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Light Chain Bioscience – A brand of Novimmune SA

On July 18, 2019 NovImmune reported that it is excited to be launching the all new company website and branding (Press release, Light Chain Bioscience, JUL 18, 2019, View Source [SID1234573675]).

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Following the successful divestment of EmaCo AG, a newly established company owning emapalumab and related assets to Sobi on 18 July 2019, NovImmune underwent major rebranding activities.

NovImmune SA will continue the successful legacy of 20+ years of antibody expertise and focus on its bispecific technology and associated programs and will rebrand as:

«Light Chain Bioscience – A brand of Novimmune SA»

The brand Light Chain Bioscience brings to life the research and development of novel multi-specific antibodies that rely on their light chain for their function.

A key distinctive feature of these multispecific antibodies is their native human structure, making them well tolerated and easy to develop.

Moleculin Announces Annamycin in Acute Myeloid Leukemia in Poland Advances to 3rd Cohort

On July 18, 2019 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported additional positive interim safety and efficacy data from its ongoing open label, single arm Phase 1/2 study of Annamycin in Poland (Press release, Moleculin, JUL 18, 2019, View Source [SID1234537617]). Three patients were treated at dose level of 150 mg/m2 with no drug-related adverse events, including no signs of cardiotoxicity. The results for all 3 patients were reviewed by the Drug Safety Review Committee, which determined that the trial could progress to the next higher dose level of 180 mg/m2. To date in Poland, one patient experienced grade 2 mucositis (which resolved to grade 1 within 2 days) and no other adverse events related to Annamycin have been reported. One patient has completed treatment in the 120 mg/m2 (second) cohort in the Company’s parallel US clinical trial (the US trial started at a lower initial dose of 100 mg/m2).

"Recruitment in Poland continues to move rapidly," commented Walter Klemp, Moleculin’s Chairman and CEO. "And, moving beyond the 150 mg/m2 dosing level is quite significant, as the prior developer of Annamycin was unable to dose beyond this level. We remain optimistic that new methods for reducing the onset of mucositis (the dose limiting toxicity for Annamycin in prior clinical trials) will allow us to safely increase dosing to 180 mg/m2 or potentially even higher."

Mr. Klemp continued: "It’s also important to remind people that one of the advantages we believe Annamycin will offer is a lack of cardiotoxicity. We continue to see no evidence of cardiotoxicity in any of the patients treated thus far. We intend to advance the clinical study of Annamycin with the goal of ultimately demonstrating the drug’s safety and effectiveness to support regulatory approval in both the US and European Union."

Study Design

The Company is studying Annamycin in both the US and Poland in open label, single arm clinical trials to assess the safety and efficacy of Annamycin for the treatment of adults with relapsed or refractory acute myeloid leukemia. Both the US and Polish trials have the same study design, providing for a Phase 1 intended to establish a "Recommended Phase 2 Dose," ("RP2D") with cohorts of 3 patients each where the first cohort starts at a low beginning dose and each successive cohort receives the next higher dose level until "dose limiting toxicities" prevent further increases. In the case of cohort 1 in the US, one patient did not complete the evaluation protocol, so a fourth patient was added to complete that cohort.

A key difference in the US is that the starting dose was 100 mg/m2, whereas, in Poland, the starting dose was 120 mg/m2. Having completed the first cohort in the US, the Company is seeking patients for the second cohort at a dose level of 120 mg/m2 and 1 of the 3 patients required to fill the cohort has now been treated. Now that 3 patients have completed the safety evaluation period of the second cohort in Poland,

the third cohort will begin there at a dose level of 180 mg/m2. Once the Company establishes an RP2D, the intent is for each trial to advance to a Phase 2 arm planned to assess the safety and efficacy of Annamycin in 21 additional patients.

The US trial also differs from the Polish trial in that the FDA would like to review safety data relating to cardiotoxicity from patients treated prior to advancing beyond 120 mg/m2. The Company believes that the additional patient safety data gained from the Polish trial will assist in the FDA’s review of cardiac safety.

Atara Biotherapeutics Announces Proposed Offering of Common Stock

On July 18, 2019 Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported that it has commenced an underwritten public offering of $125,000,000 of shares of its common stock (Press release, Atara Biotherapeutics, JUL 18, 2019, View Source [SID1234537613]). In connection with the proposed offering, Atara Biotherapeutics expects to grant the underwriters a 30-day option to purchase up to an additional $18,750,000 of shares of its common stock at the public offering price, less the underwriting discounts and commissions. All of the shares in the proposed offering will be sold by Atara Biotherapeutics. The proposed offering is subject to market and other conditions, and there can be no assurances as to whether or when the proposed offering may be completed, or as to the actual size or terms of the proposed offering.

Citigroup, Goldman Sachs & Co. LLC and Cowen are acting as joint book-running managers for the proposed offering. Mizuho Securities and Canaccord Genuity are acting as co-managers.

The shares described above are being offered by Atara Biotherapeutics pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Atara Biotherapeutics with the Securities and Exchange Commission (the "SEC") and that became automatically effective on February 27, 2018. A preliminary prospectus supplement and accompanying prospectus relating to the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the proposed offering, when available, may be obtained from: Citigroup, by mail at Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146; Goldman Sachs & Co. LLC, by mail at Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at 1-866-471-2526, or by email at [email protected]; or Cowen, by mail at Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at 1-631-592-5973, or by email at [email protected]. The final terms of the proposed offering will be disclosed in a final prospectus supplement to be filed with the SEC.

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.

Danaher Reports Second Quarter 2019 Results

On July 18, 2019 Danaher Corporation (NYSE: DHR) reported results for the second quarter 2019. For the quarter ended June 28, 2019, net earnings were $731.3 million, or $0.97 per diluted share which represents a 2.0% year-over-year increase from the comparable 2018 period (Press release, Danaher, JUL 18, 2019, View Source [SID1234537612]).

Non-GAAP adjusted diluted net earnings per share were $1.19 which represents a 3.5% increase over the comparable 2018 period. For the second quarter 2019, revenues increased 3.5% year-over-year to $5.2 billion, with non-GAAP core revenue growth of 5.5%.

Operating cash flow for the second quarter 2019 was $1.2 billion and non-GAAP free cash flow was $1.0 billion.

For the third quarter 2019, the Company anticipates that diluted net earnings per share will be in the range of $0.86 to $0.89 and non-GAAP adjusted diluted net earnings per share will be in the range of $1.12 to $1.15.

For the full year 2019, the Company now anticipates that diluted net earnings per share will be in the range of $3.38 to $3.43 versus previous guidance of $3.34 to $3.42. The Company is raising its 2019 non-GAAP adjusted diluted net earnings per share guidance to $4.75 to $4.80 versus previous guidance of $4.72 to $4.80.

Thomas P. Joyce, Jr., President and Chief Executive Officer, stated, "We are very pleased by our strong start to 2019, with our team’s execution driving another quarter of 5.5% core revenue growth. We believe that recent investments in innovation and commercial initiatives contributed to share gains in many of our businesses. Combined with solid operating margin expansion and cash flow generation, the strength of our results is a testament to our team and the power of the Danaher Business System."

Joyce added, "We continue to make progress on our anticipated acquisition of GE Biopharma and the planned initial public offering of our Dental business, which will be called Envista. Both transactions remain on track relative to our previously indicated expectations. We are excited about the opportunities ahead, and we believe the combination of our differentiated portfolio and our team’s DBS-driven execution positions us well to continue our strong performance through 2019 and beyond."

Danaher will discuss its results during its quarterly investor conference call today starting at 8:00 a.m. ET. The call and an accompanying slide presentation will be webcast on the "Investors" section of Danaher’s website, www.danaher.com, under the subheading "Events & Presentations." A replay of the webcast will be available in the same section of Danaher’s website shortly after the conclusion of the presentation and will remain available until the next quarterly earnings call.

The conference call can be accessed by dialing 866-503-8675 within the U.S. or by dialing +1 786-815-8792 outside the U.S. a few minutes before the 8:00 a.m. ET start and telling the operator that you are dialing in for Danaher’s investor conference call (access code 8699843). A replay of the conference call will be available shortly after the conclusion of the call and until July 25, 2019. You can access the replay dial-in information on the "Investors" section of Danaher’s website under the subheading "Events & Presentations." In addition, presentation materials relating to Danaher’s results have been posted to the "Investors" section of Danaher’s website under the subheading "Quarterly Earnings."

ABOUT DANAHER

Danaher is a global science and technology innovator committed to helping its customers solve complex challenges and improving quality of life around the world. Its family of world class brands has leadership positions in the demanding and attractive health care, environmental and applied end-markets. With more than 20 operating companies, Danaher’s globally diverse team of approximately 71,000 associates is united by a common culture and operating system, the Danaher Business System, and our Shared Purpose, Helping Realize Life’s Potential. For more information, please visit www.danaher.com.

NON-GAAP MEASURES

In addition to the financial measures prepared in accordance with generally accepted accounting principles (GAAP), this earnings release also contains non-GAAP financial measures. Calculations of these measures, the reasons why we believe these measures provide useful information to investors, a reconciliation of these measures to the most directly comparable GAAP measures and other information relating to these non-GAAP measures are included in the supplemental reconciliation schedule attached.

ViewRay Announces Conference Call and Webcast of Second Quarter 2019 Financial Results to be Held After Market on August 8, 2019

On July 18, 2019 ViewRay, Inc. (Nasdaq: VRAY) reported that details relating to the release of its second quarter 2019 financial results (Press release, ViewRay, JUL 18, 2019, View Source [SID1234537611]).

ViewRay will hold a conference call to discuss results on Thursday, August 8, 2019 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in numbers are (844) 277-1426 for domestic callers and (336) 525-7129 for international callers. The conference ID number is 1695303. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at www.viewray.com.

After the live webcast, a replay of the webcast will remain available online on the investor relations page of ViewRay’s corporate website, www.viewray.com, for 14 days following the call. In addition, a telephonic replay of the call will be available until August 15, 2019. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the conference ID number 1695303.