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Revolutionary Lung Cancer Robot Is Unveiled Detecting Earlier And More-Accurate Lung Cancer Diagnosis As Lung Cancer Is #1 Leading Cause Of Cancer-Related Deaths Worldwide In Both Men And Women

On November 7, 2019 Eisenhower Health reported a revolutionary robot can now detect lung cancer at an early stage allowing for more-accurate diagnosis, changing the prognosis for many now diagnosed with the #1 cancer killer worldwide for both men and women (Press release, Eisenhower Health, NOV 7, 2019, View Source [SID1234550848]). Monarch Platform by Auris Health, Inc. has changed the medical detection landscape by viewing inside the lungs and obtaining a tissue sample for biopsy, enabling earlier and more-accurate analysis of small and hard-to-reach nodules in the periphery of the lung. Renowned Eisenhower Health (View Source) in Rancho Mirage, California is one of the first in the U.S., and one of the first in Southern California to now offer this new innovative and state-of-the-art technology in the fight against lung cancer, the #1 cancer killer today.

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Monarch Platform, recently cleared by the U.S. Food and Drug Administration (FDA), integrates the latest advancements in robotics, software, micro-instrumentation, sensing, data science and endoscopy into one platform to improve outcomes and reduce cost. This technology leverages the power of flexible robotics to enable new possibilities in endoscopy, using small cameras and tools to enter the body through its natural openings. It is intended for diagnostic and therapeutic bronchoscopic procedures.

"Lung cancer is now the leading cause of cancer deaths worldwide, in part because it has no symptoms in it’s early stages. This provides improved reach, vision and control for bronchoscopic procedures and is a very important piece of technology that now provides physicians continuous bronchoscope vision throughout the procedure leading to earlier detection, better outcomes, and a more hopeful future for patients," says Justin Thomas, MD, Board Certified Internal Medicine, Pulmonary Disease and Critical Care Medicine and Director of the Bronchoscopy Laboratory at Eisenhower Health.

News Facts:

Lung cancer is #1 global leading cause of cancer-related deaths for both men and women according to the American Cancer Society
Although the disease is rare among those under the age of 45, more people die from lung cancer than from colon, breast and prostate cancers combined, for both smokers and non-smokers, however, the risks are much greater for smokers
More than 90% of people diagnosed with lung cancer do not survive, often due to detection at an advanced stage
A variety of diagnostic options are currently available for lung cancer but all have limitations in accuracy, safety, or invasiveness. Limitations can lead to false positives, false negatives, or side effects such as pneumothorax (collapsed lung) and hemorrhage, which may increase health care costs and extend hospital stays
Monarch Platform was made possible to Eisenhower Health through a generous donation from Circle of Stars, a group of all female philanthropists established by Eisenhower Health’s Foundation.

American Lung Association and the Ad Council Launch New PSAs for Lung Cancer Awareness Month to Promote Lifesaving Screening

On November 7, 2019 To raise awareness of lung cancer—the leading cancer killer of women and men—the American Lung Association and the Ad Council have launched a new phase of work this November during Lung Cancer Awareness Month for their successful "Saved By The Scan" campaign (Press release, American Lung Association, NOV 7, 2019, View Source [SID1234550847]). The campaign, created pro bono by advertising agency Hill Holliday, educates current and former smokers about the low-dose CT scan that can detect lung cancer in the early stages, when the disease is more curable.

Consider the facts about lung cancer:

Lung cancer kills 422 people every day – approximately 18 deaths each hour, or 1 death every 3.4 minutes.
Early detection can save lives. In fact, survival rates are more than four times higher when lung cancer is detected early, but most cases are not diagnosed until later stages.
If the 8 million Americans considered at high-risk were screened, an estimated 48,000 lives would be saved.
Screening is currently underutilized, with less than 5% of those eligible getting screened.
The television spot features a pair of lungs made of matches, which slowly burn and dissolve as a narrator proclaims, "You quit smoking and thought ‘That’s that.’ But here’s the thing about lung cancer: by the time you see the symptoms, it could be too late." Revealing a room with a CT machine at its center, an uplifting voice is then heard saying, "But now, thanks to a new scan, lung cancer can be detected earlier when it is more curable. If you smoked, get scanned," ultimately encouraging current and former smokers to talk to their doctor and visit SavedByTheScan.org.

"Lung cancer screening is a powerful tool, but its lifesaving potential will never be fully realized if it’s underutilized," said Harold P. Wimmer, National President and CEO, American Lung Association. "Spreading the word about screening is essential, and the American Lung Association is proud to continue partnering with the Ad Council and Hill Holliday to raise awareness of this lifesaving test."

This iteration of the campaign raises awareness of the benefits of early detection through lung cancer screening and drives current and former smokers to take a lung cancer screening eligibility quiz at SavedByTheScan.org (SalvaTuPulmon.org in Spanish). The site also provides information about lung cancer screening and insurance coverage, and includes a section for people to share their personal stories about how they were "saved by the scan."

In the two years since "Saved By The Scan" was launched, the campaign has been flooded with stories from people who saw the ads and as a result spoke with their doctors, got the scan and caught the disease early – saving their lives.

"I saw the first Saved By The Scan video while I was watching my favorite show one night. I saw a woman climbing a mountain of cigarette butts and learned that I was potentially at high risk for lung cancer," said Milli Wilson, a 62-year-old singer and now a lung cancer screening advocate. "At my next doctor’s visit, I requested the low-dose CT scan. While I had no symptoms, I was diagnosed with early stage lung cancer and my doctor recommended a procedure to remove the mass. Today I’m a living example of how screening can save your life."

"We continue to hear reports from consumers who saw ‘Saved By The Scan’ materials, got the scan and caught the disease early," said Michelle Hillman, Chief Campaign Development Officer of the Ad Council. "When it comes to the power of communications, there’s nothing greater than saving a life and we are eager to share this new round of work, hopefully inspiring more high-risk individuals to talk to their doctors and get the scan if they are eligible."

To extend the campaign’s message further, the American Lung Association and Ad Council are releasing new TV, print, billboard, bus shelter and digital work.

"When smokers hear the words lung cancer, they are rightfully scared. But with this new scanning technology, there’s hope. With the help of our production partner, Psyop, we created a visually arresting film that will let people know lung cancer doesn’t have to be so terrifying. There’s hope," said Lance Jensen, Hill Holliday Chief Creative Officer. "Hill Holliday is proud to work with the American Lung Association and the Ad Council for the second year in a row on this amazing project."

The "Saved By The Scan" campaign has received more than $46 million in donated media support to date and has collaborated on lung cancer screening content with top-tier content platforms, including Facebook Creative Shop, The New York Post, USA Today and WebMD. The lung cancer screening eligibility quiz on SavedByTheScan.org also continues to effectively reach qualified respondents; there have been more than 291,000 quiz completions since the campaign launch, 90,000 people were found to be at high risk and were encouraged to speak with their doctor. Additionally, awareness of the lung cancer screening method has increased 75% since launch and continues to grow year over year.

The campaign targets the estimated 8 million people in the U.S. who are at high risk for lung cancer and should talk to their doctor about getting screened. A person is considered high risk for lung cancer if they: are between 55–80 years old (or between 55–77 years old and on Medicare), have a 30 pack year history of smoking (this means 1 pack a day for 30 years, 2 packs a day for 15 years, etc.), and are a current smoker, or have quit within the last 15 years.

Individuals who may be at high risk are encouraged to visit SavedByTheScan.org (English) or SalvaTuPulmon.org (Spanish), where they can take the lung cancer screening eligibility quiz and find additional information on the campaign and lung cancer.

Lilly Announces the Pricing Terms of its Cash Tender Offer for Up to $2,000,006,000 Aggregate Principal Amount of Its Outstanding Debt Securities

On November 7, 2019 Eli Lilly and Company (NYSE: LLY) reported the pricing terms of its previously announced cash tender offer for up to $2,000,006,000 aggregate principal amount of its outstanding debt securities (Press release, Eli Lilly, NOV 7, 2019, View Source [SID1234550846]).

Holders of notes who tendered, and did not validly withdraw, their notes on or before 5:00 p.m., New York City time, on November 6, 2019 (the early tender date), and which are accepted for purchase by Lilly, are eligible to receive the total consideration. The total consideration for each series of notes is based on the applicable reference yield plus a fixed spread, in each case as set forth in the table below, and is payable to holders of the notes listed in the table below who validly tendered and did not validly withdraw their notes on or before the early tender date and which are accepted for purchase by Lilly. The reference yields listed in the table were determined at 10:00 a.m., New York City time, on November 7, 2019. The total consideration for each series of notes includes an early tender premium of $30 per $1,000 principal amount of notes validly tendered and not validly withdrawn by such holders and accepted for purchase by Lilly.

(1) Per $1,000 principal amount of notes that are tendered and accepted for purchase.

(2) The total consideration includes the early tender premium of $30 per $1,000 principal amount of notes.

(3) The maximum principal amount of 3.950% Notes due 2049 that will be purchased by Lilly is $200,000,000.

(4) The maximum principal amount of 4.150% Notes due 2059 that will be purchased by Lilly is $200,000,000.

(5)The maximum principal amount of 2.350% Notes due 2022 that will be purchased by Lilly is $250,000,000.

All payments for notes purchased in connection with the early tender date will also include accrued and unpaid interest on the principal amount of notes tendered up to, but not including, the initial settlement date, which is currently expected to be November 8, 2019.

Holders of notes who validly tender their notes after the early tender date will, if such notes are accepted by Lilly, receive the tender consideration, which is equal to the total consideration minus $30 per $1,000 principal amount of notes tendered by such holders and accepted for purchase by Lilly. Accrued and unpaid interest up to, but excluding, the applicable settlement date will be paid in cash on all validly tendered notes accepted and purchased by Lilly in the tender offer.

The tender offer is scheduled to expire at 11:59 p.m., New York City time, on November 21, 2019, unless extended or earlier terminated.

In accordance with the terms of the tender offer, the withdrawal date was 5:00 p.m., New York City time, on November 6, 2019. As a result, tendered notes may no longer be withdrawn, except in certain limited circumstances where additional withdrawal rights are required by law.

The tender offer is being conducted upon the terms and subject to the conditions set forth in the Offer to Purchase, dated October 24, 2019, and the related Letter of Transmittal, each as supplemented by the press release dated November 7, 2019 that increased the size of the tender cap.

Lilly has retained Citigroup Global Markets Inc. and Morgan Stanley & Co. LLC to serve as lead dealer managers for the tender offer and BNP Paribas Securities Corp. and J.P. Morgan Securities LLC to serve as co-dealer managers. Lilly has retained Global Bondholder Services Corporation to serve as tender agent and information agent for the tender offer.

Requests for documents relating to the tender offer may be directed to Global Bondholder Services Corporation by telephone at (866) 470-3900, by email at [email protected] or in writing at 65 Broadway, Suite 404, New York, NY 10006. Questions regarding the tender offer may be directed to Citigroup Global Markets Inc. at (212) 723-6106 or to Morgan Stanley & Co. LLC at (800) 624-1808.

Amyris Continues to Deliver Strong Revenue Growth

On November 7, 2019 Amyris, Inc. (Nasdaq:AMRS), a leader in the development and production of sustainable ingredients for the Health & Wellness, Clean Beauty and Flavors & Fragrances markets, reported preliminary unaudited financial results for the third quarter ended September 30, 2019 (Press release, Amyris Biotechnologies, NOV 7, 2019, View Source [SID1234550845]).

"We are pleased with our Q3 results," said John Melo, President and CEO of Amyris. "We are continuing to double our product revenue year over year and we are on track to exceed our $150 million in revenue guidance for 2019. While capital constraints proved challenging, we were able to carefully manage the business to deliver on significant demand across most of our core products. These capital constraints should be lessened as a result of having achieved SEC filing and Nasdaq compliance, resolving our CVI Heights debt, expanding our gross margin, and continuing the revenue growth of our business over the coming quarters."

Continued Melo, "Our Biossance brand is redefining consumer expectations for high performing, clean and sustainable skin care. Purecane sweetener and Pipette baby care are experiencing excellent early engagement with consumers and the early consumer product ratings for both of these new brands are outstanding. These brands provide clean, sustainable and highly effective products with ingredients produced by Amyris. Products such as these that deliver the best performance in their respective categories is where we excel and where we are capturing a market leadership position. Our fourth quarter has started strong and we are on track for a great finish to 2019.

"Our cannabinoids development program is advancing at a much better rate than we expected, and we will have product available for sampling and early formulation development early in 2020. We remain confident in our ability to commercially launch these cannabinoids in 2020, assuming regulatory conditions have been met. Upon commercial scale, this program should generate significant product revenue as well as royalties to Amyris."

Key Highlights

Other operating and development highlights included:

Successfully launched Pipette brand, the new standard in clean baby care with better-performing, safer products for moms and babies using ingredients from the purest sources.
Biossance clean skin care brand has entered the Australian and New Zealand markets as global expansion continues. Biossance revenue growth is escalating based on growing geographic footprint and number of Sephora stores (now 219 out of 480 total North American stores carrying the full end cap of all product SKUs at quarter end). More recently, Sephora introduced Biossance to the South Korea and Thailand markets furthering the brand’s continued geographic expansion and growth opportunity.
Cannabinoids development progressing better than expected with CBD ahead of target delivery with anticipated commercialization of both CBD and a second unnamed (due to partner’s competitive considerations) cannabinoid molecule, subject to regulatory clearance, available for commercialization in 2020.
Significantly expanded collaboration agreement with Yifan of China.
Closed on financings to support working capital and revenue growth as well as agreement to resolve the CVI Heights unsecured convertible senior notes debt.
Financial Performance (preliminary unaudited)

Third Quarter 2019

GAAP revenue for the third quarter of 2019 was $35.0 million, compared with $14.3 million for the third quarter of 2018. Renewable products revenue (including royalties connected to renewable products we produced and shipped) for the quarter was $19.7 million compared with $9.8 million for the same period a year ago. Grants and collaborations revenue was $15.3 million for the third quarter of 2019 compared with $4.5 million for the year-ago period.
Sales, general and administrative expenses were $33.3 million for the third quarter of 2019 compared with $27.2 million for year-ago period, primarily reflecting Biossance growth and an increase in headcount as well as certain one-time expenses. Research and development expenses of $19.0 million for the quarter were up from $16.4 million for the third quarter of 2018 due to increased R&D costs for product development connected to the increase in collaboration revenue over 2018.
GAAP net loss attributable to Amyris common stockholders for the third quarter of 2019 was $53.2 million, or $0.51 per basic and diluted share, compared with a GAAP net loss attributable to Amyris common stockholders for the third quarter of 2018 of $76.8 million, or $1.26 per basic and diluted share.
Non-GAAP net loss for the third quarter of 2019 was $46.4 million, or $0.45 per basic share. This compared with a non-GAAP net loss of $46.7 million, or $0.77 per basic share for the third quarter of 2018.
Nine Months Ended September 30, 2019

GAAP revenue for the first nine months ended September 30, 2019 was $112.0 million, compared with $47.2 million for the same period of 2018. Product revenue (including royalties connected to renewable products we produced and shipped) more than doubled for the 2019 period versus the prior year period.
GAAP net loss attributable to Amyris common stockholders for first nine months of 2019 was $188.0 million, or $2.06 per basic and diluted share. This compared to a net loss of $175.7 million, or $3.15 per basic and diluted share for the first nine months of 2018.
Non-GAAP net loss for the first nine months of 2019, excluding the non-cash items mentioned, was $119.4 million, or $1.31 per basic share, compared to a non-GAAP net loss for the first nine months of 2018 of $114.3 million, or $2.05 per basic share.
FINANCIAL RESULTS AND NON-GAAP INFORMATION

To supplement our financial results and guidance presented on a GAAP basis, we use non-GAAP measures that we believe are helpful in understanding our results. These non-GAAP measures are among the factors management uses in planning and forecasting future periods. These non-GAAP financial measures also facilitate management’s internal comparisons to Amyris’s historical performance as well as comparisons to the operating results of other companies. Management believes these non-GAAP financial measures are useful to investors because they allow for greater transparency into the indicators used by management to understand, manage, and evaluate our business and make operating decisions. Our non-GAAP financial measures include the following:

Non-GAAP net income (loss) is calculated as GAAP net income/loss excluding impairment, stock-based compensation expense, gain on divestitures, gains and losses from changes in the fair value of derivatives, debt extinguishment costs, and depreciation and amortization.

Non-GAAP financial information is not prepared under a comprehensive set of accounting rules, and therefore, should only be read in conjunction with financial information reported under U.S. GAAP in order to understand Amyris’s operating performance. A reconciliation of the non-GAAP financial measures presented in this release, including non-GAAP net income (loss), to the most directly comparable GAAP financial measure, is provided in the tables attached to this press release.

QUARTERLY CONFERENCE CALL TODAY

Amyris will discuss these results and provide a business update in a conference call scheduled for 4:30 p.m. ET (1:30 p.m. PT) today. Investors may access the call by dialing (877) 870-4263. Participants should ask to be joined to the Amyris, Inc. call.

A live audio webcast of this conference call and accompanying presentation is also available by visiting the investor relations section of the company’s website at View Source A replay of the webcast will be available at the investor relations section of the company’s website approximately two hours after the conclusion of the call.

Proteostasis Therapeutics Reports Third Quarter 2019 Financial Results and Provides Corporate Update

On November 7, 2019 Proteostasis Therapeutics, Inc. (NASDAQ:PTI), a clinical stage biopharmaceutical company dedicated to the discovery and development of groundbreaking therapies to treat cystic fibrosis (CF) and other diseases caused by dysfunctional protein processing, reported financial results for the third quarter ended September 30, 2019 and provided a corporate update (Press release, Proteostasis Therapeutics, NOV 7, 2019, View Source [SID1234550844]).

"With equally strong demand from both US and ex-US clinical centers, we were able to complete enrollment in a little over four months for our 28-day global Phase 2 study of our doublet and triplet cystic fibrosis transmembrane conductance regulator (CFTR) combinations, and we now expect to report top line results later this quarter," said Meenu Chhabra, President and Chief Executive Officer of Proteostasis Therapeutics. "CFTR modulator therapy is on the threshold of transforming CF from a life limiting disease into a chronic condition, increasing life span and quality of life. Yet standard of care CFTR modulator treatment still leaves behind many people with CF, as tolerability, efficacy, access and eligibility remain disparate across patient populations. PTI is committed to delivering additional CFTR modulator treatment options to address these significant unmet needs."

Recent Highlights and Upcoming Milestones

Earlier this week, PTI announced the completion of enrollment in the Company’s 28-day, Phase 2 study evaluating its proprietary doublet (PTI-808 and PTI-801) and triplet (PTI-808, PTI-801 and PTI-428) CFTR modulator combinations, at doses selected based on the totality of dose range finding data from approximately 250 CF subjects studied thus far. The study design targeted up to 30 F508del homozygous and up to 30 F508del heterozygous subjects. Study endpoints include safety, changes in sweat chloride concentration and changes in percent predicted FEV1 (ppFEV1). Due to rapid enrollment from centers in the United States, Canada, Western Europe, and New Zealand, data from the study are now expected in the fourth quarter of 2019 instead of the first quarter of 2020.

Data from the Company’s CF clinical development programs were recently highlighted at the North American Cystic Fibrosis Conference in presentations delivered by Patrick Flume, M.D., Professor of Medicine and Pediatrics, Medical University of South Carolina and Jennifer L. Taylor-Cousar, M.D., M.S.C.S., Associate Professor of Medicine and Pediatrics, and Co-Director and CF Therapeutics Development Network Director of the Adult CF Program at National Jewish Health.

Last month, PTI hosted a cystic fibrosis patient summit on the disparity in access to CFTR modulator treatments. The event featured members of the CF community, including thought leaders, people with CF and CF advocates, and panel discussions focused on current unmet needs in CF.

In July, PTI announced the appointment of Geoffrey S. Gilmartin, M.D., M.M.Sc., as the Company’s Chief Medical Officer (CMO), and Andrey E. Belous, M.D., Ph.D., as a Senior Medical Director. Dr. Gilmartin served previously as the medical lead for the Kalydeco label expansion program at Vertex Pharmaceuticals Inc. Dr. Belous joined the Company from Galapagos NV, where he most recently served as a Medical Director for the Company’s Phase 3 program in Idiopathic Pulmonary Fibrosis (IPF).

Third Quarter 2019 Financial Results

Proteostasis reported a net loss of approximately $12.8 million for the three months ended September 30, 2019, as compared to a net loss of $18.4 million for the same period in the prior year.

There was no revenue for the three months ended September 30, 2019, as compared to $1.1 million for the same period in the prior year. The decrease of $1.1 million is due to the termination of the Company’s collaboration agreement with Astellas.

Research and development expenses for the three months ended September 30, 2019 were $10.1 million, as compared to $15.6 million for the same period in the prior year. The decrease was primarily due to a decrease in clinical-related research activities.

General and administrative expenses for the third quarter of 2019 were $3.2 million, as compared to $4.2 million for the same period in the prior year. The decrease in general and administrative expenses in these periods was due primarily to lower professional fees and facility expenses.

Cash, cash equivalents and short-term investments totaled $77.8 million as of September 30, 2019, compared to $88.0 million as of June 30, 2019. We believe that our existing cash, cash equivalents and short-term investments are sufficient to fund our operations into 2021, allowing us to complete our Phase 2 study and fund activities supporting our pathway to product registrations.