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.

RedHill Biopharma Increases Previously Announced Bought Deal to $35 Million of American Depositary Shares

On March 2, 2021 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that due to demand, the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 4,375,000 American Depositary Shares (ADSs) of the Company, at a price to the public of $8.00 per ADS, less underwriting discounts and commissions (Press release, RedHill Biopharma, MAR 2, 2021, View Source [SID1234575976]). Each ADS represents ten ordinary shares, par value NIS 0.01 per share, of the Company. The closing of the offering is expected to occur on or about March 4, 2021, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

In addition, the Company has granted to the underwriter a 30-day option to purchase up to additional 656,250 ADSs at the public offering price, less underwriting discounts and commissions.

The gross proceeds to RedHill, before deducting underwriting discounts and commissions and offering expenses and assuming no exercise of the underwriter’s option to purchase additional ADSs, are expected to be $35 million. The Company intends to use the net proceeds from this offering to fund its clinical development programs, commercialization activities and for acquisitions and general corporate purposes.

The securities described above are being offered by RedHill pursuant to a "shelf" registration statement on Form F-3 (File No. 333-232777) previously filed with the Securities and Exchange Commission (the "SEC") on July 24, 2019 and declared effective by the SEC on August 8, 2019. The offering of the securities is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the securities being offered have been filed with the SEC and are available on the SEC’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source A final prospectus supplement and the accompanying prospectus relating to the offering will be filed with the SEC and , upon filing, may be obtained on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Applied BioMath, LLC Announces Collaboration with Immunitas Therapeutics

On March 2, 2021 Applied BioMath (www.appliedbiomath.com), the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, reported their collaboration with Immunitas Therapeutics, Inc. (www.immunitastx.com) for the development of a systems pharmacology model for an oncology pathway with complex receptor-ligand dynamics (Press release, Applied BioMath, MAR 2, 2021, View Source [SID1234575975]). The model will be used to understand the importance of targeting multiple receptors simultaneously and will inform the optimal therapeutic modality. "Efficiently translating early research into a clinical candidate is a top priority at Immunitas," said Tarek Samad, CSO of Immunitas. "We look forward to leveraging Applied BioMath’s mathematical models to better understand the best path forward for this therapeutic program."

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Applied BioMath employs a rigorous fit-for-purpose model development process which quantitatively integrates knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms. Their approach employs proprietary algorithms and software that were designed specifically for systems pharmacology model development, simulation, and analysis. "Our proprietary software platforms and high-performance computing were designed to model biological systems and enable us to compare various dosing regimens more quickly than traditional approaches," said John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath. "This ability early on in therapeutic R&D is critical and we are excited to collaborate with Immunitas on this project."