On November 14, 2022 Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a biopharmaceutical company focused on autoimmune diseases, reported third quarter 2022 results and provided a business update (Press release, Tocagen, NOV 14, 2022, View Source [SID1234624082]).

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"Forte is making excellent progress with its lead program FB-102, which is a direct result of the team’s hard work and diligent efforts. FB-102 holds significant potential in a variety of indications with market potential in excess of $6 billion." said Paul Wagner, Ph.D., Chairman and Chief Executive Officer of Forte Biosciences. "FB-102 is expected to be in the clinic late 2023 or early 2024. Beyond FB-102, the Forte team continues to explore additional opportunities for pipeline development to drive long-term value creation."

Third Quarter 2022 Business Highlights

In November 2022, Forte appointed Scott Brun, M.D. to its board of directors, which further strengthened Forte’s board of directors. Dr. Brun is currently a Venture Partner at Abingworth and in addition to his consulting practice, he is also a Senior Advisor for Horizon Therapeutics, and a Senior Medical Advisor at Launch Therapeutics. Dr. Brun previously served in numerous executive capacities at AbbVie most recently as Head of AbbVie Ventures, and previously as Head of Pharmaceutical Development. Dr Brun received his M.D. at The Johns Hopkins University School of Medicine.

"Given Dr. Brun’s extensive experience in pharmaceutical product development, R&D and scientific affairs, his agreeing to join our board is pivotal for Forte. We are extremely fortunate to have board members of Dr. Brun’s caliber join the team to help guide the pipeline development." said Paul Wagner, Ph.D., Forte’s Chairman and CEO.

Forte ended the third quarter of 2022 with approximately $44.0 million in cash and cash equivalents. Forte had approximately 21.0 million shares of common stock outstanding as of September 30, 2022.

Third Quarter 2022 Operating Results

Research and development expenses were $1.4 million and $5.7 million for the three months ended September 30, 2022 and 2021, and $3.1 million and $12.5 million for the nine months ended September 30, 2022 and 2021, respectively. The decreases in 2022 were primarily due to the wind down of our FB- 401 program as the Company began the shift in development activities to autoimmune indications with FB-102. While research and development expenses decreased in 2022 compared to 2021, we anticipate research and development expenses to increase in the future as we continue to develop our current lead product candidate, FB-102.

General and administrative expenses were $2.0 million for the three months ended September 30, 2022 and 2021. General and administrative expenses remained relatively flat as an increase in legal and professional expenses of $0.4 million was mostly offset by a decrease of approximately $0.4 million in payroll and related expenses. General and administrative expenses were $5.9 million and $5.7 million for the nine months ended September 30, 2022 and 2021, respectively. The increase of $0.2 million was primarily due to an increase in stock-based compensation expenses.

Net losses per share were ($0.18) and ($0.54) for the three months ended September 30, 2022 and 2021, and ($0.56) and ($1.34) for the nine months ended September 30, 2022 and 2021, respectively.

On November 14, 2022 Idera Pharmaceuticals, Inc. ("Idera," the "Company," "we," "us," or "our") (Nasdaq: IDRA) reported its consolidated financial and operational results for the third quarter ended September 30, 2022 (Press release, Idera Pharmaceuticals, NOV 14, 2022, View Source [SID1234624081]).

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"We are pleased to have completed the merger of Idera and Aceragen at the end of the third quarter, better enabling us to deliver important therapies for people living with rare diseases," stated John Taylor, Idera’s Chief Executive Officer. "Our resulting cash position is expected to provide runway into Q3 2023 and fund the advancement of our pipeline, including ACG-701 and ACG-801, through important anticipated 2023 clinical milestones. Our team continues to execute on the integration effort and diligently progress toward our near-term clinical milestones, which include initiation of our cystic fibrosis (CF) and Farber disease clinical trials and anticipated data from our melioidosis study."

Clinical Development Updates

REPRIEVE Study in Cystic Fibrosis: Randomized, double-blind, placebo-controlled Phase 2 study evaluating treatment with ACG-701, a proprietary oral formulation of sodium fusidate, in newly diagnosed pulmonary exacerbations in CF patients.

The REPRIEVE study is on track for initiation by the end of 2022, with data anticipated in Q3 2023
TERRA Study for Melioidosis: Randomized, double-blind, placebo-controlled Phase 2 study evaluating ACG-701 in hospitalized melioidosis patients.

The independent Data Monitoring Committee (DMC) for the TERRA Study is expected to meet by the end of 2022 to recommend whether the study should continue as planned or, if efficacy and safety data are compelling, to be immediately unblinded for full analysis. This DMC assessment is intended to be in lieu of the interim analysis originally anticipated in Q1 2023.
ADVANCE Study for Farber Disease: Randomized, double-blind, placebo-controlled, first-in-human, Phase 2 study of ACG-801 in patients with Farber disease.

The ADVANCE study is on track for initiation in the second half of 2023.
Corporate Updates
Since June 30, 2022, the following corporate updates were announced:

As previously disclosed, on September 28, 2022, the Company announced its acquisition, via a stock-for-stock transaction, of Aceragen, Inc., a private biotechnology company addressing severe, rare pulmonary and rheumatic diseases for which there is significant medical need and limited or no available treatments.
The combined cash of the two companies is expected to provide runway into Q3 2023, funding the advancement of ACG-701 and ACG-801 through important 2023 clinical milestones.
In connection with the acquisition, the Company announced several leadership and Board changes:
John Taylor, the former Chief Executive Officer of Aceragen, was named Chief Executive Officer of the Company. Additional management team members are Carl Kraus, Aceragen’s former Chief Medical Officer, who now serves in that role for Idera; Bryant Lim, who continues in his role as Idera’s Chief Business Officer and General Counsel; Daniel Salain, Aceragen’s former Chief Operating Officer, who serves in that role for Idera; Andy Jordan, Aceragen’s former Chief Financial Officer, who was appointed Chief Strategy Officer for Idera; and John Kirby, who continues in his role as Idera’s Chief Financial Officer.
Vincent Milano, Idera’s former Chief Executive Officer, was named Chair of the Board of Directors for the Company. Idera Board members Cristina Csimma, Pharm. D., M.H.P., James Geraghty, Maxine Gowen, Ph.D., and Michael Dougherty continue in their positions and are joined by John Taylor and Ron Wooten, Senior Founding Partner, NovaQuest Capital Management LLC. Mr. Taylor and Mr. Wooten previously served on Aceragen’s board.
Third Quarter Financial Results
The Company’s pro forma cash position as of September 30, 2022 was $26.8 million. Research and development expenses for the three months ended September 30, 2022 totaled $1.5 million, compared to $3.5 million for the same period in 2021. General and administrative expenses for the three months ended September 30, 2022 totaled $2.3 million, compared to $2.3 million for the same period in 2021. Restructuring costs for the three months ended September 30, 2022 totaled approximately $2.8 million, compared to $0.1 million for the same period in 2021, and relate to a reduction in force due to our acquisition of Aceragen. Merger related costs for the three months ended September 30, 2022 totaled $2.8 million. The Company recorded an income tax benefit of $6.0 million in the three months ended September 30, 2022.

As a result of the factors above, net loss applicable to common stockholders for the three months ended September 30, 2022 was $3.1 million or $0.06 per basic and diluted share compared to net loss applicable to common stockholders of $6.0 million or $0.11 per basic and diluted share for the same period in 2021.

On November 14, 2022 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported financial results for the third quarter of 2022 (Press release, CASI Pharmaceuticals, NOV 14, 2022, View Source [SID1234624057]).

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Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "We are pleased to report $10.2 million in EVOMELA sales revenue for the third quarter of 2022. This is a 26% of increase compared to the same period last year. Our teams in both China and US delivered strong performance despite the continued COVID lockdown in several major cities in China. Since the third quarter, the COVID-19 pandemic has gradually spread nationwide in China, with many small to medium-sized cities upgrading their control measures. The implementation of these enhanced pandemic control measures is expected to adversely impact our sales activities for the remainder of the year."

Dr. He continued, "Advancement, development, and commercialization of the portfolio remains our strategic focus. Through our partner Juventas, the CNCT-19 New Drug Application (NDA) submission to the National Medical Products Administration (NMPA) is on track, and we are in preparation for the anticipated CNCT-19 launch in China. As we continue the development of the regulatory framework for BI-1206 in China, we were pleased with the recent dosing of the first patient in the BI-1206 phase I trial in China. We expect CB-5339 to receive Clinical Trial Application approval from the NMPA in early 2023; Meanwhile, our CID-103’s Phase I study continues. We plan to build on the momentum to drive our portfolio forward by executing on several milestones in the quarters ahead."

Third Quarter 2022 Financial Highlights

Revenues consist primarily of product sales of EVOMELA. Revenue was $10.2 million for the three months ended September 30, 2022, compared to $8.1 million for the three months ended September 30, 2021.
Costs of revenues consist primarily of the cost of inventories of EVOMELA and sales-based royalties related to the sale of EVOMELA. Costs of revenues were $4.2 million for the three months ended September 30, 2022, compared to $3.4 million for the three months ended September 30, 2021.
Research and development expenses for the three months ended September 30, 2022, were $3.9 million, compared with $2.9 million for the three months ended September 30, 2021. The increase of research and development expenses for the three months periods was mainly due to expense incurred for BI-1206 and CID-103.
General and administrative expenses for the three months ended September 30, 2022, were $4.8 million, compared with $5.3 million for the three months ended September 30, 2021.
Selling and marketing expenses for the three months ended September 30, 2022, were $3.6 million, compared with $3.4 million for the three months ended September 30, 2021.
Acquired in-process R&D expenses for the three months ended September 30, 2022 and 2021, were both nil.
As of September 30, 2022, CASI had cash and cash equivalents of $29.2 million.

On November 14, 2022 IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, reported it has signed a Sales Agency Agreement to promote its IRRAflow system in the United States with Medtronic, a global leader in healthcare technology (Press release, Medtronic, NOV 14, 2022, View Source [SID1234624056]).

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During the initial pilot phase of the agreement, Medtronic shall have the exclusive right to promote IRRAflow in a select number of its territories in the United States. The IRRAS neurocritical education team will closely support the Medtronic sales professionals to train new customers, fulfill customer orders, and support patient treatments within these designated territories.

In areas of the United States that are not governed by this Sales Agency Agreement, IRRAS’ team of sales professionals will continue to directly promote IRRAflow to stroke center customers.

"Medtronic is a company that is unsurpassed in its focus on therapies that extend life, restore health, and improve patient outcomes," said Will Martin, President and Chief Executive Officer of IRRAS. "As the largest medical device company in the world, Medtronic is the ideal partner to accelerate the commercial launch of our IRRAflow system in the world’s largest market. This partnership will build broader awareness of IRRAS’ cutting-edge technology and will ensure that more patients with intracranial bleeding can receive the latest available advances in treatment."

At the current time, IRRAS’ previously stated financial targets remain unchanged. As the partnership with Medtronic matures, IRRAS will assess the impact of the shift in its sales strategy on these targets and will provide all needed updates in a timely fashion.

About the IRRAflow Active Fluid Exchange System

Patients that suffer from intracranial bleeding historically have suffered from subpar clinical outcomes due to the inherent shortcomings of passive drainage catheters that are used to drain excess fluid and remove collected blood within the brain. Traditional drainage catheters experience unacceptably high rates of complications, such as catheter occlusions, insufficient drainage, and infection, that are well documented in clinical evidence, and the IRRAflow system has been designed to address such shortcomings and advance treatment options for these critically ill patients

As the only system that enables active exchange of intracranial fluids, IRRAflow combines automated irrigation, controlled drainage, and continuous monitoring of the patient’s intracranial pressure (ICP) within one intelligent system. IRRAflow’s unique mechanism of action uses recurring irrigation to prevent solid particles from blocking the drainage holes on the catheter tip and also to dilute collected toxic material, making it easier to remove. This enhanced treatment has been shown to improve patient outcomes and reduced required treatment time across a variety of intracranial pathologies in more than 15 manuscripts published in peer-reviewed journals.

On November 14, 2022 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported its financial results for the quarter ended September 30, 2022 and provided a clinical update of its anti-cancer drug candidates currently in development for the treatment of primary and metastatic brain and CNS cancer (Press release, CNS Pharmaceuticals, NOV 14, 2022, View Source [SID1234624055]).

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"In the past quarter, we successfully expanded our potentially pivotal Berubicin trial into Europe with a number of clinical sites initiated and most recently the initiation of patient enrollment and dosing in France. This expansion into Europe drives us toward our goal of interim analysis, expected in mid-2023, which we believe has the potential to be transformational milestone. Moving forward, we are focused on building momentum and advancing this important program across the finish line," commented John Climaco, CEO of CNS Pharmaceuticals.

Berubicin Highlights
Ongoing potentially pivotal trial evaluating lead product candidate Berubicin for the treatment of recurrent glioblastoma multiforme (GBM)

Upcoming Milestones

Continued site initiations across the U.S., Italy, France, Spain, and Switzerland for potentially pivotal study to evaluate efficacy of Berubicin in the treatment of adult GBM;
Regulatory and ethics approval in Italy;
Interim analysis of the trial when 30-50% of the total expected patients have been on study for 6 months (expected mid-year 2023); and
Complete enrollment in potentially pivotal clinical trial for GBM.
The FDA has granted CNS Pharmaceuticals Fast Track Designation and Orphan Drug Designation for Berubicin. For more information about the potentially pivotal Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.

Summary of Financial Results for the Third Quarter 2022
The net loss for the three months ended September 30, 2022 was approximately $3.4 million compared to approximately $3.8 million for the comparable period in 2021. The change in net loss is primarily attributable to decreases due to the timing of drug development expenses (significant manufacturing activity occurred in the prior year period with much less occurring in the current year), as well as a credit to research and development expense for the funds collected from WPD Pharmaceuticals related to their purchase of Berubicin drug product for their clinical trials, partially offset by an increase in CRO expenses related to continued progress with our potentially pivotal clinical trial of Berubicin as well as increases in legal and professional fees and other expenses..

The Company reported Research and development expenses of $2.2 million for the three months ended September 30, 2022 compared to approximately $2.6 million for the comparable period in 2021. The change in net loss is primarily attributable to the timing of drug development expenses (significant manufacturing activity occurred in the prior year period with much less occurring in the current year, and this lower level of manufacturing activity is expected to continue throughout this year), as well as a credit to research and development expense for the funds collected from WPD Pharmaceuticals related to their purchase of Berubicin drug product for their clinical trials, partially offset by an increase in contract research organization (CRO) expenses related to continued progress with our potentially pivotal clinical trial of Berubicin..

General and administrative expense was approximately $1.2 million for the three months ended September 30, 2022 compared to approximately $1.2 million for the comparable period in 2021. This change is primarily due to decreases of approximately $204,000 for stock-based compensation, $46,000 in advertising and marketing, $32,000 in insurance and $31,000 in other expenses, which were offset by an increase of approximately $289,000 in legal and professional expenses.

As of September 30, 2022, the Company had cash of approximately $7.0 million and working capital of approximately $7.5 million. The Company’s current expectation is that the cash on hand and the proceeds from the offering during January is sufficient to fund our operations into the first quarter of 2023. The timing and costs of clinical trials are difficult to predict and trial plans may change in response to evolving circumstances and as such the foregoing estimates may prove to be inaccurate.