On January 31, 2019 Repare Therapeutics, Inc., a privately held precision oncology company pioneering synthetic lethality to develop novel therapeutics that target specific vulnerabilities of tumors in clearly defined patient populations, reported that it has entered into an exclusive strategic research, development and commercialization partnership with ONO Pharmaceutical Co., Ltd., for Repare’s small molecule Polθ inhibitor program in Japan, South Korea, Taiwan, Hong Kong, Macau and ASEAN countries, excluding mainland China (Press release, Repare Therapeutics, JAN 31, 2019, View Source [SID1234532999]). Repare retains all rights to develop and commercialize the products outside the ONO territory, including the US, Canada and EU.

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"We’re excited to have ONO as a discovery and development partner," said Lloyd M. Segal, President and CEO of Repare. "This relationship will support our drive to and through the clinic in this important new area of precision oncology therapeutic development."

"ONO identified Repare Therapeutics as the partner of choice for bringing in a potential first-in-class and best-in-class Polθ inhibitor to our portfolio," said Gyo Sagara, President, Representative Director and CEO of ONO. "We are excited to work with Repare for the benefit of cancer patients."

Under the terms of the agreement, ONO will provide an up-front payment and research service payments potentially totaling US $15M, plus additional cost-sharing through IND. Beyond IND, significant clinical, regulatory and commercial milestones are also included in the agreement, with a potential total of US $160M. ONO will also pay to Repare high single-digit to low double-digit tiered royalties based on net sales of the product. Repare retains all rights to develop and commercialize the products outside the ONO territory, including the US, Canada and the EU.

Polθ inhibitor opportunity

DNA Polymerase θ (Polθ) is a unique, multifunctional DNA polymerase essential to repairing DNA breaks, especially in homologous recombination deficient (HRD) cells. HRD, including deficiency in the BRCA1 and BRCA2 genes, is a clinically important feature across a variety of important tumor types, including breast, ovarian, prostate and pancreatic cancers. Polθ gene expression is low in normal cells but elevated across a broad range of tumor types, including those with HRD. Currently, HRD tumors may be treated with Poly(ADP-ribose) Polymerase (PARP) inhibitors, which represent a rapidly growing, multi-billion dollar global market. A significant fraction of patients does not initially respond to PARP inhibitor treatment, and the vast majority of treated patients eventually develop PARP inhibitor resistance. A Polθ inhibitor has potential as both a mono-therapy across multiple tumor types and in combination with PARP inhibitors, where its distinct mechanism of action may help address both forms of PARP resistance. Additional clinical populations may also be attractive for combination treatment with a Polθ inhibitor, including possible combinations with chemotherapy, radiotherapy and Immuno-Oncology agents

On January 31, 2019 Corcept Therapeutics Incorporated (NASDAQ: CORT), a company engaged in the discovery, development and commercialization of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, reported preliminary fourth quarter revenue of $66.8 million, compared to $53.3 million in the fourth quarter of 2017 (Press release, Corcept Therapeutics, JAN 31, 2019, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-fourth-quarter-and-full-year-2018 [SID1234532998]). Preliminary 2018 revenue was $251.2 million, an increase of 58 percent from 2017. Corcept projects 2019 revenue of $285 – $315 million. These results are prior to the completion of the company’s annual independent audit and are subject to adjustment.

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Cash and investments increased by $10.1 million in the fourth quarter, to $206.8 million. This increase was after the expenditure of $14.8 million to acquire 1.1 million shares of the company’s common stock pursuant to its stock repurchase program. Under the terms of the program as currently authorized, $76.3 million remains available for the repurchase of shares.

"Our Cushing’s syndrome franchise grew significantly in 2018, as more physicians prescribed Korlym for the first time and experienced prescribers identified additional patients who could benefit from the medication," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "We expect the increase in first-time and repeat Korlym prescribers to continue in 2019.

"Korlym’s robust revenue has allowed us, and will continue to allow us, to advance our proprietary selective cortisol modulators as potential treatments in a wide variety of serious disorders. Relacorilant, our candidate to succeed Korlym, began Phase 3 last year. In 2019, we plan to start Phase 2 trials in patients with metastatic ovarian, pancreatic and castration-resistant prostate cancers, non-alcoholic steatohepatitis (NASH) and antipsychotic-induced weight gain. These programs represent the future of Corcept."

Hypercortisolism

Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the stress hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing’s syndrome, with about 3,000 new patients being diagnosed each year. Symptoms vary, but most people experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Cushing’s syndrome can affect every organ system in the body and can be lethal if not treated effectively.

On January 31, 2019 Pulmatrix, Inc. ("Pulmatrix," the "Company," "we," "our" or "us") (NASDAQ: PULM) reported the closing and funding of its previously announced underwritten public offering of 1,561,177 shares of its common stock at a price to the public of $0.17 per share (Press release, Pulmatrix, JAN 31, 2019, View Source [SID1234532995]). The gross proceeds from the offering, before deducting the underwriting discounts and commissions and estimated offering expenses are $265,400.

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Pulmatrix currently intends to use the net proceeds from the offering for working capital and general corporate purposes.

A shelf registration statement on Form S-3 (Registration No. 333-212546) relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission ("SEC") and was declared effective on August 3, 2016. A prospectus supplement describing the terms of the offering was filed with the SEC on January 29, 2019, and is available on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected].

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

On January 31, 2019 Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that it has commenced an underwritten public offering of its common stock and warrants to purchase common stock (Press release, Leap Therapeutics, JAN 31, 2019, View Source [SID1234532994]). All shares of common stock and warrants to be sold in the offering will be offered by Leap. Leap intends to grant the underwriters a 30-day option to purchase up to an aggregate of an additional 15% of the shares of its common stock and/or warrants to purchase shares of its common stock offered in the public offering. The offering is subject to market, regulatory and other conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Raymond James & Associates, Inc. and Ladenburg Thalmann will act as book-running managers for the offering.

Leap intends to use the net proceeds from the offering for general corporate purposes, which may include, without limitation, funding new clinical trials of DKN-01 and TRX518 and the continuation of ongoing studies, capital expenditures, working capital and general and administrative expenses.

The securities described above are being offered by the Company pursuant to an effective shelf registration statement on Form S-3 (File No. 333-223419) that was previously filed by Leap with the Securities and Exchange Commission (the "SEC") on March 2, 2018 and was declared effective by the SEC on March 16, 2018. A preliminary prospectus supplement and the related prospectus will be filed with the SEC and will be available for free on the SEC’s website at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, or by telephone at (800) 248-8863, or e-mail at [email protected]; or from Ladenburg Thalmann, 277 Park Avenue, 26th Floor, New York, NY 10172, 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 January 31, 2019 Takeda Pharmaceutical Company Limited (TOKYO:4502)(NYSE:TAK) reported that (Press release, Takeda, JAN 31, 2019, View Source [SID1234532993]):

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Underlying Revenue +4.8% year-to-date with growth of prescription drug portfolio in all regions

Solid Underlying Revenue growth of +4.8%, with continued strong momentum from Takeda’s Growth Drivers (Gastroenterology, Oncology, Neuroscience and Emerging Markets), which grew +10.5%.
Key growth products Entyvio (+35.1%), Ninlaro (+36.6%) and Trintellix (+19.5%) were important drivers of revenue growth, as were the products obtained through the Ariad acquisition in 2017, Iclusig (+26.0%) and Alunbrig (+151.4%).
Every region grew their prescription drug portfolio versus prior year (U.S. +8.5%, Japan +4.9%*, Europe & Canada +4.9%, Emerging Markets +5.1%).
*Japan +3.0% excluding upfront payment received for product out-licensing

Reported revenue grew +0.8% year-to-date to 1,380 billion yen, despite the negative impact from foreign exchange rates (-1.1pp) and divestitures (-3.0pp). The divestiture impact included the sale of additional products to the Teva JV in FY2017, and Multilab and Techpool in FY2018.
Underlying Core Earnings +32.3% year-to-date, with margin +530 basis points driven by business momentum and execution of the Global Opex Initiative

Underlying Core Earnings grew +32.3%, with margin expansion of 530 basis points. 70% of this margin improvement was driven by OPEX discipline, indicative of how the Global Opex Initiative has become fully integrated into ways of working at Takeda. The remaining margin expansion was driven by favorable product mix.
Reported operating profit declined -11.7% year-to-date to 284.4 billion yen. This was impacted by two large one-time gains booked in FY2017: the sale of Wako shares for 106.3 billion yen, and the sale of additional products to the Teva JV. Furthermore, Takeda booked one-time expenses in FY2018 related to the proposed acquisition of Shire. Excluding these major one-time items, Operating Profit grew +55.5%.
Underlying Core EPS was up +34.2% year-to-date. Reported EPS declined -32.0% to 210 yen per share, impacted by divestitures, Shire related costs, and loss of associates accounted for using the equity method due to an impairment charge recognized by Teva Takeda Pharma Ltd.
R&D milestones in Q3

Global Ph-3 trial of dengue vaccine candidate TAK-003 met primary efficacy endpoint.
Ninlaro post-transplant Multiple Myeloma maintenance data was submitted to the FDA in November 2018, and after further discussion with them, Takeda made the decision to withdraw the filing and to resubmit when more mature survival data are available.
Alunbrig approved in EU for post-crizotinib ALK+ Non-Small Cell Lung Cancer.
Adcetris positive CHMP opinion in EU for front line CD30+ stage IV Hodgkin Lymphoma.
Advanced multiple collaborations in our novel immuno-oncology portfolio.
Unlocking cash by improving business focus and streamlining the balance sheet

Year-to-date Operating Free Cash Flow decreased -20.2% mainly due to the impact of the sale of additional products to the Teva JV in FY2017.
Sale of real estate and marketable securities generated an additional 45.4 billion yen of cash, and sale of non-core businesses Techpool and Multilab generated a further 27.5 billion yen.
Rating agencies confirm investment grade credit ratings.
Costa Saroukos, Chief Financial Officer, commented:

"Takeda’s strategic focus and superior execution continue to drive robust performance through the first three quarters of FY2018. In addition to strong commercial execution, we have continued to deliver on our commitment to margin expansion, with the Underlying Core Earnings margin increasing by 530 basis points driven by our Global Opex Initiative.
In addition to delivering compelling financial results, we also closed the Shire acquisition on January 8th. We completed the deal financing at highly competitive interest rates, and also listed Takeda American Depository Shares on the New York Stock Exchange on December 24th. Integration of the two companies is now progressing as planned, and this is an exciting time for Takeda as we become a truly global, values-based, R&D driven biopharmaceutical leader."

Core Earnings represents net profit adjusted to exclude income tax expenses, our 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 intangible assets associated with products and other items that management believes are unrelated to our core operations, such as purchase accounting effects and transaction related costs.

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 impacts of divestitures and other amounts that are unusual, non-recurring items or unrelated to our ongoing operations.

Attributable to the owners of the company.

FY2018 revised full year guidance including Shire impact to be announced in April

For more details on Takeda’s FY2018 third quarter results and other financial information, please visit View Source