Portage Biotech Reports Results for Fiscal Quarter Ended December 31, 2023, and Business Update
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Insights
The financial results released by Portage Biotech Inc. indicate the company's performance for the last quarter, which is a critical indicator of its operational health and strategic direction. The progress in their clinical trials, specifically the ADPORT-201 Phase 1a/1b, is of particular interest to investors as clinical milestones can significantly affect a biotech company's valuation. The advancement to the third cohort in dose escalation is a positive sign, suggesting that the earlier stages met safety and protocol criteria. However, the costs associated with these trials are substantial and the burn rate during this stage could impact the company's financial reserves. Investors would benefit from understanding the potential market size for these therapies and the competitive landscape, which could influence the stock's performance in anticipation of trial outcomes.
From an oncological perspective, the development of adenosine 2A and 2B inhibitors, such as PORT-6 and PORT-7, represents a promising area of research in immuno-oncology. Adenosine signaling is known to play a role in tumor immune evasion and its inhibition could enhance anti-tumor immune responses. The fact that these trials are being conducted at academic centers adds a level of credibility and expertise to the research. The selection of solid tumors as targets for these trials suggests a broad potential application, which could be transformative if successful. However, it is essential to note that Phase 1 trials primarily assess safety and efficacy is typically more rigorously evaluated in later phases. The long-term impact on patients and the healthcare system will depend on the demonstration of clear clinical benefits in subsequent trials.
When analyzing the implications of Portage's update on the stock market, it's important to consider the biotech sector's sensitivity to clinical trial updates. Positive trial results can lead to stock surges, while setbacks can have the opposite effect. The anticipation of clinical updates at major conferences like ASCO and SITC can create speculative interest in the stock. Additionally, the involvement of multiple academic centers in the trial not only diversifies the risk but also potentially accelerates patient enrollment, which is a critical factor in the timely completion of clinical studies. The market will be watching closely for the final data from the Phase 1a portion of ADPORT-601, as it will provide a more concrete basis for evaluating the drug's potential efficacy and marketability.
Company focused on adenosine platform clinical development
WESTPORT, Conn., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Portage Biotech Inc. (NASDAQ: PRTG) (“Portage” or the “Company”), a clinical-stage immuno-oncology company advancing novel multi-targeted therapies for use as monotherapy and in combination, today reported financial results for the fiscal quarter ended December 31, 2023.
“The Company is focused on advancing its ADPORT-201 Phase 1a/1b clinical trial of PORT-6 (adenosine 2A inhibitor) and PORT-7 (adenosine 2B inhibitor) in selected solid tumors. The trial is progressing well with eight academic center clinical sites enrolling patients. The Phase 1a dose escalation portion of the trial has progressed to the third cohort. The Company looks forward to making a clinical update at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and presenting final data from the Phase 1a portion of ADPORT-601 (PORT-6) at the 2024 Society for Immunotherapy of Cancer (SITC) Annual Meeting later this year,” said Dr. Ian Walters, Chief Executive Officer and Chairman of Portage. “We are excited about future development with these candidates, including combining our potential best-in-class adenosine 2A and adenosine 2B inhibitors at the optimum biologic doses in a biomarker enriched population and collaborating with Merck to study combinations with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy,” continued Dr. Walters.
Pipeline Updates
- Following the Trial Safety Committee recommendation, the Company commenced the third dose escalation cohort for PORT-6 Phase 1a portion of the ADPORT-601 trial.
- After a review of its funding requirements, the Company’s Board of Directors made the difficult decision to pause further drug development in the PORT-2 iNKT program. As a result, the Company will evaluate a range of potential strategic options which may include, among other things, finding a partner for the Company’s iNKT program or other restructuring transaction.
Upcoming Clinical Milestones
- The Company looks forward to presenting interim and final data from Phase 1a portion of ADPORT-601 (PORT-6) at ASCO in June and SITC in November, respectively.
Financial Results from Quarter Ended December 31, 2023
The Company incurred a net loss of approximately
Operating expenses for the Fiscal 2024 Quarter, which include research and development (“R&D”) costs and general and administrative (“G&A”) expenses, were
R&D costs increased slightly by approximately
G&A expenses decreased by approximately
The Company’s other pre-tax items of income and expense were substantially non-cash in nature and aggregated to approximately
The Company recognized a non-cash net deferred income tax benefit of
Finally, other comprehensive income (loss) in the Fiscal 2024 Quarter of
As of December 31, 2023, the Company had cash and cash equivalents of approximately
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. The Company is focused on advancing its potentially best-in-class adenosine antagonists in the ADPORT-601 trial of PORT-6 (adenosine 2A inhibitor) and PORT-7 (adenosine 2B inhibitor). 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
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are forward-looking statements. Words such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, though not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include statements concerning, among other things, the Company’s plans to evaluate a range of potential strategic options which may include, among other things, finding a partner for the Company’s iNKT program or other corporate transactions. As a result, forward-looking statements are subject to certain risks and uncertainties, including, but not limited to: the Company’s plans and ability to develop and commercialize its product candidates and the timing of its 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 need for financing and its estimates regarding its capital requirements and future revenues and profitability; the Company’s estimates of the size of the potential markets for its product candidates; the Company’s 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 press 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:
ir@portagebiotech.com
Media Relations:
media@portagebiotech.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)
| Three Months Ended December 31, | Nine Months Ended December 31, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Expenses | ||||||||||||||||
| Research and development | $ | 2,771 | $ | 2,535 | $ | 10,636 | $ | 5,976 | ||||||||
| General and administrative expenses | 1,254 | 2,224 | 4,316 | 6,523 | ||||||||||||
| Loss from operations | (4,025 | ) | (4,759 | ) | (14,952 | ) | (12,499 | ) | ||||||||
| Change in fair value of deferred purchase price payable - Tarus and deferred obligation - iOx milestone | 5,200 | (498 | ) | 3,976 | (428 | ) | ||||||||||
| Loss on Registered Direct Offering | (2,432 | ) | – | (2,432 | ) | – | ||||||||||
| Offering costs | (662 | ) | – | (662 | ) | – | ||||||||||
| Change in fair value of warrant liability | 989 | 8 | 989 | 33 | ||||||||||||
| Impairment loss - iOx IPR&D | (46,922 | ) | – | (46,922 | ) | – | ||||||||||
| Impairment loss - Stimunity | (557 | ) | – | (557 | ) | – | ||||||||||
| Commitment fee under Committed Purchase Agreement | (389 | ) | – | (389 | ) | – | ||||||||||
| Share of loss in associate accounted for using equity method | (136 | ) | (152 | ) | (226 | ) | (268 | ) | ||||||||
| Depreciation expense | (15 | ) | (1 | ) | (41 | ) | (1 | ) | ||||||||
| Foreign exchange transaction gain (loss) | 8 | 50 | 9 | (60 | ) | |||||||||||
| Interest income | 75 | 50 | 214 | 115 | ||||||||||||
| Interest expense | (9 | ) | – | (25 | ) | (9 | ) | |||||||||
| Loss before benefit (expense) for income taxes | (48,875 | ) | (5,302 | ) | (61,018 | ) | (13,117 | ) | ||||||||
| Income tax benefit (expense) | 9,497 | (2,199 | ) | 10,549 | 2,906 | |||||||||||
| Net loss | (39,378 | ) | (7,501 | ) | (50,469 | ) | (10,211 | ) | ||||||||
| Other comprehensive income (loss) | ||||||||||||||||
| Net unrealized gain (loss) on investments | 2,975 | (4,017 | ) | 3,444 | (4,017 | ) | ||||||||||
| Total comprehensive loss for period | $ | (36,403 | ) | $ | (11,518 | ) | $ | (47,025 | ) | $ | (14,228 | ) | ||||
| Net loss attributable to: | ||||||||||||||||
| Owners of the Company | $ | (39,373 | ) | $ | (7,485 | ) | $ | (50,450 | ) | $ | (10,163 | ) | ||||
| Non-controlling interest | (5 | ) | (16 | ) | (19 | ) | (48 | ) | ||||||||
| Net loss | $ | (39,378 | ) | $ | (7,501 | ) | $ | (50,469 | ) | $ | (10,211 | ) | ||||
| Comprehensive loss attributable to: | ||||||||||||||||
| Owners of the Company | $ | (36,398 | ) | $ | (11,502 | ) | $ | (47,006 | ) | $ | (14,180 | ) | ||||
| Non-controlling interest | (5 | ) | (16 | ) | (19 | ) | (48 | ) | ||||||||
| Total comprehensive loss for period | $ | (36,403 | ) | $ | (11,518 | ) | $ | (47,025 | ) | $ | (14,228 | ) | ||||
| Loss per share | ||||||||||||||||
| Basic and diluted | $ | (1.88 | ) | $ | (0.44 | ) | $ | (2.68 | ) | $ | (0.65 | ) | ||||
| Weighted average shares outstanding | ||||||||||||||||
| Basic and diluted | 20,897 | 17,039 | 18,804 | 15,719 | ||||||||||||
Portage Biotech Inc.
Condensed Consolidated Interim Statements of Financial Position
(U.S. Dollars in thousands)
| December 31, 2023 | March 31, 2023 | |||||||
| (Audited) | ||||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 5,341 | $ | 10,545 | ||||
| Prepaid expenses and other receivables | 2,175 | 2,689 | ||||||
| Convertible note receivable | – | 442 | ||||||
| Total current assets | 7,516 | 13,676 | ||||||
| Non-current assets | ||||||||
| Investment in associate | 452 | 806 | ||||||
| Investment in public company | 5,544 | 2,087 | ||||||
| In-process research and development | 34,761 | 81,683 | ||||||
| Deferred commitment fee, net of amortization of | 450 | 839 | ||||||
| Right to use asset | 263 | – | ||||||
| Other assets, including equipment, net | 49 | 38 | ||||||
| Total non-current assets | 41,519 | 85,453 | ||||||
| Total assets | $ | 49,035 | $ | 99,129 | ||||
| Liabilities and Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable and accrued liabilities | $ | 2,658 | $ | 1,865 | ||||
| Lease liability - current, including interest | 50 | – | ||||||
| Total current liabilities | 2,708 | 1,865 | ||||||
| Non-current liabilities | ||||||||
| Lease liability - non-current | 225 | – | ||||||
| Warrant liabilities | 7,443 | – | ||||||
| Deferred tax liability | – | 10,564 | ||||||
| Deferred purchase price payable - Tarus | 7,329 | 7,179 | ||||||
| Deferred obligation - iOx milestone | – | 4,126 | ||||||
| Total non-current liabilities | 14,997 | 21,869 | ||||||
| Total liabilities | 17,705 | 23,734 | ||||||
| Shareholders’ Equity | ||||||||
| Capital stock | 219,494 | 218,782 | ||||||
| Stock option reserve | 23,452 | 21,204 | ||||||
| Accumulated other comprehensive loss | (881 | ) | (4,325 | ) | ||||
| Accumulated deficit | (210,066 | ) | (159,616 | ) | ||||
| Total equity attributable to owners of the Company | 31,999 | 76,045 | ||||||
| Non-controlling interest | (669 | ) | (650 | ) | ||||
| Total equity | 31,330 | 75,395 | ||||||
| Total liabilities and equity | $ | 49,035 | $ | 99,129 | ||||
| Commitments and Contingent Liabilities | ||||||||
FAQ
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