Portage Biotech Reports Fiscal Year-Ended March 31, 2023 Financial Results and Business Update
- Positive interim data for lead iNKT engager, PORT-2, presented at the 2023 ASCO Annual Meeting
- First patient dosed in Phase 1a trial of PORT-6 (A2AR antagonist) in select solid tumors
- Clinical collaboration agreement with Merck for the evaluation of PORT-2 in combination with KEYTRUDA® for patients with first-line and PD-1 refractory NSCLC
- Key Opinion Leader webinar highlighting the potential of targeting the adenosine pathway
- Generated a net loss of approximately $104.7 million and other comprehensive loss of approximately $109.9 million during the fiscal year ended March 31, 2023
- Net loss of approximately $104.7 million for the fiscal year ended March 31, 2023
- Increase in net loss of $85.5 million year-over-year
- Operating expenses were $16.6 million in Fiscal 2023
- Non-cash losses on impairment relating to the Company’s identifiable intangible assets, goodwill, and certain investments and convertible note receivable
- Company poised to accelerate accrual in all clinical programs as it activates numerous sites across multiple U.S. cities and abroad and takes over sponsorship from the investigator-led program
- Updated interim data for lead iNKT engager, PORT-2, presented at the 2023 ASCO Annual Meeting showed early evidence of monotherapy activity with minimal toxicity
- First patient dosed in Phase 1a trial of PORT-6 (A2AR antagonist) in select solid tumors
WESTPORT, Conn., July 31, 2023 (GLOBE NEWSWIRE) -- Portage Biotech Inc. (NASDAQ: PRTG), a clinical-stage immuno-oncology company advancing novel multi-targeted therapies for use as monotherapy and in combination, today announced financial results for the fiscal year ended March 31, 2023.
“We continue to advance our clinical programs with important progress made recently in both our iNKT engager and adenosine programs and are pleased to see the trials generating interest from the academic community,” said Dr. Ian Walters, Chief Executive Officer and Chairman of Portage Biotech. “At ASCO we presented favorable interim data from the Phase 1/2 trial of our lead program, PORT-2 for the treatment of patients with advanced melanoma and metastatic non-small cell lung cancer. The presented data showed early evidence of monotherapy activity and meaningful reduction of several target lesions with minimal toxicity. This has led to our expansion of the trial globally and transition of sponsorship from the academic sponsor to Portage.”
“We also recently announced the dosing of the first patient in our adaptive Phase 1a/1b trial, ADPORT-601 (NCT04969315), evaluating PORT-6, our adenosine 2A receptor (A2AR) antagonist candidate, in patients with biomarker selected solid tumors including prostate cancer, renal and non-small cell lung cancer (NSCLC),” continued Dr. Walters. “The ADPORT-601 trial includes plans to also evaluate PORT-7, our adenosine 2B receptor (A2BR) antagonist, and is designed to adapt over time, including safety and efficacy cohorts for both candidates as monotherapy and in combination with checkpoint inhibitors as well as other immune activating agents from Portage’s pipeline. Recently, having chaired a new conference focused on the adenosine pathway, we were encouraged to see the work many companies are doing in this space. We remain confident in our highly differentiated assets and development strategy as clinical trial sites continue to open in the U.S., to accelerate patient accrual in our clinical programs.”
Company Highlights
- Entered into a clinical collaboration agreement with Merck for the evaluation of PORT-2, in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, for patients with first-line as well as PD-1 refractory NSCLC.
- The Company hosted a Key Opinion Leader webinar highlighting the potential of targeting the adenosine pathway, featuring Lawrence Fong, M.D., from The University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center, and Sumit Subudhi, M.D., Ph.D., from MD Anderson Cancer Center. The event covered the immunologic rationale and current clinical landscape that set the foundation for Portage’s development approach. A replay of the event is available here.
Financial Results from Year Ended March 31, 2023
The Company generated a net loss of approximately
Operating expenses, which include research and development (“R&D”) costs and general and administrative (“G&A”) expenses, were
R&D costs increased by approximately
G&A expenses decreased by approximately
The Company’s other items of income and expense were substantially non-cash in nature and aggregated approximately
Additionally, the Company recognized a non-cash net deferred income tax benefit of
Finally, in Fiscal 2023, the Company also performed a fair value analysis on its investment in Intensity Therapeutics, Inc. (“Intensity”) (NASDAQ: INTS), and determined a fair value of
As of March 31, 2023, the Company had cash and cash equivalents of approximately
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. LLC., Rahway, N.J., USA.
About Portage Biotech Inc.
Portage is a clinical-stage immuno-oncology company advancing multi-targeted therapies to extend survival and significantly improve the lives of patients with cancer. Lead programs in the Portage portfolio include first-in-class invariant natural killer T cell (iNKT) small molecule engagers and potentially best-in-class adenosine antagonists. These programs are being advanced using innovative trial designs and translational data to identify the patient populations most likely to benefit from treatment. The Company’s unique business model leverages a strong network of academic experts and large pharma partners to rapidly and efficiently advance multiple products. For more information, please visit www.portagebiotech.com, follow us on Twitter at @PortageBiotech or find us on LinkedIn at Portage Biotech Inc.
Forward-Looking Statements
All statements in this news release, other than statements of historical facts, including without limitation, statements regarding about the Company’s information that are forward-looking in nature and, business strategy, plans and objectives of management for future operations and those statements preceded by, followed by or that otherwise include the words "believe," "expects," "anticipates," "intends," "estimates," “will,” “may,” “plan,” “potential,” “continue,” or similar expressions or variations on such expressions are forward-looking statements. For example, statements regarding the Company's plans to advance first-in-class therapies to improve long-term treatment response and quality of life in patients with evasive cancers; the Company’s ability to accelerate accrual in all of its clinical programs as it activates numerous sites across multiple U.S. cities and abroad; the Company’s plans to advance its clinical programs, including it iNKT engager and adenosine programs; the Company’s confidence in its highly differentiated assets and development strategy; are forward-looking statements. As a result, forward-looking statements are subject to certain risks and uncertainties, including, but are not limited to: the Company's plans and ability to develop and commercialize product candidates and the timing of these development programs; the Company's clinical development of its product candidates, including the results of current and future clinical trials; the benefits and risks of the Company's product candidates as compared to others; the Company's maintenance and establishment of intellectual property rights in its product candidates; the Company's ability to obtain financing in the future to cover its operational costs and progress its plans for clinical development, its estimates regarding its capital requirements, and its ability to continue as a going concern; the Company’s estimates of future revenues and profitability; the Company's estimates of the size of the potential markets for its product candidates; its selection and licensing of product candidates; and other factors set forth in “Item 3 - Key Information-Risk Factors” in the Company’s Annual Report on Form 20-F for the year ended March 31, 2023. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, undue reliance should not be placed on them as actual results may differ materially from these forward-looking statements. The forward-looking statements contained in this news release are made as of the date hereof, and the Company undertakes no obligation to update publicly or revise any forward-looking statements or information, except as required by law.
FOR MORE INFORMATION, PLEASE CONTACT:
Investor Relations
Chuck Padala
chuck@lifesciadvisors.com
Media Relations
Raena Mina
rmina@lifescicomms.com
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Portage Biotech Inc.
Condensed Consolidated Interim Statements of Operations and Other Comprehensive Income (Loss)
(U.S. Dollars in thousands, except per share amounts)
Years Ended March 31, | ||||||||||
2023 | 2022 | 2021 | ||||||||
Expenses | ||||||||||
Research and development | $ | 8,214 | $ | 6,769 | $ | 7,312 | ||||
General and administrative expenses | 8,361 | 8,819 | 5,128 | |||||||
Loss from operations | (16,575 | ) | (15,588 | ) | (12,440 | ) | ||||
Change in fair value of deferred purchase price payable - Tarus and deferred obligation - iOx milestone | 2,711 | – | – | |||||||
Impairment loss - iOx IPR&D | (59,320 | ) | – | – | ||||||
Impairment loss - Tarus IPR&D | (4,585 | ) | – | – | ||||||
Impairment loss - Goodwill | (43,862 | ) | ||||||||
Impairment loss - Stimunity | (818 | ) | ||||||||
Share of loss in associate accounted for using equity method | (260 | ) | (62 | ) | (490 | ) | ||||
Change in fair value of warrant liability | 33 | 852 | (790 | ) | ||||||
Loss on equity issued at a discount | – | – | (1,256 | ) | ||||||
Loss on extinguishment of notes payable | – | – | (223 | ) | ||||||
Gain on sale of marketable equity securities | – | – | 72 | |||||||
Gain on disposition of subsidiaries | – | – | 412 | |||||||
Foreign exchange transaction (loss) gain | (53 | ) | 24 | – | ||||||
Depreciation expense | (1 | ) | – | – | ||||||
Interest income | 217 | – | – | |||||||
Interest expense | (9 | ) | (43 | ) | (177 | ) | ||||
Loss before provision for income taxes | (122,522 | ) | (14,817 | ) | (14,892 | ) | ||||
Income tax benefit (expense) | 17,856 | (4,352 | ) | (2,297 | ) | |||||
Net loss | (104,666 | ) | (19,169 | ) | (17,189 | ) | ||||
Other comprehensive income (loss) | ||||||||||
Net unrealized loss on investments | (5,283 | ) | – | – | ||||||
Total comprehensive loss for year | $ | (109,949 | ) | $ | (19,169 | ) | $ | (17,189 | ) | |
Net loss attributable to: | ||||||||||
Owners of the Company | $ | (104,611 | ) | $ | (16,870 | ) | $ | (15,833 | ) | |
Non-controlling interest | (55 | ) | (2,299 | ) | (1,356 | ) | ||||
Net loss | $ | (104,666 | ) | $ | (19,169 | ) | $ | (17,189 | ) | |
Comprehensive loss attributable to: | ||||||||||
Owners of the Company | $ | (109,894 | ) | $ | (16,870 | ) | $ | (15,833 | ) | |
Non-controlling interest | (55 | ) | (2,299 | ) | (1,356 | ) | ||||
Total comprehensive loss for year | $ | (109,949 | ) | $ | (19,169 | ) | $ | (17,189 | ) | |
Loss per share | ||||||||||
Basic and diluted | $ | (6.49 | ) | $ | (1.29 | ) | $ | (1.35 | ) | |
Weighted average shares outstanding | ||||||||||
Basic and diluted | 16,119 | 13,060 | 11,733 |
Portage Biotech Inc.
Condensed Consolidated Interim Statements of Financial Position
(U.S. Dollars in thousands)
March 31, | |||||||
2023 | 2022 | ||||||
Assets | |||||||
Current assets | |||||||
Cash and cash equivalents | $ | 10,545 | $ | 23,352 | |||
Prepaid expenses and other receivables | 2,689 | 1,480 | |||||
Convertible note receivable | 442 | – | |||||
Total current assets | 13,676 | 24,832 | |||||
Non-current assets | |||||||
Investment in associate | 806 | 1,673 | |||||
Investment in private company | 2,087 | 7,409 | |||||
Goodwill | – | 43,324 | |||||
In-process research and development | 81,683 | 117,388 | |||||
Deferred commitment fee | 839 | – | |||||
Other assets, including equipment, net | 38 | 36 | |||||
Total non-current assets | 85,453 | 169,830 | |||||
Total assets | $ | 99,129 | $ | 194,662 | |||
Liabilities and Equity | |||||||
Current liabilities | |||||||
Accounts payable and accrued liabilities | $ | 1,865 | $ | 750 | |||
Warrant liability | – | 33 | |||||
Total current liabilities | 1,865 | 783 | |||||
Non-current liabilities | |||||||
Deferred tax liability | 10,564 | 28,445 | |||||
Deferred purchase price payable – Tarus | 7,179 | – | |||||
Deferred obligation - iOx milestone | 4,126 | – | |||||
Total non-current liabilities | 21,869 | 28,445 | |||||
Total liabilities | 23,734 | 29,228 | |||||
Shareholders’ Equity | |||||||
Capital stock | 218,782 | 158,324 | |||||
Stock option reserve | 21,204 | 16,928 | |||||
Accumulated other comprehensive (loss) income | (4,325 | ) | 958 | ||||
Accumulated deficit | (159,616 | ) | (55,005 | ) | |||
Total equity attributable to owners of the Company | 76,045 | 121,205 | |||||
Non-controlling interest | (650 | ) | 44,229 | ||||
Total equity | 75,395 | 165,434 | |||||
Total liabilities and equity | $ | 99,129 | $ | 194,662 | |||
Commitments and Contingent Liabilities |
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