On July 28, 2021 Portage Biotech Inc. (NASDAQ: PRTG) ("Portage" or the "Company") a clinical-stage immuno-oncology company focused on the development of therapies and treatments targeting cancer treatment resistance, reported financial results for the fiscal year ended March 31, 2021 (Press release, Portage Biotech, JUL 28, 2021, View Source [SID1234585260]).

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"Over the past year, we’ve transformed Portage, positioning the Company to capitalize on our promising portfolio of immuno-oncology platforms and assets as well as leverage our innovative drug development engine," said Dr. Ian Walters, chief executive officer of Portage Biotech. "Throughout this transformation, we’ve maintained efficiency in our capital expenditures and operations to maximize value for shareholders thanks to the support of our lean, experienced team. Our efficiency coupled with our recent financing provides us with sufficient cash runway to complete Phase 1 and Phase 2 clinical trials for our lead invariant natural killer T cell (iNKT) agonists and is our first with formal biotech institutional support. We believe iNKTs have the potential to re-sensitize PD-1 tumors and could significantly expand the PD-1 market opportunity. With sufficient resources now in place, we are poised to advance our iNKT agonists and other assets through multiple data milestones and other value-driving catalysts in the coming year."

Financial & Business Highlights from FY 2021 (April 2020 – March 2021) and Recent Weeks

Increased financial resources with over $29 million raised since fiscal year end:
Successful public offering of 1,150,000 ordinary shares with gross proceeds of $26.5 million, securing a 2-year cash runway sufficient to advance programs and enable achievement of numerous milestones.
Generation of an additional $2.6 million through the sale of approximately 91,000 shares via the Company’s At-the-Market offering as of June 7, 2021.
Improved stock liquidity:
Listing of common shares on the NASDAQ exchange and subsequent voluntary delisting from the Canadian Securities Exchange.
Inclusion in the Russell 2000 Index, bringing added visibility to the Company’s robust immuno-oncology pipeline.
Immuno-oncology focused: Divestiture of three legacy businesses (Portage Pharmaceuticals Limited, including subsidiaries Portage Glasgow Ltd. and EyGen Ltd) to Juvenescence Ltd. Through this divestiture, Portage may be entitled to share in revenues upon the achievement of certain milestones based on specified development criteria and may be eligible to receive potential royalties on net sales of products developed utilizing legacy intellectual property.
Clinical Highlights from FY 2021 (April 2020 – March 2021) and Recent Weeks

Acceleration of development programs from the Company’s first-in-class immuno-oncology asset portfolio, including milestones related to lead iNKT agonists PORT-2 and PORT-3 and intratumoral amphiphilic therapy PORT-1. Key milestones included:
Initiation of the PRECIOUS-01 Study of PORT-3 for the treatment of NY-ESO-1 positive solid tumors, the first in a comprehensive clinical development plan to evaluate the Company’s iNKT agonists (PORT-2 and PORT-3) to improve outcomes in a variety of solid tumors.
Initiation of the INVINCIBLE Trial, a Phase 2 early-stage breast cancer study of INT230-6 (PORT-1) conducted by Intensity Therapeutics.
Presentation of interim data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference from the IT-01 Phase 2 trial conducted by Intensity Therapeutics demonstrating strong safety and survival data for INT230-6 (PORT-1) as both a monotherapy and in combination with pembrolizumab or ipilimumab in solid tumors.
Financial Results FY 2021 (April 2020 – March 2021)

The Company generated a net loss of $17.2 million in fiscal year 2021, compared to a net loss of $7.2 million in fiscal year 2020, an increase in net loss of $10.0 million year over year. Operating expenses, which include research and development and general and administrative expenses, were $12.4 million in fiscal year 2021, compared to $6.0 million in fiscal year 2020, an increase of $6.4 million. Operating expenses included $8.8 million of non-cash stock-based compensation expense in fiscal year 2021, compared to $2.1 million in fiscal year 2020.

Research and development ("R&D") costs increased by $3.2 million, or approximately 78%, from $4.1 million in fiscal year 2020, to $7.3 million in fiscal year 2021. The increase was attributable to non-cash stock-based compensation expense associated with grants made under the 2021 Equity Incentive Plan of $5.1 million, partially offset by a decrease in iOx related stock-based compensation expense of $0.8 million. Finally, fiscal 2021 development was slowed by the impact of the pandemic.

General and administrative ("G&A") expenses increased by $3.2 million, from $1.9 million in fiscal year 2020, to $5.1 million in fiscal year 2021. The principal reason for the increase was the $2.8 million of non-cash stock-based compensation expense associated with the Company’s 2021 Equity Incentive Plan in fiscal 2021. Additionally, the Company incurred approximately $0.2 million relating to initiatives associated with a corporate restructuring and business development.

Other items of income and expense were substantially non-operating in nature and were $2.5 million net expense in fiscal year 2021, compared to $0.5 million net expense in fiscal year 2020. $2.0 million of the net expense in fiscal year 2021 was non-cash. Other items of income and expense included:

A loss on equity issued at a discount of $1.3 million in fiscal year 2021, representing the difference between the market price and the contractual exercise price, relating to the settlement of the SalvaRx Notes and warrants;
A loss from our equity investment in Stimunity of $0.5 million, compared to a small gain in fiscal year 2020;
A loss of $0.8 million representing the change in the fair value of the warrants issued with respect to the SalvaRx settlement;
A non-cash gain relating to the settlement of related liabilities on the disposition of PPL of $0.4 million, of which $0.2 million was recorded in operations in fiscal year 2021; and
Interest expense of $0.2 million is fiscal year 2021, compared to $0.6 million in fiscal year 2020 due to the settlement of the SalvaRx Notes. The Company also recorded a loss of $0.2 million on the early extinguishment of the SalvaRx Notes in fiscal year 2021.
Additionally, the Company reflected net deferred income tax provisions of $2.3 million and $0.7 million in the fiscal years 2021 and 2020, respectively.

As of June 30, 2021, the Company had approximately $28.6 million of cash on hand.