On June 18, 2021 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported its full year 2021 financial guidance to incorporate the GW Pharmaceuticals (GW) business, which the Company acquired on May 5, 2021 (Press release, Jazz Pharmaceuticals, JUN 18, 2021, View Source [SID1234584148]).

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"We expect 2021 to be another exciting, productive and transformational year for Jazz and are pleased to update our guidance to include the addition of GW. Our guidance reflects strong execution across our commercial portfolio, continued investment in both our ongoing and planned launches and strategic investments in R&D to advance therapies to patients in critical need of new treatment options. These investments will support the recent successful launches of both Xywav and Zepzelca, the ongoing growth of Epidiolex, the anticipated launches of JZP458 for ALL or LBL and Xywav in idiopathic hypersomnia, and the rolling launch of Epidyolex in Europe. As part of our continued R&D efforts we also look forward to advancing our PTSD and essential tremor programs, the nabiximols clinical trial program to support a U.S. regulatory approval, and our new cannabinoid research platform," said Renée Galá, chief financial officer of Jazz Pharmaceuticals. "We believe Epidiolex has near-term blockbuster potential and expect the addition of Epidiolex and the GW pipeline to deliver double-digit revenue growth, accelerated revenue diversification and substantial shareholder value. With the addition of GW, we are excited to transform the lives of even more patients and their families."

As a result of the acquisition, the Company expects:

Accelerated revenue diversification with double digit revenue growth; expect to generate 65% of 2022 revenues from products that have been launched or acquired since 20191
Earnings accretion, with the GW acquisition expected to be non-GAAP adjusted EPS accretive in the first full calendar year of combined operations and substantially accretive thereafter
Strong cash flows, which will enable rapid deleveraging, targeting less than 3.5x net leverage by the end of 2022
Continued investment in its broad and productive pipeline to drive long-term shareholder value
Additional value to be delivered through continued corporate development activity, while achieving deleveraging targets
2021 Financial Guidance2
The Company is updating its full year 2021 financial guidance for the combined organization, which includes the anticipated results of GW from May 5, 2021 to December 31, 2021.

Products acquired or launched since 2019 include Xywav, Epidiolex, Zepzelca and Sunosi, as well as the anticipated U.S. launches of JZP458 in acute lymphoblastic leukemia (ALL) / lymphoblastic lymphoma (LBL) and Xywav in idiopathic hypersomnia (in each case subject to FDA approval).
The Company’s 2021 financial guidance includes the anticipated results of the acquired GW business from the date of acquisition (May 5, 2021) and preliminary estimates of acquisition accounting adjustments related to the acquisition of GW, which estimates are subject to change; any such change could be material.
The Company expects the transaction to be dilutive to both GAAP and non-GAAP adjusted net income per diluted share in 2021. On a GAAP basis, this is expected to be primarily due to an increase in the amortization of acquisition-related intangible asset and transaction and integration expenses, the amortization of inventory fair value step-up, increased interest expense and the increase in number of outstanding shares relating to the GW acquisition. On a non-GAAP adjusted basis, this is expected to be due to increased cash interest expense and an increase in the number of outstanding shares.
Excludes $200-$225 million of amortization of acquisition-related inventory fair value step-up, $8-$10 million of share-based compensation expense and $2-$4 million of transaction and integration expenses relating to the GW acquisition from estimated GAAP gross margin.
Excludes $221-$245 million of transaction and integration expenses relating to the GW acquisition and $127-$135 million of share-based compensation expense from estimated GAAP SG&A expenses.
Excludes $35-$45 million of share-based compensation expense and $7-$11 million of transaction and integration expenses relating to the GW acquisition from estimated GAAP R&D expenses.
Excludes the income tax effect of adjustments between GAAP net income and non-GAAP adjusted net income.
See "Non-GAAP Financial Measures" below. Reconciliations of non-GAAP adjusted guidance measures are included above and in the table titled "Reconciliation of GAAP to Non-GAAP Adjusted 2021 Net Income Guidance" at the end of this press release.

On June 18, 2021 InnoCare (HKEX: 09969), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, reported the company presented the latest clinical data of the Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib at the 16th International Conference on Malignant Lymphoma (ICML) (Press release, InnoCare Pharma, JUN 18, 2021, View Source [SID1234584142]). Orelabrutinib showed a significant higher rate of complete response (CR) with the extended time of treatment.

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Updated Efficacy and Safety Results of Orelabrutinib in the Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Cell lymphoma.

Abstract Number: 131

Orelabrutinib is a novel and highly selective irreversible BTK inhibitor. According to the previous reported data, orelabrutinib had high bioavailability with near 100% BTK occupancy at 24 hours at 150 mg daily dosing regimen and had demonstrated excellent safety and efficacy profiles in a phase II trial of r/r CLL/SLL. The median follow-up time was 25.6 months.

The efficacy results were evaluated by both IRC and investigators, with the ORR of 93.8% with 21.3% CR/CRi, 61.3% PR, and 11.3% PR-L by investigators, and the ORR of 92.5% with 16.3% CR/CRi, 65.0% PR and 11.3% PR-L by IRC. These results revealed high concordance rate for overall response assessments between IRC and investigator. Median time for achieving first response was 1.87 months. The median DOR and PFS were not reached. Orelabrutinib showed a significant higher CR/CRi rate in r/r CLL/SLL comparing to other BTK inhibitors at a similar median follow-up period.

Extended follow-up analysis did not reveal new safety concerns. Similar to the previous reported safety results, most AEs were mild to moderate.

Professor Wei Xu, deputy director of the Department of Hematology, Jiangsu Provincial People’s Hospital, said, "This updated study result further confirms that orelabrutinib is efficacious in treating r/r CLL patients with a significant higher CR rate, durable response and improved safety profiles. Orelabrutinib provides a favorable therapeutic choice for patients with r/r CLL/SLL and a potential best candidate for the combination therapy."

The ICML is held online from June 18 to 22, 2021, which is organized every two years. The ICML meeting represented a high level of lymphoma research and treatment, which not only gathered international experts in the field of lymphoma, but also demonstrated the trend of malignant lymphoma treatment.

On June 18, 2021 Ampio Pharmaceuticals (NYSE American: AMPE), a clinical stage biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, reported that the Company is expected to join the small cap Russell 2000 Index and the broad-market Russell 3000 Index at the conclusion of this year’s reconstitution of the Russell stock indexes, effective after the U.S. stock market opens on Monday, June 28, 2021, accordingly to a preliminary list of additions posted on June 4, 2021 (Press release, Ampio, JUN 18, 2021, View Source [SID1234584141]).

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Michael Macaluso, the Company’s President and Chief Executive Officer, stated, "Inclusion in the Russell Indexes is an important milestone and will increase the overall awareness and exposure of our Company within the investment community."

Annual Russell indexes reconstitution captures the 4,000 largest U.S. stocks as of May 7, 2021, ranking them by total market capitalization. Membership in the U.S. all-cap Russell 3000 Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000 Index or small-cap Russell 2000 Index as well as the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective market-capitalization rankings and style attributes.

Russell U.S. Indexes are part of the FTSE Russell, a leading global index provider, and are widely used by investment managers and institutional investors as the basis for index funds and as benchmarks for active investment strategies. FTSE Russell reports approximately $10.6 trillion in assets are benchmarked against Russell’s U.S. indexes. For more information on the Russell 3000 Index and Russell 2000 Index and the Russell U.S. Indexes reconstitution, visit the "Russell Reconstitution" section at FTSE Russell website.

On June 18, 2021 Protagonist Therapeutics, Inc. (Nasdaq:PTGX), a clinical stage biopharmaceutical company, reported the closing of its previously announced underwritten public offering of 3,503,311 shares of its common stock, including 456,953 shares sold pursuant to the underwriters’ exercise in full of their "green shoe" option to purchase additional shares, at a price to the public of $37.75 per share (Press release, Protagonist, JUN 18, 2021, View Source [SID1234584140]). Aggregate gross proceeds to Protagonist from the offering were approximately $132.2 million, before deducting underwriting discounts and commissions and offering expenses.

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J.P. Morgan Securities LLC, Jefferies LLC and Piper Sandler acted as joint book-running managers for the offering. JMP Securities LLC and H.C. Wainwright & Co., LLC acted as co-lead managers for the offering.

A shelf registration statement relating to the offered shares of common stock was filed with the Securities and Exchange Commission (SEC) on December 10, 2020. A final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and is available on the SEC’s website, located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus related to the offering may be obtained, when available, from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at 866-803-9204, or by email at [email protected]; Jefferies LLC (Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022; telephone: 877-821-7388; email: [email protected]); or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email at [email protected].

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

On June 18, 2021 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders inside and outside of the brain, reported the closing of its previously announced underwritten public offering of 15 million shares of its common stock at a price to the public of $3.00 per share (Press release, Inhibikase Therapeutics, JUN 18, 2021, View Source [SID1234584139]). The gross proceeds to Inhibikase from the public offering, before deducting underwriting discounts and commissions and offering expenses payable by Inhibikase, were $45 million. Inhibikase has granted the underwriters a 45-day option to purchase up to an additional 2,250,000 shares of common stock, at the public offering price less discounts and commissions.

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Inhibikase intends to use the net proceeds from the public offering, together with existing funds, to fund the costs of a Phase 1b extension study for IkT-148009 in Parkinson’s patients and to validate target engagement markers in the central and peripheral nervous system; to fund production of IkT-148009 for Phase 1b and Phase 2 clinical studies and to fund a Phase 2 efficacy trial of IkT-148009 in Parkinson’s patients. This funding will further support the clinical dose calibration study(ies) of IkT-001Pro in healthy subjects to support approval under the Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act and to fund drug product production for IkT-001Pro. The balance will support general research and development activities, medicinal chemistry for additional molecules and IND-enabling studies, team building, and other general corporate activities.

ThinkEquity, a division of Fordham Financial Management, Inc., acted as sole book-running manager for the offering. JonesTrading Institutional Services LLC acted as the co-manager for the offering.

The offering was made pursuant to a registration statement on Form S-1 (File No. 333-257032) that was declared effective by the Securities and Exchange Commission (the "SEC") on June 15, 2021. A final prospectus related to the offering has been filed with the SEC and is available on the SEC’s website, located at www.sec.gov. Copies of the final prospectus relating to this offering may be obtained from the offices of ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, or by email 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 jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.