On November 1, 2019 Pulmatrix, Inc. (NASDAQ: PULM) reported its third quarter results (Press release, Pulmatrix, NOV 1, 2019, View Source [SID1234550191]).

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!

Q3 2019 Highlights

Pulmatrix achieved clinical and business milestones which reflect the Company’s progress. These milestones include the following:

Received regulatory approval for Poland and India to commence patient enrollment in its Pulmazole Phase 2 clinical trial – Pulmatrix now has approval in each country that has a clinical trial site
Received US Patent (Pat. No. 10376465) Covering iSPERSE Formulations for Pulmazole Program
"We are excited with the Pulmazole program momentum over the past quarter. With regulatory approval to commence patient enrollment now achieved in all countries, we activated 12 additional study sites in the third quarter and anticipate increased patient enrollments from the 19 study sites now active," said Ted Raad, chief executive officer of Pulmatrix. "In addition to the Pulmazole program progress, we continue to advance the PUR1800 program towards a Phase 1b study start in first half of 2020. Both the Pulmazole Phase 2 and the PUR1800 Phase 1b studies are fully funded with data read-outs expected in the second half of 2020."

Financials

As of September 30, 2019, Pulmatrix had $27.9 million in cash, compared to $2.6 million as of December 31, 2018. In April 2019, Pulmatrix completed a financing that resulted in $16.6 million of total gross proceeds and executed a Definitive Agreement with Cipla for the co-development and commercialization of Pulmazole. In early May 2019, Pulmatrix received a $22 million upfront payment from Cipla. Following the completion of the initiated Phase 2 clinical trial, Pulmatrix and Cipla will equally share costs related to the future development and commercialization of Pulmazole and will equally share worldwide free cash flow from future sales of Pulmazole.

Pulmatrix generated $1.4 million of revenue in the third quarter of 2019, compared to no revenues in the third quarter of 2018. The revenue for the third quarter of 2019 was the result of the recognition of income pursuant to the Cipla Agreement.

Research and development expenses for the third quarter of 2019 were $3.3 million, compared to $3.1 million for the same period last year. The increase was primarily due to increased clinical development costs on the Pulmazole project, partially offset by decreases in clinical development costs on the PUR1800 project and decreased employment costs. General and administrative expenses for the both third quarter of 2019 and for the third quarter of 2018 were $1.8 million.

Net loss was $3.6 million for the third quarter of 2019 and $4.8 million for the third quarter of 2018. The reduction in net loss was primarily due to the increase in revenue recognized.

On November 1, 2019 Nektar Therapeutics (NASDAQ:NKTR) reported that it will webcast an analyst and investor conference call with a melanoma specialist and company management on Sunday, November 10, 2019 at 9:00 a.m. EST in Washington, D.C. during the 2019 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (Press release, Nektar Therapeutics, NOV 1, 2019, https://www.prnewswire.com/news-releases/nektar-therapeutics-to-host-webcast-conference-call-with-melanoma-specialist-for-analysts–investors-during-2019-society-for-immunotherapy-of-cancer-34th-annual-meeting-300949732.html [SID1234550190]). The call will be hosted by Nektar management and will also include Dr. Adi Diab, Assistant Professor, Melanoma Medical Oncology at the University of Texas MD Anderson Cancer Center. The event will follow Dr. Diab’s oral presentation on Saturday evening of clinical data from a cohort of first-line Stage IV metastatic melanoma patients in the PIVOT-02 study of NKTR-214 in combination with nivolumab.

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!

Analyst Call with Melanoma Specialist

Date: Sunday, November 10th at 9:00 a.m. Eastern Standard Time

Dial-in: 877-881-2183 (toll-free) or 970-315-0453 (enter access code 9059428)

Investors and analysts can also view slides and listen to the live audio webcast of the presentation at View Source The event will also be available for replay for two weeks on the company’s website, www.nektar.com.

Details of the oral presentation at SITC (Free SITC Whitepaper) are as follows:

Oral Presentation at SITC (Free SITC Whitepaper)

Date: Saturday, November 9th from 5:15 p.m. – 5:30 p.m. Eastern Standard Time

Session Title: Concurrent Session 310: Combination Phase 1-2 Clinical Trials

Abstract Title: "Clinical activity of BEMPEG plus NIVO in previously untreated patients with metastatic melanoma: updated results from the phase 1/2 PIVOT-02 study"

Abstract: O35

Presenter: Dr. Adi Diab, MD Anderson Cancer Center

Details of the poster presentations are as follows:

Additional Presentations at SITC (Free SITC Whitepaper)

Abstract P619: "NKTR-255, a polymer-conjugated IL-15 receptor agonist, enhances efficacy of therapeutic monoclonal antibodies with ADCC activity in solid tumor models", Kivimäe, S., et al.

Session Date and Time: Friday, November 8th from 7:00 a.m. – 8:00 p.m. Eastern Standard Time

Abstract P623: "Bempegaldesleukin in combination with local radiation and systemic checkpoint blockade induces a robust systemic anti-tumor immunity", Pieper, A., et al.

Session Date and Time: Friday, November 8th from 7:00 a.m. – 8:00 p.m. Eastern Standard Time

Abstract P622: "Characterization and comparison of NKTR-255, a polymer-conjugated IL-15 versus IL-15 superagonist", Miyazaki, T., et al.

Session Date and Time: Saturday, November 9th from 7:00 a.m. – 8:00 p.m. Eastern Standard Time

Details of the Trials in Progress poster presentation are as follows:

Trials in Progress Poster Presentation at SITC (Free SITC Whitepaper)

Abstract P387: "A Multicenter, Open-Label, Exploratory Platform Study to Evaluate Biomarkers and Immunotherapy Combinations for the Treatment of Patients with Metastatic Castration-resistant Prostate Cancer (PORTER)", Nissola, L., et al.

Session Date and Time: Friday, November 8th from 7:00 a.m. – 8:00 p.m. Eastern Standard Time

On November 1, 2019 Encore Medical Education (www.encoremeded.com) reported that it will publish the Official SABCS News highlighting the key findings presented at the 42nd San Antonio Breast Cancer Symposium (SABCS), held on December 10-14, 2019 in San Antonio, Texas, USA (Press release, Encore Medical Education, NOV 1, 2019, View Source [SID1234550189]).

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!

Registration is now open to access the Official Best of SABCS NEWS. Registration is open to HCPs at no fee at www.bestofsabcsnews.com. The first news from General Sessions will be published starting December 12, 2019 at 4:00 pm CDT (UTC -6).

The Official Best of SABCS News English website (www.bestofsabcsnews.com) will include expert video summaries with original presentation slides of the most significant clinical trials presented each day. World-renowned experts such as Drs. Kaklamani, Rugo, and Gradishar among others will report the key takeaways from the major trials, including:

Primary results of SOLTI-1402/CORALLEEN Phase 2 Trial
Primary results from DESTINY-Breast01
Results from POTENT Trial
Interim overall survival analysis of APHINITY (BIG 4-11)
Primary results from IMpassion131
Results from Phase 3 SOPHIA Study
Effects of capecitabine as part of neo-/adjuvant chemotherapy
Results from ATEMPT Study
And many others…
Additional SABCS News language versions will be accessible on View Source

The Official SABCS News program in German
The Official SABCS News program in Spanish
The Official SABCS News program in Japanese
About Best of SABCS programs

The San Antonio Breast Cancer Symposium, now in its 42nd year, is the premier conference for basic, translational, and clinical cancer research professionals. It is well-known for presenting the latest breast cancer data from all over the world.

Best of SABCS programs offer professionals, who are unable to travel to San Antonio, the opportunity to experience and discuss the most current research and advances in the field of breast cancer with colleagues and key opinion leaders with access to the original presentations and posters.

For information on Best of SABCS opportunities, please contact Encore Medical Education LLC, the exclusive agent of the SABCS for the dissemination of Symposium content internationally, at [email protected].

On November 1, 2019 Checkmate Pharmaceuticals Inc., a clinical stage biopharmaceutical company focused upon activation of innate immunity to treat cancer, reported two oral presentations at The 34th Annual Meeting of The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, Checkmate Pharmaceuticals, NOV 1, 2019, View Source [SID1234550187]).

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 Friday, November 8, 2019 at 12:15pm ET, Dr. John M. Kirkwood, professor of medicine, dermatology, and clinical and translational science at the University of Pittsburgh School of Medicine and the Clinical and Translational Science Institute at the University of Pittsburgh, will present late-breaking data from a Checkmate Sponsored Clinical Study of CMP-001 in Combination With Pembrolizumab or as a Monotherapy.

Title: Durable responses in anti-PD-1 refractory melanoma following intra-tumoral injection of a Toll-like receptor 9 (TLR9) agonist, CMP-001, in combination with pembrolizumab
Abstract #: 11548/O87

On Saturday, November 9, 2019 at 6:15pm ET, Dr. Diwakar Davar, an assistant professor of medicine at the University of Pittsburgh School of Medicine, will present data from his investigator-sponsored trial evaluating neoadjuvant treatment with CMP-001 in combination with nivolumab in Stage IIIB/C/D Melanoma.

Title: Phase II Trial of neoadjuvant nivolumab (Nivo) and intra-tumoral (IT) CMP-001 in high risk resectable melanoma (MEL): Preliminary Results
Abstract #: 11648/O34

About CMP-001

CMP‐001 is a first‐in‐class CpG‐A Toll‐like receptor 9 (TLR9) agonist that is encapsulated in a virus‐like particle. CMP‐001 is designed to induce both innate and adaptive anti‐tumor immune responses, thereby converting immunologically "cold" tumors into immunologically "hot" tumors, with the potential to mediate tumor regression. It is the only CpG‐A class TLR9 agonist in clinical trials and differs from other CpG classes in clinical development by having a native DNA backbone that induces the highest levels of type I Interferon (IFN). Based on analyses of gene expression in human tumors showing that increased IFN and related immune gene expression is associated with better response to PD‐1 inhibition, it is believed that this mechanism of action may restore, enable or improve responses to anti‐PD‐1/PD‐L1 therapeutics. CMP‐001 is being evaluated in multiple tumor types to assess safety, activity, alternative routes of administration and combination with other immunotherapies and modalities. For information on CMP‐001 trials that are currently recruiting patients, please visit www.clinicaltrials.gov.

On November 1, 2019 Biodesix, Inc., reported that it has completed acquisition of Oncimmune’s laboratory and incidental pulmonary nodule (IPN) malignancy test in the United States, further extending the company’s blood-based lung cancer diagnostic portfolio (Press release, Biodesix, NOV 1, 2019, View Source [SID1234550186]). The United Kingdom-based company’s U.S. commercial and lab operations, including a Clinical Laboratory Improvement Amendments (CLIA) lab in DeSoto, Kansas, today transitioned to Biodesix. The Kansas lab is the sole U.S. provider of the EarlyCDT Lung test.

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!

"Biodesix is a leader in the development and delivery of blood-based diagnostic solutions for lung cancer. The completion of the acquisition of Oncimmune in the U.S. is emblematic of our continued growth in providing support across the continuum of patient lung care," said David Brunel, CEO of Biodesix. "Oncimmune shares this commitment, and we are proud to continue our partnership. We are both dedicated to robust science and quality, while putting the individual patient experience first."

Biodesix will offer complementary tests that help empower physicians to stratify patients into distinct nodule management pathways. The EarlyCDT Lung test helps physicians determine if an incidental pulmonary nodule (IPN) is potentially cancerous, while the Nodify XL2TM Test is used to help physicians identify those IPNs with a very low risk of cancer. In addition to lung nodule management, the EarlyCDT Lung test may have future utility in lung cancer screening. Results from Early detection of Cancer of the Lung Scotland (ECLS), a randomized controlled study of 12,209 people at high risk of developing cancer, were presented at the International Association for the Study of Lung Cancer’s (IASLC) 2019 World Conference on Lung Cancer in Barcelona.

"We are delighted to be working with Biodesix, a company with a successful track record of commercializing clinical diagnostic lung tests in the U.S. and that is dedicated to improving patient management and outcomes. In the near term, EarlyCDT Lung is a very synergistic addition to the Nodify XL2 test in helping physicians manage IPNs. Longer term, the addition of a screening indication for EarlyCDT Lung in the U.S. will fully realize the value of the test and will ultimately save lives through earlier detection of lung cancer," said Adam M. Hill, M.D., Ph.D., CEO of Oncimmune.