Monopar Partners with Seasoned Medtech Executive to Explore the Potential of MNPR-101 as a uPAR Imaging Agent in Cancer Surgery

On March 2, 2021 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported it has entered into an agreement with serial medtech entrepreneur, Andrew Cittadine, to explore over the next few months strategic and developmental options for MNPR-101 as an intraoperative imaging agent in bladder cancer surgery as well as other cancers (Press release, Monopar Therapeutics, MAR 2, 2021, View Source [SID1234575996]).

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Mr. Cittadine is an experienced healthcare executive with a track record of building new businesses from concept through acquisition, including successful exits of Sensant Corp. to Siemens and American Biooptics to Olympus. Mr. Cittadine was the co-founder and Vice President of Marketing at Sensant Corp., and co-founder and CEO of American Biooptics. Sensant was an oncology imaging startup that developed 3D ultrasound imaging systems, and American Biooptics was a startup that developed an advanced oncology diagnostic test for gastrointestinal cancers. His most recent endeavors include serving as the CEO of Diagnostic Photonics, an imaging systems company for cancer surgeries.

"It is a strong fit," said Chandler Robinson, MD, Chief Executive Officer of Monopar, speaking to Mr. Cittadine’s expertise and the recent MNPR-101 bladder cancer imaging data published in a peer-reviewed article in the European Journal of Cancer.

"Mr. Cittadine’s extensive experience in the oncology diagnostics and surgical imaging space combined with his previous successes makes for an ideal collaboration on exploring the potential of MNPR-101," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar.

"The MNPR-101 based imaging agent has shown early promise in in vivo human bladder cancer models. I am excited to work with the Monopar team exploring ways to further the development of MNPR-101, be it through a spin-out, an out-licensing, a partnership, or developing it in-house," said Andrew Cittadine, MBA.

Myriad Genetics Joins Forces with Intermountain Precision Genomics for a Comprehensive Offering of Germline and Somatic Tumor Testing Services

On March 2, 2021 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported a new strategic precision oncology collaboration with Intermountain Precision Genomics, a service of Intermountain Healthcare (Press release, Myriad Genetics, MAR 2, 2021, View Source [SID1234575994]). This collaboration creates a comprehensive germline genetic testing and somatic tumor offering that combines Myriad’s advanced hereditary cancer and companion diagnostic tests with Intermountain Precision Genomics’ world-class laboratory services, utilizing the TheraMap test—powered by the TruSight Oncology 500 (TSO 500) next-generation sequencing test from Illumina, Inc. (NASDAQ: ILMN).

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TSO 500 is rapidly becoming a standard in oncology. Through the offering, oncologists will obtain a complete genetic analysis in one, easy-to-interpret report, enabling them to leverage the benefits of comprehensive genomic profiling.

"As cancer treatment continues to evolve, most oncologists seek both germline and somatic tumor testing results to best guide treatment decisions. Advancing precision oncology requires strong collaboration between forward-looking organizations across the healthcare ecosystem. This alliance with Intermountain Precision Genomics is an example of our drive to improve health outcomes for patients with cancer and expand innovative treatment options for the healthcare providers who care for them," said Paul J. Diaz, president and CEO, Myriad Genetics. "We are successfully merging the power of companion diagnostics, next-generation tumor sequencing, and world-class testing services to help raise the global standard of care in precision oncology."

"As a physician, I’m excited to make this comprehensive offering available to more patients," said Lincoln Nadauld, MD, PhD, oncologist and vice president and chief of precision health and academics at Intermountain Healthcare. "This partnership allows us to make a tremendous impact by providing the best that precision cancer care has to offer."

Strategic Partnership with Intermountain Precision Genomics
Intermountain Precision Genomics is a nationally recognized program focused on building partnerships to accelerate the field even further. The new, comprehensive offering – set to be available in the second half of 2021 – will utilize germline genetic testing with the Myriad myRisk Hereditary Cancer test, and somatic tumor profiling with Myriad myChoice CDx. Intermountain Precision Genomics will perform tumor profiling and tissue analysis using its TheraMap test that is powered by Illumina’s TSO 500 assay.

Myriad myChoice CDx is widely supported by private insurance payers. Both myChoice CDx and TheraMap are covered by Medicare.

About TheraMap
TheraMap: Solid Tumor is a hybrid capture DNA- and RNA-based test that detects SNV, INDELs, Copy Number Variants (CNV), and fusions in solid tumors. TheraMap is validated for all solid tumor types and includes sequencing over 500 genes identified as relevant to cancer treatment, relevant gene fusion events, including NTRK fusions, as well as the important microsatellite instability (MSI) and tumor mutational burden (TMB) biomarkers. TheraMap is powered by Illumina’s TSO 500 assay.

About Myriad myRisk Hereditary Cancer
The Myriad myRisk Hereditary Cancer test uses an extensive number of sophisticated technologies and proprietary algorithms to evaluate 35 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma. For more information, visit View Source

About myChoice CDx
Myriad myChoice is the most comprehensive HRD test, enabling physicians to identify patients with tumors that have lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. The myChoice test includes tumor sequencing of the BRCA1 and BRCA2 genes and a composite of three proprietary technologies (loss of heterozygosity, telomeric allelic imbalance, and large-scale state transitions). For more information, visit View Source

Ad hoc: MorphoSys AG preliminary results for the fiscal year 2020 exceeding guidance

On March 2, 2021 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported that according to the analysis of the preliminary results during the ongoing year end closing process, MorphoSys’ outlook has been exceeded (Press release, MorphoSys, MAR 2, 2021, View Source [SID1234575983]). Group revenues for 2020 are expected to amount to € 327.7 million and therefore slightly above the upper end of the guidance range from € 317 to 327 million. Group revenues include € 18.5 million (USD 22.0 million) revenues from product sales of Monjuvi as well as € 42.5 million for royalties on net sales of Tremfya. EBIT (Earnings before Interests and Taxes) for 2020 is expected to be € 27.4 million, and therefore significantly above the upper end of the guidance range of € 10 to 20 million. Expenses for research and development are expected to amount to € 141.4 million and therefore slightly above the guided range of € 130 to 140 million.

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All figures are preliminary. Full results will be published as planned on March 15, 2021.

Condensed Consolidated Interim Financial Statements For the Three and Six Months Ended September 30, 2020

On March 2, 2021 Portage Biotech Inc. reported Condensed Consolidated Interim Financial Statements (U.S. Dollars) (Unaudited – See Notice to Reader dated November 30, 2020) (Press release, Portage Biotech, MAR 2, 2021, View Source [SID1234575982])

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NOTE 1. NATURE OF OPERATIONS Portage Biotech Inc. (the "Company") is incorporated in the British Virgin Islands ("BVI") with its registered office located at FH Chambers, P.O. Box 4649, Road Town, Tortola, BVI. Its Toronto agent, Portage Services Ltd., is located at 6 Adelaide Street East, Suite 300, Toronto, Ontario, M5C 1H6, Canada. The Company is a reporting issuer with the Ontario Securities Commission on the Canadian Stock Exchange under the symbol PBT-U and U.S. Securities and Exchange Commission on the OTC market under the symbol PTGEF. The Company is engaged in the business of researching and developing pharmaceutical and biotechnology products through to clinical "proof of concept" with an initial focus on unmet clinical needs. Following proof of concept, the Company intends to seek to sell or license the products to large pharmaceutical companies for further development and commercialization.

On June 5, 2020, the Company effected a 100:1 reverse stock split. All share and per share information included in the condensed consolidated interim financial statements have been retroactively adjusted to reflect the impact of the reverse stock split. The shares of ordinary shares authorized remained at an unlimited number of ordinary shares without par value. The Company’s existing subsidiaries are in the pre-clinical stage, and as such no revenue has been generated from their operations. Liquidity and Capital Resources The Company has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the foreseeable future and may never become profitable. The losses result primarily from its conduct of research and development activities.

As of September 30, 2020, the Company had cash balances totaling approximately $4.4 million and working capital of approximately $0.025 million (approximately $4.3 million adjusted for accrued equity issuable and warrant liability settleable on a non-cash basis), as compared to approximately $3.2 million and approximately $1.2 million, respectively, as of March 31, 2020. On June 16, 2020, in a private placement, the Company issued 698,145 restricted ordinary shares for gross proceeds of $6.98 million. The Company incurred costs of approximately $0.25 million in connection with the offering, which were recorded as a reduction of the offering proceeds. The Company historically has funded its operations principally from proceeds from issuances of equity and debt securities. The Company will require significant additional capital to make the investments it needs to execute its longerterm business plan. The Company’s ability to successfully raise sufficient funds through the sale of debt or equity securities when needed is subject to many risks and uncertainties and, future equity issuances would result in dilution to existing stockholders and any future debt securities may contain covenants that limit the Company’s operations or ability to enter into certain transactions. The Company’s believes its current cash will be sufficient to fund operations for at least 12 months from the date of issuance of the financial statements contained herein. However, the Company believes it will need to raise additional funding through strategic relationships, public or private equity or debt financings, grants or other arrangements in order to advance the Company’s existing and new product candidates through development and regulatory processes. If such funding is not available or not available on terms acceptable to the Company, the Company’s current development plan and plans for expansion of its general and administrative infrastructure may be modified or even curtailed. F-5 Portage Biotech Inc. Notes to Condensed Consolidated Interim Financial Statements (U.S. Dollars) (Unaudited – See Notice to Reader dated November 30, 2020)

NOTE 1. NATURE OF OPERATIONS (Cont’d) COVID-19 Effect Beginning in early March 2020, the COVID-19 pandemic and the measures imposed to contain this pandemic have disrupted and are expected to continue to impact the Company’s business operations. The magnitude of the impact of the COVID-19 pandemic on the Company’s productivity, results of operations and financial position, and its disruption to the Company’s business and clinical programs and timelines, will depend, in part, on the length and severity of these restrictions and on the Company’s ability to conduct business in the ordinary course.

NOTE 2. BASIS OF PRESENTATION Statement of Compliance and Basis of Presentation These condensed consolidated interim financial statements have been prepared in accordance with the International Financial Reporting Standards ("IFRS") issued by the International Accounting Standards Board ("IASB"), IAS 34 Interim Financial Reporting and interpretations of the International Financial Reporting Interpretations Committee.

These condensed consolidated interim financial statements do not include all of the information required for full annual financial statements and should be read in conjunction with the audited consolidated financial statements of the Company for the year ended March 31, 2020. These condensed consolidated interim financial statements have been prepared on an historical cost basis except for items disclosed herein at fair value. In addition, these condensed consolidated interim financial statements have been prepared using the accrual basis of accounting, except for cash flow information.

The Company has only one material operating segment. These condensed consolidated interim financial statements were approved and authorized for issue by the Audit Committee and Board of Directors on November 30, 2020.

Consolidation The condensed consolidated interim financial statements include the accounts of the Company and,
(a) Portage Services Ltd., a wholly owned subsidiary incorporated in Ontario on January 31, 2011.
(b) Portage Pharmaceuticals Ltd. ("PPL") a wholly owned subsidiary acquired in a merger on July 23, 2013, incorporated in the British Virgin Islands.
(c) EyGen Limited, ("EyGen"), a wholly owned subsidiary of PPL, incorporated on September 20, 2016, in the British Virgin Islands.
(d) SalvaRx Limited ("SalvaRx"), a wholly owned subsidiary, incorporated on May 6, 2015 in the British Virgin Islands.
(e) Portage Glasgow Ltd ("PGL"), a 65% subsidiary of PPL, incorporated in Glasgow, Scotland.
(f) iOx Therapeutics Ltd ("iOx"), a United Kingdom based immune-oncology company, a 60.49% subsidiary, incorporated in the United Kingdom on February 10, 2015.
(g) Saugatuck, a 70% owned subsidiary incorporated in the British Virgin Islands. F-6 Portage Biotech Inc. Notes to Condensed Consolidated Interim Financial Statements (U.S. Dollars) (Unaudited – See Notice to Reader dated November 30, 2020)

NOTE 2. BASIS OF PRESENTATION (Cont’d) Consolidation (Cont’d)
(h) Portage Developmental Services, a 100% owned subsidiary incorporated in Delaware. All inter-company balances and transactions have been eliminated on consolidation. Non-controlling interest in the equity of a subsidiary is accounted for and reported as a component of stockholders’ equity. Non-controlling interests represent the 39.51% shareholder ownership interest in iOx and the 30% shareholder ownership interest in Saugatuck, and the 35% shareholder ownership interest in PGL, which are consolidated by the Company. Functional and Presentation Currency The Company’s functional and presentation currency is U.S. Dollar. Use of Estimates and Judgments The preparation of the condensed consolidated interim financial statements in conformity with IFRS requires management to make judgments, estimates and assumptions that affect the application of accounting policies and the reported amounts of assets, liabilities, income and expenses. Actual results may differ from these estimates. Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected. Significant areas where estimates are made include valuation of financial instruments, research and development costs, fair value used for acquisition and measurement of share-based compensation. Significant areas where critical judgments are applied include assessment of impairment of investments and goodwill and the determination of the accounting acquirer and acquiree in the business combination accounting. Reclassifications Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no effect on the reported results of operations.

NOTE 3. SIGNIFICANT ACCOUNTING POLICIES The accounting policies are set out in Note 3 to the fiscal 2020 audited consolidated financial statements. These policies have been applied consistently to all periods presented in these condensed consolidated interim financial statements. New accounting standards, interpretations and amendments Standards issued but not yet effective up to the date of issuance of the Company’s condensed consolidated interim financial statements are listed below. This listing is of standards and interpretations issued, which the Company reasonably expects to be applicable at a future date. The Company intends to adopt those standards when they become effective.

GEMoaB Announces Publication of Clinical Data From Ongoing Phase I Study of Their Lead Asset UniCAR-T-CD123 in Relapsed/Refractory AML in "Blood"

On March 2, 2021 GEMoaB, a biopharmaceutical company focused on the development of next-generation immunotherapies for hard-to-treat cancers, reported the publication of clinical data obtained from the ongoing Phase I study of their rapidly switchable UniCAR platform lead asset, UniCAR-T-CD123, in relapsed/refractory acute myeloid leukemia (rrAML), in the journal "Blood" (Press release, GEMoaB, MAR 2, 2021, View Source [SID1234575977]).

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The interim data of UniCAR-T-CD123 in rrAML, published online ahead of print as a letter in "Blood" (Wermke et al. 2021, View Source), demonstrate that UniCAR-T-CD123 in rrAML is well-tolerated with rapid recovery of hematopoiesis and encouraging early efficacy.

"The Blood publication nicely underpins the clinical advantages of our rapidly switchable UniCAR platform, which have also been recently presented at the 3rd EHA (Free EHA Whitepaper)-EBMT CART-Cell Meeting," said Prof. Dr. Gerhard Ehninger, Chief Medical Officer of GEMoaB. "We believe that the benefit-risk profile of UniCAR-T-CD123 obtained in rrAML promises to be highly differentiated, and while we are finishing up our Phase IA clinical study, we are looking forward to enter into the next phase of our clinical development program in this high unmet need indication."

Phase I studies of UniCAR-T-CD123 for the treatment of rrAML and UniCAR-T-PSMA directed against CRPC and other PSMA-expressing late-stage solid tumors are ongoing.

About the UniCAR-T-CD123 Phase IA Study

This first-in-human phase I study is an open-label, non-randomized, dose-finding study designed to evaluate the safety and activity of UniCAR-T-CD123 in up to 16 CD123 positive patients with relapsed/refractory AML. Its purpose is to determine the maximum tolerated dose (MTD) as well as Dose limiting toxicities (DLT) of the combined application of a single dose of UniCAR-T and the continuous infusion of TM123 over 25 days. Application follows post bridging therapy and lymphodepletion. The study also investigates response rates, response duration, persistence of UniCAR-T cells over time as well as the ability to rapidly switch UniCAR-T cells on and off through stopping TM infusion in case of side effects. The study takes place at selected Phase I, Acute Leukemia and CAR-T experienced University centers in Germany. The study is supported by a grant from the German Federal Ministry for Education and Research (project "TurbiCAR"). To learn more about the trial, please visit clinicaltrials.gov.

About UniCAR

GEMoaB is developing a rapidly switchable universal CAR-T platform, UniCAR, to improve the therapeutic window and increase efficacy and safety of CAR-T cell therapies in challenging cancers, including acute leukemias and solid tumors. Conventional CAR-T cells depend on the presence and direct binding of cancer antigens for activation and proliferation. An inherent key feature of the UniCAR platform is a rapidly switchable on/off mechanism (less than 4 hours after interruption of TM supply) enabled by the short pharmacokinetic half-life and fast internalization of soluble adaptors termed TMs. These TMs provide the antigen-specificity to activate UniCAR gene-modified T-cells (UniCAR-T) and consist of a highly flexible antigen-binding moiety, linked to a small peptide motif recognized by UniCAR-T.