On January 23, 2019 Gossamer Bio, Inc., a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported that it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (the "SEC") in connection with the commencement of a proposed initial public offering of its common stock. Gossamer Bio is offering 14,375,000 shares of its common stock at an initial public offering price of $16.00 per share. Gossamer Bio has applied to list its stock for trading on the Nasdaq Global Select Market under the symbol "GOSS (Press release, Gossamer Bio, JAN 23, 2019, View Source [SID1234532832])." Gossamer Bio expects to grant the underwriters a 30-day option to purchase up to an additional 2,156,250 shares of common stock in connection with the offering. All of the shares are being sold by Gossamer Bio.

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Gossamer Bio has included in the registration statement the proposed public offering price and the number of shares offered and specific language under Rule 473(b) promulgated under the Securities Act of 1933, as amended (the "Securities Act"), such that the registration statement is expected to become automatically effective 20 calendar days after today’s filing, or February 12, 2019, pursuant to Section 8(a) of the Securities Act. Gossamer Bio expects to complete the pricing of the offering on such date. In the event that the federal government and the SEC resume normal operations prior to February 12, 2019, Gossamer Bio will re-evaluate the use of Section 8(a) in connection with the offering.

BofA Merrill Lynch, SVB Leerink, Barclays and Evercore ISI are acting as joint book-running managers for the proposed offering.

A registration statement relating to these securities has been filed with the SEC, but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or 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 such state or jurisdiction.

The proposed offering will be made only by means of a prospectus. Copies of the preliminary prospectus relating to the proposed offering may be obtained, when available, from: BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected]; or from SVB Leerink, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by email at [email protected], or by telephone at (800) 808-7525, ext. 6132; or from Barclays, c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (888) 603-5847, or by email at [email protected]; or from Evercore ISI, Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, or by telephone at (888) 474-0200, or by email at [email protected].

On January 23, 2019 CEL-SCI Corporation (NYSE American: CVM) reported the U.S. Patent and Trademark Office has issued two new U.S. patents for the Company’s LEAPS platform technology (Press release, Cel-Sci, JAN 23, 2019, View Source [SID1234532831]).

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U.S. patent office issues CEL-SCI two patents for its LEAPS vaccine platform technology

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Patent #10,179,174 B2 titled "Method for inducing an immune response and formulations thereof" is focused on influenza
Patent #10,179,164 B2 titled "Method for inducing an immune response for treatment of cancer and autoimmune diseases or conditions"
CEL-SCI’s LEAPS inventions relate to methods for diagnosing, preventing, and treating disease by generating or modulating the immune response through the use of specific peptides. LEAPS is a patented, T-cell modulation, peptide epitope delivery technology that enables CEL-SCI to design and synthesize proprietary peptide immunogens. LEAPS compounds consist of a small T-cell binding peptide ligand linked with a disease-associated peptide antigen.

The LEAPS platform technology is currently being developed as a therapeutic vaccine for rheumatoid arthritis (RA) under a $1.5 million grant from the U.S. National Institutes of Health (NIH). Upon completion of preclinical and Investigational New Drug (IND) enabling studies for the LEAPS-based rheumatoid arthritis vaccine candidate CEL-4000, CEL-SCI intends to file an IND application with the U.S. Food and Drug Administration.

"These patents will help provide the protection we need as development of our LEAPS candidates progress from preclinical to clinical studies and they strengthen our ability to attract potential partners to license this technology," said Dr. Daniel Zimmerman, Senior Vice President of Research, Cellular Immunology.

This platform technology has been shown in several animal models to preferentially direct the immune response to a cellular (e.g. T-cell), humoral (antibody) or mixed pathway and has been shown to involve upregulation of T-regulatory (Treg) cells in some animal models. It has the potential to be utilized in diseases for which antigenic epitope sequences have already been identified, such as: a number of infectious diseases, some cancers, autoimmune diseases (e.g., RA), allergic asthma and allergy, and select CNS diseases (e.g., Alzheimer’s).

On January 23, 2019 Selecta Biosciences, Inc. (Nasdaq: SELB) ("Selecta"), a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance platform technology, ImmTOR (SVP Rapamycin), reported the pricing of an underwritten public offering of 20,000,000 shares of its common stock, at a public offering price of $1.50 per share, before underwriting discounts and commissions (Press release, Selecta Biosciences, JAN 23, 2019, View Source [SID1234532830]). Selecta also granted the underwriters a 30-day option to purchase up to an additional 3,000,000 shares of its common stock. The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be $30.0 million, excluding any exercise of the underwriters’ option to purchase additional shares. All of the shares in the offering are to be sold by Selecta. The offering is expected to close on or about January 25, 2019, subject to customary closing conditions.

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Stifel is acting as book-running manager for the offering. Canaccord Genuity and Needham & Company are acting as co-lead managers, and Janney Montgomery Scott is acting as co-manager for the offering.

Selecta intends to use the net proceeds from the offering, in addition to its existing cash resources, to advance the clinical development of SEL-212, including the completion of a head-to-head superiority trial of SEL-212 compared to the current FDA-approved uricase therapy, completion of the Phase 2 clinical trial and preparations for a Phase 3 clinical trial, for other pre-clinical programs, including gene therapy development work, and for other operational activities and general corporate purposes.

The securities described are being offered by Selecta pursuant to a shelf registration statement on Form S-3 (No. 333-219900), including a base prospectus, which was declared effective by the Securities and Exchange Commission ("SEC") on August 28, 2017. A preliminary prospectus supplement and accompanying prospectus related to and describing the terms of the offering was filed with the SEC on January 17, 2019 and is available on the SEC’s website located at www.sec.gov. The final prospectus supplement and accompanying prospectus related to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus relating to the offering may also be obtained, when available, from: Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at 415-364-2720 or by email at [email protected].

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

On January 23, 2019 Sierra Oncology, Inc. (Nasdaq: SRRA), a clinical stage drug development company focused on advancing targeted therapeutics for the treatment of patients with significant unmet needs in hematology and oncology, reported that its Chief Scientific Officer, Dr. Christian Hassig, will present "Addressing Intrinsic & Acquired PARP Inhibitor (PARPi) Resistance Through Chk1 Inhibition" at the DNA Damage Response (DDR) Therapeutics Summit in Boston, MA (Press release, Sierra Oncology, JAN 23, 2019, View Source [SID1234532829]). The presentation is scheduled for 9:00 am Eastern Time (ET) on January 30, 2019.

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"Targeting components of the DDR machinery that regulate replication stress, such as Chk1, represents an attractive therapeutic strategy to address both intrinsic and acquired PARPi resistance," noted Dr. Hassig. "For example, CCNE1-driven tumors, frequently found in high grade serous ovarian, breast and endometrial cancers, are associated with high replication stress and are generally insensitive to PARPi therapy. We have demonstrated that our Chk1 inhibitor, SRA737, plus low dose gemcitabine is highly effective in CCNE1-amplified preclinical models, where low-dose gemcitabine induces an additional exogenous form of replication stress further enhancing sensitivity to Chk1 inhibition. Moreover, PARPi acquired resistance is driven, in part, through increased replication fork stabilization and partial recovery of homologous recombination repair, two processes regulated by Chk1. As such, our preclinical results suggest that combining PARPi with SRA737 may prove effective in treating this significant emerging clinical issue."

Sierra Oncology is a key sponsor of the DNA Damage Response Therapeutics Summit, which will gather leading stakeholders from across drug development over two days to discuss how to advance the therapeutic potential of targeting DNA repair pathways.

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

Sierra also announced that on January 21, 2019 the Compensation Committee of Sierra Oncology’s Board of Directors granted non-qualified stock options to purchase an aggregate of 141,000 shares of its common stock to 5 new employees under Sierra Oncology’s 2018 Equity Inducement Plan.

The 2018 Equity Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Sierra (or following a bona fide period of non-employment), as an inducement material to such individual’s entering into employment with Sierra, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.

The options have an exercise price of $1.41 per share, which is equal to the closing price of Sierra’s common stock on January 22, 2018, the first day on which markets are open following the date of grant. Each option will vest and become exercisable as to 25% of the shares on the first anniversary of the recipient’s start date, and then will vest and become exercisable as to the remaining 75% of the shares in 36 equal monthly installments following the first anniversary, in each case, subject to each such employee’s continued employment with Sierra on such vesting dates. The options are subject to the terms and conditions of Sierra’s 2018 Equity Inducement Plan, and the terms and conditions of the stock option agreement covering the grant.

On January 23, 2019 Abbott reported financial results for the fourth quarter and full year ended Dec. 31, 2018, and issued financial outlook for 2019 (Press release, Abbott, JAN 23, 2019, View Source [SID1234532828]) (Press release, Abbott, JAN 23, 2019, View Source [SID1234532828]).

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· Full-year 2018 worldwide sales of $30.6 billion increased 11.6 percent on a reported basis and 7.3 percent on an organic* basis.

· Reported diluted EPS from continuing operations under GAAP was $1.31 in the full year 2018 and adjusted diluted EPS from continuing operations, which excludes specified items, was $2.88, reflecting 15.2 percent growth1.

· Fourth-quarter worldwide sales of $7.8 billion increased 2.3 percent on a reported basis and 6.4 percent on an organic basis.

·Reported diluted EPS from continuing operations under GAAP was $0.37 in the fourth quarter and adjusted diluted EPS from continuing operations, which excludes specified items, was $0.81.

·Abbott issues full-year 2019 guidance for organic sales growth of 6.5 to 7.5 percent2, which excludes the impact of foreign exchange, and diluted EPS from continuing operations on a GAAP basis of $1.80 to $1.90. Projected full-year adjusted diluted EPS from continuing operations is $3.15 to $3.25, reflecting double-digit growth at the mid-point.

· In 2018, Abbott generated strong operating cash flow and paid down more than $8 billion of debt.

·During 2018, Abbott returned $2 billion to shareholders in the form of dividends and, in December, announced a 14.3 percent increase in its quarterly common dividend.

·In October, Abbott received U.S. FDA approval of its HeartMate 3TM left ventricular assist device as a destination (long-term use) therapy. In January 2019, Abbott announced U.S. FDA approval of its TactiCathTM Contact Force Ablation Catheter, Sensor EnabledTM, a new catheter designed to help physicians accurately and effectively treat atrial fibrillation, a form of irregular heartbeat.

"2018 was another outstanding year for Abbott," said Miles D. White, chairman and chief executive officer, Abbott. "We exceeded the organic sales growth range we set at the beginning of the year, achieved a number of significant advances in our pipeline, and significantly improved our balance sheet and strategic flexibility. We’re very well-positioned heading into 2019."

FOURTH-QUARTER AND FULL-YEAR 2018 BUSINESS OVERVIEW

Note: Management believes that measuring sales growth rates on an organic basis is an appropriate way for investors to best understand the underlying performance of the business.

For 2018, Organic sales growth:

· Excludes prior year results for the Abbott Medical Optics (AMO) and St. Jude Medical vascular closure businesses, which were divested during the first quarter 2017;

· Excludes the current and prior year results for Rapid Diagnostics, which reflect results for Alere Inc., which was acquired on Oct. 3, 2017;

· Excludes the prior year fourth quarter results for a non-core business within U.S. Adult Nutrition, which was discontinued during the third quarter 2018; and

· Excludes the impact of foreign exchange.

Total YTD 2018 Abbott sales from continuing operations include Other Sales of $62 million.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Fourth-quarter 2018 worldwide sales of $7.8 billion increased 2.3 percent on a reported basis. On an organic basis, worldwide sales increased 6.4 percent. For the full-year 2018, worldwide sales increased 11.6 percent on a reported basis and 7.3 percent on an organic basis. Refer to pages 16 and 17 for a reconciliation of adjusted historical revenue.

Worldwide Nutrition sales decreased 0.4 percent on a reported basis in the fourth quarter. On an organic basis, sales increased 3.6 percent. For the full-year 2018, worldwide sales increased 4.4 percent on a reported basis and 5.2 percent on an organic basis. Refer to pages 16 and 17 for a reconciliation of adjusted historical revenue.

Worldwide Pediatric Nutrition sales increased 1.2 percent on a reported basis in the fourth quarter, including an unfavorable 2.5 percent effect of foreign exchange, and increased 3.7 percent on an organic basis. International pediatric sales decreased 0.8 percent on a reported basis, including an unfavorable 4.5 percent effect of foreign exchange, and increased 3.7 percent on an organic basis. Performance in the quarter was led by above-market growth in the U.S. and strong growth across several markets in Asia and Latin America, including China, Vietnam and Mexico.

Worldwide Adult Nutrition sales decreased 2.5 percent on a reported basis in the fourth quarter, and increased 3.5 percent on an organic basis. International adult sales increased 0.9 percent on a reported basis, including an unfavorable 5.7 percent effect of foreign exchange, and increased 6.6 percent on an organic basis. Worldwide sales performance was led by strong growth of Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading diabetes-specific nutrition brand.

Rapid Diagnostics reflects sales from Alere Inc., which was acquired on Oct. 3, 2017. Organic growth rates above exclude results from the Rapid Diagnostics business.

n/a = Percent change is not applicable as organic results exclude Rapid Diagnostics in 2018.

Rapid Diagnostics reflects sales from Alere Inc., which was acquired on Oct. 3, 2017. Organic growth rates above exclude results from the Rapid Diagnostics business.

n/m = Percent change is not meaningful.

Worldwide Diagnostics sales increased 2.9 percent on a reported basis in the fourth quarter. On an organic basis, sales increased 7.4 percent. For the full-year 2018, worldwide sales increased 33.5 percent on a reported basis and 6.7 percent on an organic basis. Refer to pages 16 and 17 for a reconciliation of adjusted historical revenue.

Core Laboratory Diagnostics sales increased 5.0 percent on a reported basis in the fourth quarter, including an unfavorable 4.4 percent effect of foreign exchange, and increased 9.4 percent on an organic basis, reflecting above-market growth in the U.S. and internationally, where Abbott is seeing continued strong adoption of Alinity TM, Abbott’s family of innovative and highly differentiated diagnostic instruments.

Molecular Diagnostics sales increased 1.4 percent on a reported basis in the fourth quarter, including an unfavorable 2.4 percent effect of foreign exchange, and increased 3.8 percent on an organic basis. Worldwide sales were led by growth in infectious disease testing, Abbott’s core area of focus in the molecular diagnostics market.

Point of Care Diagnostics sales decreased 5.5 percent on a reported basis in the fourth quarter, including an unfavorable 0.4 percent effect of foreign exchange, and decreased 5.1 percent on an organic basis.

Rapid Diagnostics worldwide sales of $548 million were led by infectious disease and cardiometabolic testing.

Established Pharmaceuticals sales decreased 4.8 percent on a reported basis in the fourth quarter, including an unfavorable 8.4 percent effect of foreign exchange, and increased 3.6 percent on an organic basis. As expected, sales growth in the fourth quarter was negatively impacted by a comparison versus the fourth-quarter of 2017, when organic sales grew 14.0 percent.

Key Emerging Markets include India, Brazil, Russia and China along with several additional emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies decreased 6.2 percent on a reported basis in the fourth quarter, including an unfavorable 10.5 percent effect of foreign exchange, and increased 4.3 percent on an organic basis. For the full-year 2018, sales in key emerging markets increased 1.7 percent on a reported basis and 7.4 percent on an organic basis led by double-digit growth in India and China.

Other sales increased 0.2 percent on a reported basis in the fourth quarter and 1.3 percent on an organic basis. For the full-year 2018, Other sales increased 8.1 percent on a reported basis and 5.8 percent on an organic basis.

Worldwide Medical Devices sales increased 6.7 percent on a reported basis in the fourth quarter. On an organic basis, sales increased 9.0 percent. For the full-year 2018, worldwide sales increased 10.1 percent on a reported basis and 9.1 percent on an organic basis. Refer to page 17 for a reconciliation of adjusted historical revenue.

In Electrophysiology, growth was led by strong performance in cardiac mapping and ablation catheters. In January 2019, Abbott announced U.S. FDA approval of its TactiCath Contact Force Ablation Catheter, Sensor Enabled, a new catheter designed to help physicians accurately and effectively treat atrial fibrillation.

Growth in Structural Heart was driven by several product areas across Abbott’s broad portfolio, including AMPLATZERTM PFO Occluder, a device designed to close a hole-like opening in the heart, and MitraClip, Abbott’s market-leading device for the minimally invasive treatment of mitral regurgitation, a leaky heart valve.

In Diabetes Care, sales increased 28.3 percent on a reported basis and 32.4 percent on an organic basis in the fourth quarter, led by rapid market uptake of FreeStyle Libre, Abbott’s revolutionary sensor-based continuous glucose monitoring system, which removes the need for routine fingersticks3 for people with diabetes.

ABBOTT ISSUES GUIDANCE FOR 2019

Abbott is issuing full-year 2019 guidance for organic sales growth of 6.5 to 7.5 percent2, which excludes the impact of foreign exchange, and diluted earnings per share from continuing operations under Generally Accepted Accounting Principles (GAAP) of $1.80 to $1.90. Abbott forecasts net specified items for the full year 2019 of $1.35 per share. Specified items include intangible amortization expense, acquisition-related expenses, charges associated with cost reduction initiatives and other expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $3.15 to $3.25 for the full year 2019.

Abbott is issuing first-quarter 2019 guidance for diluted earnings per share from continuing operations under GAAP of $0.25 to $0.27. Abbott forecasts specified items for the first quarter 2019 of $0.35 per share primarily related to intangible amortization, acquisition-related expenses, cost reduction initiatives and other expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $0.60 to $0.62 for the first quarter.

ABBOTT ANNOUNCES INCREASE IN QUARTERLY DIVIDEND

Dec. 14, 2018, the board of directors of Abbott increased the company’s quarterly dividend to $0.32 per share from $0.28 per share, an increase of 14.3 percent. Abbott’s cash dividend is payable Feb. 15, 2019, to shareholders of record at the close of business on Jan. 15, 2019. This marks the 380th consecutive quarterly dividend to be paid by Abbott.

Abbott has increased its dividend payout for 47 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.