On November 10, 2021 atrix, 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 third quarter 2021 financial results and provides a business update (Press release, Pulmatrix, NOV 10, 2021, View Source [SID1234595147]).

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"The resolution of our contract dispute with Cipla is an important milestone which will enable the continued development of Pulmazole globally with our valued partners," said Ted Raad, Chief Executive Officer of Pulmatrix. "After our successful FDA Type C Meeting in February, we are excited to resume clinical activities with Pulmazole which has the potential to address the underlying cause of ABPA while avoiding the side effects of oral antifungals and prolonged steroid treatment. In parallel, we are making steady progress across our pipeline with top-line data expected in Q1 2022 from our fully enrolled PUR1800 Phase 1b study and we expect the initiation of a PUR3100 Phase 1study in Q2 2022."

Third Quarter and Recent Highlights:

Pulmazole

On November 8, 2021, we entered into an amendment (the "Amendment") to our development and commercialization agreement with Cipla (the "Cipla Agreement"), which modifies certain provisions of the Cipla Agreement and resolves the current dispute between us and Cipla regarding each party’s respective performance of the Cipla Agreement. Cipla will continue to share 50% of all third-party costs for the development of Pulmazole and will share 40% of our personnel, consulting and overhead costs and will reimburse us for another 10% of such costs upon the timely achievement of development milestones.
As part of the resolution, the Cipla Agreement was amended to grant Cipla exclusive rights to Cipla territories (India, South Africa, Sri Lanka, Nepal, Iran, Yemen, Myanmar and Algeria) in exchange for 2% royalties under certain circumstances. For the Cipla territories, Cipla will be initiating a clinical program and potential commercialization at its own expense. The rest of the global rights will maintain the equal cost sharing related do development and commercialization costs and equal share of free cash flow from future sales of Pulmazole.
Pulmatrix has successfully completed a Type C Meeting with the U.S. Food and Drug Administration (FDA) for the further clinical development of Pulmazole and based on feedback from the Type C Meeting, intends to initiate a Phase 2b clinical study of Pulmazole in allergic bronchopulmonary aspergillosis (ABPA) with registration endpoints in Q1 2023 with topline data expected Q2 2024 which may enable a Phase 3 registration study.
PUR3100

We plan to request a Type C meeting with the FDA to further clarify some of the responses in relation to the overall nonclinical and clinical program. We expect to submit the IND in Q1 2022 and initiate the Phase 1 study in Q2 2022 with top line data expected in Q3 2022. Following the Phase 1 study, we plan to conduct a randomized placebo-controlled Phase 2 study in patients with migraine to assess the safety and effectiveness of 2 PUR3100 doses, in which the selection of the 2 doses has been informed by the initial clinical study. We anticipate that this Phase 2 study will initiate in Q4 2022 and complete in mid 2023.

PUR1800

Enrollment is complete in the ongoing Phase 1b clinical study of PUR1800 in acute exacerbations in COPD (AECOPD). Study endpoints include safety, tolerability, and exploratory biomarkers to demonstrate target engagement and anti-inflammatory effect.
PUR1800 Phase 1b top-line data is expected in Q1 2022.
Financials

As of September 30, 2021, Pulmatrix had $53.5 million in cash and cash equivalents, compared to $31.7 million for the year ended December 31, 2020.

Revenue for the third quarter of 2021 was $1.1 million, compared to $4.4 million for the same period in 2020. The revenue for the third quarter of 2021 was the result of the collaboration and licensing agreements with JJEI.

Research and development expense was $4.0 million in the third quarter of 2021 compared to $3.9 million for the same period in 2020. The increase year–over-year was primarily attributable to increased preclinical and manufacturing costs related to the PUR3100 project partially offset by decreased spend on the PUR1800 program and the Pulmazole Ph2 clinical trial.

General and administrative expense was $1.7 million for the third quarter of 2021 compared to $1.8 million for the same period in 2020. The decrease year–over-year was primarily attributable to decreased employment costs partially offset by increased legal expense.

Net loss was $8.2 million for the third quarter of 2021 compared to a net loss of $10.6 million for the same period of 2020. The $2.4 million decrease in net loss year-over-year resulted from a one- time warrant inducement charge of $9.3 million in 2020 which was partially offset by $3.6 million and $3.3 million that resulted from a goodwill impairment charge and fluctuation in revenue recognition, respectively, in 2021.

On November 10, 2021 TScan Therapeutics, Inc. (Nasdaq: TCRX), a biopharmaceutical company focused on the development of T-cell receptor (TCR) engineered T cell (TCR-T) therapies for the treatment of patients with cancer, reported financial results for the quarter ended September 30, 2021, highlighted recent program progress, and outlined key upcoming expected milestones (Press release, TScan Therapeutics, NOV 10, 2021, View Source [SID1234595217]).

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"Throughout the third quarter of 2021, we’ve continued to execute on our long-term goals of advancing transformational TCR-T therapy candidates and expect to file IND applications for our lead liquid tumor candidates TSC-100 and TSC-101 by the end of the year," said David Southwell, President and Chief Executive Officer. "We look forward to sharing additional details on our liquid tumor program at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. We also made significant progress across our solid tumor pipeline, particularly the advancement of TSC-200 into IND-enabling studies and the launch of a new TCR program based on the discovery of a novel epitope on the validated solid tumor target MAGE-A1."

Third Quarter 2021 and Recent Business Highlights

TScan recently announced that two abstracts related to lead liquid tumor TCR-T therapy candidates TSC-100 and TSC-101 have been accepted for poster presentations at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition being held from December 11-14, 2021.

During the third quarter, TScan advanced a lead TCR-T therapy candidate for its TSC-200 program for HPV16 into investigational new drug (IND)-enabling activities and plans to submit an IND for this program in the second half of 2022. HPV is a well validated cancer target found in HPV-positive tumors, including many cases of head & neck and cervical cancers. Using its proprietary ReceptorScan and TargetScan platforms, TScan screened over half a billion T cells from a variety of human donors to identify a naturally occurring, ultra-high affinity TCR that recognizes an HLA-A*02:01-restricted epitope derived from the E7 protein of HPV16. Previously, clinical data from the National Cancer Institute (NCI) demonstrated a favorable safety and efficacy profile for an HPV TCR. TScan intends to build on the positive NCI results by developing an enhanced autologous TCR-T therapy using its T-Integrate cell manufacturing platform and by multiplexing its HPV TCR with additional TCRs in its TSC-2xx series of cell therapy candidates. TScan has used the large cargo capacity of T-Integrate to include in the TSC-200 construct features that enable engineering of both cytotoxic and helper T cells and features designed to help confer resistance to the immunosuppressive micro-environment of solid tumors.

TScan has recently discovered a novel HLA-C*07:02-restricted epitope encoded by the well-known cancer/testis gene MAGE-A1, using its TargetScan platform. This cancer-specific gene is frequently overexpressed in a wide variety of solid tumors. In the U.S., the target is expressed in as many as 45% of head & neck cancer patients, 50% of melanoma patients, 50% of cervical cancer patients and 50% of non-small cell lung cancer patients. The TCR that recognizes this novel epitope was isolated from a patient with head & neck cancer who exhibited an exceptional response to immune checkpoint inhibitor therapy. TScan has launched a new program, TSC-204, that will include multiple TCRs for different HLA-restricted epitopes on this same protein. TScan believes that it is the only company with a disclosed TCR program in MAGE-A1 for HLA types other than A*02:01. The Company has now advanced TSC-204 into lead TCR-T therapy candidate optimization.

The Company expanded its management team with the appointments of Zoran Zdraveski, J.D., Ph.D., as Chief Legal Officer, and Heather Savelle as Vice President, Investor Relations.

In July 2021, TScan completed its initial public offering, raising $100 million in aggregate gross proceeds, before deducting underwriting discounts and commissions and offering expenses, and began trading on The Nasdaq Global Market. The IPO followed the closing of a Series C preferred stock financing of $100 million in gross proceeds in January 2021.

In July 2021, Gavin MacBeath, Ph.D., TScan’s Chief Scientific Officer, presented findings from TScan’s work to discover the targets of T cells in recovering COVID-19 patients at the Cell-Mediated Therapies for Infectious Disease Summit. The presentation also featured in vitro data comparing several polyepitope T cell vaccine candidates based on the Company’s novel T cell target discoveries. TScan is now advancing these T cell-eliciting vaccine candidates through pre-clinical development with the goal of engineering a COVID-19 vaccine that generates long-term immunity with less susceptibility to resistance from emerging variants. In addition to addressing the current pandemic, this program represents proof-of-concept for a novel class of vaccines that are designed to elicit a long-lasting T cell response to infectious pathogens.

Upcoming Expected Milestones and Key Priorities

Liquid Tumor Programs: TScan’s two lead liquid tumor TCR-T therapy candidates, TSC-100 and TSC-101, are designed to target HA-1 and HA-2, respectively, and treat patients with hematological malignancies who are undergoing allogeneic hematopoietic stem cell transplantation.

TScan will present two posters related to TSC-100 and TSC-101 at the upcoming ASH (Free ASH Whitepaper) Annual Meeting and Exposition.

IND-enabling studies and the submission of IND applications to the U.S. Food and Drug Administration (FDA) are planned for TSC-100 and TSC-101 during the fourth quarter 2021.

Following the IND submissions and pending acceptance by the FDA, clinical trials for TSC-100 and TSC-101 are expected to begin in the first half of 2022 with preliminary data expected in the second half of 2022.

Solid Tumor Programs: TScan’s TSC-200 series of TCR-T therapy candidates include a combination of known targets, such as HPV16 for TSC-200, PRAME for TSC-203, and MAGE-A1 for TSC-204, as well as targets that are novel antigens for TCR-T therapy, such as those for TSC-201 and TSC-202.

TScan plans to present preclinical data of the TSC-2xx series during the first half of 2022.

·TScan plans to progress IND-enabling studies for the TSC-2xx series and submit IND applications during the second half of 2022, including for TSC-200 for HPV, during the second half of 2022. Further INDs are planned for 2023.

Infectious Disease Program

Research is continuing into potential T cell-focused COVID-19 vaccine constructs utilizing TScan’s novel T cell target discoveries.

Third Quarter 2021 Financial Results

As of September 30, 2021, the Company had cash and cash equivalents totaling $182.3 million, excluding restricted cash of $0.6 million. Based on the Company’s current operating plan, TScan expects that cash and cash equivalents as of September 30, 2021, will enable it to fund its operating expenses into 2024.

Research and development expenses for the third quarter 2021 were $14.2 million, compared to $5.8 million for the third quarter 2020.

General and administrative expenses for the third quarter 2021 were $4.0 million, compared to $1.6 million for the third quarter 2020.

Net loss for the third quarter 2021 was $15.8 million or $0.80 per common share, compared to a net loss of $7.2 million or $7.16 per common share for the third quarter 2020. Net loss per share was calculated using 19.9 million weighted average common shares and 1.0 million weighted average common shares outstanding for the third quarter of 2021 and 2020, respectively.

On July 20, 2021, the Company issued 6,666,667 shares of common stock in its IPO, raising gross proceeds of $100 million. In addition, upon closing of the IPO, all of the Company’s outstanding shares of convertible preferred stock automatically converted into 15,616,272 shares of common stock (of which 5,143,134 shares are non-voting common stock). This brings the total shares outstanding as of November 5, 2021, to 23,768,036, which consists of 18,624,902 shares of voting common stock and 5,143,134 shares of non-voting common stock.

TScan’s latest presentation is available on the "Events and Presentations" section of the Company’s website, and can be accessed here.

On November 10, 2021 HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company advancing precision medicine through its innovative transcriptome-wide profiling technology, reported its financial results for the quarter ended September 30, 2021 (Press release, HTG Molecular Diagnostics, NOV 10, 2021, View Source [SID1234595234]).

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Recent Business Highlights

Total revenue for the quarter ended September 30, 2021 increased by approximately 42% when compared to the same period in 2020.

HTG Transcriptome Panel revenue increased in the third quarter and accounted for 27% and 18% of consumables product revenue for the three and nine months ended September 30, 2021, respectively.

Continued collaboration with participants in the Early Adopter Program (EAP) for the Company’s HTG Transcriptome Panel (HTP) throughout the US and EU who are exploring potential applications for the panel in their research and clinical programs. EAP collaborators are expected to assist HTG with customer testimonials, white papers, technical notes and peer-reviewed publications highlighting their use of the HTP and their overall experience relative to alternative technologies.

Completed an audit of HTG’s quality management system for continued certification to ISO 13485:2016, valid through June 2024.

Announced the creation of a drug discovery business unit, HTG Therapeutics, and the hiring of the leadership team for the unit. HTG Therapeutics is expected to leverage HTG’s proprietary RNA profiling technology platform to inform advanced chemical library designs seeking to improve efficacy and lower toxicity profiles for drug candidates. The team has signed up several KOL’s to assist in the development of a portfolio of potentially licensable drug candidates for drug discovery. This effort is aimed at the generation of high-quality primary data from our proprietary profiling platform from known and well annotated cohorts and overcoming the notable shortfalls of data mined from public sources. HTG Therapeutics intends to leverage the Company’s past experience partnering with biopharma to collaborate throughout the drug development process, with a view toward creating future revenue and opportunities for HTG.
"Our profiling revenue has continued to grow quarter over quarter in 2021, reflecting the efforts of our employees and our customers’ response to and recovery from the challenges imposed on our industry and by the many challenges we faced as a company in 2020," said John Lubniewski, President and CEO of HTG. "Increasing instrument placements resulting from the reopening of customer facilities and increased sample processing activity in our VERI/O laboratory drove our quarterly growth. A resurgence of consumable product orders from existing and new customers is expected to drive continued growth in our product revenue. Our commercial team remains focused on our strategic priorities of customer and market diversification, while continuing to strengthen relationships with our existing customers.
"We will continue this drive throughout the remainder of 2021, with expected increasing demand for our HTP," Mr. Lubniewski added. "Our HTG Therapeutics team continues to make strides toward our vision for disrupting drug discovery by using advanced transcriptomic profiling capabilities to de-risk drug candidate development."

Third Quarter 2021 Financial Highlights:

Total revenue for the quarter ended September 30, 2021 was $2.5 million, compared with $1.8 million for the same period in 2020.

Product and product-related services revenue increased by 48% for the quarter ended September 30, 2021 to $2.5 million, compared with $1.7 million for the same period in 2020. This reflects an increase in instrument sales and RUO sample processing services for which demand has begun to recover to pre-COVID-19 levels as customers have resumed development activities. Revenue for the quarter ended September 30, 2020 included $0.1 million of collaborative development services revenue.

Net loss from operations for the quarter ended September 30, 2021 was $4.2 million, compared with $5.2 million for the same period in 2020. Net loss per share was $(0.60) for the quarter ended September 30, 2021 compared with $(1.12) for the third quarter of 2020.

Cash, cash equivalents and short-term available-for-sale securities totaled $25.4 million as of September 30, 2021, with current liabilities of approximately $8.1 million and non-current liabilities of $11.5 million.

Conference Call and Webcast:

HTG will host a conference call for the investment community today beginning at 4:30 p.m. Eastern Time. Conference call and webcast details are as follows:

On November 10, 2021 EDAP TMS SA (Nasdaq: EDAP), the global leader in therapeutic ultrasound, reported that it will release its financial results for the third quarter ended September 30, 2021 after the markets close on Wednesday, November 17, 2021 (Press release, EDAP TMS, NOV 10, 2021, View Source [SID1234595268]).

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An accompanying conference call and webcast will be conducted by Marc Oczachowski, Chairman of the Board and Chief Executive Officer, Ryan Rhodes, Chief Executive Officer of EDAP U.S.A., and François Dietsch, Chief Financial Officer. The call will be held at 8:30am ET on Thursday, November 18, 2021. Please refer to the information below for conference call dial-in information and webcast registration.

On November 10, 2022 Aucentra Therapeutics reported that it is hoping to reverse this with a new investigational drug call AU3-14 (Auceliciclib) (Press release, Aucentra, NOV 10, 2021, View Source [SID1234606758]). AU3-14 is taken as an oral capsule and demonstrating safety and therapeutic potential in clinical trials in patients with glioblastoma, colorectal cancer, and ovarian cancer .

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"Pancreatic cancer is extremely difficult to diagnose at an early stage as there are very few symptoms," Prof Shudong Wang says, "once it spreads into other organs it is lethal, and chemotherapy and radiotherapy only buy patients a little extra time."

AU3-14 has been developed by Prof Wang and her team to specifically target the enzymes called cyclin-dependent kinases 4 and 6 (CDK4/6). As over activation of CDK4/6 is the major cause of pancreatic tumour growth and spread, AU3-14 has potential to kill the cancer cells without damaging healthy tissue.

A stage 4 pancreatic cancer patient from Adelaide, Gaynor van der Walt described her experience living with pancreatic cancer, and emphasised the importance of supporting clinical trials for drugs such as Auceliciclib.