On October 28, 2021 Novocure (NASDAQ: NVCR) reported that the final patient has been enrolled in phase 3 pivotal INNOVATE-3 trial evaluating the efficacy of Tumor Treating Fields (TTFields) together with paclitaxel for treatment of patients with platinum-resistant ovarian cancer (Press release, NovoCure, OCT 28, 2021, View Source [SID1234592134]).

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"This is a major step forward for our clinical trial program and an important achievement for patients, trial investigators and our company," said William Doyle, Novocure’s Executive Chairman. "Ovarian cancer is the fifth leading cause of cancer death in women, impacting nearly 100,000 patients annually in the U.S., Europe and Japan, alone. INNOVATE-3 is the largest abdominal trial to complete enrollment in Novocure history, and we are excited to be enhancing the clinical field in support of people with this deadly disease."

Following the completion of enrollment, an independent Data Monitoring Committee (DMC) will conduct the pre-specified interim analysis pursuant to the trial protocol. Final data from the INNOVATE-3 trial is anticipated in 2023.

INNOVATE-3 is a randomized, open-label study which was designed to enroll 540 adult patients with recurrent, platinum-resist ovarian cancer. Patients have been randomized to receive either weekly paclitaxel alone or weekly paclitaxel concomitant with TTFields tuned to 200 kHz until progression. The primary endpoint is overall survival. Secondary endpoints include progression free survival, objective response rate, severity and frequency of adverse events, time to undisputable deterioration in health-related quality of life or death, and quality of life. The European Network for Gynecological Oncological Trials (ENGOT) and The GOG Foundation, Inc. collaborated with Novocure on the design and facilitation of this trial.

About Ovarian Cancer

In the U.S., ovarian cancer ranks fifth in cancer deaths among women, with approximately 24,000 women diagnosed each year. Ovarian cancer incidence increases with age, and the median age at time of diagnosis is 63 years old. Physicians use different combinations of surgery and pharmacological therapies to treat ovarian cancer, depending on the stage of the disease. Surgery is usually used in early stages of the disease and is usually combined with chemotherapy, including paclitaxel and platinum-based chemotherapy. Unfortunately, the majority of patients are diagnosed at an advanced stage when the cancer has spread outside of the ovaries to include regional tissue involvement and/or metastases. Platinum-based chemotherapy remains part of the standard of care in advanced ovarian cancer, but most patients with advanced ovarian cancer will have tumor progression or, more commonly, recurrence. Almost all patients with recurrent disease ultimately develop platinum resistance, and the prognosis for this population remains poor.

About Tumor Treating Fields

Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division.

When cancer develops, rapid and uncontrolled division of unhealthy cells occurs. Electrically charged proteins within the cell are critical for cell division, making the rapidly dividing cancer cells vulnerable to electrical interference. All cells are surrounded by a bilipid membrane, which separates the interior of the cell, or cytoplasm, from the space around it. This membrane prevents low frequency electric fields from entering the cell. TTFields, however, have a unique frequency range, between 100 to 500 kHz, enabling the electric fields to penetrate the cancer cell membrane. As healthy cells differ from cancer cells in their division rate, geometry and electric properties, the frequency of TTFields can be tuned to specifically affect the cancer cells while leaving healthy cells mostly unaffected.

Whether cells are healthy or cancerous, cell division, or mitosis, is the same. When mitosis starts, charged proteins within the cell, or microtubules, form the mitotic spindle. The spindle is built on electric interaction between its building blocks. During division, the mitotic spindle segregates the chromosomes, pulling them in opposite directions. As the daughter cells begin to form, electrically polarized molecules migrate towards the midline to make up the mitotic cleavage furrow. The furrow contracts and the two daughter cells separate. TTFields can interfere with these conditions. When TTFields are present in a dividing cancer cell, they cause the electrically charged proteins to align with the directional forces applied by the field, thus preventing the mitotic spindle from forming. Electrical forces also interrupt the migration of key proteins to the cell midline, disrupting the formation of the mitotic cleavage furrow. Interfering with these key processes disrupts mitosis and can lead to cell death.

TTFields are intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect.

Fundamental scientific research extends across two decades and, in all preclinical research to date, TTFields has demonstrated a consistent anti-mitotic effect. The TTFields global development program includes a network of preclinical collaborators and a broad range of clinical trials across all phases, including four phase 3 pivotal trials in a variety of tumor types. To date, more than 20,000 patients have been treated with TTFields.

On October 28, 2021 Novocure (NASDAQ: NVCR) reported financial results for the quarter ended September 30, 2021, highlighting commercial strength and strategic investment across clinical, product development and commercial initiatives intended to fuel future growth (Press release, NovoCure, OCT 28, 2021, View Source [SID1234592133]). Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields). TTFields are electric fields that disrupt cancer cell division.

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(1) Adjusted EBITDA is a non-U.S. GAAP measurement of earnings before interest, taxes, depreciation, amortization and share-based compensation.

(2) An "active patient" is a patient who is receiving treatment under a commercial prescription order as of the measurement date, including patients who may be on a temporary break from treatment and who plan to resume treatment in less than 60 days.

(3) A "prescription received" is a commercial order for Optune or Optune Lua that is received from a physician certified to treat patients for a patient not previously on Optune or Optune Lua. Orders to renew or extend treatment are not included in this total.

"The third quarter was another period of solid execution at Novocure," said William Doyle, Novocure’s Executive Chairman. "We generated $134 million in net revenues and invested $48 million across our research, clinical and product development initiatives. We recently completed enrollment in our phase 3 INNOVATE-3 trial and our phase 2 EF-31 trial, and announced a new collaboration with global oncology leader, Roche. The fundamentals of our business are strong, and we are energized by the opportunities before us to help many more cancer patients and to drive the growth of our company."

"As we look ahead, we are nearing a key inflection point for patients and our organization as several of our late-stage clinical trials approach full enrollment," added Asaf Danziger, Novocure’s Chief Executive Officer. "We have completed enrollment in our INNOVATE-3 trial studying recurrent ovarian cancer, and our LUNAR trial studying non-small cell lung cancer is expected to enroll the final patient by year-end. As this cycle of late-stage trials nears conclusion, we are eager to further explore the efficacy of TTFields in new indications, together with other treatment modalities, and in partnerships with global oncology leaders."

Third quarter 2021 financial update

For the quarter ended September 30, 2021, net revenues were $133.6 million, representing 1% growth compared to the third quarter 2020.

In the United States, net revenues totaled $88.0 million in the quarter ended September 30, 2021, representing a 5% decrease compared to the same period in 2020.
In EMEA markets, net revenues totaled $30.3 million in the quarter ended September 30, 2021, representing 7% growth compared to the same period in 2020.
In Japan, net revenues totaled $8.8 million in the quarter ended September 30, 2021, representing 17% growth compared to the same period in 2020.
In Greater China, net revenues totaled $6.5 million in the quarter ended September 30, 2021, representing 52% growth compared to the same period in 2020.
For the three months ended September 30, 2021, the increase in net revenues from the third quarter of 2020 resulted primarily from an increase of 141 active patients in our currently active markets and the launch of Optune in China.

We recorded $10.6 million in revenues from Medicare fee-for-service beneficiaries in the third quarter 2021, an increase of 9% from the $9.7 million recognized in the same period in 2020. We believe we have completed the administrative ramp-up associated with processing Medicare claims and efficiently pursuing appeals. In the third quarter of 2021, we did not record a material amount of incremental net revenue resulting from the successful appeal of previously denied claims for Medicare fee-for-service beneficiaries billed prior to established coverage.

Cost of revenues for the three months ended September 30, 2021 was $30.2 million compared to $28.4 million for the same period in 2020, representing an increase of 6%. The increase in cost of revenues was primarily due to the cost of shipping transducer arrays to a higher volume of commercial patients and increasing shipments of equipment to Zai Lab. Gross margin was 77% for the three months ended September 30, 2021 compared to 79% for the three months ended September 30, 2020.

Research, development and clinical trials expenses for the three months ended September 30, 2021 were $48.1 million compared to $32.8 million for the same period in 2020, representing an increase of 47%. This was primarily due to an increase in clinical trial and personnel expenses for our phase 3 pivotal and label expansion trials, an increase in development and personnel expenses to support our product development programs, and increased investments in preclinical research and the expansion of our medical affairs activities.

Sales and marketing expenses for the three months ended September 30, 2021 were $32.6 million compared to $29.4 million for the same period in 2020, representing an increase of 11%. This was primarily due to an increase in personnel and professional services costs as we continue to enhance our commercial capabilities in anticipation of potential future approvals in new indications.

General and administrative expenses for the three months ended September 30, 2021 were $31.2 million compared to $27.1 million for the same period in 2020, representing an increase of 15%. This was primarily due to an increase in personnel costs and professional services.

Net loss for the three months ended September 30, 2021 was $13.1 million compared to net income of $9.3 million for the same period in 2020.

At September 30, 2021, we had $933.8 million in cash, cash equivalents and short-term investments, an increase of $91.2 million compared to $842.6 million at December 31, 2020. The increase in our cash, cash equivalents and short-term investments was primarily due to the cash flow from operations and the exercise of options.

Third quarter 2021 operating statistics

There were 3,502 active patients at September 30, 2021, representing 4% growth compared to September 30, 2020.

In North America, there were 2,223 active patients at September 30, 2021, representing no change compared to September 30, 2020.
In EMEA markets, there were 987 active patients at September 30, 2021, representing 9% growth compared to September 30, 2020.
In Japan, there were 292 active patients at September 30, 2021, representing 21% growth compared to September 30, 2020.
Additionally, 1,380 prescriptions were received in the quarter ended September 30, 2021, representing 1% growth compared to the same period in 2020.

In North America, 931 prescriptions were received in the quarter ended September 30, 2021, representing a 3% decrease compared to the same period in 2020.
In EMEA markets, 339 prescriptions were received in the quarter ended September 30, 2021, representing 3% growth compared to the same period in 2020.
In Japan, 110 prescriptions were received in the quarter ended September 30, 2021, representing 28% growth compared to the same period in 2020.
Third quarter 2021 non-U.S. GAAP measures

We also measure our performance based upon a non-U.S. GAAP measurement of earnings before interest, taxes, depreciation, amortization and shared-based compensation ("Adjusted EBITDA"). We believe Adjusted EBITDA is useful to investors in evaluating our operating performance because it helps investors compare the results of our operations from period to period by removing the impact of earnings attributable to our capital structure, tax rate and material non-cash items, specifically share-based compensation.

Adjusted EBITDA was $19.9 million for the three months ended September 30, 2021, a decrease of $17.4 million, or 47%, from $37.3 million for the three months ended September 30, 2020. The decrease was driven by increased investments in research and development activities intended to further our exploration of TTFields therapy, and in sales and marketing readiness initiatives in anticipation of future potential launches in new indications. Adjusted EBITDA as a percentage of net revenues reached 15% in the quarter, despite research and development investment reaching 36% of third quarter net revenues. We believe these focused investments are critical to our efforts to realize the long-term potential of the TTFields platform.

Recent achievements

In September, the FDA granted breakthrough device designation to the NovoTTF-200T system for the treatment of advanced liver cancer, in part based on clinical data from Novocure’s phase 2 HEPANOVA trial. Our team, along with trial investigators, are actively designing a phase 3 pivotal trial studying the efficacy of TTFields together with atezolizumab and bevacizumab for the first-line treatment of patients with unresectable or metastatic liver cancer.
In September, we announced a clinical trial collaboration with Roche to evaluate the use of TTFields together with atezolizumab for the treatment of metastatic pancreatic cancer.
In October, we announced the last patient had been enrolled in our phase 2 pilot EF-31 trial for the treatment of gastric cancer.
Today, we announced that the last patient was enrolled in our phase 3 pivotal INNOVATE-3 trial for the treatment of recurrent ovarian cancer.
Anticipated clinical milestones

Data from phase 2 pilot EF-31 trial in gastric cancer (2022)
Data from phase 2 pilot EF-33 trial with high-intensity arrays in recurrent glioblastoma (2022)
Final data from phase 3 pivotal LUNAR trial in NSCLC (2022)
Last patient enrollment in phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2023)
Data from phase 3 pivotal METIS trial in brain metastases (2023)
Final data from phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (2023)
Final data from phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2024)
Conference call details

Novocure will host a conference call and webcast to discuss second quarter 2021 financial results at 8 a.m. EDT today, Thursday, October 28, 2021. Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 6394785.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

On October 28, 2021 Takeda Pharmaceutical Company Limited (TOKYO:4502/NYSE:TAK) ("Takeda") reported that its Board of Directors resolved today to engage in the acquisition of its own shares pursuant to the provision of its Articles of Incorporation in accordance with Article 459, paragraph 1 of the Companies Act of Japan, as detailed below (Press release, Takeda, OCT 28, 2021, View Source [SID1234592132]).

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"At our current share price, we see an opportunity to buy back our shares at a substantial discount to what we perceive is their underlying value," said Costa Saroukos, director and Chief Financial Officer of Takeda. "We expect that this share buyback of up to 100B yen will not impact our deleveraging plans, and that we will remain firmly on track to deliver on our target for 2x (‘low twos’) net debt to Adjusted EBITDA by the end of FY23. We are also maintaining our existing dividend policy and updating our capital allocation policy to allow for share buybacks in the future when appropriate. This underscores our business’ strong cash generation ability, our confidence in our fundamental growth driven by the 14 global brands, and our belief that the R&D strategy with ~40 new molecular entities in the pipeline, will deliver for the long term."

This buyback of shares will be funded by Takeda’s operating cash flow driven by growth in our 14 global brands and working capital improvements.

1. Reason for acquisition of its own shares

To enhance capital efficiency and improve shareholder returns.

2. Details of acquisition

(1) Class of shares to be acquired:

Shares of common stock

(2) Number of shares to be acquired:

Up to 35 million shares

(equivalent to 2.23% of the total number of shares outstanding excluding treasury shares)

(3) Total amount of shares to be acquired:

Up to JPY 100 billion

(4) Schedule of acquisition:

From November 2, 2021 to April 29, 2022

(5) Method of acquisition:

Open-market repurchase through a trust bank

(Reference)

Treasury shares held by Takeda as of September 30, 2021
Aggregate number of issued shares (excluding treasury shares)

1,572,829,854 shares

Number of treasury shares

9,422,671 shares

Updated Capital Allocation Policy

Takeda is delivering on its financial commitments and has a strong cash flow outlook driven by business momentum, cost synergies, and non-core asset divestitures. Guided by our values and our commitment to Patients, People and Planet, we will allocate capital to maximize value for patients and shareholders.

Takeda’s policy in the allocation of capital is as follows:

• Invest in growth drivers;
• Deleverage rapidly; and
• Shareholder returns.

In respect of "Invest in growth drivers", Takeda makes disciplined and focused investments in value-creating business opportunities including R&D, new product launches, including in China, and plasma-derived therapies. With regards to "Deleverage rapidly", Takeda is targeting a 2x (i.e. "low-twos") net debt/adjusted EBITDA ratio within fiscal years ending March 2022 – March 2024 and has committed to maintaining solid investment grade credit ratings. In respect of "Shareholder returns", Takeda maintains its well-established dividend policy of 180 yen per share annually, alongside share buybacks when appropriate. We expect underlying growth momentum to continue over the mid-term.

On October 28, 2021 Takeda Pharmaceutical Company Limited (TOKYO:4502/NYSE:TAK) ("Takeda") reported financial results for the first half of fiscal year 2021 (period ended September 30, 2021) (Press release, Takeda, OCT 28, 2021, View Source [SID1234592131]). Based on the strong first half results, the company also confirmed its fiscal year 2021 management guidance.

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Fiscal year 2021, ending in March 31, 2022, continues to be a year of growth with anticipated topline acceleration driven by the company’s 14 global brands. In addition, the company is committed to the potential of its highly innovative R&D strategy built on a combination of in-house innovation and strategic partnerships that tap cutting-edge science at the source. Recent key pipeline wins, including the U.S. Food and Drug Administration (FDA) approval of EXKIVITY and unanimous recommendation for approval of maribavir by a U.S. FDA Advisory Committee further underscore its promise and potential. The company also announced today the intent to buy back shares up to 100B yen, underscoring confidence in its business strategy and commitment to delivering value to shareholders.

Christophe Weber, Chief Executive Officer, commented:

"Our strategic vision to discover and deliver life-transforming treatments will be realized by the strength of our leading products and our innovative pipeline. Takeda’s Q2 and first-half results are evidence of progress and conviction in our strategy while consistently delivering on our fundamentals. As a result, we are confirming full-year FY2021 guidance as we track toward topline growth and strong core operating profit margins."
"Takeda’s growth continues to be driven by our 14 Global Brands, which will remain our primary growth driver for the coming years. In addition, our ambitious pipeline is starting to deliver results, including the recent U.S. FDA approval of EXKIVITY. This underscores the potential of the pipeline to transform lives and our business."
"The announcement of our new share buyback program, approved by Takeda’s Board of Directors, further demonstrates commitment to delivering shareholder value and our confidence in our business strategy."
"Takeda’s strong commercial portfolio and R&D pipeline are diversified across four core therapeutic areas and represent innovative and potentially transformative benefits for patients. Altogether, we believe that the combination of these growth drivers will continue to propel our business forward and help to ensure our future growth is resilient, for not just the next quarter but the next decade."

(a) Further information on certain of Takeda’s Non-IFRS measures is posted on Takeda’s investor relations website at View Source." target="_blank" title="View Source." rel="nofollow">View Source
(b) Underlying growth compares two periods (quarters or years) of financial results under a common basis and is used by management to assess the business. These financial results are calculated on a constant currency basis and excluding the impact of divestitures and other amounts that are unusual, non-recurring items or unrelated to our ongoing operations.
(c) Core Operating Profit represents net profit adjusted to exclude income tax expenses, the share of profit or loss of investments accounted for using the equity method, finance expenses and income, other operating expenses and income, amortization and impairment losses on acquired intangible assets and other items unrelated to Takeda’s core operations, such as non-recurring items, purchase accounting effects and transaction related costs.
(d) Free Cash Flow represents cash flows from operating activities, excluding acquisition of plant, property and equipment, intangible assets and investments, and any other cash that is not available to Takeda’s immediate or general business use, and including proceeds from sales of property, plant, sales and redemption of investments and businesses, net of cash and cash equivalents divested.
View Source

Reported Revenue increased +12.8%, Underlying Core Revenue increased +6.8% vs H1 FY2020, driven by 14 global brands

Takeda’s 14 global brands, with an aggregate reported revenue of 692.2 billion yen ($6.2B), posted year-over-year underlying revenue growth of +11.4% and now represent 42% of total core revenue, with further acceleration expected in H2.
Takeda’s 5 key business areas with 1,434.6 billion yen ($12.9B) in reported revenue.
GI with 429.1 billion yen ($3.85B) in reported revenue, with underlying revenue growth of +8% spearheaded by gut-selective ENTYVIO.
Rare Diseases with 300.1 billion yen ($2.69B) in reported revenue declined -2% on an underlying basis with rare hematology decline in line with expectations due to competition and HAE growth being impacted by phasing dynamics; remain on track toward full year forecast.
Plasma Derived Therapy (PDT) Immunology with 238.0 billion yen ($2.13B) in reported revenue, with underlying revenue growth +11% driven by Immunoglobulin and ALBUMIN/FLEXBUMIN.
Oncology with 233.7 billion yen ($2.09B) in reported revenue, with underlying revenue growth of +8% driven by indication expansion across portfolio.
Neuroscience with 233.7 billion yen ($2.09B) in reported revenue, with underlying revenue growth of +9% driven by strong rebound of VYVANSE following impact of COVID-19 in prior year.
Reported Operating Profit increased +60.5%; Underlying Core Operating Profit Margin was 29.1% for H1

Reported operating profit increased +60.5% to 346.0 billion yen ($3.1B) compared to H1 FY2020, reflecting a gain on the sales of the diabetes portfolio in Japan and declining purchase price accounting and integration costs.
Core operating profit for the current period decreased -4.3% due to divestitures and increased R&D investment. On track towards full year forecast of 930.0 billion yen ($8.34B)
Important R&D Milestones as Innovative Pipeline Begins to Deliver

Received U.S. FDA approval for EXKIVITY (mobocertinib) as the first and only approved oral therapy specifically designed for patients with EGFR Exon20 insertion mutations+ NSCLC, with filing under review in China and other countries.
Received unanimous recommendation from a U.S. FDA Advisory Committee for maribavir as a treatment for post-transplant recipients with refractory CMV infection with or without resistance. A decision is expected by next month (PDUFA November 23, 2021).
Partnership with Novavax in Japan for development, manufacturing (250 million doses per year) and commercialization of TAK-019, their COVID-19 vaccine candidate with distribution in Japan expected to begin in early calendar year 2022, subject to regulatory approval.
Received approval from the Japan Ministry of Health, Labour and Welfare for Alofisel (darvadstrocel) to be manufactured and marketed for the treatment of complex perianal fistulas in patients with non-active or mildly active luminal Crohn’s disease.
Announced an exclusive collaboration and license agreement with JCR Pharmaceuticals to commercialize JR-141 (INN: pabinafusp alfa) for the treatment of Hunter syndrome (also known as Mucopolysaccharidosis type II or MPS II).
Announced intent to acquire Gamma Delta Therapeutics to accelerate the development of allogeneic gamma delta T-cell therapies with the intention to finalize deal in Q1 FY22. Closing of the transaction is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S.
Entered into three next generation gene therapy collaborations, including with Selecta Biosciences, Poseida Therapeutics and Immusoft.
Additional Pipeline Developments

Suspended dosing of patients in two Phase 2 studies of TAK-994, an investigational oral orexin agonist for the treatment of narcolepsy type 1 (NT1), after a liver toxicity signal emerged in two clinical studies. Takeda, as well as many experts and regulatory authorities, remain excited and optimistic about the potential of orexin agonists given the transformative efficacy demonstrated by TAK-994 in NT1 patients, and Takeda has a number of differentiated molecules in the pipeline that are part of its orexin franchise.
Announced that the Phase 3 PANTHER (pevonedistat-3001) study did not achieve statistical significance for the primary endpoint of event-free survival.
Other Important Developments in H1

Broke ground in Woodlands, Singapore for company’s first building to follow the Singapore Green Mark Zero Energy certification scheme as the first ‘net zero carbon emissions’ building in its global network and first-of-its-kind investment within the biotechnology industry in Singapore.
Selected four new partners for the annual global Corporate Social Responsibility program to help strengthen health systems in low- and middle-income countries.
(a) Previously 160 yen per Share. This change reflects the recording of a tax provision involving Irish taxation of the break fee Shire received from AbbVie in connection with the terminated offer to acquire Shire made by AbbVie in 2014. This change reflects an update to Takeda’s forecasted net income attributable to owners of the Company for the fiscal year ending March 31, 2022 filed today with the Tokyo Stock Exchange. See the release entitled "Summary of Financial Statements for the Six-month Period Ended September 30, 2021 (IFRS, Consolidated)" for additional information.

Key Assumptions in FY2021 Forecast

Company guidance reflects management’s expectations for continued business momentum across Takeda’s five key business areas and underlying revenue growth of its 14 global brands, while also increasing investment in R&D.

FY2021 guidance reflects key assumptions, including (1) Takeda expects at least one 505(b)2 competitor for subcutaneous VELCADE to launch in the U.S. around mid FY2021; (2) Takeda does not expect to restart sales of NATPARA in the U.S. market in FY2021; and (3) FY2021 guidance does not include the impact of any potential further divestitures beyond what has already been disclosed by Takeda.

To date, Takeda has not experienced a material effect on its financial results as a result of the global spread of the novel coronavirus infectious disease (COVID-19). Based on currently available information, Takeda believes that its financial results for FY2021 will not be materially affected by COVID-19 and, accordingly, Takeda’s FY2021 forecast reflects this belief. However, the situation surrounding COVID-19 remains highly fluid, and future COVID-19-related developments in FY2021, including new or additional COVID-19 outbreaks and additional or extended lockdowns, shelter-in-place orders or other government action in major markets, could result in further or more serious disruptions to Takeda’s business, such as slowdowns in demand for Takeda’s products, supply chain related issues or significant delays in its clinical trial programs. These events, if they occur, could result in an additional impact on Takeda’s business, results of operations or financial condition, as well as result in significant deviations from Takeda’s FY2021 forecast.

For more details on Takeda’s H1 FY2021 results and other financial information, please visit: View Source

On October 28, 2021 CohBar, Inc. (NASDAQ: CWBR) (the "Company"), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, reported the pricing of an underwritten public offering of 20,833,334 shares of the Company’s common stock and accompanying warrants to purchase 20,833,334 shares of common stock at a price to the public of $0.72 per share and accompanying warrant (Press release, CohBar, OCT 28, 2021, View Source [SID1234592130]). Each warrant will have an exercise price of $0.72 per share and be exercisable for 5 years from the closing date of the offering. The aggregate gross proceeds from this offering are expected to be approximately $15.0 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. The offering is expected to close on or about November 1, 2021, subject to customary closing conditions.

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Cantor Fitzgerald & Co. is acting as sole book-running manager for the offering. Brookline Capital Markets, a division of Arcadia Securities, LLC, is acting as co-manager.

CohBar intends to use the net proceeds from the offering, together with its existing cash resources, for general corporate purposes, which may include funding preclinical and clinical development of its peptides, increasing working capital, operating expenses and capital expenditures.

The securities will be issued pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission (SEC) on August 24, 2020. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the prospectus supplement, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Ave., 4th Floor, New York, New York 10022, or by e-mail at [email protected].

This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.