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Chemomab Announces Appointment of Matthew Frankel, MD, MBA as Chief Medical Officer

On November 14, 2022 Chemomab Therapeutics, Ltd. (Nasdaq: CMMB) (Chemomab), a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, reported the appointment of Matthew Frankel, MD, MBA as Chief Medical Officer (CMO) and Vice President of Drug Development (Press release, Anchiano Therapeutics, NOV 14, 2022, View Source [SID1234624085]).

"We believe Dr. Frankel’s wealth of experience across all aspects of clinical development and medical affairs, along with his outstanding performance in helping to bring biologic and small molecule drugs to market for both rare and chronic diseases, will be invaluable as we advance the CM-101 clinical program," said Dale Pfost, PhD, Chief Executive Officer of Chemomab. "We have greatly benefitted from the singular talents of interim CMO Dave Weiner, who will be staying on as a Senior Advisor, and are fortunate now to have Matt Frankel, with his exceptional breadth of experience and track record of success, joining as our full- time CMO."

Dr. Frankel most recently served as Vice President, Clinical Development and Medical Affairs, Specialty Pharma at Boehringer Ingelheim, where he led functional teams developing new drugs for oncology, immunology, pulmonary, and central nervous system diseases. Previously Dr. Frankel was Vice President & Head, Immunology and Dermatology Medical Unit at Novartis, where he oversaw medical affairs activities and late phase clinical development for Cosentyx, Ilaris, and Zortress. At the Sandoz unit of Novartis, Dr. Frankel successfully built and led the medical affairs organization supporting the biopharmaceutical, biosimilar and generics businesses for launches including Kerydin, Glatopa and Zarxio.

"Chemomab’s CM-101 is an intriguing investigational drug, with its novel CCL24 target, dual mechanism of action, breadth of application and disease-modifying potential in serious progressive diseases with few effective treatment options," said Dr. Frankel. "Chemomab scientists have assembled an impressive body of preclinical and early clinical evidence supporting the utility of their approach, and I welcome the opportunity to join this talented team as we move to rapidly expand and accelerate our CM-101 clinical programs."

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Earlier in his career, Dr. Frankel held clinical development leadership roles across geographies and therapeutic disease areas at Reata, Fibrogen, Abbott Labs, and Schering Plough. Dr. Frankel received a BA degree from Vassar College, an MD degree from the University of California School of Medicine, Los Angeles and an MBA from the J. L. Kellogg Graduate School of Management at Northwestern University.

He is board certified in internal medicine.

Arcellx Reports Third Quarter 2022 Financial Results and Business Progress

On November 14, 2022 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported business highlights and financial results for the third quarter ended September 30, 2022 (Press release, Arcellx, NOV 14, 2022, View Source [SID1234624084]).

"Helping patients is at the core of everything we do at Arcellx," said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. "To that end, we made significant progress advancing our lead program, CART-ddBCMA for the treatment of relapsed or refractory multiple myeloma with the initiation of our iMMagine-1 pivotal study. Following the submission of IND amendments for the technical transfer of our cell and vector manufacturing, we have begun to operationally scale by initiating clinical sites, enrolling patients and dosing our first patients from Lonza, our pivotal cell manufacturer. We are currently manufacturing cells with Oxford vector at Lonza and plan to dose patients with our pivotal drug product by the end of the year. Additionally, we look forward to presenting longer-term patient data from our Phase 1 CART-ddBCMA expansion trial at the 64th ASH (Free ASH Whitepaper) Annual Meeting. We continue to plan to initiate our Phase 1 ARC-SparX clinical trial of ACLX-002 in patients with acute myeloid leukemia and high-risk myelodysplastic syndrome by year end. We’re continuing to build our organization, attracting exceptional talent and fostering a diverse and collaborative culture, allowing us to deliver on the incredible promise of our technology and company. I’m incredibly proud of our team who’ve driven these remarkable results and who make Arcellx a special place to be. Each and every one of us at Arcellx recognizes the potential for our therapy to save lives and to be a game-changer in how hematologic and solid tumors are treated. Collectively, our team is committed to maximizing the potential of our cell therapies for patients and the physicians who treat them."

Third Quarter 2022 Financial Highlights

Cash, cash equivalents, and marketable securities:
As of September 30, 2022, Arcellx had cash, cash equivalents, and marketable securities of $280.8 million, which is anticipated to fund its operations for at least the next 12 months.

R&D expenses:
Research and development expenses were $83.5 million and $12.3 million for the quarters

ended September 30, 2022 and 2021, respectively, an increase of $71.2 million. This increase was primarily driven by the accounting for a one-time, non-cash expense of $63.1 million related to Lonza manufacturing services agreements. In accordance with ASC 842, the Company was required to expense the related right of use asset associated with the embedded lease which was determined to have no alternative future use. Other increases were related to higher external costs associated with the advancement of the Company’s CART-ddBCMA clinical program, other pipeline candidates, and increased headcount.

G&A expenses:
General and administrative expenses were $10.4 million and $4.8 million for the quarters ended September 30, 2022 and 2021, respectively, an increase of $5.6 million. This increase was driven by increased headcount, and costs to operate as a public company during the three months ended September 30, 2022, as compared to the same period in 2021, including professional fees related to consulting and accounting, audit and legal services.

Net loss:
Net loss was $92.9 million and $17.1 million for the quarters ended September 30, 2022 and 2021, respectively.

VBL Therapeutics Reports Third Quarter 2022 Financial Results and Provides Corporate Update

On November 14, 2022 VBL Therapeutics (Nasdaq: VBLT), a clinical stage biotechnology company developing targeted medicines for immune-inflammatory diseases, reported financial results for the third quarter ended September 30, 2022, and provided a corporate update (Press release, VBL Therapeutics, NOV 14, 2022, View Source [SID1234624083]).

"VBL’s management team and board continue to make good progress on the evaluation of strategic options for the company’s assets, including the GMP manufacturing facility and VB-601 program, with the goal of maximizing shareholder value," said Dror Harats, M.D., Chief Executive Officer of VBL. "We recently submitted our regulatory filings for a first-in-human clinical trial for the VB-601 program, and expect to initiate this trial in the first quarter of 2023, subject to the outcome of our strategic process."

Third Quarter Highlights

Filed a regulatory submission to the Israel Ministry of Health and institutional review board to conduct a Phase 1 first-in-human trial for its lead immunology product candidate,VB-601, a targeted antibody for immune-inflammatory applications.
Retained Chardan Capital to act as financial advisor to explore and evaluate strategic options for maximizing shareholder value.
Took steps to preserve capital, including the workforce reduction and ceasing internal development of ofra-vec.
Financial Results for the Third Quarter of 2022

At September 30, 2022, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposits of $27.7 million. VBL expects that its cash, cash equivalents, short-term bank deposits, and restricted bank deposits will be sufficient to fund currently planned operating expenses and capital expenditures for at least twelve months. VBL’s ongoing review of its strategic options and any transactions resulting from such review may impact this projection.
For the quarter ended September 30, 2022, VBL reported a net loss of $9.2 million, or ($0.12) per basic share, compared to a net loss of $6.1 million, or ($0.09) per basic share, in the comparable period in 2021.
Revenues for the quarter ended September 30, 2022, were $0.5 million, as compared to $0.2 million in the comparable period in 2021.
For the quarter ended September 30, 2022, total operating expenses were approximately $9.7 million, consisting of $6.0 million in research and development expenses, net, and $3.7 million in general and administrative expenses. This compares with total operating expenses of $6.6 million in the quarter ended September 30, 2021, which was comprised of $5.0 million in research and development expenses, net, and $1.6 million in general and administrative expenses.

FORTE BIOSCIENCES, INC. ANNOUNCES THIRD QUARTER 2022 RESULTS AND PROVIDES BUSINESS UPDATE

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]).

"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.

Idera Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Corporate Update

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]).

"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.