On November 7, 2019 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage, immunotherapy and targeted oncology company, reported financial results and recent corporate highlights for the third quarter ended September 30, 2019 (Press release, Checkpoint Therapeutics, NOV 7, 2019, View Source [SID1234550712]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We achieved a key inflection point in September with the presentation of positive interim clinical results for cosibelimab (formerly CK-301), our fully human anti-PD-L1 antibody, at the European Society for Medical Oncology ("ESMO") Congress 2019. These compelling clinical data demonstrated anti-tumor activity across multiple advanced cancers, with a 50% objective response rate observed in cutaneous squamous cell carcinoma ("CSCC"), a 40% objective response rate observed in non-small cell lung cancer ("NSCLC"), as well as a well-tolerated safety profile across all cohorts. These results highlight the potential of cosibelimab to be potentially differentiated from other drugs in its class, in addition to our intended commercial strategy to position cosibelimab as a lower-cost alternative to available anti-PD-1/L1 mAbs. Enrollment in this trial is ongoing and, with additional data, could support the submission of an initial Biologics License Application ("BLA") for cosibelimab in CSCC. We also look forward to soon reporting additional clinical data for CK-101, our novel, oral, third-generation epidermal growth factor receptor ("EGFR") inhibitor, in order to support the potential initiation of a Phase 3 clinical trial in first-line EGFR mutation-positive NSCLC."

Financial Results:

Cash Position: As of September 30, 2019, Checkpoint’s cash and cash equivalents totaled $13.1 million, compared to $13.2 million as of June 30, 2019, and $22.0 million as of December 31, 2018, a decrease of $0.1 million for the quarter and a decrease of $8.9 million year-to-date.
R&D Expenses: Research and development expenses for the third quarter of 2019 were $3.9 million, compared to $7.8 million for the third quarter of 2018, a decrease of $3.9 million. Research and development expenses for the third quarter of 2019 included $0.2 million of non-cash stock expenses, compared to $0.6 million in stock compensation expense for the third quarter of 2018. The Company expects that for the balance of 2019, research and development expenses will continue to remain lower than the comparable period in 2018.
G&A Expenses: General and administrative expenses for the third quarter of 2019 were $1.6 million, compared to $1.5 million for the third quarter of 2018, an increase of $0.1 million. General and administrative expenses for the third quarters of 2019 and 2018 each included $0.7 million of non-cash stock expenses.
Net Loss: Net loss attributable to common stockholders for the third quarter of 2019 was $5.2 million, or $0.15 per share, compared to a net loss of $9.3 million, or $0.32 per share, for the third quarter of 2018. The net loss for the third quarter of 2019 included $0.9 million of non-cash stock expenses, compared to $1.3 million for the third quarter of 2018.

On November 7, 2019 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that management will present at the Credit Suisse Healthcare Conference on Tuesday, November 12, 2019 at 1:30 p.m. ET (Press release, Vertex Pharmaceuticals, NOV 7, 2019, View Source [SID1234550792]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Management’s remarks will be available live through Vertex’s website at www.vrtx.com in the "Investors" section under the "News and Events" page. A replay of the conference webcast will be archived on the company’s website.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

On November 7, 2019 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that the company is scheduled to participate in the Stephens 2019 Nashville Investment Conference in Nashville, Tennessee (Press release, Ligand, NOV 7, 2019, https://investor.ligand.com/news/detail/396/ligand-to-participate-in-the-stephens-2019-nashville-investment-conference [SID1234550602]). The fireside chat is scheduled to take place on Wednesday, November 13, 2019 at 3:30 p.m. Eastern Time. Matt Korenberg, CFO will attend for Ligand.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On November 7, 2019 eGenesis, a biotechnology company utilizing breakthrough gene editing technologies for the development of effective human-compatible organs to address the global organ shortage, successfully completed a USD 100 million Series B financing (Press release, Bayer, NOV 7, 2019, View Source [SID1234550648]). The financing was led by Fresenius Medical Care Ventures (FMCV), with participation from new investors including Leaps by Bayer and Wellington Partners. Existing investors, including, but not limited to, ARCH Venture Partners, Biomatics Capital, Alta Partners, and Khosla Ventures, all participated.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

eGenesis is committed to helping solve the global organ shortage by pioneering an alternative source of human-compatible organs. It is currently estimated that there are between 1.5 to 2 million people on the organ transplant waitlist globally. This financing will enable the acceleration of the eGenesis kidney xenotransplant program into the clinic, as well as support advancement of a range of other xenotransplant programs across islet cell, liver, heart, and lung. The focus of the company is to rapidly advance an entirely new set of options across the transplantation field.

"Leaps by Bayer" is built for the specific purpose of tackling fundamental breakthrough solutions in the fields of health and nutrition with the help of new technologies. Sustainable organ replacement is one of the ten areas of engagement and investment (called "leaps") for Leaps by Bayer. "We believe eGenesis is poised to revolutionize the entire organ transplantation market. This could save lives in a way that was previously not thought possible just a few years ago," noted Jürgen Eckhardt, Head of Leaps by Bayer. Eckhardt and Dr. Lucio Iannone will represent Leaps by Bayer by actively participating on the eGenesis Board of Directors.

"eGenesis has a bold vision to solve the organ shortage crisis through xenotransplantation," said Paul Sekhri, president and chief executive officer of eGenesis. "As we look ahead, we are proud to partner with Leaps by Bayer who has demonstrated a commitment for ushering in paradigm-shifting advances in the life sciences that will bring forward tomorrow’s medicines."

Kemal Malik, Member of the Board of Management, Bayer AG, and responsible for Innovation, added, "Within Bayer’s innovation strategy, Leaps is driving breakthrough invention at Bayer and the eGenesis approach represents a truly transformational option, addressing the unmet medical need of patients suffering from a disease where organ transplantation could be a potentially lifesaving treatment."

Leaps by Bayer, a unit of Bayer is investing into solutions to some of today’s biggest challenges in health and agriculture. Previous Leaps investments into potentially breakthrough technologies include Casebia Therapeutics (Cure genetic diseases), BlueRock Therapeutics (Regenerate lost tissue function), Joyn Bio (Reduce environmental impact of farming) as well as Khloris, Century Therapeutics and Pyxis Oncology (Prevent and cure cancer).

About Transplantation and Xenotransplantation
The demand for lifesaving organs far outnumbers available supply. In the U.S. today, 20 people die every day due to lack of available organs for transplant and every 10 minutes an additional name is added to the national transplant waitlist. There are more than 113,000 people in need of a lifesaving organ transplant in the U.S. alone. Globally, there are an estimated 1.5 to 2 million people on an organ waitlist.

The concept of xenotransplantation, or the transplantation of organs, tissue and cells from one species into another, has been explored for several decades, with the pig considered the most suitable donor for humans. However, until the development of modern gene editing tools, incompatibilities related to virology and immunology have prevented porcine organ xenotransplantation from entering clinical development