of $0.7 million in the Production and Service Business segment, slightly offset by an increase of $5.8 million in the Commercial Business segment. Revenue attributable to the Commercial Business segment increased during the year ended December 31, 2021 due to a $7.3 million increase in sales of the Company’s promoted products (Blexten, Cambia, Suvexx and Neovisc), offset by a $1.5 million decrease in sales of the Company’s mature products. The Production and Service Business segment revenue decreased during the year ended December 31, 2021, primarily due to a decrease in Pennsaid 2% and Resultz product sales, as well as the stronger Canadian dollar against the U.S. dollar and euro, which reduced the contribution from certain U.S. and euro denominated product revenue streams, slightly offset by an increase in sales of Pennsaid.

The decrease in revenue attributable to the License and Royalty business segment during the year ended December 31, 2021 was primarily attributable to a $4.5 million reduction in U.S. Vimovo royalty revenue due to a competitor launch of a generic version of Vimovo in the U.S. during March 2020, as well as the stronger Canadian dollar against the U.S. dollar and euro, which reduced the contribution from certain U.S. and euro denominated royalty streams during the current year. In addition, in the comparative year, the Company received a $2.5 million (US $1.8 million) milestone payment, net of withholding taxes related to the use of its Yosprala intellectual property in Japan. Adjusted total revenue for the three months ended December 31, 2021 increased to $17.8 million compared to $17.3 million for the three months ended December 31, 2020.

Adjusted EBITDA was $22.2 million for the year ended December 31, 2021 compared to $28.4 million for the year ended December 31, 2020. During the year ended December 31, 2021, a $5.5 million increase in gross profit from the Company’s Commercial Business segment (net a $1.4 million decrease in inventory step-up expense) was more than offset by a $6.7 million decrease in the contribution from the Company’s License and Royalty Business segment, a $1.5 million decrease in gross profit contribution from the Production and Service Business segment, a $1.9 million increase in sales and marketing expenses and a $0.1 million increase in general and administrative (G&A) expenses (net a $0.1 million increase in stock-based compensation). Adjusted EBITDA for the three months ended December 31, 2021 was $3.4 million compared to $6.2 million for the three months ended December 31, 2020. Non-IFRS Measures The Company discloses non-IFRS financial measures (adjusted total revenue, adjusted EBITDA, and cash value of loans) and a non-IFRS ratio (adjusted EBITDA per share) that are not recognized under and do not have standardized meanings prescribed by IFRS. Accordingly, such measures are not necessarily comparable and may not have been calculated in the same way as similarly named financial measures presented by other companies. These measures should be considered as supplemental in nature and not as a substitute for related financial information prepared in accordance with IFRS. The Company believes that shareholders, investment analysts and other readers find such measures helpful in understanding and assessing the Company’s financial performance.

We utilize these measures in managing our business, including as means of performance measurement, cash management and debt compliance. Because non-IFRS financial measures and non-IFRS ratios do not have standardized meanings prescribed under IFRS, securities regulations require that such measures be clearly defined, identified, and for non-IFRS financial measures, reconciled to their nearest IFRS measure.

The applicable definition, calculation and reconciliation of each such measure used in this MD&A is provided below. Adjusted Total Revenue The Company defines adjusted total revenue as total revenue, plus amounts billed to customers for existing contract assets, less revenue recognized upon recognition of a contract asset. Management believes adjusted total revenue is a useful supplemental measure to determine the Company’s ability to generate cash from its customer contracts used to fund its operations. Adjusted EBITDA EBITDA refers to net income (loss) determined in accordance with IFRS, before depreciation and amortization, net interest expense (income) and income tax expense (recovery).

The Company defines adjusted EBITDA as EBITDA, plus amounts billed to customers for existing contract assets, inventory step-up expenses, stock-based compensation expense, loss on fair value of derivative liabilities, loss on fair value of contingent and variable consideration, impairment loss, foreign currency loss, other losses less revenue recognized upon recognition of a contract asset, stock-based compensation recovery, gain on fair value of derivative liabilities, gain on fair value of contingent and variable consideration, impairment recovery, foreign currency gain and other income. Management believes adjusted EBITDA is a useful supplemental measure to determine the Company’s ability to generate cash available for working capital, capital expenditures, debt repayments, interest expense and income taxes.

(1) Income tax expense for the year ended December 31, 2021 includes $2.4 million for deferred income tax due to the utilization of loss carryforwards that were previously recognized. The Company did not recognize deferred income tax expense in the comparative year.
(2) The Company’s derivative liabilities are measured at fair value through profit or loss at each reporting date. As a result of the increase in the share price in the current year and an increase in the volatility of the Company’s shares, amongst other inputs, the value of the Company’s derivative liabilities increased, and the Company recognized net losses of $15.6 million on the change in fair value of derivative liabilities for the year ended December 31, 2021.
(3) During the year ended December 31, 2021, the Company recorded impairment of $17.9 million of goodwill and certain intangible assets in the Commercial Business and Licensing and Royalty segments. Additional details regarding the Company’s methodology and assumptions are disclosed in Note 9, Intangible Assets and Note 10, Goodwill to the Consolidated Financial Statements for the year ended December 31, 2021. See Impairment and Risk Factors in the Management’s, Discussion and Analysis for the year ended December 31, 2021.

Management to Host Conference Call/Webcast Management will host a conference call to discuss the results today (Monday, March 28, 2022) at 11:00 a.m. ET. To participate in the conference call, please dial (289) 536-4777 or 1 (888) 550-2239 / Conference ID: 6216508. Please call in 15 minutes prior to the call to secure a line. You will be put on hold until the conference call begins. A live audio webcast and replay webcast of the conference call will be available through View Source