On August 7, 2020 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, repoted financial results for the second quarter ended June 30, 2020 and provided a corporate update (Press release, Jounce Therapeutics, AUG 7, 2020, View Source [SID1234563153]).

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"We made great strides in the second quarter and this year as a whole has proven to be a time of execution and important foundational work in advance of important future milestones. Of note, we completed EMERGE enrollment to support the interim analysis despite the challenges of the COVID-19 pandemic, and are on track for the interim analysis of efficacy and biomarker data in early 2021. We also expect to initiate enrollment this year of the Phase 1 trial for JTX-8064, an inhibitor of the LILRB2 receptor (or ILT4) on macrophages," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "We continue to build a leading immuno-oncology company, focusing on the importance of deeply rooted science, translational analyses and well-informed clinical trial design. We look forward to continuing to execute on our milestones as we progress our broad pipeline of clinical and preclinical programs to bring the right immunotherapies to the right patients."

Pipeline Update:
Clinical Programs: Vopratelimab and JTX-4014
•Completed enrollment to support interim analysis of Phase 2 EMERGE trial: Enrollment of patients with non-small cell lung cancer (NSCLC) who have progressed on or after both a platinum-based regimen and a PD-1 or PD-L1 inhibitor to support the interim analysis of the Phase 2 EMERGE trial is complete. Jounce is on track to complete this analysis of preliminary efficacy and biomarker data on more than 40 evaluable patients at different doses in early 2021.
•Phase 2 SELECT trial initiation on track: Jounce remains on track to initiate the randomized Phase 2 SELECT trial to evaluate vopratelimab in combination with JTX-4014, a PD-1 inhibitor, versus JTX-4014 alone in immunotherapy naïve TISvopra biomarker selected, second line NSCLC patients. Jounce expects to enroll approximately 75 patients outside the U.S. and expects to report clinical data in 2021.
•Presented vopratelimab translational data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper): In June 2020, Jounce presented new translational data on vopratelimab at the AACR (Free AACR Whitepaper) Virtual Annual Meeting detailing important characteristics of ICOS hi CD4 T cells associated with vopratelimab treatment that may contribute to durable clinical responses in monotherapy and combination. The ICOS hi CD4 T cell population within peripheral blood of ICONIC responders is comprised of Th1, T central memory (Tcm) and T follicular helper (Tfh) subsets, which may

contribute to direct anti-tumor effects as well as durability of clinical responses. Jounce has found that the generation of these functionally specialized subsets of CD4 cells does not occur with PD-1 inhibitors. The T cell central memory cells are consistent with a role for vopratelimab in durable clinical benefit.

Preclinical Development Programs: JTX-8064 and JTX-1811
•Regained worldwide rights to JTX-8064 and on track to initiate Phase 1 clinical trial: In June 2020, Jounce announced that it regained the worldwide rights to JTX-8064 from Bristol Myers Squibb. JTX-8064 is a highly-selective, potential first-in-class antibody that targets the Leukocyte Immunoglobulin Like Receptor B2 (LILRB2 or ILT4) on macrophages, and was previously licensed to Celgene in July 2019. As part of its Celgene integration process, Bristol Myers Squibb has streamlined its pipeline and addressed areas of overlap. As a result, Bristol Myers Squibb notified Jounce that the JTX-8064 License Agreement was being terminated. JTX-8064 is the first tumor-associated macrophage candidate to emerge from Jounce’s Translational Science Platform. When LILRB2 (ILT4) binds to HLA molecules, including HLA-G, on cancer cells and macrophages, it induces an immunosuppressive state in the macrophages. JTX-8064 inhibits this immunosuppressive interaction, reprogramming the macrophages to a more immuno-stimulatory state. Jounce expects to begin enrollment in the Phase 1 dose escalation trial of JTX-8064 in 2020.
•Presented new JTX-1811 preclinical data at AACR (Free AACR Whitepaper): In June 2020, Jounce introduced its JTX-1811 program at the AACR (Free AACR Whitepaper) Virtual Annual Meeting with preclinical data demonstrating that by selectively eliminating tumor infiltrating T regulatory cells (T regs), Jounce believes it can eliminate the immunosuppressive effect of these cells. Importantly, this biology may be independent of PD-1. In mouse tumor models, targeting and eliminating CCR8 positive T regs in the tumor showed single agent activity for JTX-1811 where PD-1 inhibitors did not, and showed an ability to restore PD-1 inhibitor responsiveness. Evaluation of T regs in human tumors versus blood showed the enriched expression of CCR8, allowing the establishment of an optimal window for depletion of T regs in the tumor. Jounce plans to continue IND-enabling activities for JTX-1811 and remains on track to file an Investigational New Drug, or IND, in the first half of 2021.

Second Quarter 2020 Financial Results:
•Cash position: As of June 30, 2020, cash, cash equivalents and investments were $127.2 million, compared to $170.4 million as of December 31, 2019. The decrease in cash, cash equivalents and investments was primarily due to operating expenses incurred during the period.
•License and collaboration revenue: Jounce did not recognize any revenue in the second quarter of 2020. License and collaboration revenue recognized during the second quarter of 2019 was comprised solely of non-cash revenue recognition related to the original strategic collaboration with Celgene which ended in July 2019.
•Research and development expenses: Research and development expenses were $21.0 million for the second quarter of 2020, compared to $18.1 million for the same period in 2019. The increase in research and development expenses was primarily due to increased external clinical and regulatory costs associated with the EMERGE and SELECT clinical trials and increased employee compensation costs, partially offset by decreased IND-enabling expenses.
administrative expenses were $7.2 million for the second quarter of 2020, compared to $7.3 million for the same period in 2019. The decrease in general and administrative expenses was primarily due to decreased professional service fees.
•Net loss: Net loss was $28.0 million for the second quarter of 2020, resulting in basic and diluted net loss per share of $0.82. Net loss was $7.0 million for the same period in 2019, resulting in a basic and diluted net loss per share of $0.21. The increase in net loss and net loss per share was primarily attributable to a decrease in license and collaboration revenue and an increase in operating expenses.

Financial Guidance:
Based on its current operating and development plans, Jounce continues to expect gross cash burn on operating expenses and capital expenditures for the full year 2020 to be approximately $80.0 million to $95.0 million.
Jounce expects its existing cash, cash equivalents and investments to be sufficient to enable the funding of its operating expenses and capital expenditure requirements through the end of 2021.

Conference Call and Webcast Information:
Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 3898328. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. The webcast will be archived and made available for replay on Jounce’s website approximately two hours after the call and will be available for 30 days.

On August 7, 2020 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported financial results and provided a business update for the second quarter ended June 30, 2020 (Press release, Mersana Therapeutics, AUG 7, 2020, View Source [SID1234563152]).

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"Mersana is in a strong position to deliver on our vision of significantly advancing the ADC field for the benefit of patients in need. In just the first half of 2020, we have demonstrated strong proof of concept with XMT-1536 in ovarian cancer patients who have few options, initiated patient enrollment in the Phase 1 dose escalation study for XMT-1592, progressed our earlier programs into late-stage discovery and strengthened our balance sheet. We are working to rapidly advance XMT-1536 into registration-enabling studies and look forward to presenting a more comprehensive data disclosure around the end of the year as well as providing an incremental interim update on the ovarian cancer patient data at ESMO (Free ESMO Whitepaper)," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "Additionally, we look forward to disclosing our B7-H4 DolaLock candidate and first STING-agonist ADC candidate from our Immunosynthen platform in the second half of the year."

Recent Highlights and Updates

Clinical Programs

Reported positive interim data from expansion portion of the XMT-1536 Phase 1 study at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program. In May 2020, the Company reported interim safety, tolerability and efficacy data from the ongoing expansion portion of the Phase 1 study evaluating XMT-1536, its first-in-class ADC candidate targeting NaPi2b, in patients with ovarian cancer and non-small cell lung (NSCLC) adenocarcinoma. These data show a safety profile without severe neutropenia, peripheral neuropathy, or ocular toxicities; promising antitumor activity in ovarian cancer with 2/20 (10%) achieving confirmed complete responses (CRs) and 5/20 (25%) achieving confirmed partial responses (PRs) for an objective response rate (ORR) of 35%; and continued support for a NaPi2b biomarker-based patient selection strategy.

Mersana plans to provide a comprehensive data disclosure from the ovarian cancer cohort of the expansion portion of the XMT-1536 Phase 1 study around year-end. The Company now expects to exceed its recruitment goal in ovarian cancer of 40-45 patients and will continue to enroll patients throughout the remainder of 2020. The year-end disclosure will include additional ovarian cancer patients, longer patient follow up as well as the Company’s plans for registration-enabling and lifecycle management studies for XMT-1536.

Mersana plans to provide an incremental interim update on the ovarian cancer cohort of the expansion portion of the XMT-1536 Phase 1 study at the upcoming European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress to be held September 19-21, 2020. The Company’s abstract was accepted for an e-poster presentation at the ESMO (Free ESMO Whitepaper) Virtual Congress 2020 on September 17, 2020. The Company plans to discuss these data during a live conference call and webcast featuring study investigator, Erika Hamilton, MD, Director of the Breast Cancer and Gynecologic Cancer Research Program from the Sarah Cannon Research Institute at Tennessee Oncology on Thursday, September 17, 2020 at 8:00 a.m. ET. The ESMO (Free ESMO Whitepaper) presentation will include additional follow up from the ovarian cancer patients presented at ASCO (Free ASCO Whitepaper) as well as an incremental number of patients who entered the study after the ASCO (Free ASCO Whitepaper) disclosure cutoff of May 1, 2020.

NSCLC adenocarcinoma patient cohort from the expansion portion of the XMT-1536 Phase 1 study continues to enroll patients. The Company has efforts ongoing to increase enrollment in the lung cancer expansion cohort including initiating recruitment at international sites that had been put on hold for several months because of COVID-19. The Company will continue to evaluate its progress in enrollment and provide updates on its future quarterly calls which will include the timing of a data disclosure for this expansion cohort.

·Initiated Phase 1 dose escalation study of XMT-1592, a Dolasynthen ADC targeting NaPi2b. In May 2020, the Company announced the initiation of patient dosing in a Phase 1 dose escalation study evaluating XMT-1592, its Dolasynthen ADC targeting NaPi2b. XMT-1592 is the Company’s first clinical candidate created using its new Dolasynthen ADC platform. In preclinical studies, XMT-1592 has shown four times greater efficacy in a patient-derived lung tumor model in comparison to XMT-1536, the Company’s Dolaflexin ADC that has already shown success when targeted to NaPi2b in the clinic. Upon completion of the dose-escalation portion of the study, the Company will determine the path forward to further assess the safety and activity of XMT-1592 in the expansion portion of the study.

·Presented preclinical data on XMT-1592 demonstrating excellent activity, tolerability and pharmacokinetics, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2020 Virtual Annual Meeting. In June 2020, the Company presented XMT-1592 preclinical data showing improved in vivo activity, pharmacokinetics and clinical pathology relative to its stochastically conjugated ADC counterpart. These data also show that XMT-1592 induced sustained tumor regressions in an NSCLC adenocarcinoma patient-derived xenograft.
Presented preclinical data on multiple Immunosynthen STING-agonist ADCs, showing complete tumor regressions after a single dose, excellent tolerability and immune memory, at the AACR (Free AACR Whitepaper) 2020 Virtual Annual Meeting. In June 2020, the Company presented data showing target-dependent anti-tumor immune responses in vitro and in vivo after a single, well-tolerated dose, across multiple targets and in multiple preclinical models. These data also show that the Immunosynthen STING-agonist ADCs were more active (over 100-fold increased potency) with significantly lower induction of systemic cytokines when compared to intravenously administered unconjugated (free) agonist, demonstrating its potential to confer an improved therapeutic index. In addition, potent ADC-mediated tumor regression led to durable immunological memory in an immune competent model. Disclosure of the Company’s first Immunosynthen candidate remains on track for the second half of 2020.

·First-in-class ADC targeting B7-H4 on track for candidate selection in the second half of 2020. B7-H4 is expressed on both tumor cells and immunosuppressive tumor-associated macrophages (TAMs). This provides the potential for both a direct, cytotoxic antitumor effect as well as for additional payload delivery to the tumor microenvironment that can further contribute to immunogenic cell death, dendritic cell activation, and stimulation of an immune response consistent with the features of the Company’s unique DolaLock payload. IND-enabling studies are ongoing, and the Company remains on track to disclose its development candidate and supporting data in the second half of 2020.

Corporate

·Raised $65.2 million in gross proceeds from ATM facility. In April 2020, Mersana raised gross proceeds of $65.2 million through its At-the-Market (ATM) facility. Following this transaction, Mersana established a new ATM equity offering program which allows it to sell up to $100.0 million. As of June 30, 2020, the Company had not sold any shares under the new ATM.

·Raised $174.8 million in gross proceeds from public offering. In June 2020, Mersana closed an underwritten registered public offering of 9,200,000 shares of its common stock at the public offering price of $19.00 per share, which included the exercise in full of the underwriters’ option to purchase additional shares of common stock.

Upcoming Events
·Mersana will participate in a fireside chat at the BTIG Virtual Biotech Conference scheduled for August 11, 2020.
·Mersana will give a corporate presentation at the Wedbush PacGrow Virtual Healthcare Conference scheduled for August 12, 2020.
·Mersana will give a corporate presentation at the Baird Healthcare Conference scheduled for September 10, 2020.

Second Quarter 2020 Financial Results

Cash, cash equivalents and marketable securities as of June 30, 2020, were $291.4 million, compared to $99.8 million as of December 31, 2019. Net cash used in operating activities in the second quarter of 2020 was $15.9 million.

In addition, the Company has the option to draw additional funds of up to $15.0 million through the existing debt financing agreement with Silicon Valley Bank. The Company expects that its cash, cash equivalents and marketable securities will enable it to fund its current operating plan commitments for more than two years.

Collaboration revenue for the second quarter of 2020 was $0.8 million, compared to $0.2 million for the same period in 2019. The increase in collaboration revenue was primarily a result of the completion of research services associated with a target included in the Merck KGaA agreement.
·Research and development expenses for the second quarter of 2020 were approximately $15.4 million, compared to $13.8 million for the same period in 2019. The difference was primarily due to an increase in XMT-1536 and XMT-1592 clinical and regulatory expenses, a milestone payment related to the initiation of XMT-1592 patient dosing, XMT-1536 manufacturing, and advancement of companion diagnostics development efforts for the NaPi2b biomarker. The increase was partially offset by a decrease in preclinical development and manufacturing expenses for XMT-1592 and termination of XMT-1522.
·General and administrative expenses for the second quarter of 2020 were approximately $5.2 million, compared to $4.2 million during the same period in 2019 primarily due to an increase in the valuation of stock-based awards granted to employees, resulting in a higher non-cash stock compensation expense.
·Net loss for the second quarter of 2020 was $19.8 million, or $0.33 per share, compared to a net loss of $17.1 million, or $0.36 per share, for the same period in 2019. Weighted average common shares outstanding for the quarters ended June 30, 2020 and June 30, 2019, were 60,748,225 and 47,708,085, respectively.

Conference Call Details

Mersana Therapeutics will host a conference call and webcast today at 8:00 a.m. ET to report financial results for the second quarter of 2020 and provide certain business updates. To access the call, please dial 877-303-9226 (domestic) or 409-981-0870 (international) and provide the Conference ID 1081289. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com.

On August 7, 2020 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) reported that the first patient has been enrolled in the Immunoglobulin Light Chain (AL) amyloidosis (OP201) study (Press release, Oncopeptides, AUG 7, 2020, View Source [SID1234563150]). This open-label, phase 1/2 study of melflufen and dexamethasone for patients with AL amyloidosis, following at least one prior line of therapy, is the first study to explore the effect of melflufen outside of multiple myeloma.

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"Today we embarked upon the next phase of our journey with melflufen as we initiated patient enrollment in our phase 1/2 AL amyloidosis study," says Klaas Bakker, CMO of Oncopeptides. "This study will build upon the promising pre-clinical data that we presented at ASH (Free ASH Whitepaper) in December of 2019. With a median overall survival of only three and a half years from diagnosis, we hope to see melflufen providing benefit for patients in this clinical setting where new treatment options are desperately needed."

This information was submitted for publication on August 7, 2020 at 08:00 (CET).

About AL amyloidosis
Amyloidosis describes a highly heterogenous collection of diseases that involve some form of protein deposition in one or several organs. Patients with light chain (AL) amyloidosis suffer from a clonal plasma-cell disease, usually a monoclonal gammopathy of unknown sig­nificance (MGUS) or more rarely, myeloma. It is a rare disease that occurs in about 30,000 to 45,000 patients in the U.S. and Europe. Current treatment alternatives are limited to a median overall survival of 3.5 years.

About the OP201 AL amyloidosis study
The AL amyloidosis study is an open-label, phase 1/2 dose-escalation and dose-expansion study of melflufen and dexamethasone in patients with Immunoglobulin Light Chain (AL) amyloidosis following at least one prior line of therapy. The study will enroll approximately 40 patients. The primary endpoints in the phase 1 part are safety and tolerability, and in the phase 2 part of the trial Overall Response Rate (ORR). More information about the OP-102 AL amyloidosis study can be found at:
View Source;rank=4

About melflufen
Melflufen (INN melphalan flufenamide) is a first in class peptide-drug conjugate (PDC) that targets aminopeptidases and rapidly releases alkylating agents into tumor cells. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately hydrolyzed by peptidases to deliver an entrapped hydrophilic alkylator payload. Peptidases play a key role in protein homeostasis and feature in cellular processes such as cell-cycle progression and programmed cell death. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the increased intracellular alkylator concentration. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies. In the pivotal phase 2 HORIZON study melflufen plus dexamethasone demonstrated encouraging efficacy and a clinically manageable safety profile in heavily pretreated patients with relapsed refractory multiple myeloma, with primarily hematologic Adverse Events (AE) and a low incidence of non-hematologic AEs.

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 [SID1234563149]).

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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 Pulmatrix (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 [SID1234563148]).

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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

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"The second quarter has been marked with important progress for our strategic partnership with Sensory Cloud," said , 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.