On January 31, 2019 Geron Corporation (Nasdaq: GERN) reported an expansion of its leadership team with the appointment of a new chief medical officer to support the Company’s clinical drug development efforts in hematology-oncology (Press release, Geron, JAN 31, 2019, View Source [SID1234533009]).

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"As we transition to a late-stage development company, we are very pleased to welcome Dr. Aleksandra Rizo to Geron as Chief Medical Officer," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "With Aleksandra’s prior experience as the clinical lead for the imetelstat program for more than three years at Janssen, as well as her wealth of leadership experience with other hematology-oncology development projects at both Janssen and Celgene, we believe she is uniquely suited to build and lead our clinical development team."

"I am excited to be joining Geron at this pivotal time," said Dr. Rizo. "I strongly believe that imetelstat has great promise in hematology-oncology given my experience with the drug at Janssen and the recent data reported at the ASH (Free ASH Whitepaper) meeting in December, and look forward to the initiation of imetelstat’s Phase 3 trial in lower risk myelodysplastic syndromes."

New Chief Medical Officer Appointed

Aleksandra Rizo, M.D., Ph.D., was appointed Chief Medical Officer as of January 30, 2019 and will be a member of the Company’s Executive Management Committee. Dr. Rizo will be responsible for directing imetelstat’s clinical development strategy, including designing a product development plan for current and potential future indications. Functions under Dr. Rizo’s oversight include clinical science, clinical operations, data management, biostatistics, clinical pharmacology, translational research and medical affairs.

Dr. Rizo has more than 10 years of experience in hematology-oncology clinical development, leading teams through the entire drug development process from Phase 1 through Phase 3 clinical trials and regulatory submissions. Most recently, she was Executive Director, Strategy and Clinical Lead at Celgene Corporation, working across the myeloid portfolio. While there, she led submission activities and participated in strategic and business development initiatives. Prior to that, Dr. Rizo was a Senior Director, Compound Development Team Leader at Janssen Research and Development, LLC (Janssen) for all Phase 1 myeloid assets, and Global Clinical Leader for all late-stage myeloid assets, including imetelstat from 2014-2018. In these roles, she had oversight and leadership responsibilities for overall clinical development strategy, study designs, execution and data interpretation for all related programs. In addition, Dr. Rizo was a core member of Janssen’s Hematology Strategy Team, and in this role, participated and led diligence projects in hematology. Previously, Dr. Rizo was Global Clinical Leader for the ibrutinib mantle cell lymphoma (MCL) program and was responsible for all MCL studies led by Janssen. During her initial tenure with Janssen, Dr. Rizo worked on a variety of Velcade clinical trials in lymphoma and multiple myeloma.

Dr. Rizo holds an M.D. from the University Ss Cyril and Methodius, Skopje, Macedonia, where she also completed a residency in internal medicine/hematology. She also has a Ph.D. in human leukemic stem cell biology from the University of Groningen, Groningen, Netherlands, and a Ph.D. in mouse stem cell biology from the University of Tokyo, Tokyo, Japan.

Additional Office to be Opened in New Jersey

The Company will open an additional office in northern New Jersey in order to enhance its ability to attract talented employees from local biopharmaceutical companies with late-stage clinical drug development expertise, as well as provide support for future global clinical trials. Other corporate functions also expected to be managed from the New Jersey office include business development and, assuming imetelstat is approved, future commercial operations.

Other Executive Leadership Appointments and Responsibilities

Andrew J. Grethlein, Ph.D., has been appointed Chief Operating Officer and will be responsible for global regulatory affairs, pharmacovigilance and drug safety, manufacturing, quality, program management, human resources and information technology.

Melissa A. Kelly Behrs has been appointed Chief Business Officer and will be responsible for business development, portfolio management, alliance management, and strategic market assessment and planning.

Stephen N. Rosenfield has been appointed Chief Legal Officer and will be responsible for legal affairs, corporate compliance, intellectual property and corporate governance.

Preliminary 2019 Financial Guidance

The Company expects its operating expenses to increase as it assumes full responsibility for the development and potential commercialization of imetelstat. For fiscal year 2019, the Company expects its operating expense burn to range from $65 to $70 million, of which approximately $10 to $15 million represent one-time costs, such as imetelstat program transition activities, including the transfer of the investigational new drug (IND) sponsorship from Janssen to Geron, and purchase of raw materials and other supplies in preparation for new drug manufacturing. In addition to the one-time costs, the preliminary 2019 operating expense guidance includes costs for the expansion of the internal development team, the global Phase 3 clinical trial in lower risk myelodysplastic syndromes (MDS) and the opening of a New Jersey office. According to current hiring plans, the Company expects the total number of full-time employees to grow to be approximately 30 to 40 by year-end 2019, with half being research and development personnel. As of December 31, 2018, the Company had approximately $182 million in cash and marketable securities, which is expected to be sufficient to support its plans to initiate the Phase 3 clinical trial of imetelstat in lower risk MDS by mid-year 2019.

Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

In connection with the commencement of Dr. Rizo’s employment with the Company, the Company granted her a non-statutory stock option to purchase 750,000 shares of Geron common stock on January 30, 2019 which vests over four years, with 12.5% of the shares underlying the option vesting on the six-month anniversary of commencement of employment and the remaining shares vesting over the following 42 months in equal installments of whole shares, subject to Dr. Rizo’s continued employment with Geron. In addition, Dr. Rizo was granted non-statutory stock options to purchase an aggregate of 750,000 shares of Geron common stock on January 30, 2019 with vesting conditioned on the achievement of certain regulatory milestones for imetelstat, subject to Dr. Rizo’s continued employment with Geron on the vesting dates. All of Dr. Rizo’s stock options have a 10-year term and an exercise price of $1.03 per share, which is equal to the closing price of Geron common stock on the date of grant. The stock options were granted as a material inducement to Dr. Rizo’s employment in accordance with Nasdaq Listing Rule 5635(c)(4) and are subject to the terms and conditions of stock option agreements covering the grants and Geron’s 2018 Inducement Award Plan, which was adopted December 14, 2018 and provides for the granting of stock options to new employees.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Early clinical data suggest imetelstat may have disease-modifying activity through the suppression of malignant progenitor cell clone proliferation, which allows potential recovery of normal hematopoiesis. Ongoing clinical studies of imetelstat include a Phase 2/3 trial called IMerge in lower risk myelodysplastic syndromes (MDS) and a Phase 2 trial called IMbark in Intermediate-2 or High-risk myelofibrosis. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for the treatment of patients with transfusion-dependent anemia due to lower risk MDS who are non-del(5q) and refractory or resistant to an erythroid stimulating agent

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

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 Onconova Therapeutics, Inc. (Nasdaq: ONTX), a Phase 3 stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS), reported it will host a KOL breakfast for security analysts and institutional investors on Thursday, February 7, 2019, in New York City (Press release, Onconova, JAN 31, 2019, View Source [SID1234532975]).

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The event will include presentations by Lewis Silverman, MD, Associate Professor of Medicine and Director of the Translational Research Center for the Myelodysplastic Syndrome in the Division of Hematology/Oncology/Tisch Cancer Institute and Rajwanth Veluswamy, MD, MSCR, Assistant Professor of Medicine, Thoracic Oncology, Tisch Cancer Institute, Institute for Translational Epidemiology, Icahn School of Medicine, Mount Sinai Health System. In addition, Steven Fruchtman, MD, President and Chief Executive Officer of Onconova, will present a Company overview and detailed information from the Company’s Phase 2 rigosertib trial and the Company’s clinical strategy and near-term milestones.

Presentations will begin at 8:00 a.m. Eastern Standard Time. A live and archived audio and slide webcast of the event will be available on Onconova’s Corporate Events and Presentations page. Following the presentations, all speakers will be available for questions. This on-site event is open to analysts and institutional investors only. Kindly RSVP in advance if you would like to attend in person, as space is limited. To request a spot, please send an email to [email protected].

"We are excited to host this important educational event on recent advances in the treatment of myelodysplastic syndromes and other RAS-mutated cancers, and honored that two prominent research leaders in their field, Dr. Lewis Silverman, a recognized expert in MDS, and Dr. Rajwanth Veluswamy, a prominent researcher and clinician in lung cancer, have agreed to speak," said Steven M. Fruchtman, MD, President and Chief Executive Officer of Onconova. "In addition to the presentations by Drs. Silverman and Veluswamy, we will be discussing our Phase 2 oral rigosertib data, which were recently presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December. We will also discuss future plans and near-term milestones, including pivotal Phase 3 data with IV rigosertib in high-risk MDS patients."

Key findings from the Phase 2 trial data presented at ASH (Free ASH Whitepaper) include:

Overall response rate (ORR) of 90% reported in this multi-institutional Phase 2 study in hypomethylating agent (HMA) naïve patients, including Complete Remission (CR) rate of 34%
Median duration of response for the HMA naïve patients was 12.2 months
Acceptable safety profile when oral rigosertib is combined with the FDA-approved dose of azacitidine
KOL Event Presentation Highlights

Participating Key Opinion Leaders

Lewis R. Silverman, MD, is an Associate Professor of Medicine and Director of the Myelodysplastic Syndrome and Myeloproliferative Disease Program, Mount Sinai School of Medicine, in New York City. He served as Principal Investigator of the randomized Phase 3 trial of azacitidine vs. Supportive Care, which served as the basis for approval of azacitidine by the FDA for MDS in the United States. Dr. Silverman is a pioneer in developing treatments for patients with Higher-risk MDS and has served as a Principal Investigator on Onconova’s rigosertib clinical trial program for treatment of Higher-risk MDS patients.

Rajwanth R. Veluswamy, MD, MSCR, is an Assistant Professor of Medicine, Hematology and Medical Oncology, and a board-certified medical oncologist who specializes in the treatment of lung cancer and other thoracic malignancies. He completed both a clinical fellowship in Hematology and Medical Oncology and a General Medicine research fellowship at the Icahn School of Medicine at Mount Sinai. Prior to this, he completed residency in Internal Medicine at Methodist Dallas Medical Center, and a research internship at MD Anderson Cancer Center in Houston.

New developments in the treatment of MDS and the rigosertib clinical trial program
New approaches for the treatment of RAS-mutated lung cancers
Phase 2 efficacy and safety results of oral rigosertib in combination with azacitidine (Vidaza) in high-risk MDS patients, as reported at the 2018 annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper)
Onconova’s rigosertib clinical program – the broadest in myelodysplastic syndromes

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.