On November 11, 2021 A2 Biotherapeutics, Inc., "A2 Bio", is a biotechnology company focused on the development of a first-in-class Tmod T cell therapy platform to tackle the fundamental challenge in solid tumor treatment—the ability of cancer medicines to distinguish between tumor and normal cells (Press release, A2 Biotherapeutics, NOV 11, 2021, View Source [SID1234595471]).

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A2 Bio reported the first presentation of its Tmod platform; a powerful, precise targeting system controlled by tumor deletions which transforms CEA and MSLN CAR T cells into tumor-selective agents. Preclinical results demonstrate how Tmod primary T cells selectively kill tumor cells mixed with normal cells in vitro, and display robust activity in vivo. CEA Tmod cells selectively kill tumor cells within the same mouse implanted with established "normal" and tumor xenografts. MSLN Tmod constructs show similar selectivity, illustrating the breadth and modularity of the Tmod platform. Data are being featured on Nov. 13 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting at the Walter E. Washington Convention Center in Washington, D.C.

"These data demonstrate some of the impressive properties of the Tmod system, and its potential to address a key obstacle to more effective cancer treatments: tumor vs. normal tissue selectivity," said Alexander Kamb, Founder and Chief Scientific Officer of A2 Bio.

A2 Bio is also presenting a clinical trials poster on Nov 12, BASECAMP-1 (NCT04981119): An observational study to identify relapsed solid tumor patients with human leukocyte antigen (HLA) loss of heterozygosity (LOH). The study will use the Tempus xT-Onco Next Generation Sequencing diagnostic to identify patients with loss of HLA-A*02 heterozygosity. If eligible, these patients will be leukapheresed to bank T cells for subsequent autologous Tmod CAR T cell therapy at the time of relapse. BASECAMP-1 is currently recruiting patients with colorectal, pancreatic or non-small cell lung cancer at NYU Langone Medical Center, and will soon open at other cell therapy centers of excellence, including Mayo Clinic Rochester, UCLA Medical Center, UCSD Medical Center, and MD Anderson Cancer Center.

Diane Simeone, MD, Perlmutter Professor of Surgery at NYU who is a Principal Investigator stated, "BASECAMP-1 is an exciting study that is a potential game changer for relapsed patients after surgical resection with little viable treatment options. I am completely committed to helping to identify and enroll patients in this unique logic-gated CAR T immunotherapy."

A2 Bio’s posters presented at SITC (Free SITC Whitepaper) can be viewed on the company’s website at www.a2bio.com/science/abstracts-and-publications.

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
__________________________
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.

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 Onconova Therapeutics, Inc. (NASDAQ: ONTX), ("Onconova"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported financial results for the three months ended September 30, 2021, and provided a business update (Press release, Onconova, NOV 11, 2021, View Source [SID1234595435]).

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Highlights for the third quarter of 2021 and subsequent weeks include:

The Phase 1 solid tumor studies of narazaciclib (formerly ON 123300) in the United States and China are ongoing with no dose-limiting toxicities observed to-date. The trials are currently enrolling in their second and fourth dose cohorts, respectively.
The investigator-initiated Phase 1/2a trial evaluating rigosertib in combination with the checkpoint inhibitor nivolumab in KRAS mutated (KRAS+) non-small cell lung cancer (NSCLC) continues to enroll patients in its dose-expansion cohort. Preliminary data showed that the doublet was well-tolerated and an encouraging signal of efficacy in an extensively pre-treated patient population with 2 partial responses out of 7 evaluable patients, with another patient showing stable disease, which gives objective response and disease control rates of 29% and 43%, respectively.
The investigator-initiated Phase 2 trial evaluating rigosertib monotherapy in advanced squamous cell carcinoma associated with recessive dystrophic epidermolysis bullosa (RDEB-associated SCC) continues to progress. Promising evidence of rigosertib’s clinical activity targeting the complication of squamous cell carcinoma in this indication has been observed and the Company plans to provide additional data from the trial at an upcoming medical meeting.
The Company strengthened its balance sheet with gross proceeds of $21 million through an underwritten public offering.
Management Commentary

"Our progress during the third quarter has us on track to achieve milestones across our pipeline," said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. "In our lead narazaciclib program, the advancement of our complementary Phase 1 studies has us on track to identify a recommended Phase 2 dose in the first half of 2022 and then initiate a Phase 2 safety and efficacy study in the second half. This Phase 2 study will focus on multiple oncology indications with high unmet need, including CDK 4/6 inhibitor refractory HR+ HER2- metastatic breast cancer. Preclinical studies have shown that narazaciclib may be able overcome resistance to approved CDK 4/6 inhibitors, and therefore may have an improved on-target toxicity profile. We believe this positions narazaciclib as a potentially important therapeutic in a multi-billion-dollar drug class. We look forward to evaluating this hypothesis through narazaciclib’s continued clinical development."

Dr. Fruchtman continued, "Outside our narazaciclib program, we recently reported very encouraging data from the Phase 1/2a investigator-initiated study (IIS) of oral rigosertib plus the PD-1 checkpoint inhibitor nivolumab in advanced KRAS+ NSCLC. These data showed partial responses across multiple KRAS variants in patients who previously failed the standard of care including PD-1 checkpoint inhibitors. This suggests rigosertib may augment the efficacy of checkpoint inhibitors and could differentiate it from competing RAS pathway modulators that target a particular KRAS mutation. Looking ahead, we expect to provide an additional data update from this study in 2022 and begin an additional IIS evaluating rigosertib in combination with anti-PD-1 therapy in malignant melanoma in the first half of next year. Through the progression of these and our other IIS in RDEB-associated SCC, we aim to generate value and address the needs of patients through rigosertib’s development, while maintaining our primary focus on our lead narazaciclib program."

Third Quarter Financial Results

Cash and cash equivalents as of September 30, 2021, were $59.4 million, compared with $19.0 million as of December 31, 2020. The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations for more than two years.

Research and development expenses were $1.8 million for the third quarter of 2021, compared with $4.2 million for the third quarter of 2020. The decrease was primarily related to higher costs related to the INSPIRE study in the 2020 period.

General and administrative expenses were $2.3 million for the third quarter of 2021, compared with $2.1 million for the third quarter of 2020.

Net loss for the third quarter of 2021 was $3.5 million, or $0.22 per share on 16.0 million weighted average shares outstanding, compared with a net loss for the third quarter of 2020 of $6.2 million, or $0.52 per share on 12.1 million weighted average shares outstanding.

Conference Call and Webcast

Onconova will host an investment community conference call today beginning at 4:30 p.m. Eastern Time, during which management will discuss financial results for the third quarter of 2021, provide a business update, and answer questions. Interested parties can participate by dialing (855) 428-5741 (domestic callers) or (210) 229-8823 (international callers) and using conference ID 5367655.

A live webcast of the conference call will be available in the Investors & Media section of the Company’s website at www.onconova.com. A replay of the webcast will be available on the Onconova website for 90 days following the call.

On November 11, 2021 Vyant Bio, Inc. ("Vyant Bio", "Company") (Nasdaq: VYNT), an emerging global drug discovery company, reported that is rapidly identifying small and large molecule therapeutics to treat central nervous system (CNS) and oncology-related diseases (Press release, Vyant Bio, NOV 11, 2021, View Source [SID1234595434]). With leading-edge capabilities in data science, biological and chemical sciences, engineering, and regulatory affairs, Vyant Bio capitalizes on in silico, human cell-derived in vitro disease models, and in vivo discovery technologies to identify novel biological targets and valuable therapeutics for patients. Today, Vyant Bio reports its Third Quarter 2021 strategic and business updates in a conference call scheduled for 4.30pm ET.

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"We are pleased with the progress our R&D team is making to further our CNS rare disease and oncology related HER2+ drug discovery programs," stated Jay Roberts, CEO of Vyant Bio. The timing of Dr. Robert Fremeau’s arrival as our Chief Scientific Officer coincides well with our acceleration to later-stage drug discovery. Dr. Fremeau’s extensive experience with scientific research and drug discovery will be invaluable to us as we complete feasibility programs with leading biopharma companies, and develop our preclinical and translational strategy for driving a portfolio of therapeutic candidates from early discovery to human proof-of-concept".

"Vyant Bio is committed to transforming the way drugs are discovered by quickly adapting to exciting new technologies and combining our internal capabilities in ways that leverage the strength of our scientific and data science teams along with innovative technologies," stated Robert Fremeau, CSO of Vyant Bio. "Our internal teams of scientists, data scientists, and engineers, coupled with the capabilities of select strategic partners that are now integrated into our platform, allow us all to work together to design and develop superior therapeutics and position us to build a robust pipeline of novel therapeutics targeting degenerative and developmental neurological disorders and cancers with high unmet needs."

The Company expects to file its quarterly report for the Third Quarter 2021 on Form 10-Q tomorrow with the Securities and Exchange Commission. Please refer to Vyant Bio’s Form 10-Q for more detailed information with respect to our financial results for the three and nine months ended September 30, 2021.

THIRD QUARTER 2021 FINANCIAL RESULTS1

As StemoniX, Inc. was deemed to have acquired Cancer Genetics, Inc. for accounting purposes and the Merger closed on March 30, 2021, the Company’s Third Quarter 2021 financial results include the post-merger results of the combined companies, now known as Vyant Bio. The analysis below excludes the Third Quarter 2020 results as they are based solely on StemoniX’s historical stand-alone operations and therefore do not reflect the post-merger enterprise.

Cash and cash equivalents totaled $23.2 million as of September 30, 2021.

Total revenues were $1.5 million for the three months ended September 30, 2021. Cost of goods sold – service aggregated to $1.1 million for the three months ended September 30, 2021 resulting in a cost of goods sold of 80% of service revenues. Cost of goods sold – product aggregated to $159 thousand for the three months ended September 30, 2021 resulting in a cost of goods sold gross margin deficit of $196 thousand. Our product manufacturing capabilities currently have excess capacity to support future growth. Research and development expenses were $1.2 million for the three months ended September 30, 2021. Selling, general and administrative expenses were $3.3 million for the three months ended September 30, 2021.

While the Company executes its drug development strategy for long-term growth, the Company currently generates revenue from its vivoPharm and StemoniX subsidiaries. On a pro forma basis, assuming the Merger occurred on January 1, 2020, revenues for the three and nine-month ended September 30, 2021 were $1.5 million and $5.3 million, respectively, as compared with $1.9 million and $5.0 million for the respective prior-year periods. On a pro forma basis, revenues (decreased) increased by (21)% and 5% in the current-year three and nine-month periods as compared with the same prior-year periods.

1Pro forma information gives effect to the Merger between Cancer Genetics, Inc. and StemoniX, Inc. as if the Merger had occurred as of January 1, 2020. The pro forma information is presented solely for informational purposes and is not necessarily indicative of the combined results of operations or financial position that might have been achieved for the periods or dates indicated, nor is it necessarily indicative of the future results of the Company.

Vyant Bio’s Conference Call and Webcast and Information

Vyant Bio’s management will host a conference call on Thursday, November 11, 2021 at 4:30 pm ET to discuss the Third Quarter 2021 results and provide strategic business updates as well as answer questions. Event information is below:

The live event will be recorded and available for replay. The conference call and webcast details are also included inside the Investors section of the Vyant Bio corporate website at www.vyantbio.com.