On August 7, 2020 Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE technology, reported its Q2 2020 financial results and provides a business update (Press release, Pulmatrix, AUG 7, 2020, View Source [SID1234563191]).

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"The second quarter has been marked with important progress for our strategic partnership with Sensory Cloud," said Ted Raad, Chief Executive Officer of Pulmatrix. "The recent publication of data demonstrating the ability of FEND to suppress the exhalation of respiratory droplets, which can transmit airborne infections, leaves us confident that our proprietary NasoCalm technology can be applied to provide an important new OTC hygiene option for addressing the spread of COVID-19. We look forward to an anticipated commercial launch in the fall of this year and believe the royalty stream from the commercialization of FEND, upon the commencement of sales, could be an important source of non-dilutive funding to fuel our internal development pipeline."

Mr. Raad continued, "Together with our partner Cipla, we decided to end our Phase 2 clinical study of Pulmazole for the treatment of asthma patients with ABPA. We are leveraging this pause in our development program to prepare for a new Phase 2b study of longer study duration and inclusion of efficacy endpoints that are intended to better inform and propel the program forward. While we prepare for a potential study start in 3Q 2021, we are working with Cipla to amend the Phase 2 development and commercialization agreement to include the new Phase 2b development plan and budget. In our partnership with Johnson & Johnson, we achieved a significant milestone with the MRHA approval of the PUR1800 Ph1b study, enabling us to start the study in 2H 2020."

Q2 and Recent Highlights:

Announced partner Sensory Cloud’s progress towards the commercialization of FEND, an over the counter (OTC) nasal hygiene product that is comprised of proprietary Pulmatrix NasoCalm formulations (PUR003 and PUR006) of sodium chloride and calcium chloride salts licensed from Pulmatrix. FEND is designed to provide, among other potential benefits, an ability to suppress the exhalation of droplets of airway lining fluid, which can transmit airborne infection with an anticipated commercial launch in the fall of 2020. Pulmatrix will receive escalating royalties from worldwide revenues upon commencement of sales.
Announced the publication of NasoCalm development data, along with data generated by Sensory Cloud, in the Quarterly Reviews of Biophysics, demonstrating a reduction in airborne particles in exhaled air over time following FEND administration. These data suggest FEND provides hygienic benefit that may augment current social distancing and hygiene measures for addressing the spread of COVID-19 and other airborne pathogens.
Due to past enrollment delays, coupled with the impact of the COVID-19 pandemic on enrollment, Pulmatrix and Cipla ended its Phase 2 clinical study of Pulmazole for the treatment of allergic bronchopulmonary Aspergillosis (ABPA). Pulmatrix intends to initiate a new Phase 2b clinical study in 3Q 2021 with up to four months of dosing and the addition of trial efficacy endpoints, replacing the Phase 2 clinical study which focused on safety and tolerability endpoints. Top-line data is anticipated 18 months after site activation start. Due to the changes in the development of Pulmazole, Pulmatrix and Cipla are negotiating amendments to the development and commercialization agreement.
The Medicines and Healthcare Products Regulatory and Approval Agency (MHRA) approved in July the PUR1800 Ph1b clinical trial, enabling Pulmatrix plans to begin the study in the United Kingdom during 2H 2020.
Appointed Chris Cabell, M.D. to the Pulmatrix Board of Directors. As current Head of Research & Development and Chief Medical Officer at Arena Pharmaceuticals, with prior experience as Chief Medical and Scientific Officer at Quintiles, Dr. Cabell possesses the critical skills that will be beneficial in the strategy for Pulmatrix pipeline programs. Steven Gills, Ph.D., will step down from the Board of Directors on September 1, 2020.
Strengthened balance sheet with gross proceeds from a registered direct offering in April and a warrant exercise transaction in July, in order to support ongoing preclinical and anticipated clinical programs for Pulmazole, PUR1800, other pipeline assets and general working capital needs.
Financials

As of June 30, 2020, Pulmatrix had $27.3 million in cash compared to $23.4 million as of December 31, 2019.

Pulmatrix generated $3.5 million of revenue in the second quarter of 2020, compared to $4.8 million in the second quarter of 2019. The revenue for the first quarter of 2020 was the result of the collaboration and licensing agreements with Cipla and JJEI, respectively.

Research and development expenses for the second quarter of 2020 and 2019 were $3.2 million. Included in the second quarter of 2020 costs were pre-clinical toxicology costs for the PUR1800 program and clinical study costs incurred for the Phase 2 Pulmazole study.

General and administrative expenses for the second quarter of 2020 were $1.5 million compared to $3.1 million in the second quarter of 2019. The decrease of $1.6 million was due to decreased spend in employment costs primarily as a result of reduced share-based compensation expense of $1.1 million in 2020, a $0.3 million milestone payment in 2019 and a $0.2 million reduction in legal and patent expense in 2020.

Net loss was $1.2 million for the first quarter of 2020 and $7.8 million for the first quarter of 2019. The net loss for both periods was due to spend on the Pulmazole study and PUR1800 manufacturing costs for the upcoming planned Phase 1b clinical study.

On August 7, 2020 Guardant Health reported the U.S. Food and Drug Administration (FDA) has approved liquid biopsy, Guardant360 CDx, for tumor mutation profiling in patients across all solid cancers (Press release, Guardant Health, AUG 7, 2020, View Source [SID1234563190]).

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For Guardant Health Asia, Middle East and Africa (AMEA), this FDA approval represents a landmark achievement for the Guardant360 test. Currently, the liquid biopsy is commercially available in 41 countries in AMEA. For advanced cancer patients, this FDA approval lends even greater credibility to the test and its ability to provide comprehensive genomic profiling information that is critical to their cancer treatment.

"This FDA approval is a significant milestone for us and it will certainly boost our efforts in offering Guardant360 as the preferred liquid biopsy option in AMEA. We remain committed to making the Guardant360 test available to as many advanced cancer patients as possible so that they can undergo complete genotyping and have the best opportunity to receive the right treatment for their cancer," said Mr Simranjit Singh, Chief Executive Officer of Guardant Health AMEA.

"The US FDA approval validates the technology behind the Guardant360 assay that we offer to advanced stage cancer patients in AMEA. Treatment guidelines recommend testing for more than 20 different genomic biomarkers. Evaluating each mutation individually wastes time and delays treatment. With Guardant360, physicians and patients can feel confident that relevant genes are being assessed with a single blood test. Results are available within 7 days from receipt in the laboratory. This will help more patients start treatment sooner with appropriate precision cancer medicines," said Dr. Steve Olsen, Chief Medical Officer of Guardant Health AMEA.

Guardant Health AMEA hopes to accelerate wider adoption of guideline-recommended genomic profiling in clinical practice among medical oncologists so that advanced cancer patients in AMEA can benefit from reliable and comprehensive liquid biopsies such as Guardant360 and be treated quickly and accurately.

On August 7, 2020 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported the pricing of an underwritten offering of $1.250 billion aggregate principal amount of senior unsecured notes due 2030 (the "2030 notes") and $750 million aggregate principal amount of senior unsecured notes due 2050 (the "2050 notes" and, together with the 2030 notes, the "notes") (Press release, Regeneron, AUG 7, 2020, View Source [SID1234563189]). The 2030 notes will bear interest at 1.750% per annum and will mature on September 15, 2030. The 2050 notes will bear interest at 2.800% per annum and will mature on September 15, 2050. The issuance of the notes is expected to close on or around August 12, 2020, subject to customary closing conditions.

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Regeneron intends to use the net proceeds from the offering to repay in full the $1.5 billion principal amount of loans outstanding under the bridge facility incurred to fund a portion of the repurchase by Regeneron of shares of its common stock held by Sanofi in May 2020, and to pay accrued interest and related fees and expenses in connection therewith. The remainder will be used for other general corporate purposes.

Goldman Sachs & Co. LLC, BofA Securities, and J.P. Morgan are acting as joint book-running managers for the offering. US Bancorp, Barclays, Citigroup, Fifth Third Securities, and MUFG are also acting as book-running managers for the offering. Bank of Ireland, Citizens Capital Markets, Loop Capital Markets, and PNC Capital Markets LLC are acting as co-managers for the offering. Regeneron has filed a registration statement (including a prospectus) with the Securities and Exchange Commission (the "SEC") for the offering. Before you invest, you should read the prospectus in that registration statement and other documents Regeneron has filed and will file with the SEC, including the preliminary prospectus supplement filed by Regeneron with the SEC, for more complete information about Regeneron and this offering. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, any underwriter or any dealer participating in the offering will arrange to send you the prospectus and the preliminary prospectus supplement, when available, if you request them by contacting Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, via telephone: (866) 471-2526, or via email: [email protected], BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department or by email at [email protected], and J.P. Morgan, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or toll free at (866) 803-9204.

On August 7, 2020 Illumina, Inc. (NASDAQ:ILMN) reported that its executives will be speaking at the following investor conference and invited investors to participate via webcast (Press release, Illumina, AUG 7, 2020, View Source [SID1234563188]).

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UBS Genomics 2.0 and MedTech Innovations Virtual Summit
Wednesday, August 12, 2020 at 10:00am Pacific Time

The live webcasts can be accessed in the Investor Info section of Illumina’s web site under the "company" tab at www.illumina.com. A replay of the presentations will be posted on Illumina’s website after the event and will be available for at least 30 days following.

On August 7, 2020 Cancer Targeted Technology (CTT), a privately-held Seattle-based biotechnology company, reported that the NIH awarded CTT $1.44M on the second year of a competitive Small Business Innovation Research (SBIR) Phase IIB grant (Press release, Cancer Targeted Technology, AUG 7, 2020, View Source [SID1234563187]). The three year grant commenced in 2019 and totals $3.3M and this second year of funding supports the current CTT1403 clinical trial.

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The clinical trial, conducted at University of California, San Francisco with Dr. Rahul Aggarwal as Principal Investigator, is a 30-40 patient dose escalation/expansion trial in men with advanced castration-resistant prostate cancer. The trial is designed to show safety and efficacy of CTT1403 and is halfway through the initial dose escalation phase. To date there have been no safety issues with the drug and the pharmacokinetic data support the longer circulation time of CTT1403 in the blood stream as compared to other PSMA agents currently in clinical trials. "These PSMA-targeted agents are already transforming how prostate cancer is diagnosed and treated and we are very pleased that the NIH continues to support the development of these exciting new agents. CTT1403, with its longer circulating time and better tumor targeting characteristics, offers distinct advantages in this treatment arena providing the patient with cost and treatment benefits," commented Dr. Beatrice Langton-Webster, CTT’s CEO and Principal Investigator on the grant. The unique chemical structure for CTT1403 was conceived of by Dr. Cliff Berkman, Professor at Washington State University (WSU).

CTT1403 targets Prostate Specific Membrane Antigen (PSMA) which is over-expressed on prostate cancer. Two features make CTT1403 unlike other PSMA-targeted drugs currently in development: 1) Due to a unique core scaffold, CTT’s molecules bind irreversibly to PSMA and this distinctive mode of binding enables rapid uptake of the drug within the tumor; and 2) CTT1403 is engineered to increase the circulation time of the drug in the body which further substantially increases the dose of drug that accumulates at the tumor sites. CTT1403 is labeled with the radionuclide Lutetium-177 and once delivered to the tumor, the radionuclide acts to destroy the tumor cells.

CTT completed two clinical trials at UCSF with CTT1057, the companion PET diagnostic imaging agent to CTT1403, with excellent safety and imaging results for both prostate cancer and renal cell carcinoma. CTT1057 is undergoing further development for prostate cancer by CTT’s licensing partner AAA/Novartis. CTT1057 and CTT1403 serve as a theranostic pair to both diagnose and treat solid tumors that express PSMA, and are being used together in the current clinical trial. More information on the trial can be found at clinicaltrials.gov.