Laminar Pharma announces that it will reach 1.2M euros with its latest round of financing

On November 19, 2020 Laminar Pharma, a biotech company based in the Balearic Islands, reported that it is getting closer and closer to its IPO (Press release, Laminar Pharma, NOV 19, 2020, View Source [SID1234572013]). It launched a funding round this month to increase its investment in research staff and advance the development of clinical trials.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This operation aims to raise 1.2 million euros

The financing round was launched on October 30 with the aim of raising 1.2 million euros and is currently available on the Fellow Funders Crowd Investment platform. In the first two weeks, thanks to the trust of numerous investors, more than one million euros have been raised, which is equivalent to 92% of the target set. As there are still another two weeks left, everything suggests that the target will be met. In addition to this main source of financing, which is private investment, Laminar Pharma has received support from the Spanish government, Spain’s regional governments and the European Commission.

Pablo Escribá, CEO of the biopharmaceutical company, has a positive outlook: "We are optimistic about exceeding the planned target, as we did in the round at the end of last year. Currently at Laminar Pharma we hold patents for 8% of all drugs under development by Spanish biotechnology companies in our country, according to the pipeline of the Spanish Association of Bio-companies (ASEBIO) and we hope to grow in valuation as we advance in the clinical research stages of our drugs undergoing development. The company plans to request marketing authorization from regulatory agencies in two years, with the aim of announcing our first market launch in 2023."

Fellow Funders partner Mariano Colmenar is satisfied with the operation, which is run by his own collective financing platform, authorized and supervised by the National Securities Market Commission (CNMV) since 2016. "We have shown that investors see a promising future in the biotechnology sector, anticipating good benefits. The pharmaceutical market is a long-term market, since years of research and clinical trials are necessary before the products can safely be launched to market."

PFIZER INC.UNAUDITED PRO FORMA CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

On November 16, 2020, Pfizer Inc. ("Pfizer") reported that it completed the previously disclosed transactions (the "Transactions") contemplated by (i) the Business Combination Agreement, dated as of July 29, 2019, as amended (the "Business Combination Agreement"), by and among Pfizer, Viatris Inc., formerly known as Upjohn Inc. ("Viatris"), Utah Acquisition Sub Inc., a wholly owned subsidiary of Viatris, Mylan N.V. ("Mylan"), Mylan I B.V., a wholly owned subsidiary of Mylan ("Mylan Newco"), and Mylan II B.V., a wholly owned subsidiary of Mylan Newco; and (ii) the Separation and Distribution Agreement, dated as of July 29, 2019, as amended (the "Separation and Distribution Agreement"), by and between Pfizer and Viatris. Specifically, (1) Pfizer contributed its global, primarily off-patent branded and generic established medicines business (the "Upjohn Business") to Viatris, so that the Upjohn Business was separated from the remainder of Pfizer’s businesses (the "Separation"), (2) following the Separation, Pfizer distributed, on a pro rata basis (based on the number of shares of Pfizer common stock held by holders of Pfizer common stock as of the record date of November 13, 2020), all of the shares of Viatris common stock held by Pfizer to Pfizer stockholders as of the record date (the "Distribution"); and (3) immediately after the Distribution, the Upjohn Business combined with Mylan in a series of transactions in which Mylan shareholders received one share of Viatris common stock for each Mylan ordinary share held by such shareholder, subject to any applicable withholding taxes (the "Combination") (Press release, Pfizer, NOV 19, 2020, View Source [SID1234571516]). Prior to the Distribution, Viatris made a cash payment to Pfizer equal to $12 billion as partial consideration for the contribution of the Upjohn Business from Pfizer to Viatris. As of the closing of the Combination, Pfizer stockholders owned approximately 57% of the outstanding shares of Viatris common stock, and Mylan shareholders owned approximately 43% of the outstanding shares of Viatris common stock, in each case on a fully diluted, as-converted and as-exercised basis. The Transactions are generally expected to be tax free to Pfizer and Pfizer stockholders. Effective as of the closing date of the Transactions, Viatris operates both Mylan and the Upjohn Business as an independent publicly traded company under the symbol "VTRS" on the NASDAQ.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The following unaudited pro forma condensed consolidated financial statements were derived from Pfizer’s historical consolidated financial statements. Prior to the Separation, the Upjohn Business, and beginning in 2020, Pfizer’s Meridian Medical Technologies business ("Meridian"), the manufacturer of EpiPen and other auto-injector products, and a pre-existing strategic collaboration between Pfizer and Mylan for generic drugs in Japan (the "Mylan-Japan collaboration") were managed as part of Pfizer’s Upjohn operating segment. Revenues and expenses associated with Meridian and the Mylan-Japan collaboration were included in Pfizer’s Upjohn operating segment results along with the results of operations of the Upjohn Business in Pfizer’s historical consolidated financial statements.

Meridian supplies EpiPen Auto-Injectors to Mylan under a supply agreement expiring December 31, 2024, with an option for Viatris to further extend the term for an additional one-year period thereafter. Meridian will remain with Pfizer.

On November 13, 2020, subsidiaries of Pfizer and Mylan entered into a definitive agreement under which Pfizer will transfer certain assets, liabilities and operations that currently form part of the Mylan-Japan collaboration to Viatris. The transfer of the Mylan-Japan collaboration to Viatris is subject to the completion of customary closing conditions, including but not limited to, receipt of any necessary regulatory approvals.

The unaudited pro forma condensed consolidated financial statements of Pfizer are prepared in accordance with the Securities and Exchange Commission ("SEC") Regulation S-X Article 11 and are presented to illustrate the estimated effects of (i) the Distribution and the related $12 billion cash payment received by Pfizer from Viatris; and (ii) the planned transfer of the Mylan-Japan collaboration to Viatris (collectively, the "Upjohn Separation"). On November 18, 2020, Pfizer issued redemption notices for the full redemption of all $342,004,000 aggregate principal amount outstanding of its 5.80% Notes due August 12, 2023 (the "2023 Notes") and the full redemption of all $1,150,000,000 aggregate principal amount outstanding of its 1.950% Notes due June 3, 2021 (the "2021 Notes" and, together with the 2023 Notes, the "Notes"). The following unaudited pro forma condensed consolidated financial statements of Pfizer do not give effect to the redemption of the Notes. For additional information, see the notes to unaudited pro forma condensed consolidated financial statements, note 3.c.

The unaudited pro forma condensed consolidated statements of income for the nine months ended September 27, 2020 and the years ended December 31, 2019, 2018 and 2017 give effect to the Upjohn Separation as if it had occurred on January 1, 2017. The unaudited pro forma condensed consolidated balance sheet as of September 27, 2020 gives effect to the Upjohn Separation as if it had occurred on September 27, 2020. Beginning in the fourth quarter of 2020, financial results of the Upjohn Business for periods prior to November 16, 2020 and the Mylan-Japan collaboration will be reflected as discontinued operations in Pfizer’s consolidated financial statements. The financial results of the Mylan-Japan collaboration will continue to be reported in Pfizer’s consolidated financial statements until the transfer of the Mylan-Japan collaboration to Viatris closes.

The unaudited pro forma condensed consolidated financial statements are for illustrative and informational purposes only and are not intended to represent what Pfizer’s results of operations or financial position would have been had it operated without the Upjohn Business and the Mylan-Japan collaboration during the periods presented or if the Upjohn Separation described above had actually occurred as of the dates indicated. The unaudited pro forma condensed consolidated financial statements should not be considered indicative of Pfizer’s future results of operations or financial position without the Upjohn Business and the Mylan-Japan collaboration.

Pro forma adjustments give effect to events that are (i) directly attributable to the Upjohn Separation; (ii) factually supportable; and (iii) with respect to the statements of income, expected to have a continuing impact. The unaudited pro forma condensed consolidated statements of income do not reflect pro forma adjustments related to the effects of transition services arrangements or transitional manufacturing and supply arrangements between Pfizer and Viatris or the impact of any future events that may occur after the Upjohn Separation, including, but not limited to, potential reductions in interest expense as a result of repayment or redemption of Pfizer’s third-party debt or the expected realization of any cost savings or other restructuring actions after the Upjohn Separation.

The unaudited pro forma condensed consolidated financial statements are subject to the assumptions and adjustments described in the accompanying notes, which should be read together with the unaudited pro forma condensed consolidated financial statements. Management believes that these assumptions and adjustments are reasonable given the best information available at this time.

The following unaudited pro forma condensed consolidated financial statements should be read in conjunction with the following:

the section entitled "Management’s Discussion and Analysis of Financial Condition and Results of Operations" within Pfizer’s 2019 Financial Report, which was filed as Exhibit 13 to Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019, and Pfizer’s Quarterly Report on Form 10-Q for the quarterly period ended September 27, 2020; and

Pfizer’s audited consolidated annual financial statements and accompanying notes in Pfizer’s 2019 Financial Report, which was filed as Exhibit 13 to Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and Pfizer’s unaudited condensed consolidated interim financial statements and accompanying notes in Pfizer’s Quarterly Report on Form 10-Q for the quarterly period ended September 27, 2020.


The Historical Pfizer column in the unaudited pro forma condensed consolidated financial statements represents Pfizer’s historical financial statements for the periods presented and does not reflect any adjustments related to the Upjohn Separation.

The Upjohn Separation column in the unaudited pro forma condensed consolidated statements of income reflects the revenues and expenses directly associated with the results of operations of the Upjohn Business and the Mylan-Japan collaboration, which were derived from the financial information of Pfizer and the Upjohn Business identified below, adjusted to exclude previously allocated corporate overhead costs and to include separation costs that are directly related to the separation of the Upjohn Business from Pfizer. Separation costs included in this column are $176 million and $83 million for the nine months ended September 27, 2020 and the year ended December 31, 2019, respectively, and include transaction costs and external costs directly related to the operational separation of the Upjohn Business from Pfizer that will be reclassified to discontinued operations.

Included in the Upjohn Separation column in the unaudited pro forma condensed consolidated statements of income are the following Revenues and Income from continuing operations before provision/(benefit) for taxes on income associated with the Mylan-Japan collaboration:

The Upjohn Separation column in the unaudited pro forma condensed consolidated balance sheet includes the assets and liabilities of the Upjohn Business transferred to Viatris and the assets of the Mylan-Japan collaboration expected to transfer to Viatris. The Upjohn Separation column reflects, among other assets and liabilities, the elimination of goodwill attributed to the Upjohn operating segment and long-term debt and related accrued interest and restricted short-term investments identified with the Upjohn Business from Pfizer’s historical unaudited condensed consolidated balance sheet as of September 27, 2020. The Upjohn Separation column in the unaudited pro forma condensed consolidated balance sheet does not include assets and liabilities retained by Pfizer, which were not transferred to Viatris pursuant to the terms of the Business Combination Agreement, the Separation and Distribution Agreement and related ancillary agreements (collectively, the "Transaction Agreements").

Included in the Upjohn Separation column in the unaudited pro forma condensed consolidated balance sheet are total assets of the Mylan-Japan collaboration of approximately $154 million, consisting primarily of Trade accounts receivable, less allowance for doubtful accounts (approximately $61 million) and Inventories (approximately $94 million).

The historical financial results of the Upjohn Business and the Mylan-Japan collaboration in the Upjohn Separation column were derived from the following, adjusted for certain items, which are associated with the continuing operations of Pfizer:

Pfizer’s audited consolidated financial statements for the years ended December 31, 2019, 2018 and 2017, Pfizer’s unaudited condensed consolidated interim financial statements for the nine months ended September 27, 2020, and Pfizer’s related accounting records;

the Upjohn Business’s audited combined financial statements for the years ended December 31, 2019, 2018 and 2017 included in Upjohn Inc.’s registration statement on Form 10 (File No. 000-56114) filed with the SEC; and

the terms of the Transaction Agreements.

Pfizer believes that the adjustments included within the Upjohn Separation column of the unaudited pro forma condensed consolidated financial statements are consistent with the guidance under U.S. GAAP for discontinued operations in Accounting Standards Codification 205, "Presentation of Financial Statements." Pfizer’s current estimates of the discontinued operations amounts are preliminary and could change as Pfizer finalizes the discontinued operations accounting to be reported in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020.

The Pro Forma Adjustments column in the unaudited pro forma condensed consolidated statements of income for the nine months ended September 27, 2020 and for the year ended December 31, 2019 and the unaudited pro forma condensed consolidated balance sheet as of September 27, 2020 includes the following pro forma adjustments:

Reflects adjustments for an intercompany lease entered into prior to the Upjohn Separation between Pfizer (as lessee) and the Upjohn Business (as lessor) that became a third-party lease between Pfizer and Viatris as of the closing date of the Transactions. The activity associated with this lease was eliminated in Pfizer’s consolidated financial statements prior to the Upjohn Separation but is no longer eliminated after the Upjohn Separation (see adjustment 3.d.).

CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Represents the tax impact of amounts in the Pro Forma Adjustments column impacting Income from continuing operations before provision/(benefit) for taxes on income at the applicable statutory income tax rates.

In order for the Transactions to be generally tax free to Pfizer and Pfizer stockholders, within thirty days of the closing date of the Transactions (the "Cash Disbursement Period"), Pfizer can only use the $12 billion proceeds to (i) repurchase Pfizer common stock, (ii) make pro rata special cash distributions to its stockholders, (iii) repay or repurchase certain debt (including principal, interest and associated premiums and fees) held by third-party lenders, and/or (iv) make contributions to one or more single-employer defined benefit plans for Pfizer’s employees and retirees.

Part of the $12 billion proceeds will be used by Pfizer for the: (i) full redemption of all $342,004,000 aggregate principal amount outstanding of its 5.80% Notes due August 12, 2023 (the "2023 Notes") and (ii) full redemption of all $1,150,000,000 aggregate principal amount outstanding of its 1.950% Notes due June 3, 2021 (the "2021 Notes" and, together with the 2023 Notes, the "Notes"). The redemption date of the Notes is November 28, 2020. On November 30, 2020, Pfizer will pay the applicable "make-whole" redemption prices as set forth in the indentures, as supplemented, pursuant to which the Notes were issued. The 2021 Notes are included in the Historical Pfizer column in the unaudited pro forma condensed consolidated balance sheet in Short-term borrowings, including current portion of long-term debt at a carrying value of approximately $1.15 billion and the 2023 Notes are included in Long-term debt at a carrying value of approximately $364 million. Also included in the Historical Pfizer column in the unaudited pro forma condensed consolidated balance sheet in Other current liabilities is accrued interest payable related to the Notes of approximately $10 million. The Historical Pfizer column in the unaudited pro forma condensed consolidated statements of income includes in Other (income)/deductions––net interest expense associated with the Notes of approximately $32 million for the nine months ended September 27, 2020, and approximately $45 million for the year ended December 31, 2019, which includes stated interest expense and amortization of bond discount and issuance costs. The Historical Pfizer column in the unaudited pro forma condensed consolidated statements of income includes in Other (income)/deductions––net amortization income related to purchase accounting adjustments associated with the 2023 Notes of approximately $5 million for the nine months ended September 27, 2020, and approximately $7 million for the year ended December 31, 2019. Pfizer expects it may incur a loss on the redemption date from the early extinguishment of the Notes, but the amount of such potential loss is not known at this time. The redemption of the Notes reflects only the partial use of the $12 billion proceeds. Pfizer’s expectation is to use the remaining proceeds to repay some of its third-party debt, in particular outstanding commercial paper borrowings, but that expectation may change before the Cash Disbursement Period expires. Accordingly, no pro forma adjustment for Pfizer’s use of the $12 billion proceeds has been made in the unaudited pro forma condensed consolidated financial statements.

CASI PHARMACEUTICALS ANNOUNCES PARTNER JUVENTAS COMPLETES $65 MILLION FINANCING AND INITIATES REGISTRATION STUDY FOR CNCT19 (CD19 CAR-T)

On November 19, 2020 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported partner Juventas has completed the equivalent of $65 million financing and has initiated and enrolled the first patient in a Phase II registration study for CNCT19 (CD19 CAR-T) in China in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) (Press release, CASI Pharmaceuticals, NOV 19, 2020, View Source [SID1234571426]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Wei-Wu He, CASI’s Chairman, and CEO, commented, "Initiating the Phase II B-NHL registration study and enrolling the first patient is an exciting milestone for the development of CNCT19. Our partner Juventas is also making good progress in the Phase I clinical trial for the treatment of relapsed or refractory acute lymphoblastic leukemia (B-ALL) and is expecting to start the Phase II study by the end of 2020. Its financing provides Juventas with resources to continue moving CNCT19 through registration and we remain excited about its potential as a first-line treatment for B-NHL. In addition, as a large (16%) shareholder of Juventas, we are pleased to see Juventas’ progress in their pipeline and expect its financing to help accelerate its pipeline development. Juventas is an example of CASI’s entrepreneurial partnership model that is built on two components, co-development and equity investment. We believe investments in our partners deepen our collaboration and provides additional potential return to our shareholders. With this approach, we will continue to build CASI’s pipeline, one asset at a time."

About CNCT19

CNCT19 targets CD19, a B-cell surface protein widely expressed during all phases of B-cell development and a validated target for B-cell driven hematological malignancies. CD19- targeted CAR constructs from several different institutions have demonstrated consistently high antitumor efficacy in children and adults with relapsed B-cell acute lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL), and B-cell non-Hodgkin lymphoma (B-NHL). CD19 antigen is the most frequently used target in the CAR-T cell therapy clinical trials for hematological malignancies such as leukemia and lymphoma. Juventas is responsible for the development of CNCT19. CASI and Juventas with co-commercialize together under the direction of the program’s joint steering committee.

About Juventas

Juventas Cell Therapy Ltd. is a China-based domestic company located in Tianjin City, China focused on cell therapy. The company’s lead product, CNCT19, devolved from the CD19 CAR-T, was originally created at the Institute of Hematology, Chinese Academy of Medical Sciences, one of the top hematology centers in China. CD19 CAR-T is used to treat patients with acute lymphoblastic leukemia and relapsed non-Hodgkin lymphoma.

Immutep completes a A$29.6 million placement to accelerate and broaden its clinical development

On November 19, 2020 Australian biotechnology company Immutep Limited ("Immutep" or the "Company"), which is listed on NASDAQ and the Australian Securities Exchange, reported that it has today successfully completed a A$29.6 million a private placement of ordinary shares to professional and institutional investors (Placement) (Press release, Immutep, NOV 19, 2020, View Source [SID1234571464]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Use of Funds

The Company will use the proceeds from the Placement to finance its LAG-3 related clinical programs in immuno-oncology and autoimmune disease. This includes the ongoing clinical development of eftilagimod alpha ("efti" or "IMP321), including the expansion of the Phase II TACTI-002 study through an additional 74 patients with 1st line NSCLC and a new Phase II clinical trial in 1st line HNSCC. Details of these expansion plans were also announced today.

The funds will also be used for the cell-line development of IMP761, R&D, manufacturing, the offering costs and working capital purposes.

Placement

123.2 million new fully paid ordinary shares ("New Shares") will be issued under the Placement at an issue price of A$0.24 per New Share (representing a 11.2% discount to the volume weighted average price ("VWAP") of the Company’s ordinary shares as traded on ASX over the 30 days up to and including Tuesday, November 17, 2020), raising a total of A$29.6 million before transaction-related expenses.

Timetable

Settlement of the Placement is expected to occur on Tuesday, 24 November 2020 with the issue of New Shares expected to occur on Wednesday 25 November 2020. The New Shares issued under the Placement will rank pari passu with the Company’s existing fully paid ordinary

Alphamab and 3D Medicines File China NDA for PD-L1 Therapy

On November 19, 2020 Alphamab Oncology and 3D Medicines reported that it filed a China NDA for their partnered anti-PD-L1 therapy as a treatment for MSI-H/dMMR cancer (Press release, Alphamab, NOV 19, 2020, View Source [SID1234571462]). In a Phase II registration trial, patients with MSI-H/dMMR colorectal cancer experienced an objective response rate of 32%. The patients had previously failed a fluoropyrimidine, oxaliplatin and irinotecan regimen. The results were roughly equivalent to those produced by BMS’s Opdivo and Merck’s Keytruda. In the US, Tracon Pharma partners the candidate with the two China pharmas

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!