On November 11, 2021 IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") reported financial results for the third quarter ended September 30, 2021 (Press release, IntelGenx, NOV 11, 2021, View Source,in%20the%202020%20third%20quarter. [SID1234595436]). All dollar amounts are expressed in U.S. currency, unless otherwise indicated, and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise .

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2021 Third Quarter Financial Summary:

Revenue was $593,000, compared to $510,000 in the 2020 third quarter.
Net comprehensive loss was $2.2 million, compared to $1.6 million in Q3-2020.
Adjusted EBITDA loss was $1.4 million, compared to $1.2 million in the 2020 third quarter.
Third Quarter and Recent Developments:

Resumed patient screening in the ongoing ‘BUENA’ Montelukast VersaFilm Phase 2a clinical trial in patients with mild to moderate Alzheimer’s Disease ("AD") following Health Canada’s issuance of a No Objection Letter in response to the Company’s amended Clinical Trial Application.
Graduated to the Toronto Stock Exchange.
Announced that its co-development and commercialization partner for Tadalafil oral films for the treatment of erectile dysfunction (ED) and benign prostatic hyperplasia (BPH), Aquestive Therapeutics, Inc. (NASDAQ:AQST), entered into a definitive license and supply agreement with an undisclosed leading men’s health company.
Announced that atai Life Sciences AG ("atai") committed $6.0 million in future financial support to IntelGenx via amendments to the loan facility between the parties.
Announced that Exeltis Healthcare S.L., the Company’s commercialization partner in the European Union for RIZAPORT, a unique treatment for acute migraines, launched the product in Spain.
Completed an initial shipment of CBD Filmstrips in support of Heritage Cannabis Holdings Corp.’s (CSE:CANN) Canadian market launch of its "CB4 Control" branded product.
Closed a $2.1 million private placement of 8% convertible notes due July 31, 2025, which the Company intends to use to finance its BUENA trial of Montelukast in AD.
Increased the size of the Board of Directors from six to eight with the appointments of Srinivas (Srini) G. Rao, M.D., Ph.D. and Frank Stegert.
"The past few months have been a very productive and exciting period for IntelGenx, marked by the achievement of five major milestones," commented Dr. Horst G. Zerbe, CEO of IntelGenx. "Our graduation to the TSX, Canada’s most senior exchange, came on the heels of our successful transition from a development-stage to a commercial-stage leader in pharmaceutical films as well as our transformational partnership with atai. We were also pleased to resume patient screening in our ongoing ‘BUENA’ Montelukast VersaFilm Phase 2a clinical trial in patients with mild to moderate AD. Having executed on many elements of our growth strategy this quarter, we look forward to continuing to advance our portfolio of innovative film products and product candidates."

Financial Results:

Total revenues for the three-month period ended September 30, 2021 amounted to $593,000, an increase of $83,000, or 16%, compared to $510,000 for the three-month period ended September 30, 2020. The change is mainly attributable to increases in sales milestone revenues of $320,000, product revenues of $70,000, partially offset by a $308,000 decrease in revenues from licensing agreements.

Operating costs and expenses were $2.2 million for the third quarter of 2021, versus $1.9 million for the corresponding three-month period of 2020. The increase for the three-month period ended September 30, 2021 is mainly attributable to increases of $26,000 in R&D expense, $255,000 in manufacturing expenses, $37,000 in selling, general and administrative expenses, $17,000 in depreciation of tangible assets.

For the third quarter of 2021, the Company had an operating loss of $1.6 million, compared to an operating loss of $1.4 million for the comparable period of 2020.

Net comprehensive loss for the three-month period ended September 30, 2021 was $2.2 million, or $0.01 per basic and diluted share, compared to net comprehensive loss of $1.6 million, or $0.01 per basic and diluted share, for the comparable period of 2020.

As at September 30, 2021, the Company’s cash and short-term investments totalled $12.0 million.

Conference Call Details:

IntelGenx will host a conference call to discuss these third quarter 2021 financial results today at 4:30 p.m. ET. The dial-in number for the conference call is (888) 506-0058 (Canada and the United States) and (973) 528-0135 (International), access code 995615. The call will also be webcast live and archived on the Company’s website at www.intelgenx.com under "Webcasts" in the Investors section.

On November 11, 2021 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported that two abstracts and posters have been accepted for presentation at the upcoming San Antonio Breast Cancer Symposium (SABCS) (Press release, Greenwich LifeSciences, NOV 11, 2021, View Source [SID1234595250]).

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SABCS 2021 will be held in a hybrid in-person and virtual format from December 7-10, 2021. SABCS anticipates publishing the two posters on the evening of December 8, 2021.

Snehal Patel, CEO of Greenwich LifeSciences, commented, "We are thrilled to be presenting our 4th poster of our 5 year Phase IIb data at SABCS, completing a full year of publications. This data is a result of our ongoing data analysis and will speak to the mechanism of GP2 and the potential to use immune response data in novel ways. As a result of our previously published immune response data and this upcoming data, we plan to substantially improve the immune response technology and to increase the frequency of testing and sample collection in our Phase III trial. This data will be published on the 1 year anniversary of our initial poster at SABCS showing the 100% disease free survival or 0% metastatic breast cancer recurrence rate over 5 years of follow-up."

The second abstract and poster will present additional features of the Phase III clinical trial providing information to breast cancer clinicians who will be attending the in-person conference, visiting our poster session, and participating in our first Phase III trial investigator meeting where the global primary investigator and the Company will present the trial to participating clinicians.

About SABCS

The 44th annual SABCS has grown to be the industry’s premier breast cancer 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. More than 7,500 health care professionals from more than 90 countries attend annually. For more information, please visit the conference website at: View Source

About FLAMINGO-01 and GLSI-100

The Phase III clinical trial will be called FLAMINGO-01 and the combination of GP2 + GM-CSF will be called GLSI-100. The Phase III trial is comprised of 2 blinded, randomized, placebo-controlled arms for approximately 500 HLA-A*02 patients and 1 open label arm of up to 100 patients for all other HLA types. An interim analysis has been designed to detect a hazard ratio of 0.3 in IDFS, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. The trial is currently being registered on clinicaltrials.gov and the link and trial identifier will be published shortly. For future updates about FLAMINGO-01 please visit the Company’s clinical trial tab at View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On November 11, 2021 Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, reported that the Company will present at the Jefferies London Healthcare Conference (Press release, Verastem, NOV 11, 2021, View Source [SID1234595284]). The presentation will be made available for on-demand listening beginning Thursday, November 18, 2021 at 8:00 a.m. GMT (3:00 a.m. ET).

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A webcast of the presentation will be available on investors section of the Company’s website at www.verastem.com. An archived presentation will be made available for 30 days.

On November 11, 2021 NanoString Technologies, Inc. (NASDAQ: NSTG), a leading provider of life science tools for discovery and translational research, reported the launch of the nCounter TCR Diversity Panel and companion cloud-based TCR analysis report created for use with the ROSALIND platform (Press release, NanoString Technologies, NOV 11, 2021, View Source [SID1234595300]). This new gene expression panel allows researchers to measure the usage of T cell receptor (TCR) variable regions and shifts in TCR diversity with a simple assay that can deliver results in less than 24 hours.

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A diverse population of TCRs is a hallmark of a healthy immune system. The mix and abundance of TCR variable regions changes upon challenge with a pathogen, cancer, or any disease that triggers an adaptive immune response. TCRs are studied to understand disease onset, progression, response or non-response to treatment, and disease recovery. By directly quantifying the expression of each TCR variable region, the nCounter TCR Diversity Panel can rapidly screen samples without the time and cost of laborious sequencing methods.

"The nCounter TCR Diversity Panel provides an intuitive, powerful new tool for use with clinical samples," said Dr. Léon van Kempen, an early access user and scientific lead at the Laboratory for Molecular Pathology at University Medical Center Groningen, Netherlands. "The panel allows for a TCR diversity score to be easily calculated based on expression and objectively quantifies a T cell response allowing for broad utility of the panel throughout all types of research."

The new panel utilizes the unique oligonucleotide barcoding chemistry of the nCounter Analysis System to detect mRNA transcripts directly. It contains probes for 129 human genes covering all TCR alpha, beta, gamma, delta variable regions as well as constant regions. The panel also allows for customization with the ability for researchers to add in and measure unique TCRs of interest. This novel solution is coupled with an automated data analysis report purchased separately and accessible within the ROSALIND platform, allowing researchers to analyze results and generate TCR diversity scores within minutes.

"We remain committed to developing innovative tools to advance our understanding of the human immune response. Leveraging the simplicity of the nCounter workflow makes it possible to gain broader insights with higher throughput," said Joseph Beechem, Ph.D., chief scientific officer, NanoString. "In the future, we expect to enable our GeoMx Digital Spatial Profiler to study TCRs spatially within tissues, providing an entirely new dimension of knowledge."

Learn more about the nCounter TCR Diversity Panel and the latest scientific advances in the field of immuno-oncology using the nCounter and GeoMx Digital Spatial Profiler platforms at the virtual symposium and booth #8 at the 36th annual Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference.

Virtual Symposium: "Quantifying T-cell receptor diversity via expression analysis" is on Friday, Nov. 12, from 1:00 – 1:30 pm EST. The symposium is an opportunity to talk with Dr. Léon van Kempen, a clinical scientist in molecular pathology, about getting started with the spatial biology revolution and the GeoMx Whole Transcriptome Atlas. In addition, this workshop will focus on the nCounter TCR Diversity Gene Expression Panel and a case study on the use of the panel for clinical research.

On November 11, 2021 Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension and, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, reported financial results for its first fiscal quarter ended September 30, 2021 (Press release, Beyond Air, NOV 11, 2021, View Source [SID1234595437]).

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Steve Lisi, Chairman and Chief Executive Officer of Beyond Air commented, "This has been an exciting quarter for Beyond Air, as the team continues to deliver both operationally and strategically. On the strategic front, the launch of Beyond Cancer under the new leadership of CEO Selena Chaisson, M.D. is a special achievement. The separation of the UNO franchise to an independently managed affiliate was made possible through the support of investors in a $23.9 million ongoing private financing. We believe that the spin-off will accelerate UNO’s path to the clinic and create long-term value for shareholders. Beyond Cancer will leverage our NO expertise, IP portfolio, preclinical oncology team, regulatory progress, and initially use existing Company infrastructure. The separation enables Beyond Air to focus on its core business of advancing its LungFit platform for the treatment of respiratory diseases."

Mr. Lisi continued, "Consistent with our global regulatory update from September, our PMA for LungFit PH continues to be under review at FDA. We successfully completed our Stage 1 Assessment Audit for a CE Mark in Europe and anticipate approval during the first half of calendar year 2022, after which we plan to partner the program internationally. In the United States, we continue to guide a commercial launch in the fourth quarter of this calendar year. Our commercial team has grown considerably and is ready to bring the first-ever integrated generator and delivery system that produces NO to hospitals across the country. The Beyond Air team also continues to execute on the R&D front with the release of interim data from our NTM pilot study using LungFit GO to deliver up to 250 ppm NO in a home setting. Despite the COVID-19 related lockdowns in Australia, as of September 6th we had 8 patients successfully enrolled and titrated up to 250 ppm NO, with no study discontinuations and no treatment-related serious adverse events. The pilot study continues enrolling patients, and we expect to report complete safety and efficacy results in 2022."

Recent Highlights and Upcoming Milestones

LungFit PH
Commercial launch in the United States on track for the fourth quarter of calendar year 2021, pending FDA PMA approval
Successfully completed Stage 1 Assessment Audit in the CE Mark process; expect to receive CE Mark in 1H CY2022 followed by international commercial partnership

LungFit PRO
Acute Viral Pneumonia Data
Ongoing pilot study for acute viral pneumonia in adults, including COVID-19 patients, in Israel using LungFit PRO at 150 ppm NO
Upcoming Study (pending discussion with FDA)
Plan on initiating a pivotal trial for patients hospitalized with viral lung infections in the fourth quarter of calendar year 2022

LungFit GO
Reported positive interim data for at-home pilot study in Australia using LungFit GO for self-administration of up to 250 ppm NO for the treatment of refractory NTM lung disease in adult patients
Interim results showed that 250 ppm NO was well-tolerated with no study discontinuations or treatment-related serious adverse events observed in 8 patients, with methemoglobin and NO2 concentrations remaining within acceptable safety ranges in all subjects
Expect to report full efficacy and safety data for the at-home NTM lung infection pilot study at a medical or scientific conference in calendar year 2022
Published a compassionate use case study called "Non-tuberculous mycobacteria infection treated with intermittently inhaled high-dose nitric oxide" using high concentration NO treatment to treat the Mycobacterium abscessus strain of NTM in The BMJ1

Beyond Cancer’s Solid Tumor Program
Secured commitments of $23.9 million in a concurrent private placement of common shares, not to exceed $30 million, to form Beyond Cancer that will leverage Beyond Air’s NO experience and accelerate and enhance the solid tumor pipeline
After this financing, Beyond Air will retain at least 80% equity ownership in Beyond Cancer
Anticipate beginning enrollment of patients in the first half of calendar year 2022
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1 Goldbart A, Gatt D, Golan Tripto I. BMJ Case Rep 2021;14:e243979. doi:10.1136/bcr-2021-243979

Financial results for the fiscal quarter ended September 30, 2021

Revenue for the fiscal quarter ended September 30, 2021 was $0 as compared to $350,000 for the fiscal quarter ended September 30, 2020, all of which was licensing revenue.

Research and development expenses for the fiscal quarter ended September 30, 2021 were $2.8 million, compared to $3.1 million for the fiscal quarter ended September 30, 2020.

General and administrative expenses for the fiscal quarter ended September 30, 2021 were $3.4 million, compared to $2.2 million for the fiscal quarter ended September 30, 2020.

Other income and expense for the fiscal quarter ended September 30, 2021 was a loss of $2.5 million, compared to a loss of $0.2 million for the fiscal quarter ended September 30, 2020.

For the fiscal quarter ended September 30, 2021, the Company had a net loss of $8.7 million, or ($0.36) per share, compared to a net loss of $5.1 million, or ($0.30) per share for the fiscal quarter ended September 30, 2020.

As of September 30, 2021, the Company had cash, cash equivalents and restricted cash of $48.7 million.