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Portage Biotech Reports Fiscal Year-Ended March 31, 2023 Financial Results and Business Update

On August 1, 2023 Portage Biotech Inc. (NASDAQ: PRTG), a clinical-stage immuno-oncology company advancing novel multi-targeted therapies for use as monotherapy and in combination, reported financial results for the fiscal year ended March 31, 2023 (Press release, Portage Biotech, JUL 31, 2023, View Source [SID1234633594]).

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"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 (Free ASCO Whitepaper) 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 $104.7 million and other comprehensive loss of approximately $109.9 million during the year ended March 31, 2023 ("Fiscal 2023"), which includes approximately $88.0 million of net non-cash expenses compared to a net loss and comprehensive loss of approximately $19.2 million during the year ended March 31, 2022 ("Fiscal 2022"), an increase in net loss of $85.5 million and an increase in other comprehensive loss of $90.7 million, year-over-year. The increase was primarily due to non-cash losses on impairment relating to the Company’s identifiable intangible assets, goodwill, and certain investments and convertible note receivable.

Operating expenses, which include research and development ("R&D") costs and general and administrative ("G&A") expenses, were $16.6 million in Fiscal 2023, compared to $15.6 million in Fiscal 2022, an increase of $1.0 million due primarily to the addition and start of the PORT-6 clinical trial and the iNKT clinical trial for PORT-2, which is discussed more fully below.

R&D costs increased by approximately $1.4 million, or approximately 21%, from approximately $6.8 million in Fiscal 2022, to approximately $8.2 million in Fiscal 2023. The increase was primarily attributable to the start-up and manufacturing costs associated with the adenosine assets (PORT-6 and PORT-7) acquired in the Tarus acquisition of $1.9 million and the clinical trial costs of $1.5 million associated with the iNKT clinical trial for PORT-2. There were no such costs incurred in Fiscal 2022. Additionally, the Company incurred additional R&D service costs totaling $0.4 million in Fiscal 2023. These increases were partially offset by a reduction in non-cash share-based compensation expense of $2.4 million with respect to stock options to purchase ordinary shares granted to employees, which was attributable to (a) the vesting over time of a portion of prior year grants; and (b) the decrease in the fair value of grants of stock options made in Fiscal 2023, as well as the timing of the grants.

G&A expenses decreased by approximately $0.4 million, or approximately 5%, from approximately $8.8 million in Fiscal 2022, to approximately $8.4 million in Fiscal 2023. Professional fees increased by $1.3 million, of which $0.8 million was attributable to legal fees associated with the Tarus acquisition and $0.5 million was attributable to audit and accounting related expenses and filing fees in Fiscal 2023 associated with the updating of public filings, as well as costs associated with the Tarus acquisition review and to the iOx purchase of the then existing non-controlling interest. Payroll-related and board expenses increased by $1.1 million due to the adoption of a compensation program in Fiscal 2023 designed to attract and retain management and board members, which was partially offset by a decrease in non-cash share-based compensation expense of $2.4 million attributable to the vesting of certain stock options granted in prior years and lower fair value associated with more recent grants and the decrease of $0.4 million associated with D&O insurance, which was attributable to a decrease in the D&O premium market year-over-year.

The Company’s other items of income and expense were substantially non-cash in nature and aggregated approximately $105.9 million net expense in Fiscal 2023, compared to approximately $0.8 million net income in Fiscal 2022. The primary reason for the year-over-year difference in other items of income and expense were the non-cash losses on impairment relating to the carrying value of in-process research and development ("IPR&D") for iOx and Tarus of $59.320 million and $4.585 million, respectively, the impairment of goodwill totaling $43.862 million, and the loss on impairment relating to our investment in Stimunity and the Stimunity convertible note of $0.607 million and $0.211 million, respectively. The impairment analysis was undertaken as a result of indications of impairment from the overall life sciences market and our market capitalization. We considered a number of factors relating to the fair value analysis of the assets as of March 31, 2023, including the cost of capital, discount rates, and the impact of timing delays of obtaining data. These losses were slightly offset by non-cash gains from the change (decrease) in fair value of the deferred purchase price payable to the former Tarus shareholders and the deferred obligation – iOx milestone totaling $2.711 million and net interest income, net from investments in short-term investments in Fiscal 2023.

Additionally, the Company recognized a non-cash net deferred income tax benefit of $17.9 million in Fiscal 2023, compared to the prior year, primarily attributable to the tax effect of the non-cash loss on impairment on the IPR&D in iOx , as well as changes related to the future U.K. tax rates and the effect of the change in exchange rates on the liability settleable in British pound sterling.

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 $2.087 million, as compared to its original carrying value of $7.409 million, resulting in a non-cash unrealized loss in value in Intensity of $5.322 million recorded as other comprehensive income (loss) in Fiscal 2023.

As of March 31, 2023, the Company had cash and cash equivalents of approximately $10.5 million and total current liabilities of approximately $1.9 million.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. LLC., Rahway, N.J., USA.

Adicet Bio Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

On July 31, 2023 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, reported that it has granted inducement awards on July 31, 2023 (Press release, Renovorx, JUL 31, 2023, View Source [SID1234633561]).

Four individuals were hired by Adicet in July 2023. In the aggregate, Adicet granted new hires non-qualified stock options to purchase 73,400 shares of Adicet’s common stock with an exercise price of $2.67 per share, the closing price of Adicet’s common stock as reported by Nasdaq on July 31, 2023. One-fourth of the shares underlying each employee’s option will vest on the one-year anniversary of each recipient’s start date and thereafter the remaining three-fourths of the shares underlying each employee’s option will vest in thirty-six substantially equal monthly installments, such that the shares underlying the option granted to each employee will be fully vested on the fourth anniversary of the recipient’s start date, in each case, subject to each such employee’s continued employment with Adicet on such vesting dates.

All of the above-described awards were granted outside of Adicet’s stockholder-approved equity incentive plans pursuant to Adicet’s 2022 Inducement Plan (the Inducement Plan), which was adopted by the board of directors in January 2022 and subsequently amended in January 2023. The awards were authorized by the compensation committee of the board of directors, which is comprised solely of independent directors, as a material inducement to the employees entering into employment with Adicet in accordance with Nasdaq Listing Rule 5635(c)(4).

Natera Files Patent Infringement Suit Against NeoGenomics

On July 31, 2023 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported that it has filed a lawsuit in the North Carolina Federal District Court against NeoGenomics Labs, Inc. ("NeoGenomics") for infringement of Natera’s U.S. Patent Nos. 11,519,035 and 11,530,454 by NeoGenomics’ RaDaR molecular residual disease assay (Press release, NeoGenomics Laboratories, JUL 31, 2023, View Source [SID1234633560]).

This lawsuit builds on Natera’s current patent infringement lawsuit in the United States District Court for the District of Delaware related to RaDaR tests sold by Inivata, an affiliate of NeoGenomics. The company’s filing of this new suit follows a recent jury verdict in favor of Natera in the U.S. District Court for the District of Delaware in the patent infringement suit it filed against ArcherDX/Invitae Corp.

About Signatera

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. Signatera is intended to detect and quantify cancer left in the body, at levels down to a single tumor molecule in a tube of blood, to identify recurrence earlier and to help optimize treatment decisions.

J INTS BIO, Novel Oral 4th Generation EGFR TKI ‘JIN-A02’ – Dosing of First Patient in the Global Multi-center Phase 1/2 Clinical Study began

On July 31, 2023 J INTS BIO reported the successful dosing of the first patient in its global multi-center Phase 1/2 clinical study of ‘JIN-A02’ on 31st July at Severance Hospital, Seoul, Korea (Press release, J INTS BIO, JUL 31, 2023, View Source;dosing-of-first-patient-in-the-global-multi-center-phase-12-clinical-study-began-301888973.html [SID1234633559]).

More clinical sites will follow suit, including seven more hospitals in Korea (National Cancer Center, Chungbuk National University Hospital, Samsung Seoul Hospital, Seoul National University Hospital, Seoul St. Mary’s Hospital, St. Vincent Hospital, Asan Medical Center), two in the United States, and one in Thailand.

This global phase 1/2 clinical trial seeks to evaluate the safety, pharmacokinetics and anti-tumor activity of "JIN-A02" in advanced NSCLC patients carrying EGFR mutations.

‘JIN-A02’ is a novel orally administered 4th Generation EGFR TKI, which is highly selective for and strongly inhibits NSCLC with C797S double or triple mutations, showing efficacy even against intracranial tumors by exhibiting high blood-brain barrier penetrance.

Anna Jo, CEO of J INTS BIO, said, "We expect the positive results of ‘JIN-A02’ in the pre-clinical studies to translate to positive outcomes for patients in the clinical trial" adding that, "We hope also to proceed with the application for designation of orphan drug, and thereby quickly occupy the global NSCLC therapy market through conditional use."

Cleveland-based Biotech Celloram Inc. Strikes Landmark Licensing Deal with French Biotech GENFIT to Propel its lead asset CLM-022 in Liver Disease Treatment

On July 31, 2023 Celloram Inc., a dynamic biotech startup based in Cleveland, Ohio and developing novel medicines for cancer and immune disorders, reported a groundbreaking licensing agreement with French biotech GENFIT SA to advance Celloram’s first-in-class inflammasome inhibitor, CLM-022 (Press release, Celloram, JUL 31, 2023, View Source [SID1234633558]). The agreement grants GENFIT exclusive global rights to develop CLM-022 in liver disease indications.

"This exclusive licensing agreement with GENFIT aims to expand our inflammasome inhibitor platform into liver disease indications for the first time," said Tej Pareek, Ph.D., Celloram CEO. "We believe that GENFIT has the potential to rapidly advance the development of this class of inhibitors, ultimately bringing therapies and hope to a large population of patients who desperately need life-saving treatments. We are thrilled to work alongside GENFIT, a leading biopharmaceutical company, to bring this potential life-saving treatment to patients worldwide."

As part of this agreement, GENFIT will not only add to its arsenal of drug candidates for liver disease, but also gain access to Celloram’s scientists and medicinal chemistry expertise to help synthesize and validate CLM-022 as GENFIT advances on its goal to secure an IND for future clinical trials.

In recognition of this transformative collaboration, Celloram Inc. is eligible to receive up to €160 million in clinical, regulatory, and commercial milestone payments, which will further fuel its mission to deliver cutting-edge solutions for critical medical challenges. Celloram co-founders, Dr. John Letterio and Dr. Seong-Jin Kim, jointly stated, "Our vision at Celloram Inc. has always been driven by a passion for revolutionizing patient care by creating safer, more effective therapies. With this licensing agreement, we are one step closer to realizing Celloram’s vision and we are grateful for the opportunity to partner with GENFIT."

About Liver Disease

Liver disease is a progressive deterioration of liver functions lasting more than six months, involving synthesis of clotting factors, detoxification, and bile excretion. The process entails inflammation, destruction, and regeneration of liver parenchyma, often leading to fibrosis and cirrhosis. Etiologies are diverse, encompassing toxins, prolonged alcohol abuse, infections, autoimmune diseases, and genetic/metabolic disorders. The global liver disease treatment market size is predicted to be worth 25.8.3 billion USD by 2028 from 14.1 billion USD in 2023 to grow at a CAGR of 11.72% in forecasted period. Increasing cases of acute and chronic liver diseases, including liver cancer, are driving the demand for advanced liver disease diagnostics and treatments.