On February 24, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported financial results for the fourth quarter and the full year ended December 31, 2021 and provided recent corporate highlights (Press release, Y-mAbs Therapeutics, FEB 24, 2022, View Source [SID1234609067]).

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"In recent months, we have achieved significant progress on the omburtamab BLA, which we expect to resubmit to the FDA by the end of the first quarter of 2022," said Dr. Claus Moller, Chief Executive Officer. "We believe we now have a clear regulatory path in place and are one step closer to our goal of delivering omburtamab to children suffering from high-risk neuroblastoma brain tumors. In parallel, we are continuing to advance SADA, our novel platform for targeted radioisotope delivery that can potentially be adapted to various tumor targets. We filed an IND for GD2-SADA, the first SADA construct for potential use in GD2 positive solid tumors and are now accelerating pre-clinical testing with plans to submit at least one IND per year for additional SADA targets. In the meantime, we are actively pursuing additional collaboration and partnership opportunities."

"We are very pleased with our 2021 financial results, especially with our continued execution of the DANYELZA commercial launch, which generated revenues of $32.9 million in its first year," said Thomas Gad, Founder, Chairman and President. "We continue to be focused on our oncology programs, supported by a strong balance sheet. We ended the year with $181.6 million in cash, that is anticipated to support us through multiple potentially value-creating catalysts by the end of 2023. We believe that we are well-positioned to elevate our business and we expect that 2022 will be another productive year for Y-mAbs."

Fourth Quarter 2021 and Recent Corporate Developments

Subsequent to the end of the fourth quarter, on February 11, 2022, Y-mAbs announced the completion of a Pre-BLA Meeting with FDA for omburtamab and confirmed the timeline for resubmission of the omburtamab BLA by the end of the first quarter of 2022.

On December 15, 2021, Y-mAbs announced a pipeline update, including compassionate use data from an investigational infusion protocol for naxitamab. It was observed that the protocol may help managing Grade 3 and Grade 4 adverse events.

On December 14, 2021, Y-mAbs appointed Sue Smith to the role of Senior Vice-President, Chief Commercial Officer, effective January 1, 2022. Ms. Smith brings more than 25 years of extensive commercial experience including several successful product launches within cancer, rare diseases, and endocrinology.

On October 7, 2021, Y-mAbs announced that the U.S. Food and Drug Administration ("FDA") had granted Rare Pediatric Disease Designation ("RPDD") for the Company’s lutetium labeled omburtamab antibody program for the treatment of medulloblastoma.
Financial Results

Revenues

Y-mAbs reported net revenue of $34.9 million for the year ended December 31, 2021, which consisted of product revenues of $32.9 million, generated from sales of DANYELZA, our first FDA approved product, and licensing revenues of $2.0 million related to a licensing agreement in Latin America. The gross margin for product revenues was 93% in 2021. Y-mAbs reported net revenues of $20.8 million for the year ended December 31, 2020, related to its licensing agreements in China and Israel. Y-mAbs did not have product revenues for the year ended December 31, 2020, as DANYELZA was not approved by the FDA until late November 2020.

For the fourth quarter of 2021, Y-mAbs incurred net revenues of $9.6 million, which consisted of product revenues from the sales of DANYELZA. Sales were up 7.1% from the third quarter 2021, and we have now delivered DANYELZA to 28 centers across the nation, an increase of four centers since the third quarter 2021. Treatment centers outside MSK accounted for approximately 40% of the product revenues during the fourth quarter of 2021. Y-mAbs incurred net revenues of $20.8 million for the quarter ending December 31, 2020, related to its licensing agreements in China and Israel.

Operating Expenses

Research and Development

Y-mAbs is anticipating a BLA resubmission for omburtamab by the end of the first quarter 2022 and at the same time, the Company is advancing its antibody constructs through the clinic; predominantly DANYELZA, omburtamab, and the SADA constructs. Research and development expenses were $93.2 million for the twelve months ended December 31, 2021, compared to $93.7 million for the twelve months ended December 31, 2020. The $0.5 million decrease in research and development expenses primarily reflects the following main items:

$4.8 million decrease in regulatory affairs expenses; and
$13.3 million decrease in milestones and license acquisition costs.
The decreases mentioned above were partially offset by the following increases:

$6.2 million increase in outsourced manufacturing expenses;
$4.1 million increase in personnel costs associated with research and development activities; and
$3.9 million increase in clinical trial expenses.
Selling, General, and Administration

Selling, general, and administrative expenses were $54.6 million for the twelve months ended December 31, 2021, compared to $44.8 million for the twelve months ended December 31, 2020, corresponding to an increase of $9.8 million. The increase in selling, general, and administrative expenses was primarily due to a $8.9 million increase in personnel costs, partly associated with the expansion of our commercial team that is poised to drive further adoption of DANYELZA in 2022.

Net Result

Y-mAbs reported a net loss of $55.3 million, or ($1.28) per basic and diluted share, for the year ended December 31, 2021, compared to a net loss of $119.3 million, or ($2.97) per basic and diluted share, reported for the year ended December 31, 2020. The decrease in net loss was primarily caused by the sale in January 2021 of the priority review voucher received upon the approval of DANYELZA and the DANYELZA revenues generated in 2021, partially offset by increases in operating expenses related to the commercialization of DANYELZA in the United States.

For the quarter ended December 31, 2021, Y-mAbs incurred a net loss of $36.9 million, or ($0.85) per basic and diluted share, which compares to a net loss of $19.9 million, or ($0.48) per basic and diluted share, incurred for the quarter ended December 31, 2020. The increase in net loss was primarily caused by the DANYELZA revenues in 2021 not fully offsetting the licensing income in the fourth quarter of 2020.

Cash and Cash Equivalents

The Company had approximately $181.6 million in cash and cash equivalents as of December 31, 2021.

Webcast and Conference Call

The Company will host a conference call on Friday, February 25, 2022, at 9 a.m. Eastern Time. To participate in the call, please dial 877-407-0792 (domestic) or 201-689-8263 (international) and reference the conference ID 13726652.

A webcast will be available at: View Source;tp_key=59e1f9cc51

On February 24, 2022 EVERSANA reported that it will be attending Reuters Events: Pharma USA 2022 on March 16th & 17th in Philadelphia (Press release, EVERSANA, FEB 24, 2022, View Source [SID1234609061]). Krista Pinto, President, Deployment Solutions, will participate with industry leaders in a panel discussion covering the importance of salesforce instances keeping pace with rapidly evolving HCP preferences March 17th at 12:20 PM EST . Key topics include:

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With a shift in HCP preferences, expectations and a hybrid future, learn how to maximize your salesforce outputs by shifting the way your organization sets KPI’s as well as the metrics used to read them
New methods to provide value to your HCPs in virtual calls
Learn how to match HCP preferences with sales rep interactions to leave long-lasting impressions that lead to conversions
How can we you empower the digital rep experience from a service orientation perspective?
Confirmed speakers:

Krista Pinto, President, Deployment Solutions, EVERSANA
Dion Warren, VP, Head of U.S. Oncology Business Unit, Takeda
Frank Armenante, Director, Commercial Execution, Novo Nordisk
Tatiana Yglesias, Head of Migraine Marketing, Neuroscience, Novartis
Nithya Srinivasan, Director of Marketing, Rheumatology, Janssen
Pharma USA unites North America’s visionary pharma changemakers, leading solution providers, patient experts and industry heavyweights — from commercial, marketing, medical affairs, patient engagement, market access and RWE — who’ll unlock unrestrained innovation and drastically improved health outcomes.

On February 24, 2022, Amgen Inc. (the Company) reported that entered into accelerated stock buyback agreements, pursuant to the form of ASR Agreement filed herewith (hereinafter referred to as the ASR Agreements), with each of Bank of America, N.A., Morgan Stanley & Co. LLC, and Goldman Sachs & Co. LLC (each, a Financial Institution, and together, the Financial Institutions) to repurchase an aggregate of up to $6 billion of the Company’s common stock, as previously announced on February 8, 2022 (Filing, 8-K, Amgen, FEB 24, 2022, View Source [SID1234609057]). The Company is funding the share repurchases under the ASR Agreements with existing cash resources.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Under the terms of the ASR Agreements, the Company will make payments in an aggregate amount of $6 billion to the Financial Institutions on February 25, 2022, and expects to receive on the same day initial deliveries of approximately 23,258,997 shares of the Company’s common stock in the aggregate from the Financial Institutions. The final number of shares to be repurchased by the Company will be based on the volume-weighted average stock price of the Company’s common stock during the term of the ASR Agreements, less a discount and subject to adjustments pursuant to the terms and conditions of the ASR Agreements. At settlement, under certain circumstances, one or more of the Financial Institutions may be required to deliver additional shares of common stock to the Company, or under certain circumstances, the Company may be required to deliver shares of common stock or to make a cash payment, at its election, to a Financial Institution. The final settlement under the ASR Agreements is scheduled to occur in the third quarter of 2022, subject to earlier termination under certain limited circumstances, as set forth in the ASR Agreements.

Each of the ASR Agreements contains customary terms for these types of transactions, including, but not limited to, the mechanisms to determine the number of shares or the amount of cash that will be delivered at settlement, the required timing of delivery of the shares, the specific circumstances under which adjustments may be made to the transactions, the specific circumstances under which the transactions may be terminated prior to their scheduled maturities and various acknowledgements, representations and warranties made by the Company.

From time to time, one or more of the Financial Institutions and/or their affiliates have directly and indirectly engaged, and may engage in the future, in investment and/or commercial banking transactions with the Company for which such Financial Institution has received, or may receive, customary compensation, fees and expense reimbursement.

The foregoing description of the ASR Agreements does not purport to be complete and is qualified in its entirety by reference to the form of the ASR Agreement, a copy of which is attached hereto as Exhibit 10.1, and is incorporated herein by reference.

On February 24, 2022 Portage Biotech Inc. (NASDAQ: PRTG) ("Portage" or the "Company"), a clinical-stage immuno-oncology company developing therapies to improve patient lives and increase survival by avoiding and overcoming cancer treatment resistance, reported financial results for the quarter ended December 31, 2021 (the "third quarter") (Press release, Portage Biotech, FEB 24, 2022, View Source [SID1234609046]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"During the third quarter and in recent weeks we’ve taken steps to accelerate our lead programs for PORT-2 and PORT-3, investigating options to expand our clinical sites beyond our current footprint and finding the means of accelerating patient enrollment," said Dr. Ian Walters, chief executive officer of Portage. "With our enhanced management team, efficient organization, and financial resources obtained in 2021, we are well positioned to execute our unique drug development strategy to deliver on important clinical milestones over the next two years."

Business Update

Enhanced the management team with the appointments of Brian Wiley as Chief Business Officer, Joseph Ciavarella as Chief Accounting Officer; expanded the Board of Directors with the addition of Jim Mellon, Linda Kozick, and Mark Simon.
Enrollment continues in the Company’s IMP-MEL randomized Phase 1/2 study of PORT-2 and its PRECIOUS Phase 1 study of PORT-3 in patients with NY-ESO-1 expressing tumors.
The Company plans to issue a Research & Development update in March 2022 which will include preliminary safety data on its PORT-2 and PORT-3 programs as well as other details from its clinical development plan.
Presented at high-profile investor conferences:
Management participated in January 2022 investor conferences including the LifeSci Advisors Corporate Access Event, H.C. Wainwright BioConnect Conference, and the B. Riley Securities’ Oncology Investor Conference.
Hosted Key Opinion Webinar How iNKT Agonists Could Improve Immuno-Oncology Treatment with leading researchers from La Jolla Institute of Immunology and Imperial College London. Replay available here.
Third Quarter FY 2022 Financial Results

The Company generated a net loss and comprehensive loss of approximately $4.2 million in the three months ended December 31, 2021 ("Fiscal 2022 Quarter"), compared to a net loss and comprehensive loss of approximately $1.3 million in the three months ended December 31, 2020 ("Fiscal 2021 Quarter"), an increase in loss of $2.9 million year over year. Operating expenses, which include research and development and general and administrative expenses, were approximately $4.2 million in the Fiscal 2022 Quarter, compared to $0.9 million in the Fiscal 2021 Quarter, an increase of $3.3 million, which is discussed more fully below.

The Company’s other items of income and expense were substantially non-cash in nature and were approximately $0.1 million net income in the Fiscal 2022 Quarter, compared to approximately $0.5 million net loss in the Fiscal 2021 Quarter, a change in other items of income and expense of approximately $0.6 million, year over year. The primary reasons for the year over year difference in other items of income and expense was the change of $0.8 million in the fair value of the warrants issued with respect to the SalvaRx note settlement, which was partially offset by the year over year increase in the loss from an associate accounted for under the equity method of $0.1 million and the income on equity issued at a discount of $0.1 million in the Fiscal 2021 Quarter, representing the difference between the market price and the contractual exercise price, relating to the settlement of the SalvaRx notes and warrants.

Research & development ("R&D") costs increased by approximately $1.5 million, from approximately $0.4 million during the Fiscal 2021 Quarter, to approximately $1.9 million during the Fiscal 2022 Quarter. The increase was primarily attributable to non-cash share-based compensation expense associated with grants made under the 2021 Equity Incentive Plan of $1.0 million and salaries and bonuses of $0.7 million to directors and senior management. Additionally, the Fiscal 2021 Quarter was impacted by a general slow down in expenditures resulting from the pandemic.

General and administrative ("G&A") expenses increased by approximately $1.8 million, from approximately $0.4 million during the Fiscal 2021 Quarter, to approximately $2.2 million during the Fiscal 2022 Quarter. The principal reason for the increase in the Fiscal 2022 Quarter was the $1.1 million of non-cash share-based compensation expense associated with the Company’s 2021 Equity Incentive Plan, of which $0.7 million is associated with Directors’ compensation, and $0.4 million is associated with management compensation. No share-based compensation expense under the 2021 Equity Incentive Plan was incurred during the Fiscal 2021 Quarter. Additionally, the Company incurred an increase of $0.4 million in professional fees relating to initiatives associated with a corporate restructuring and public relations / business development. Finally, D&O insurance premiums increased $0.4 million in the current year period due to market rate increases in the cost of coverage.

Additionally, the Company reflected a net income tax expense of approximately $0.1 million in the Fiscal 2022 Quarter, compared to a net income tax benefit of approximately $0.1 million in the Fiscal 2021 Quarter. The Fiscal 2022 Quarter reflects the change in the foreign currency exchange rate on deferred tax liability settleable in British pounds sterling and the Fiscal 2021 Quarter reflected recoverable research and development tax credits generated in the U.K.

As of December 31, 2021, the Company had cash and cash equivalents of approximately $25.6 million and total current liabilities of approximately $0.6 million (inclusive of approximately $0.2 million warrant liability settleable on a non-cash basis). For the nine months ended December 31, 2021, the Company is reporting a net loss of approximately $10.3 million and cash used in operating activities of approximately $4.5 million. As of January 31, 2022, the Company had approximately $25.1 million of cash on hand to enable achieving important clinical milestones over the next two years.

On February 24, 2022 Portage Biotech Inc. (NASDAQ: PRTG) ("Portage" or the "Company"), a clinical-stage immuno-oncology company developing therapies to improve patient lives and increase survival by avoiding and overcoming cancer treatment resistance, reported financial results for the quarter ended December 31, 2021 (the "third quarter") (Press release, Portage Biotech, FEB 24, 2022, View Source [SID1234609033]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"During the third quarter and in recent weeks we’ve taken steps to accelerate our lead programs for PORT-2 and PORT-3, investigating options to expand our clinical sites beyond our current footprint and finding the means of accelerating patient enrollment," said Dr. Ian Walters, chief executive officer of Portage. "With our enhanced management team, efficient organization, and financial resources obtained in 2021, we are well positioned to execute our unique drug development strategy to deliver on important clinical milestones over the next two years."

Business Update

Enhanced the management team with the appointments of Brian Wiley as Chief Business Officer, Joseph Ciavarella as Chief Accounting Officer; expanded the Board of Directors with the addition of Jim Mellon, Linda Kozick, and Mark Simon.
Enrollment continues in the Company’s IMP-MEL randomized Phase 1/2 study of PORT-2 and its PRECIOUS Phase 1 study of PORT-3 in patients with NY-ESO-1 expressing tumors.
The Company plans to issue a Research & Development update in March 2022 which will include preliminary safety data on its PORT-2 and PORT-3 programs as well as other details from its clinical development plan.
Presented at high-profile investor conferences:
Management participated in January 2022 investor conferences including the LifeSci Advisors Corporate Access Event, H.C. Wainwright BioConnect Conference, and the B. Riley Securities’ Oncology Investor Conference.
Hosted Key Opinion Webinar How iNKT Agonists Could Improve Immuno-Oncology Treatment with leading researchers from La Jolla Institute of Immunology and Imperial College London. Replay available here.
Third Quarter FY 2022 Financial Results

The Company generated a net loss and comprehensive loss of approximately $4.2 million in the three months ended December 31, 2021 ("Fiscal 2022 Quarter"), compared to a net loss and comprehensive loss of approximately $1.3 million in the three months ended December 31, 2020 ("Fiscal 2021 Quarter"), an increase in loss of $2.9 million year over year. Operating expenses, which include research and development and general and administrative expenses, were approximately $4.2 million in the Fiscal 2022 Quarter, compared to $0.9 million in the Fiscal 2021 Quarter, an increase of $3.3 million, which is discussed more fully below.

The Company’s other items of income and expense were substantially non-cash in nature and were approximately $0.1 million net income in the Fiscal 2022 Quarter, compared to approximately $0.5 million net loss in the Fiscal 2021 Quarter, a change in other items of income and expense of approximately $0.6 million, year over year. The primary reasons for the year over year difference in other items of income and expense was the change of $0.8 million in the fair value of the warrants issued with respect to the SalvaRx note settlement, which was partially offset by the year over year increase in the loss from an associate accounted for under the equity method of $0.1 million and the income on equity issued at a discount of $0.1 million in the Fiscal 2021 Quarter, representing the difference between the market price and the contractual exercise price, relating to the settlement of the SalvaRx notes and warrants.

Research & development ("R&D") costs increased by approximately $1.5 million, from approximately $0.4 million during the Fiscal 2021 Quarter, to approximately $1.9 million during the Fiscal 2022 Quarter. The increase was primarily attributable to non-cash share-based compensation expense associated with grants made under the 2021 Equity Incentive Plan of $1.0 million and salaries and bonuses of $0.7 million to directors and senior management. Additionally, the Fiscal 2021 Quarter was impacted by a general slow down in expenditures resulting from the pandemic.

General and administrative ("G&A") expenses increased by approximately $1.8 million, from approximately $0.4 million during the Fiscal 2021 Quarter, to approximately $2.2 million during the Fiscal 2022 Quarter. The principal reason for the increase in the Fiscal 2022 Quarter was the $1.1 million of non-cash share-based compensation expense associated with the Company’s 2021 Equity Incentive Plan, of which $0.7 million is associated with Directors’ compensation, and $0.4 million is associated with management compensation. No share-based compensation expense under the 2021 Equity Incentive Plan was incurred during the Fiscal 2021 Quarter. Additionally, the Company incurred an increase of $0.4 million in professional fees relating to initiatives associated with a corporate restructuring and public relations / business development. Finally, D&O insurance premiums increased $0.4 million in the current year period due to market rate increases in the cost of coverage.

Additionally, the Company reflected a net income tax expense of approximately $0.1 million in the Fiscal 2022 Quarter, compared to a net income tax benefit of approximately $0.1 million in the Fiscal 2021 Quarter. The Fiscal 2022 Quarter reflects the change in the foreign currency exchange rate on deferred tax liability settleable in British pounds sterling and the Fiscal 2021 Quarter reflected recoverable research and development tax credits generated in the U.K.

As of December 31, 2021, the Company had cash and cash equivalents of approximately $25.6 million and total current liabilities of approximately $0.6 million (inclusive of approximately $0.2 million warrant liability settleable on a non-cash basis). For the nine months ended December 31, 2021, the Company is reporting a net loss of approximately $10.3 million and cash used in operating activities of approximately $4.5 million. As of January 31, 2022, the Company had approximately $25.1 million of cash on hand to enable achieving important clinical milestones over the next two years.