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Protagonist Therapeutics Announces Amendment of Agreement with Janssen Biotech for the Continued Development and Commercialization of IL-23 Antagonists

On July 28, 2021 Protagonist Therapeutics, Inc. (Nasdaq:PTGX) ("Protagonist" or "the Company") reported its entry into an amended collaboration agreement (the "Restated Agreement") with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, relating to research, development, manufacture and commercialization of multiple oral Interleukin (IL)-23 receptor antagonist drug candidates (Press release, Protagonist, JUL 28, 2021, View Source [SID1234585331]). The compounds currently in development are PTG-200, an oral IL-23 receptor antagonist in Phase 2 development for the treatment of Crohn’s disease (CD), and PN-232 and PN-235, two second-generation oral IL-23 receptor antagonist candidates. PN-232 and PN-235 are currently in Phase 1 clinical development.

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The amended agreement provides for the concurrent development of multiple oral IL-23 receptor antagonists against a broad range of indications. As such, certain development milestones have been reconfigured based on multiple drug candidates advancing in parallel. Protagonist remains eligible to potentially receive approximately $900 million in future development and sales milestones, in addition to the $80 million in payments already received under the original agreement. Royalty rates remain unchanged. Janssen will have the right to continue research on IL-23 receptor antagonists developed during the collaboration for three years from the closing of the Restated Agreement.

Under the terms of the Restated Agreement, Janssen will conduct all future studies beyond those that are currently ongoing with PTG-200, PN-232 and PN-235 and will be solely financially responsible for any such studies. Accordingly, Protagonist’s development and expense obligations will be limited to its relative share of the currently ongoing studies with these candidates. With this revised agreement, Janssen will continue to deploy the breadth of its established global capabilities and proven experience toward further clinical development of these assets.

"We are very pleased with this amendment to our agreement, which reflects the successful trajectory of the collaboration to date, giving rise to the parallel development of multiple oral IL-23 receptor antagonists," said Dinesh Patel, PhD, President and Chief Executive Officer of Protagonist. "The progress from de novo discovery to development validates our innovative technology platform and its potential to develop oral peptide drugs for diverse clinical indications. We look forward to supporting our Janssen counterparts in their parallel development efforts for PTG-200, PN-232, and PN-235 in multiple indications, which may ultimately provide significant benefit to patients."

Janssen retains exclusive, worldwide rights to develop and commercialize PTG-200, PN-232, PN-235 and any other second-generation compounds derived from the research collaboration conducted under the Original Agreement, or Janssen’s further research under the Restated Agreement. Protagonist will have the right to co-detail up to two licensed products in ulcerative colitis (UC) and CD in the U.S. market.

Further details related to the Restated Agreement are available on the Company’s Form 8-K as submitted to the U.S. Securities and Exchange Commission.

Conference Call and Webcast Information

Protagonist management will host a conference call and webcast today at 5:00 p.m. ET to provide a brief overview of the amended collaboration agreement. To access the live call, dial (877) 870-4263 (U.S./Canada) or (412) 317-0790 (international) five minutes prior to the call and ask to be joined to the Protagonist Therapeutics call. A live and archived webcast will also be accessible in the Investors section of the Company’s website at www.protagonist-inc.com.

Fusion Pharmaceuticals Announces FDA Clearance of IND for FPI-1966, an Investigational Radiopharmaceutical for the Treatment of Head and Neck and Bladder Cancers Expressing FGFR3

On July 28, 2021 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) applications for [225Ac]-FPI-1966 (FPI-1966) and imaging agent [111In]-FPI-1967 (FPI-1967) (Press release, Fusion Pharmaceuticals, JUL 28, 2021, View Source [SID1234585330]). FPI-1966 is a targeted alpha therapy (TAT) designed to use vofatamab, a human monoclonal antibody, to target and deliver actinium-225 to tumor sites expressing fibroblast growth factor 3 (FGFR3), a protein that is overexpressed in multiple tumor types, particularly head and neck and bladder cancers. FPI-1966 utilizes Fusion’s Fast-Clear linker to connect vofatamab to actinium-225.

"Leveraging Fusion’s platform and expertise developing targeted alpha therapies, we are excited to begin our second clinical program," said Chief Executive Officer John Valliant, Ph.D. "FGFR3 is an established and validated cancer target which is found in multiple tumor types with substantial unmet need, notably head and neck and bladder cancers. We have an opportunity to selectively deliver alpha particles to these tumors and use precision radiation therapy as a new treatment paradigm. While the currently approved pan-FGFR inhibitor for bladder cancer requires the presence of a specific mutation, our approach requires only over-expression of FGFR3. If successful, this could provide an opportunity to treat a larger population of patients."

Fusion plans to initiate a Phase 1, non-randomized, open-label clinical trial in patients with solid tumors expressing FGFR3 intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose. The study employs a 3 + 3 dose escalation design to evaluate multiple ascending doses of FPI-1966. The first cohort will comprise four sub-groups in which various doses of non-radiolabeled vofatamab ("cold antibody") will be evaluated to assess the impact of pre-dosing on tumor uptake. As part of the screening process, patients will be administered an imaging analogue of FPI-1966, FPI-1967, and only those who meet predefined tumor uptake and safety criteria will go on to receive FPI-1966.

About FPI-1966
[225Ac]-FPI-1966 is a targeted alpha therapy designed to target and deliver an alpha emitting medical isotope, actinium-225, to cancer cells expressing FGFR3; a receptor that is overexpressed on several tumor types, including head and neck and bladder cancers. FPI-1966 utilizes Fusion’s Fast-Clear linker to connect vofatamab, the human monoclonal antibody that targets FGFR3, with actinium-225. Vofatamab was previously evaluated as a therapeutic agent in a Phase 1b/2 trial and was reportedly well-tolerated.

Transcenta Announces Orphan Drug Designation Granted to TST001 for Treatment of Gastric and Gastroesophageal Junction

On July 28, 2021 Transcenta Holding Limited ("Transcenta"), a clinical stage global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to TST001, its anti-Claudin18.2 monoclonal antibody currently in Phase I clinical trial, for the treatment of patients with gastric cancer or gastroesophageal junction (GC/GEJ) (Press release, Transcenta, JUL 28, 2021, View Source [SID1234585329]). According to preclinical and clinical data, TST001 displayed potent anti-tumor activities in tumor model of gastric cancer or patient of gastric cancer expressing Claudin18.2.

Gastric cancer is a rare disease in the United States, though it has a much higher incidence in Asian countries such as China and Japan. According to the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program, in 2018, there were an estimated 120,301 people living with gastric cancer in the United States. It is the third leading cause of cancer deaths worldwide, following only lung and colorectal cancer. At present, the treatment options of gastric cancer expressing Claudin18.2 are very limited other than surgical resection, chemotherapy and most recently immunotherapy.

Orphan Drug Designation (ODD) is granted by the FDA to drugs intended to treat rare disorders that affect fewer than 200,000 people in the U.S. The designation can provide development and commercial incentives, including eligibility for seven years of market exclusivity in the U.S. after product approval, tax credit of 50% clinical trial cost, waiver of BLA user fee, subsidies for R&D costs, protocol assistance and expedited regulatory approval pathway.

"GC/GEJ is a serious, life-limiting orphan disease in the US. At present, the treatment of GC/GEJ represents an urgent unmet clinical need globally. This ODD by the US FDA for the treatment of GC/GEJ marks an important milestone in the global development of TST001," said Dr. Michael Shi, EVP, Head of Global R&D and CMO of Transcenta. "We will expedite the development of TST001 for GC/GEJ either as single agent or combination therapy to benefit patients around the world."

About TST001

TST001 is the second Claudin18.2 targeting antibody therapeutic candidate being developed globally after Zolbetuximab (IMAB362). TST001 is a high-affinity recombinant humanized monoclonal antibody targeted Claudin18.2 generated by Transcenta’s Immune Tolerance Breaking Technology (IMTB) platform. TST001 can kill Claudin18.2 expressing tumor cells by mechanisms of antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Leveraging advanced bioprocessing technology, the fucose content of TST001 was significantly reduced during the production, which further enhanced the ADCC-mediated tumor killing activity of TST001. TST001 displayed more potent anti-tumor activities than IMAB362 analog in mouse xenograft experiments. Clinical trials for TST001 are ongoing in China and US since July 2020 (NCT04396821, NCT04495296/CTR20201281).

Nuvalent Announces Pricing of Initial Public Offering

On July 28, 2021 Nuvalent, Inc., a biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported the pricing of its initial public offering of 9,750,000 shares of common stock, consisting of 9,150,000 shares of Class A common stock and 600,000 shares of Class B common stock, each at a price to the public of $17.00 per share (Press release, Nuvalent, JUL 28, 2021, View Source [SID1234585328]). All shares are being offered by Nuvalent. The gross proceeds to Nuvalent from the offering, before deducting underwriting discounts, commissions and other offering expenses, are expected to be approximately $165.75 million. The Class A common stock is expected to begin trading on The Nasdaq Global Select Market under the ticker symbol "NUVL" on July 29, 2021. The offering is expected to close on August 2, 2021, subject to the satisfaction of customary closing conditions. In addition, the underwriters have a 30-day option to purchase up to an additional 1,462,500 shares of Class A common stock at the initial public offering price less underwriting discounts and commissions.

J.P. Morgan, Cowen and Piper Sandler are acting as joint book-running managers for the offering.

A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on July 28, 2021. The offering is being made only by means of a written prospectus. Copies of the final prospectus relating to the initial public offering can be obtained, when available, from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone (866) 803-9204 or by email at [email protected]; Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; and Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by telephone at (800) 747-3924, or by email at [email protected].

This press release shall not constitute an offer to sell or the 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.

Thermo Fisher Scientific Reports Second Quarter 2021 Results

On July 28, 2021 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the second quarter ended July 3, 2021 (Press release, Thermo Fisher Scientific, JUL 28, 2021, View Source [SID1234585327]).

Second Quarter 2021 Highlights

Second quarter revenue increased 34% to $9.27 billion.
Second quarter GAAP diluted earnings per share (EPS) increased 59% to $4.61.
Second quarter adjusted EPS increased 44% to $5.60.
Launched a range of new products including the Thermo Scientific Orbitrap IQ-X Tribrid Mass Spectrometer to advance complex small molecule research, and the Thermo Scientific Helios 5EXL Wafer DualBeam scanning electron microscope to support the development of increasingly smaller and more complex semiconductors. To advance cell analysis research, the Invitrogen Bigfoot Spectral Sorter and the Invitrogen Attune CytPix Flow Cytometer were also launched in the quarter.
Announced collaborations with leading academic medical centers including the Mayo Clinic to accelerate the development and adoption of more precise and personalized diagnostics for blood-based cancers; a new clinical and commercial cGMP cell therapy manufacturing facility at University of California, San Francisco, to advance innovation in cell and gene therapy; and at the University of California, Davis, a research collaboration to support the rapid scale-up of large cohort studies and clinical research in metabolomics.
Continued to expand both our capacity and capabilities to better serve our customers. In the quarter, we brought additional capacity online to support vaccine and therapy production globally and expanded the production of laboratory plastics in North America and Europe. Shortly after the quarter closed, we opened a new plasmid DNA facility in Carlsbad, California to meet rapidly growing demand for plasmid DNA-based therapies and mRNA-based vaccines.
Building on our environmental sustainability initiatives, we committed to reach net-zero carbon emissions by 2050.
Adjusted EPS, adjusted operating income, adjusted operating margin and free cash flow are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of Non-GAAP Financial Measures."

"Our team delivered an incredibly strong second quarter, building on our excellent start to the year. The strength of our base business reflects our proven growth strategy, and we continue to enable the societal response to the pandemic, which allowed us to deliver exceptional performance in revenue, earnings and free cash flow for the quarter," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "We extended our leading innovation track record, and our ongoing investments in talent, capabilities and infrastructure are positioning our company for an even brighter future."

Casper added, "We’re in a great position at the halfway point of the year and on track to deliver an outstanding 2021."

Second Quarter 2021

Revenue for the quarter grew 34% to $9.27 billion in 2021, versus $6.92 billion in 2020. Organic revenue growth was 28%; acquisitions increased revenue by 2% and currency translation increased revenue by 5%1. Organic revenue growth from the base business was 27%. COVID-19 response revenue was $1.9 billion.

GAAP Earnings Results

GAAP diluted EPS in the second quarter of 2021 increased 59% to $4.61, versus $2.90 in the same quarter last year. GAAP operating income for the second quarter of 2021 was $2.16 billion, compared with $1.39 billion in the year-ago quarter. GAAP operating margin was 23.3%, compared with 20.1% in the second quarter of 2020.

Non-GAAP Earnings Results

Adjusted EPS in the second quarter of 2021 increased 44% to $5.60, versus $3.89 in the second quarter of 2020. Adjusted operating income for the second quarter of 2021 grew 44% compared with the year-ago quarter. Adjusted operating margin was 29.0%, compared with 27.0% in the second quarter of 2020.

2021 Guidance Update

Thermo Fisher is raising its 2021 revenue and earnings guidance. The company is raising its revenue guidance by $300 million to $35.90 billion; this would result in 11% revenue growth over 2020. The company is raising its adjusted EPS guidance by $0.10 to $22.07, which would represent 13% growth year over year.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the company’s four business segments, as highlighted below. Since these results are used for this purpose, they are also considered to be prepared in accordance with GAAP.

Life Sciences Solutions Segment

Life Sciences Solutions Segment revenue grew 37% to $3.56 billion in the second quarter of 2021, compared with revenue of $2.60 billion in the second quarter of 2020. Segment adjusted operating margin was 48.3%, versus 47.4% in the 2020 quarter.

Analytical Instruments Segment

Analytical Instruments Segment revenue grew 41% to $1.48 billion in the second quarter of 2021, compared with revenue of $1.05 billion in the second quarter of 2020. Segment adjusted operating margin was 18.9%, versus 12.9% in the 2020 quarter.

Specialty Diagnostics Segment

Specialty Diagnostics Segment revenue grew 25% to $1.24 billion in the second quarter of 2021, compared with revenue of $0.99 billion in the second quarter of 2020. Segment adjusted operating margin was 19.9%, versus 21.6% in the 2020 quarter.

Laboratory Products and Services Segment

Laboratory Products and Services Segment revenue grew 29% to $3.58 billion in the second quarter of 2021, compared with revenue of $2.79 billion in the second quarter of 2020. Segment adjusted operating margin was 12.4%, versus 10.1% in the 2020 quarter.

Use of Non-GAAP Financial Measures

In addition to the financial measures prepared in accordance with generally accepted accounting principles (GAAP), we use certain non-GAAP financial measures, including adjusted EPS, adjusted operating income and adjusted operating margin, which exclude certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition and significant transaction costs; restructuring and other costs/income; and amortization of acquisition-related intangible assets. Adjusted EPS also excludes certain other gains and losses that are either isolated or cannot be expected to occur again with any predictability, tax provisions/benefits related to the previous items, and the impact of significant tax audits or events. We exclude the above items because they are outside of our normal operations and/or, in certain cases, are difficult to forecast accurately for future periods. We also use a non-GAAP measure, free cash flow, which is operating cash flow, excluding net capital expenditures to provide a view of the continuing operations’ ability to generate cash for use in acquisitions and other investing and financing activities. We believe that the use of non-GAAP measures helps investors to gain a better understanding of our core operating results and future prospects, consistent with how management measures and forecasts the company’s performance, especially when comparing such results to previous periods or forecasts.

For example:

We exclude costs and tax effects associated with restructuring activities, such as reducing overhead and consolidating facilities. We believe that the costs related to these restructuring activities are not indicative of our normal operating costs.

We exclude certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition and significant transaction costs. We exclude these costs because we do not believe they are indicative of our normal operating costs.

We exclude the expense and tax effects associated with the amortization of acquisition-related intangible assets because a significant portion of the purchase price for acquisitions may be allocated to intangible assets that have lives of up to 20 years. Based on acquisitions closed through the end of the second quarter of 2021, adjusted EPS will exclude approximately $3.40 of expense for the amortization of acquisition-related intangible assets. Exclusion of the amortization expense allows comparisons of operating results that are consistent over time for both our newly acquired and long-held businesses and with both acquisitive and non-acquisitive peer companies.

We also exclude certain gains/losses and related tax effects, the impact of significant tax audits or events (such as changes in deferred taxes from enacted tax rate changes), which are either isolated or cannot be expected to occur again with any predictability and that we believe are not indicative of our normal operating gains and losses. For example, we exclude gains/losses from items such as the sale of a business or real estate, gains or losses on significant litigation-related matters, gains on curtailments of pension plans and the early retirement of debt.

We also report free cash flow, which is operating cash flow, excluding net capital expenditures to provide a view of the continuing operations’ ability to generate cash for use in acquisitions and other investing and financing activities.

Thermo Fisher Scientific’s management uses these non-GAAP measures, in addition to GAAP financial measures, as the basis for measuring the company’s core operating performance and comparing such performance to that of prior periods and to the performance of our competitors. Such measures are also used by management in their financial and operating decision-making and for compensation purposes.

The non-GAAP financial measures of Thermo Fisher Scientific’s results of operations and cash flows included in this press release are not meant to be considered superior to or a substitute for Thermo Fisher Scientific’s results of operations prepared in accordance with GAAP. Reconciliations of such non-GAAP financial measures to the most directly comparable GAAP financial measures are set forth in the accompanying tables. Thermo Fisher Scientific does not provide GAAP financial measures on a forward-looking basis because we are unable to predict with reasonable certainty and without unreasonable effort items such as the timing and amount of future restructuring actions and acquisition-related charges as well as gains or losses from sales of real estate and businesses, the early retirement of debt and the outcome of legal proceedings. The timing and amount of these items are uncertain and could be material to Thermo Fisher Scientific’s results computed in accordance with GAAP.

Conference Call

Thermo Fisher Scientific will hold its earnings conference call today, July 28, 2021, at 8:30 a.m. Eastern time. To listen, dial (833) 714-0931 within the U.S. or (778) 560-2662 outside the U.S. The conference ID is 6292118. You may also listen to the call live on our website, www.thermofisher.com, by clicking on "Investors." You will find this press release, including the accompanying reconciliation of non-GAAP financial measures and related information, in that section of our website under "Financial Results." An audio archive of the call will be available under "Webcasts and Presentations" through Friday, August 13, 2021.