Cancer Genetics, Inc. Announces Closing of Public Offering of Common Stock

On January 31, 2019 Cancer Genetics, Inc. (Nasdaq: CGIX), a leader in enabling precision medicine for immuno-oncology and genomic medicine through molecular markers and diagnostics, reported the closing and funding of its previously announced public offering of 15,217,392 shares of its common stock ("Common Stock") at a public offering price of $0.23 per share (Press release, Cancer Genetics, JAN 31, 2019, View Source [SID1234533043]). The Company’s Chairman, John Pappajohn; board director, Ted Cannon; Chief Financial Officer, Glenn Miles; and President and Chief Executive Officer, John A. Roberts, each purchased shares in the offering. The gross proceeds from the offering, before deducting the underwriting discounts and commissions and estimated offering expenses are approximately $3.5 million.

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H.C. Wainwright & Co. acted as the sole placement agent for the offering.

Cancer Genetics intends to use the net proceeds from this offering to pay any amounts required by its lenders and if any proceeds remain available, to pay certain costs previously incurred in connection with its ongoing strategic initiatives and to fund working capital and other general corporate purposes.

A shelf registration statement on Form S-3 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 June 5, 2017. 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 located 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] or at the SEC’s website at View Source

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 state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any 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.

Geron Announces Expansion of Leadership Team with Appointment of Chief Medical Officer

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

Agios to Webcast Conference Call of Fourth Quarter and Full Year 2018 Financial Results on February 14, 2019

On January 31, 2019 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported that the company will host a conference call and live webcast on Thursday, February 14, 2019 at 8:00 a.m. ET to report its fourth quarter and full year 2018 financial results and other business highlights (Press release, Agios Pharmaceuticals, JAN 31, 2019, http://investor.agios.com/news-releases/news-release-details/agios-webcast-conference-call-fourth-quarter-and-full-year-2018 [SID1234533007]).

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A live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The conference call can be accessed by dialing 1-877-377-7098 (domestic) or 1-631-291-4547 (international) and referring to conference ID 9886713. The webcast will be archived and made available for replay on the company’s website beginning approximately two hours after the event.

Alnylam to Webcast Conference Call Discussing Fourth Quarter and Full Year 2018 Financial Results

On January 31, 2019 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, reported that it will report financial results for the fourth quarter and year ending December 31, 2018 on Thursday, February 7, 2019, after the U.S. financial markets close (Press release, Alnylam, JAN 31, 2019, View Source;p=RssLanding&cat=news&id=2385616 [SID1234533005]).

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Management will provide an update on the Company and discuss fourth quarter and year-end 2018 results as well as expectations for the future via conference call on Thursday, February 7, 2019 at 4:30 pm ET. To access the call, please dial 800-667-5617 (domestic) or 334-323-0509 (international) five minutes prior to the start time and refer to conference ID 4263166. A replay of the call will be available beginning at 7:30 pm ET on the day of the call. To access the replay, please dial 888-203-1112 (domestic) or 719-457-0820 (international) and refer to conference ID 4263166.

A live audio webcast of the call will be available on the Investors section of the Company’s website, www.alnylam.com. An archived webcast will be available on the Alnylam website approximately two hours after the event.

Chugai Announces 2018 Full Year Results and Forecasts for 2019

On January 31, 2019 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the fiscal year ended December 31, 2018 and forecasts for the fiscal year ending December 31, 2019 (Press release, Chugai, JAN 31, 2019, View Source [SID1234533002]).

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In 2018, both revenues and profits increased driven by: contribution from new products including the hemophilia A treatment Hemlibra and the immune checkpoint inhibitor Tecentriq; steady growth of mainstay products in Japan and overseas; and an increase in royalties and other operating income primarily due to one-time income from the transfer of long-term listed products and out-licensing of an investigational drug for diabetes. Revenues, operating profit and net income achieved record-high for two consecutive years. Reflecting the favorable results and based on our dividend policy, year-end dividends for the fiscal year 2018 are planned to be ¥55 per share, which is higher by ¥10 as increased regular dividend and ¥14 as special dividends than the forecast at the beginning of the fiscal year. As a result, total dividends for the fiscal year will be ¥86 per share, and the Core dividend payout ratio is 48.7%.

For the fiscal year 2019, Chugai expects growth in both revenues and profits owing to increases in overseas sales with a steady growth in Alecensa export to Roche and the continued growth in sales quantity of Actemra, and increases in royalties mainly for Hemlibra, while domestic sales are expected to decrease due to the negative impact from competition including generic competition and the NHI drug price revisions. Chugai expects total estimated dividends of ¥96. Accordingly, the forecast for the Core dividend payout ratio is 48.5%.

Domestic sales excluding Tamiflu were almost steady at ¥389.2 billion (+0.2%). Contribution from new products including the hemophilia A treatment Hemlibra created by Chugai and the immune checkpoint inhibitor Tecentriq, and the steady growth of mainstay products in bone and joint diseases area have offset the negative impact of the NHI drug price revisions. However, overall domestic sales slightly decreased to ¥399.9 billion (-1.3%) because Tamiflu sales for government stockpiles decreased remarkably.
Oncology: Sales were almost flat compared with the previous year. Sales of Tecentriq that was launched in April totaled ¥9.1 billion and sales of the mainstay product ALK inhibitor Alecensa reported steady growth. However, sales of Herceptin and Rituxan decreased mainly due to the NHI drug price revisions in April.
Bone and joint diseases: Sales increased due to the robust sales of mainstay products such as the anti-rheumatic agent Actemra and the osteoporosis agent Edirol.
Renal diseases: Sales declined mainly due to decreases in sales of the secondary hyperparathyroidism treatment Oxarol and the renal anemia agent Mircera, primarily as a result of the NHI drug price revisions in April.
Others: Sales recorded a double-digit decline due primarily to the long-term listed products transferred to Taiyo Pharma Co., Ltd., despite sales of ¥3.0 billion for Hemlibra launched in May experienced favorable market penetration.
Overseas sales increased to ¥127.9 billion (+36.1%) due to increases in exports of Alecensa and Actemra to Roche.
Royalties and other operating income increased remarkably to ¥51.9 billion (+48.7%) due to one-time income primarily from the transfer of long-term listed products to Taiyo Pharma Co., Ltd. and out-licensing of an investigational drug for diabetes OWL833 to Eli Lilly and Company.

Cost of sales ratio to revenues improved mainly due to a change in product mix and increases in royalties and other operating income. As a result, Core gross profit totaled ¥317.9 billion (+13.0%), achieving a double-digit growth.
Core operating expenses amounted to ¥187.6 billion (+5.3%) with a single-digit growth rate, contrary to Core gross profit. The increase in Core operating expenses was mainly driven by R&D expenses. As a result, Core operating profit totaled ¥130.3 billion (+26.3%). Core operating profit ratio to revenues was 22.5%, improved by 3.2 percentage points from the previous year.
Forecast for the fiscal year ending December 31, 2019
[Revenues]
Domestic sales are forecasted to decrease to ¥389.1 billion (-2.7%) compared to the previous year. The negative impact from competition including generic competition and the NHI drug price revisions will exceed the sales growth in new products including Hemlibra and Tecentriq.
Overseas sales are expected to increase to ¥138.9 billion (+8.6%), reflecting the steady growth in Alecensa export to Roche and the continued growth in sales quantity of Actemra.
Royalties and other operating income is expected to increase to ¥64.5 billion (+24.3%). Royalty and profit-sharing income is forecasted to rise to ¥53.5 billion (+122.0%) because of increases in royalties from Roche mainly for Hemlibra. Other operating income is expected to decrease to ¥11.0 billion (-60.6%) mainly because one-time income was recorded in the previous year from the transfer of long-listed products.
[Core operating profit]
Core gross profit is expected to rise to ¥340.0 billion (+7.0%) mainly due to the increase in revenues.
Core operating expenses are expected to amount to ¥197.0 billion (+5.0%). Particularly, R&D expenses are expected to increase to ¥102.0 billion (+8.3%).
As a result, Core operating profit is expected to be ¥143.0 billion (+9.7%).
About Core results
Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting non-Core items to IFRS results, and are consistent with the Core concept disclosed by Roche. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and as the basis for payment-by-results such as a return to shareholders