Agios to Focus on Developing and Commercializing Innovative Treatments for Genetically Defined Diseases and Sell Its Oncology Business to Servier for Up to $2 Billion Plus Royalties

On December 21, 2020 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported that it will move forward with a singular focus on accelerating and expanding its genetically defined disease portfolio, including the mitapivat clinical programs and a robust pipeline of therapeutic candidates, and has entered into a definitive agreement to sell its commercial, clinical and research-stage oncology portfolio to Servier, an independent global pharmaceutical company (Press release, Agios Pharmaceuticals, DEC 21, 2020, View Source [SID1234573170]). Agios will receive a cash consideration of up to $2.0 billion, including $1.8 billion in upfront cash and $200 million in a potential future milestone payment for vorasidenib, as well as 5% royalties on U.S. net sales of TIBSOVO (ivosidenib tablets) from transaction close through loss of exclusivity and 15% royalties on U.S. net sales of vorasidenib from first commercial sale through loss of exclusivity.

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"Our decision to accelerate the next chapter of Agios’ success with a singular focus on genetically defined diseases and sell our oncology portfolio to Servier is a transformational milestone for Agios. The result of a deliberative strategic review, this decision reflects the progress we have made understanding and harnessing the science and promise of PK activation and captures the full value of our oncology assets," said Jackie Fouse, Ph.D., chief executive officer of Agios. "With mitapivat poised to become a new potential treatment option for patients with pyruvate kinase (PK) deficiency, thalassemia and sickle cell disease and with a rich pipeline based on our pioneering leadership in PK activation and cellular metabolism, Agios’ near- and long-term future is filled with significant value-generating catalysts. The proceeds from the transaction will allow us to focus on rapidly advancing our genetically defined disease portfolio for patients in need, strengthen our capital structure and return at least $1.2 billion to shareholders post-closing, achieve capital markets independence and participate in the future success of TIBSOVO and vorasidenib."

"We are proud of our heritage in oncology and the novel therapies we have advanced for patients with hematologic malignancies and solid tumors, and we are pleased to have found an excellent home for our oncology portfolio in Servier, a successful, patient-focused, global pharmaceutical company," continued Dr. Fouse. "Servier is committed to the oncology patient community and to investing in our assets and our people. This transaction will allow the oncology portfolio to grow and thrive with Servier and will provide Agios with the resources required to optimize the development of our promising genetically defined disease therapies, ultimately enabling the greatest overall positive impact for patients."

"The strategic acquisition of Agios’ oncology business, including its precision medicine portfolio and pipeline, is aligned with our ambition to become a recognized player in oncology and further supports our commitment to provide innovative treatments to cancer patients with unmet medical needs. It is a key step for the Servier Group as it will significantly strengthen our position in the U.S. and reinforce our R&D capabilities in oncology," stated Olivier Laureau, president of Servier. "We look forward to welcoming the experienced Agios oncology teams to Servier following the closing."

"Agios is a leader in the cellular metabolism space with a proven track record of discovering, developing and commercializing precision medicines," said David K. Lee, CEO, Servier Pharmaceuticals, the U.S. subsidiary of Servier. "The acquisition of Agios’ oncology business, including highly experienced talent from research, development, technical operations and commercial functions, allows for an immediate expansion of our U.S. business into other hematologic malignances and provides the potential for longer-term growth into the solid tumor space, thus ensuring that we can serve more patients living with unmet cancer needs than ever before."

Transaction Details
The transaction includes the transfer of Agios’ oncology portfolio and associated employees, including its marketed medicine TIBSOVO which is approved in the U.S. as monotherapy for the treatment of adults with IDH1-mutant relapsed or refractory acute myeloid leukemia (AML) and for adults with newly diagnosed IDH1-mutant AML who are ≥75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy. TIBSOVO is also under investigation in two Phase 3 combination trials in newly diagnosed AML, and as a potential treatment for previously treated IDH1-mutant cholangiocarcinoma and IDH1-mutant myelodysplastic syndrome (MDS). Servier will also acquire Agios’ co-commercialization responsibilities for Bristol Myers Squibb’s IDHIFA (enasidenib) and conduct certain clinical development activities within the IDHIFA development program.

In addition, the transaction includes Agios’ oncology pipeline and clinical programs, including vorasidenib, an investigational, brain-penetrant, dual inhibitor of mutant IDH1 and IDH2 which is currently being studied in the registration-enabling Phase 3 INDIGO study in patients with IDH-mutant low-grade glioma; AG-270, an investigational first-in-class methionine adenosyltransferase 2a (MAT2A) inhibitor being evaluated in combination with taxanes in patients with methylthioadenosine phosphorylase (MTAP)-deleted non-small cell lung cancer and pancreatic cancer; AG-636, a novel inhibitor of dihydroorotate dehydrogenase (DHODH); and Agios’ oncology research programs.

All of Agios’ U.S.-based employees who primarily support the oncology business will receive a comparable offer at Servier.

The transaction has been approved by the Board of Directors and is subject to approval by Agios shareholders and satisfaction of regulatory conditions. It is currently expected that the transaction will close in the second quarter of 2021.

Goldman Sachs & Co. LLC and Morgan Stanley & Co. LLC are serving as financial advisers to Agios, and Wachtell, Lipton, Rosen & Katz is serving as its legal adviser.

Agios’ Genetically Defined Disease Portfolio
Agios’ genetically defined disease portfolio is anchored by its lead clinical candidate, mitapivat, which the company believes is a potential blockbuster across three distinct hemolytic anemias. Agios is conducting two global, pivotal Phase 3 studies to evaluate mitapivat as a potential treatment for adults with pyruvate kinase (PK) deficiency; the company recently announced positive topline results from the ACTIVATE study and expects to report data from the ACTIVATE-T study in the first quarter of 2021. Agios anticipates filing for U.S. and EU regulatory approval in adults with PK deficiency in 2021, with a potential 2022 commercial launch in both geographies. Mitapivat is also being evaluated in a fully enrolled Phase 2 study in adults with non-transfusion-dependent α- or β-thalassemia, and as a potential treatment for sickle cell disease under a Cooperative Research and Development Agreement (CRADA) with the U.S. National Institutes of Health. In 2021, Agios expects to initiate global, pivotal Phase 3 studies in thalassemia, including both α-and β-thalassemia, as well as transfusion dependent and non-transfusion dependent patient populations, and in sickle cell disease. In addition, Agios intends to evaluate mitapivat in pediatric patients across all three diseases.

Beyond mitapivat, Agios is advancing a growing genetically defined disease pipeline based on its core expertise in cellular metabolism and pioneering leadership in PK activation. AG-946, a clinical-stage, next-generation oral activator of both wild-type and mutated pyruvate kinase R (PKR) enzymes, entered a first-in-human clinical study in the third quarter of 2020. Agios’ late-stage research pipeline is evolving to include a rich and sustainable portfolio of genetically defined disease targets with clear disease area applications. These include hereditary and acquired anemias, myopathies, retinal diseases and diseases of inborn errors of metabolism such as aminoacidurias, aminoacidemias and others. As the company’s research efforts continue to develop, Agios may pursue value-adding partnerships that may bring complementary expertise for certain disease areas.

Investor Webcast Information
Agios will host an investor webcast today at 8:00 a.m. ET to discuss today’s announcement. The event will be webcast live and can be accessed under "Events & Presentations" in the Investors section of Agios’ website at www.agios.com. The archived webcast will be available on Agios’ website beginning approximately two hours after the event.
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Helix BioPharma Corp. announces fiscal 2021 first quarter results

On December 21, 2020 Helix BioPharma Corp. (TSX: "HBP"), ("Helix" or the "Company"), a clinical-stage biopharmaceutical company developing unique therapies in the field of immuno-oncology based on its proprietary technological platform DOS47, reported its fiscal 2021 first quarter results for the period ending October 31, 2020 (Press release, Helix BioPharma, DEC 21, 2020, View Source [SID1234573193]).

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Helix BioPharma Corp. (the "Company"), incorporated under the Canada Business Corporations Act, is an immune-oncology company primarily focused in the areas of cancer prevention and treatment. The Company has funded its research and development activities, mainly through the issuance of common shares and warrants.

The Company expects to incur additional losses and therefore will require additional financial resources, on an ongoing basis. It is not possible to predict the outcome of future research and development activities or the financing thereof.

1. Basis of presentation and going concern These condensed unaudited interim financial statements have been prepared on a going-concern basis, which assumes that the Company will continue in operation for the foreseeable future and, accordingly, will be able to realize its assets and discharge its liabilities in the normal course of operations.

The Company’s ability to continue as a going concern is dependent mainly on obtaining additional financing. The Company does not have sufficient cash to meet anticipated cash needs for working capital and capital expenditures through the next twelve months. The Company reported a net loss and total comprehensive loss of $222,000 for the three-month period ended October 31, 2020 (October 31, 2019-$2,214,000).

As at October 31, 2020 the Company had working capital of $2,426,000, shareholders’ equity of $2,596,000 and a deficit of $180,738,000. As at July 31, 2020 the Company had working capital of $2,735,000, shareholders’ equity of $2,981,000, a deficit of $180,516,000. The Company will require additional financing in the immediate near term and in the future to see the current research and development initiatives through to completion. There can be no assurance however, that additional financing can be obtained in a timely manner, or at all. Not raising sufficient additional financing on a timely basis may result in delays and possible termination of all or some of the Company’s research and development initiatives, and as a result, may cast significant doubt as to the ability of the Company to operate as a going concern and accordingly, the appropriateness of the use of the accounting principles applicable to a going concern.

These condensed unaudited interim financial statements do not include any adjustments to the carrying amount and classification of reported assets, liabilities and expenses that might be necessary should the Company not be successful in its aforementioned initiatives. Any such adjustments could be material. The Company cannot predict whether it will be able to raise the necessary funds it needs to continue as a going concern.

Statement of compliance These condensed unaudited interim financial statements have been prepared in compliance with International Accounting Standard 34, Interim Financial Reporting ("IAS 34"). The notes presented in these condensed unaudited interim financial statements include only significant events and transactions occurring since the Company’s last fiscal year end and are not fully inclusive of all matters required to be disclosed in its annual audited consolidated financial statements. The policies applied in these condensed unaudited interim financial statements are based on International Financial Reporting Standards ("IFRS") as issued by the International Accounting Standards Board ("IASB").

The condensed unaudited interim financial statements of the Company were approved and authorized for issue by the Board of Directors on December 15, 2020. Use of estimates and critical judgments The preparation of the Company’s financial statements requires management to make critical judgments, estimates and assumptions that affect the reported amounts of expenses, assets and liabilities, and the disclosure of contingent liabilities, at the reporting date. On an ongoing basis, management evaluates its judgments, estimates and assumptions using historical experience and various other factors it believes to be reasonable under the given circumstances. Actual outcomes may differ from these estimates that could require a material adjustment to the reported carrying amounts in the future. The Company has also assessed the impact of COVID-19 on estimates and critical judgements. Although the Company expects COVID-19 related disruptions to continue into the Company’s fiscal 2021 year, the Company believes that the long-term estimates and assumptions do not require significant revisions. Although the Company determined that no significant revisions to such estimates, judgements or assumptions were required, the pandemic is fluid and given the inherent uncertainty at this time, revisions may be required in future periods to the extent that the negative impacts on the Company’s business operations arising from COVID-19 continue or become worse. Any such revision could result in a material impact on the Company’s financial performance and financial condition.

The Company has received no government assistance. The most significant critical estimates and judgments made by management include the following: a) Going Concern Significant judgments related to the Company’s ability to continue as a going concern are disclosed in the first paragraph above in Note 1. 6 HELIX BIOPHARMA CORP.

Notes to condensed unaudited interim financial statements For the three-month periods ended October 31, 2020 and 2019 Tabular dollar amounts in thousands of Canadian dollars, except per share amounts

b) Consolidation Control is achieved when the Company has the power to govern the financial and operating policies of an entity so as to obtain benefits from its activities. Subsidiaries are fully consolidated from the date on which control is acquired by the Company. Intercompany transactions and balances are eliminated upon consolidation. Subsidiaries are de-consolidated from the date that control by the Company ceases. Significant judgment is used in determining whether the Company has lost control of a subsidiary resulting in de-consolidating the subsidiary.

c) Clinical study expenses Clinical study expenses are accrued based on services received and efforts expanded pursuant to contracts with contract research organizations ("CROs"), consultants, clinical study sites and other vendors. In the normal course of business, the Company contracts with third parties to perform various clinical study activities. The financial terms of these agreements vary from contract to contract and are subject to negotiations that may result in uneven payment outflows. Payments under the contracts depend on various factors such as the achievement of certain events, the successful enrolment of patients or the completion of portions of the clinical study and/or other similar conditions.

The Company determines the accruals by reviewing contracts, vendor agreements and purchase orders, and through discussions with internal personnel and external providers as to the progress or stage of completion of the clinical studies or services and the agreed-upon fee to be paid for such services. However, actual costs and timing of the Company’s clinical studies is uncertain, subject to risk and may change depending upon a number of factors, including the Company’s clinical development plans and trial protocols.

d) Valuation of share-based compensation and warrants Management measures the costs for share-based compensation and warrants using market-based option valuation techniques. Assumptions are made and estimates are used in applying the valuation techniques. These include estimating the future volatility of the share price, expected dividend yield, future employee turnover rates, and future exercise behaviours. Such estimates and assumptions are inherently uncertain. Changes in these assumptions affect the fair value estimates of share-based payments and warrants.

e) Income taxes Deferred tax assets, including those arising from unutilized tax losses, require management to assess the likelihood that the Company will generate future taxable income in future years in order to utilize any deferred tax asset which has been recognized. Estimates of future taxable income are based on forecasted cash flows. At the current statement of financial position date, no deferred tax assets have been recognized in these financial statements.

f) Impairment of long-lived assets Long-lived assets are reviewed for impairment upon the occurrence of events or changes in circumstances indicating that the carrying value of the asset may not be recoverable. For the purpose of measuring recoverable amounts, assets are grouped at the lowest levels for which there are separately identifiable cash flows (cash-generating units).

The recoverable amount is the higher of an asset’s fair value less costs to sell and value in use (being the present value of the expected future cash flows of the relevant asset or cash-generating unit). An impairment loss is recognized for the amount by which the asset’s carrying amount exceeds its recoverable amount. Management evaluates impairment losses for potential reversals when events or circumstances warrant such consideration. Functional and presentation currency The functional and presentation currency of the Company is the Canadian dollar.

2. Significant accounting policies The accounting policies set out below have been applied consistently to all periods presented in these condensed unaudited interim financial statements. Basis of accounting for subsidiary The Company’s investment in Helix Immuno-Oncology S.A. ("HIO") was consolidated and classified as held for sale and was presented as discontinued operations at July 31, 2020. At September 3, 2020 HIO completed a direct financing with an arm’s length party. As a result of the financing the Company’s ownership in HIO was diluted down to 29.89% and as a result, the Company has determined that it has lost control of HIO. As the Company’s interest allows the Company to exert significant influence over HIO, the Company’s remaining interest is now accounted for as an interest in associate using the equity method. HIO was incorporated on July 6, 2013 in Poland.

At October 31, 2020, the Company’s ownership in HIO was diluted to 29.89%. 7 HELIX BIOPHARMA CORP. Notes to condensed unaudited interim financial statements For the three-month periods ended October 31, 2020 and 2019 Tabular dollar amounts in thousands of Canadian dollars, except per share amounts Cash The Company considers cash on hand, bank deposits in Canada and Poland and bank term deposits with maturities of 90 days or less as cash. Property, plant and equipment Property, plant and equipment are recorded at cost less accumulated depreciation. Impairment charges are included in accumulated depreciation. Leases The Company recognizes a right-of-use asset and a lease liability at the lease commencement date.

The right-of-use asset is initially measured at cost. Subsequent to initial application, the right-of-use asset is measured at cost less any accumulated depreciation and impairment losses, and adjusted for certain remeasurements of the lease liability. In comparison, the lease liability is increased by the interest cost on the lease liability and decreased by lease payments made.

It is remeasured when there is a change in future lease payments arising from a change in an index or rate, a change in the estimate of the amount expected to be payable under a residual value guarantee, or as appropriate, changes in the assessment of whether a purchase or extension option is reasonably certain to be exercised or a termination option is reasonably certain to be exercised or a termination option is reasonably certain not to be exercised. The Company has applied judgment to determine the lease term for some lease contracts in which it is a lessee that include renewal options. The assessment of whether the Company is reasonably certain to exercise such options impacts the lease term, which significantly affects the amount of lease liabilities and right-of-use assets recognized.

Research and development costs Research costs are expensed as incurred. Development costs are expensed as incurred except for those which meet the criteria for deferral, in which case, the costs are capitalized and amortized to operations over the estimated period of benefit. No costs have been deferred to date. Investment tax credits The Company is entitled to Canadian federal and provincial investment tax credits, which are earned as a percentage of eligible research and development expenditures incurred in each taxation year. Investment tax credits are accounted for as a reduction of the related expenditure for items of a current nature and a reduction of the related asset cost for items of a capital nature, provided that the Company has reasonable assurance that the tax credits will be realized. Stock-based compensation The Company accounts for stock-based compensation and other stock-based payments awarded to employees in accordance with the fair value method.

The fair value of stock options granted is determined at the appropriate measurement date using the Black-Scholes option pricing model, and generally expensed over the options’ vesting period for employee awards. Awards with graded vesting are considered multiple awards for fair value measurement and stock-based compensation calculation. In determining the expense, the Company accounts for forfeitures using an estimate based on historical trends. When stock-based compensation and other stock-based payments are awarded to persons other than non-employees, share capital is increased for the fair value of goods and services received. Foreign currency translation The Company’s currency of presentation is the Canadian dollar, which is also the Company’s functional currency. Foreign currency-denominated items are translated into Canadian dollars. Monetary assets and liabilities in foreign currencies are translated into Canadian dollars at the rates of exchange in effect at the balance sheet dates. Non-monetary items are translated at historical exchange rates. Revenue and expenses are translated at the exchange rates prevailing at their respective transaction dates. Exchange gains and losses arising on translation are included in income. Income taxes The Company follows the asset and liability method of accounting for income taxes. Under this method, deferred income tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement 8

HELIX BIOPHARMA CORP.

Notes to condensed unaudited interim financial statements For the three-month periods ended October 31, 2020 and 2019 Tabular dollar amounts in thousands of Canadian dollars, except per share amounts carrying amounts of certain existing assets and liabilities and their respective tax bases. Deferred income tax assets and liabilities are measured using enacted or substantively enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the date of substantive enactment. Given the Company’s history of net losses and expected future losses, the Company is of the opinion that it is probable that these tax assets will not be realized in the foreseeable future and therefore, the deferred tax asset has not been recognized. Financial instruments The Company’s financial assets and liabilities are initially recorded at fair value and subsequently measured based on their assigned classifications as follows.

The classification depends on the nature and purpose of the financial asset or liability and is determined at the time of initial recognition. De-recognition of financial assets and liabilities De-recognition is applied for all or part of a financial asset when the contractual rights to the cash flows and benefits from the financial asset expire, the Company loses controls of the assets, or the Company substantially transfers the significant risks and rewards of ownership of the asset. De-recognition is applied for all or part of a financial liability when the liability is extinguished due to cancellation or discharge or expiry of the obligation.

Impairment
(i) Financial assets: On an individual basis, material financial assets are assessed for indicators of impairment at the end of each reporting period. Other individually non-material financial assets are tested as a group of financial assets based on similar risk characteristic. Financial assets are considered to be impaired when based upon an expected loss model as prescribed by IFRS 9, taking into consideration both historic and forward-looking information. For financial assets carried at amortized cost, the amount of the impairment is the difference between the asset’s carrying amount and the present value of estimated future cash flows, discounted at the financial asset’s effective interest rate. Impairment losses are recognized in income and reflected in an allowance account against the respective financial asset.

(ii) Non-financial assets: The carrying amounts of the Company’s non-financial assets are reviewed at each reporting date to determine whether there is any indication of impairment. If such an indication exists, the recoverable amount is estimated. The recoverable amount of an asset or a cash-generating unit is the greater of its value in use and its fair value less costs to sell. In assessing value in use, the estimated future cash flows are discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the asset or cash-generating unit. For the purpose of impairment testing, assets that cannot be tested individually are grouped together into the smallest group of assets that generates cash inflows from continuing use that are largely independent of cash inflows of other assets or cash-generating units.

An impairment loss is recognized if the carrying amount of an asset or its related cash-generating unit exceeds its estimated recoverable amount. Impairment losses recognized in prior periods are assessed each reporting date for any indications that the loss has decreased or no longer exists. An impairment loss is reversed if there has been a change in the estimates used to determine the recoverable amount. An impairment loss is reversed only to the extent that the asset’s carrying amount does not exceed the carrying amount that would have been determined, net of depreciation, if no impairment loss had been recognized. Basic and diluted loss per common share Basic loss per share is computed by dividing the net loss available to common shareholders by the weighted average number of shares outstanding during the reporting period. Diluted loss per share is computed similarly to basic loss per share, except that the weighted average shares outstanding are increased to include additional shares for the assumed exercise of stock options and warrants, if dilutive. The number of additional shares is calculated by assuming that outstanding stock options and warrants were exercised and that the proceeds from such exercises were used to acquire common shares at the average market price

9 HELIX BIOPHARMA CORP.
Notes to condensed unaudited interim financial statements For the three-month periods ended October 31, 2020 and 2019 Tabular dollar amounts in thousands of Canadian dollars, except per share amounts during the reporting periods. The inclusion of the Company’s stock options and warrants in the computation of diluted loss per share has an anti-dilutive effect on the loss per share and, therefore, they have been excluded from the calculation of diluted loss per share. Government Grants and Disclosure of Government Assistance Government grant funds are recognised in income when there is reasonable assurance that the Company has complied with the conditions attached to them and that the grant funds will be received. Grant funds receivable are recognized in income over the periods in which the entity recognizes as expenses, the related costs for which the grant is intended to compensate.

3. New accounting standards and pronouncements not yet adopted There are no new accounting standards and pronouncements issued but not yet effective up to the date of issuance of the Company’s condensed unaudited interim financial statements that are expected to have a material impact on the Company.

4. Property, plant and equipment5. Right-of-use assets The movement and carrying amounts of the Company’s right-of-use assets and lease liabilities for the three-month periods ended: 6. Shareholders’ equity Preferred shares Authorized 10,000,000 preferred shares. As at October 31, 2020 and July 31, 2020 the Company had nil preferred shares issued and outstanding.

Common shares and share purchase warrants Authorized unlimited common shares without par value. As at October 31, 2020 the Company had 132,933,017 (July 31, 2020 – 132,933,017) common shares issued and outstanding. On August 21, 2019, the Company completed a private placement financing of 13,725,500 units of the Company at a price of $0.51 per unit and the disposition of a 25% stake of its Polish subsidiary, for aggregate gross proceeds of approximately $7,000,000. Each unit consisted of one common share and one common share purchase warrant. Each common share purchase warrant entitles the holder to purchase one common share of the Company at a price of $0.72 until August 20, 2024. Of the aggregate gross proceeds, approximately $755,000 was allocated to the disposition of the Company’s 25% stake in its Polish subsidiary with costs totalling approximately $99,000. Of the residual gross proceeds amount of $6,245,000, approximately $2,275,000 was allocated to the share purchase warrants based on fair value and approximately $3,970,000 was allocated to thecommon shares.

Share issue costs totalling $815,000 were proportionately allocated to the share purchase warrants ($297,000) and the common shares ($518,000), respectively. On January 13, 2020, the Company completed a private placement financing of 2,940,000 units of the Company at a price of $1.02 per unit and the disposition of an 8.5% stake of its Polish subsidiary, for aggregate gross proceeds of approximately $2,999,000. Each unit consisted of one common share and one common share purchase warrant.

Each common share purchase warrant entitles the holder to purchase one common share of the Company at a price of $1.42 until January 12, 2025. Of the aggregate gross proceeds, approximately $433,000 was allocated to the disposition of the Company’s 8.5% stake in its Polish subsidiary with costs totalling approximately $57,000. Of the residual gross proceeds amount of $2,566,000, approximately $956,000 was allocated to the share purchase warrants based on fair value and approximately $1,610,000 was allocated to the common shares. Share issue costs totalling approximately $339,000 were proportionately allocated to the share purchase warrants ($126,000) and the common shares ($213,000), respectively.

On March 12, 2020, the Company completed a private placement financing of 5,042,016 units of the Company at a price of $1.19 per unit including the disposition of a 15.5% stake of its Polish subsidiary, for aggregate gross proceeds of approximately $6,000,000. Each unit consisted of one common share and one common share purchase warrant. Each common share purchase warrant entitles the holder to purchase one common share of the Company at a price of $1.67 until March 11, 2025. Of the aggregate gross proceeds, approximately $791,000 was allocated to the disposition of the Company’s 15.5% stake in its Polish subsidiary with costs totalling approximately $103,000. Of the residual gross proceeds amount of $5,209,000, approximately $1,900,000 was allocated to the share purchase warrants based on fair value and approximately $3,310,000 was allocated to the common shares. Share issue costs totalling approximately $682,000 were proportionately allocated to the share purchase warrants ($249,000) and the common shares ($433,000), respectively.During the three-month perioded ended October 31, 2020, a total of 4,546,000 warrants expired unexercised.

Stock options The Company’s equity compensation plan reserves up to 10% of the Company’s outstanding common shares from time to time for granting to directors, officers and employees of the Company or any person or company engaged to provide ongoing management or consulting services. Based on the Company’s current issued and outstanding common shares as at October 31, 2020, options to purchase up to 13,293,301 common shares (July 31, 2020 – 13,293,301) may be granted under the plan. As at October 31, 2020, options to purchase a total of 7,275,000 common shares (July 31, 2020 – 5,225,000) were issued and outstanding under the equity compensation plan.Weighted average market share prices for stock options exercised during the three-month periods ended October 31, 2020 and 2019 were both $nil, respectively.

For the three-month period ended October 31, 2020, 1,075,000 stock options vested (October 31, 2019 – nil) with a fair value of $327,000 (October 31, 2019 – $nil)7. Commitments, contingent liabilities and contingent assets 8. Capital risk managementSince inception, the Company has financed its operations from public and private sales of equity, the exercise of warrants and stock options, and, to a lesser extent, from interest income from funds available for investment, government grants and investment tax credits. Since the Company does not have net earnings from its operations, the Company’s long-term liquidity depends on its ability to access capital markets, which depends substantially on the success of the Company’s ongoing research and development programs, as well as capital market conditions and availability.

The Company does not currently have enough cash reserves to fully fund its clinical trials nor does the Company have sufficient cash reserves to meet anticipated cash needs for working capital and capital expenditures through at least the next twelve months. The Company does not have any credit facilities and is therefore not subject to any externally imposed capital requirements or covenants. See also Note 1-Basis of presentation and going concern.

9. Financial instruments and risk management Fair value hierarchy Financial instruments recorded at fair value on the balance sheet are classified using a fair value hierarchy that reflects the significance of the inputs used in making the measurements.

The fair value hierarchy has the following levels:

a. Level 1 reflects valuation based on quoted prices observed in active markets for identical assets or liabilities;
b. Level 2 reflects valuation techniques based on inputs that are quoted prices of similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; inputs other than quoted prices used in a valuation model that are observable for that instrument; and inputs that are derived principally from or corroborated by observable market data by correlation or other means; and c. Level 3 reflects valuation techniques with significant unobservable market inputs.

A financial instrument is classified to the lowest level of the hierarchy for which a significant input has been considered in measuring fair value. Fair value The fair value of financial instruments as at October 31, 2020 and July 31, 2020 approximates their carrying value because of the near-term maturity of these instruments.

Financial risk management The Company is exposed to a variety of financial risks by virtue of its activities: market risk (including currency and interest rate risk), credit risk and liquidity risk. The overall risk management program focuses on the unpredictability of financial markets and seeks to minimize potential adverse effects on financial performance. Risk management (the identification and evaluation of financial risk) is carried out by the finance department, in close cooperation with management. The finance department is charged with the responsibility of establishing controls and procedures to ensure that financial risks are mitigated in accordance with the approved policies.

The Company’s Board of Directors has the overall responsibility for the oversight of these risks and reviews the Company’s policies on an ongoing basis to ensure that these risks are appropriately managed. Market risk Market risk is the risk that changes in market prices, such as interest rates and foreign exchange rates, will affect the Company’s income or the value of its financial instruments. Currency risk The Company has international transactions and is exposed to foreign exchange risks from various currencies, primarily the Euro and U.S. dollar.

In addition, foreign exchange risks arise from purchase transactions, as well as recognized financial assets and liabilities denominated in foreign currencies.Any fluctuation in the exchange rates of the foreign currencies listed above could have an impact on the Company’s results from operations; however, they would not impair or enhance the ability of the Company to pay its foreign-denominated expenses. Interest rate risk Interest rate risk is the risk that future cash flows of a financial instrument will fluctuate because of changes in interest rates, which are affected by market conditions. The Company is exposed to interest rate risk arising from fluctuations in interest rates received on its cash and cash equivalents.

The Company does not have any credit facilities and is therefore not subject to any debt related interest rate risk. The Company manages its interest rate risk by maximizing the interest income earned on excess funds while maintaining the liquidity necessary to conduct its operations on a day-to-day basis. Any investment of excess funds is limited to risk-free financial instruments. Fluctuations in the market rates of interest do not have a significant impact on the Company’s results of operations due to the relatively short-term maturity of any investments held by the Company at any given point in time and the low global interest rate environment.

The Company does not use derivative instruments to reduce its exposure to interest rate risk. Credit risk Credit risk is the risk of a financial loss to the Company if a customer or counterparty to a financial instrument fails to meet its contractual obligation.Liquidity risk Liquidity risk is the risk that the Company will not be able to meet its obligations as they come due. Since inception, the Company has mainly relied on financing its operations from public and private sales of equity.

The Company does not have any credit facilities and is therefore not subject to any externally imposed capital requirements or covenants. The Company manages its liquidity risk by continuously monitoring forecasts and actual cash flow from operations and anticipated investing and financing activities. The Company’s cash reserves as at October 31, 2020 are insufficient to meet anticipated cash needs for working capital and capital expenditures through the next twelve months, nor are they sufficient to see the current research and development initiates through to completion. To the extent that the Company does not believe it has sufficient liquidity to meet its current obligations, management considers securing additional funds primarily through equity arrangements to be of utmost importance.

The Company’s long-term liquidity depends on its ability to access the capital markets, which depends substantially on the success of the Company’s ongoing research and development programs, as well as economic conditions relating to the state of the capital markets generally. Accessing the capital markets is particularly challenging for companies that operate in the biotechnology industry

10. Related party transactions

11. Research and development projects Included in research and development expenditures are costs directly attributable to the various research and development functions and initiatives the Company has underway and include: salaries; bonuses; benefits; stock-based compensation; depreciation of property, plant and equipment; patent costs; consulting services; third party contract manufacturing, third party clinical research organization services; and all overhead costs associated with the Company’s research facilities.

12. Operating, General and Administration13. Deconsolidation of subsidiary held for sale The Company’s investment in HIO was classified as held for sale and was presented as discontinued operations at July 31, 2020.

At September 3, 2020 HIO completed a direct financing with an arm’s length party. As a result of the financing the Company’s ownership in HIO was diluted down to 29.89% and as a result, the Company has determined that it has lost control of HIO. As the Company’s interest allows the Company to exert significant influence over HIO, the Company’s remaining interest is now accounted for as an interest in associate using the equity method. The Company’s remaining interest in HIO was recognized at its fair value as at September 3, 2020 based on the post financing valuation.

The difference between the carrying value of the net assets of HIO and non-controlling interest and the value assigned to the shares of $2,231,000 was recognized as a gain on loss of control of subsidiary14. Subsequent events On November 9, 2020, the Company announced that it has signed a definitive share purchase agreement with CAIAC Fund Management AG ("CAIAC") to purchase the Company’s remaining 29.89% holdings in HIO, for gross proceeds of PLN 6,700,000 (CAD$2,308,000). The funds were wired by CAIAC on November 13, 2020.

Closing of the transaction is to occur upon finalizing administrative reporting requirements and evidence of share registry changes in Poland. COVID-19 has had an impact on closing the transaction. Upon closing of the transaction, the Company is committed to paying ACMest a transaction fee equal to 12.5% of the gross proceeds. On December 4, 2020, the Company closed a private placement financing of 2,200,000 units at a price of $0.50 per unit, for aggregate gross proceeds of $1,100,000. Each unit consisted of one common share and one common share purchase warrant. Each common share purchase warrant entitles the holder to purchase one common share of the Company at a price of $0.70 and have an expiry of five years from the date of issuance.

Bio-Techne To Present At The 39th Annual J.P. Morgan Healthcare Conference

On December 21, 2020 Bio-Techne Corporation (NASDAQ: TECH) reported that Chuck Kummeth, President and Chief Executive Officer, reported that it will present at the 39th Annual J.P. Morgan Healthcare Conference on Wednesday, January 13, 2021 at 2:00 p.m. EST (Press release, Bio-Techne, DEC 21, 2020, View Source [SID1234573146]). A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

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ImmunityBio and NantKwest to Merge, Creating a Leading Immunotherapy and Cell Therapy Company

On December 21, 2020 ImmunityBio, a privately-held immunotherapy company, and NantKwest, Inc. (NASDAQ: NK), a clinical-stage, natural killer cell-based therapeutics company, reported they have entered into an agreement to merge in a stock-for-stock transaction (Press release, ImmunityBio, DEC 21, 2020, https://ir.nantkwest.com/news-releases/news-release-details/immunitybio-and-nantkwest-merge-creating-leading-immunotherapy?field_nir_news_date_value[min]= [SID1234573174]). The combination will create a leading immunotherapy and cell therapy company focused on oncology and infectious disease.

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Together, ImmunityBio and NantKwest will have a broad, clinical-stage pipeline – including 13 assets in clinical trials and 11 in Phase II to III – as well as a robust early stage pipeline to address other difficult to treat cancers. The combination of NantKwest’s Natural Killer (NK) cell platform and ImmunityBio’s immunotherapy fusion protein, immunomodulator, and adenovirus platforms have already resulted in complete responses in late stage, difficult to treat metastatic cancers. To date complete responses have been noted in patients with second line or greater metastatic pancreatic cancer, triple-negative breast cancer, head and neck cancer, and Merkel Cell Carcinoma. This strong track record of combination immunotherapies across the two companies’ platforms supports the potential of the combined assets to transform the future of immunotherapy beyond checkpoints by synergizing NantKwest’s cell-based therapies with ImmunityBio’s immunotherapy platforms.

In a separate press release issued today, ImmunityBio announced that ImmunityBio’s IL-15 fusion protein, Anktiva, with FDA Breakthrough Therapy status for non-muscle invasive bladder cancer CIS, has achieved primary endpoint with 72% complete response.

ImmunityBio was founded by Dr. Patrick Soon-Shiong, MD, a physician and scientist who invented Abraxane for the treatment of metastatic breast cancer, lung cancer and advanced pancreatic cancer. The companies, including their operations, are aligned given their long-standing collaboration programs with opportunity for advancing clinical development of the late stage Phase II and III trials.

Dr. Soon-Shiong said, "We are developing next-generation immunotherapies to defeat cancer and infectious disease. By combining ImmunityBio’s immunotherapy platform, which includes the Anktiva IL-15 superagonist, with NantKwest’s natural killer cell platform, the merged entity will have a powerful and broad product portfolio that can activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term immunological memory. What distinguishes the merged entity is the late stage immunotherapy product pipeline that is designed to eliminate the need for high-dose chemotherapy, improve the outcomes of current CAR T cell therapies, and extend beyond checkpoint inhibitors. With 13 clinical trials across multiple tumor types at Phase I to III and with the combined talent in research, clinical development and manufacturing, the merged entity is poised to be a leader in the immunotherapy space."

"We are excited to join forces with ImmunityBio, a company and team we have collaborated with for many years across our platforms," said Rich Adcock, NantKwest Chief Executive Officer. "With the integration of ImmunityBio’s pipeline, cutting-edge R&D capabilities, talented employees and clinical expertise, we expect to accelerate the delivery of new treatments for patients with unmet needs. Together we can unlock the combined potential of our assets, and look forward to building on our continued success as one company."

Michael Blaszyk, an independent director of NantKwest and member of the Special Committee stated, "This transaction is a compelling opportunity to drive value creation for shareholders. Our Special Committee carefully evaluated the ImmunityBio proposal and determined it is in the best interests of shareholders and also benefits other stakeholders, including our employees, partners and patients."

ImmunityBio is a leading late stage immunotherapy company activating both the innate (natural killer cell and macrophage) and adaptive (T cell) immune system to treat serious unmet needs within oncology and infectious diseases. Founded in 2014 and headquartered in Culver City, ImmunityBio’s platform is designed to overcome limitations of the current standards of T cell-based immunotherapies, including checkpoint inhibitors and CAR-T cells. The company has established a robust next generation immunotherapy clinical pipeline with a strategy toward registrational intent in various indications, beyond checkpoint therapy treatment alone.

Strategic and Financial Rationale

Key attributes of the combined company will include:

Expansive clinical-stage pipeline and intellectual property portfolio. 13 assets in clinical trials, including 11 in Phase II to III clinical trials, as well as a strong global intellectual property portfolio of issued and pending worldwide patent applications with patent life extending to 2035 and beyond.
Differentiated technology and assets. Best-in-class combined discovery and development platforms for novel therapies and next-generation early-stage candidates across immunotherapy, neoepitopes and molecules enhancing allogeneic and autologous NK and T-cell therapies.
Significant market opportunity. Well positioned to combine expertise, platforms and resources to address patients across oncology and infectious disease.
Cutting-edge cell manufacturing expertise and ready-to-scale facilities. Extensive and seasoned R&D, clinical trial, and regulatory operations and development teams, which together will occupy over 200,000 square feet of manufacturing and R&D facilities.
Improved ability to combine platforms and therapies. The transaction improves the ability to more seamlessly combine programs and leverage resources and expertise across both companies’ platforms, ultimately strengthening the efforts of both companies on behalf of patients to drive better outcomes in the fight against oncology and infectious disease.
Significant potential for strategic and financial synergies. This opportunity will come from meaningful streamlining of clinical operations, therapeutic discovery and development, and manufacturing.
Transaction Details

The transaction is structured as a tax-free 100% stock-for-stock merger, with ImmunityBio to reverse merge with NantKwest. Under the terms of the agreement, ImmunityBio shareholders will receive a fixed exchange ratio of 0.8190 shares of NantKwest for each share of ImmunityBio owned. Upon completion of the transaction, on a fully diluted basis, ImmunityBio shareholders will own approximately 72% of the combined company and NantKwest shareholders will own approximately 28% of the combined company, on a fully diluted basis.

A Special Committee of the NantKwest Board of Directors, consisting of independent Directors, undertook a thorough review of the transaction and unanimously recommended that the company proceed with the transaction.

The transaction, which is expected to close in the first half of 2021, is subject to shareholder approval by a majority of unaffiliated shareholders of NantKwest, in addition to other customary closing conditions. There is no filing requirement under the Hart-Scott-Rodino Antitrust Improvements Act for this transaction.

Following the closing of the transaction, the combined company will assume the ImmunityBio name and continue to be listed on the NASDAQ exchange. However, the combined company ticker symbol is expected to be changed to IBRX.

Leadership

Richard Adcock will become the CEO of the combined company, and Dr. Soon-Shiong will serve as Executive Chairman of the Board. The combined company will be headquartered at ImmunityBio’s offices in Culver City, California.

Advisors

Goldman Sachs & Co. LLC and Lazard Frères & Co. LLC are serving as financial advisors to ImmunityBio. Fried, Frank, Harris, Shriver & Jacobson LLP is serving as legal counsel for ImmunityBio.

Barclays is serving as financial advisor to NantKwest’s Special Committee. Goodwin Procter LLP acted as legal counsel for NantKwest’s Special Committee.

Conference Call and Additional Materials

ImmunityBio and NantKwest will host a conference call today at 5:30 a.m. Pacific Time (8:30 a.m. Eastern Time) to discuss this morning’s announcement. The conference call can be accessed by dialing (866) 610-1072 within the U.S. and (973) 935-2840 for all other locations. The confirmation code is 6753467. Participants should dial in 15 minutes prior to the scheduled start time.

A live webcast of the conference call and associated presentation materials will be available on the ImmunityBio website at View Source and on the NantKwest website at https://ir.nantkwest.com/. A replay of the conference call will be available after completion of the conference call and can be accessed by dialing (855) 859-2056 or (404) 537-3406. The replay confirmation code is 6753467.

Bristol Myers Squibb to Announce Results for Fourth Quarter 2020 on February 4, 2021

On December 21, 2020 Bristol Myers Squibb (NYSE:BMY) reported that it will announce results for the fourth quarter of 2020 on Thursday, February 4, 2021 (Press release, Bristol-Myers Squibb, DEC 21, 2020, View Source [SID1234573348]). During a conference call at 8:30 a.m. ET on February 4, 2021, company executives will review financial results and address inquiries from investors and analysts.

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Investors and the general public are invited to listen to a live webcast of the call at View Source or by dialing in the U.S. toll free 800-458-4121 or international +1 313-209-6672, confirmation code: 4441406, or using this link which becomes active 15 minutes prior to the scheduled start time and entering your information to be connected. Materials related to the call will be available at the same website prior to the conference call. A replay of the call will be available beginning at 12:00 p.m. ET on February 4 through 12:00 p.m. ET on February 18, 2021. The replay will also be available through View Source or by dialing in the U.S. toll free 888-203-1112 or international 719-457-0820, confirmation code: 4441406.