On November 15, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, will participate in a fireside chat during the Jefferies London Healthcare Conference, taking place virtually November 18 – 19, 2021 (Press release, TG Therapeutics, NOV 15, 2021, View Source [SID1234595622]).

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The fireside chat will be available for on demand download through the Jefferies conference platform beginning at 8:00am GMT / 3:00am ET on Thursday, November 18, 2021. The fireside chat will also be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source, beginning on November 18, 2021 and for a period of 30 days after the event.

On November 15, 2021 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, reported financial results for the quarter ended September 30, 2021 (Press release, Gamida Cell, NOV 15, 2021, View Source [SID1234595636]). Net loss for the third quarter of 2021 was $19.6 million, compared to a net loss of $14.8 million for the same period in 2020. As of September 30, 2021, Gamida Cell had total cash and cash equivalents of $120.8 million.

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During the past quarter, Gamida Cell:

Continued to execute on plans to submit a Biologic License Application (BLA) for omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant. As previously disclosed, in a recent pre-BLA meeting, the FDA requested a revised analysis of the manufacturing data generated at Gamida Cell’s wholly owned commercial manufacturing facility to demonstrate the comparability to the omidubicel that was produced at the clinical manufacturing sites for the Phase 3 study. The FDA did not request additional clinical data to initiate the BLA submission once analytical comparability is demonstrated.
Progressed activities with objective to address the FDA’s Clinical Hold on the Investigational New Drug (IND) application for GDA-201, which was imposed based on questions about donor eligibility procedures and sterility assay qualification prior to the initiation of the study in patients with follicular and diffuse large B-cell lymphomas.
Expanded the company’s NAM-enabled natural killer (NK) cell pipeline targeting solid-tumor and hematological cancers, including genetically modified variants of proprietary NK therapies using both CRISPR/Cas9 and CAR methodologies.
"We are committed to advance our programs and bring our important potential therapies to patients as quickly as possible. We are working diligently to respond to the FDA’s information requests for omidubicel and GDA-201, and now expect to submit the BLA for omidubicel to the FDA in the first half of 2022 and we hope to promptly address outstanding issues regarding our IND application relating to GDA-201." said Julian Adams, Ph.D., chief executive officer of Gamida Cell. "Additionally, at our recent NK-focused R&D Day, we provided details on our genetically modified NK cell immunotherapy programs leveraging CAR- and CRISPR-mediated strategies against hematologic malignancies and solid tumors. The company remains focused on our goal of bringing patients with cancer potentially curative cell therapies."

Recent Developments and Planned Presentations at ASH (Free ASH Whitepaper)

Omidubicel: Advanced Cell Therapy

BLA Submission: During a recent pre-BLA meeting, the FDA requested that Gamida Cell provide revised analysis of the manufacturing data generated at Gamida Cell’s wholly owned commercial manufacturing facility. Upon completing those requirements, the company anticipates submitting the BLA in the first half of 2022.
New data to be presented at ASH (Free ASH Whitepaper): Gamida Cell will have three omidubicel presentations – two presentations of additional data from the phase III randomized trial of omidubicel, and a poster presentation summarizing long term omidubicel data from multiple studies – at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (December 11-14, 2021).
Oral presentation of "Hematopoietic Stem Cell Transplantation (HSCT) with Omidubicel is Associated with Robust Immune Reconstitution and Lower Rates of Severe Infection Compared to Standard Umbilical Cord Blood Transplantation" on Saturday, December 11, 2021, at 4:30 p.m. ET. Data collected from a subset of 37 patients in the omidubicel Phase III trial shows that, in addition to more rapid short-term hematopoietic recovery, omidubicel-treated patients had more rapid recovery of a wide variety of immune cells including CD4+ T cells, B cells, monocytes, natural killer cells, and dendritic cells. The robust recovery of the broad range of the immune system correlated with and supports clinical data showing fewer severe bacterial, fungal, and viral infections in patients treated with omidubicel.
Poster presentation of "Hospitalization and Healthcare Resource Use of Omidubicel vs. Cord Blood Transplantation for Hematological Malignancies in a Global Randomized Phase III Clinical Trial" on Monday, December 13, 2021, 6:00-8:00 p.m. ET. Resource utilization data during the first 100 days after transplant were analyzed for 108 patients in the phase III trial and shows that omidubicel-treated patients has significantly shorter durations of hospitalization, intensive care unit time, consultant visits, procedures, and transfusions than the control arm. These data provide further evidence of the clinical benefit associated with the more rapid hematopoietic recovery in patients treated with omidubicel and the corresponding reduction in healthcare resource utilization.
Poster presentation, "Allogeneic Stem Cell Transplantation with Omidubicel: Long-Term Follow-up from a Single Center" on Saturday, December 11, 2021, 5:30-7:30 p.m. ET. Analysis of outcomes of 22 patients with hematologic malignancies treated with omidubicel at Duke University over a 10-year period shows long-term sustained bone marrow function and immune recovery, with a 10-year overall survival of 48%. These data provide further support for the long-term clinical benefit of omidubicel with long-lasting hematopoietic recovery.
GDA-201: NAM-Enabled NK Cell Therapy

IND for Phase 1/2 Study: Gamida Cell is working to address the clinical hold on the IND for a Phase 1/2 study of GDA-201. As a result of the clinical hold, the initiation of our planned Phase 1/2 study of GDA-201 will be delayed beyond the end of 2021, as the company previously projected.
New data presented at SITC (Free SITC Whitepaper): Gamida Cell recently presented promising new preclinical data in two posters characterizing the NAM-enabled mechanisms of action that contribute to the metabolic modulation properties and enhanced tumor cytotoxicity activity of GDA-201 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 36th Annual Meeting (SITC 2021) held from November 10-14, 2021.
New data to be presented at ASH (Free ASH Whitepaper): A poster titled "GDA-201, A Novel Metabolically Enhanced Allogeneic Natural Killer (NK) Cell Product Yields High Remission Rates in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma (NHL): 2-year survival and correlation with cytokine IL7" will be presented at the upcoming ASH (Free ASH Whitepaper) Annual Meeting and Exposition on Monday, December 13, 2021, 6:00-8:00 p.m. ET. This analysis provides longer follow-up in the investigator-led study of GDA-201 in patients with non-Hodgkin lymphoma and demonstrated an overall survival rate of 78% at two years, median duration of response of 16 months, and a safety profile that was similar to what had been previously reported.
NAM-Enabled NK Cell Pipeline Expansion

Advanced NAM-enabled genetically modified NK pipeline: During Gamida Cell’s NK-focused virtual R&D Day, the company presented new data and additional details on its genetically modified NK cell immunotherapy programs, which utilize CAR, membrane bound- and CRISPR-mediated strategies to increase targeting, potency and persistence against hematologic malignancies and solid tumors:
GDA-301: Knockout of CISH (cytokine inducible SH2 containing protein) in NK cells using CRISPR/Cas9 in combination with a membrane-bound IL-15/IL-15Ra;
GDA-501: anti HER2 CAR-engineered NK cells to target solid tumors expressing HER2, based on a single-chain variable fragment of the widely used humanized monoclonal antibody trastuzumab; and
GDA-601: CRISPR Knockout of CD38 on NK cells combined with anti CD38 CAR. CD38 is an established immunotherapeutic target in multiple myeloma, but its expression on NK cells and its further induction during ex vivo NK cell expansion represents a barrier to the development of an anti CD38 CAR-NK cell therapy. Gamida Cell recently announced a research collaboration with the Dana-Farber Cancer Institute to study the in vitro cytotoxicity of GDA-601 in fresh samples from multiple myeloma patients.
New data presented at PEGS Europe: Data from early-stage studies of GDA-501 demonstrated enhanced potency and cytotoxicity against a HER2-expressing tumor cell line. Data presented on GDA-301 showed cytotoxic activity against a chronic myelogenous leukemia cell line (K562) and a multiple myeloma cell line (RPMI). These data were presented at the 13th Annual Protein and Antibody Engineering Summit (PEGS) in Barcelona, Spain November 2-4, 2021.
Third Quarter 2021 Financial Results

Research and development expenses in the third quarter of 2021 were $12.4 million, compared to $10.5 million for the same period in 2020. The increase was mainly due to omidubicel commercial manufacturing readiness activities, and the advancement of the GDA-201 program, including broadening scientific capabilities and talent.
Commercial expenses in the third quarter of 2021 were $6.0 million, compared to $1.9 million for the third quarter of 2020. The increase was mainly attributed to progress with omidubicel commercial readiness activities. Going forward, the company anticipates reducing its near-term commercial readiness expenses in line with the revised omidubicel BLA submission timing.
General and administrative expenses were $4.8 million for the third quarter of 2021, compared to $2.7 million for the same period in 2020. The increase was mainly due to professional services and the hiring of key management positions, to support business growth.
Finance income, net, was $3.5 million for the third quarter of 2021, compared to $0.3 million for the third quarter of 2020. The increase was primarily due to non-cash income, resulting from revaluation of warrants offset by convertible note interest expenses.
Net loss for the third quarter of 2021 was $19.6 million, compared to a net loss of $14.8 million for the same period in 2020.

2021 Financial Guidance

Gamida Cell is re-assessing its planned spending and prior financial guidance as a result of the revised timing of the expected omidubicel BLA submission.

Expected Milestones in 2022

Omidubicel

BLA submission to the FDA in the first half of 2022
GDA-201

Initiation of a company-sponsored Phase 1/2 clinical study in NHL in 2022
NK cell pipeline expansion

Establish preclinical proof of concept studies of the NAM-enabled, genetically modified NK therapeutic targets in 2022
Select pipeline candidate(s) for IND enabling studies by end of 2022
Conference Call Information

Gamida Cell will host a conference call today, November 15, 2021, at 8:00 a.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com. To participate in the live call, please dial 866-930-5560 (domestic) or 409-216-0605 (international) and refer to conference ID number 4347485. A recording of the webcast will be available approximately two hours after the event, for approximately 30 days.

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with blood cancers. Omidubicel is the first bone marrow transplant graft to receive Breakthrough Therapy Designation from the U.S. FDA and has also received Orphan Drug Designation in the U.S. and EU. For more information about omidubicel, please visit View Source

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About GDA-201

Gamida Cell applied the capabilities of its nicotinamide (NAM)-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising initial clinical trial results. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, GDA-201 improves antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. For more information about GDA-201, please visit View Source

GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

On November 15, 2021 Cytovation AS, a clinical stage immune-oncology company focused on the development of its first-in-class targeted tumor membrane immunotherapy, reported that the first patient has been dosed in the expansion phase of its Phase I/IIa CICILIA clinical trial (Press release, Cytovation, NOV 15, 2021, View Source [SID1234595652]). In this phase of the trial, CyPep-1 is being administered in combination with KEYTRUDA (pembrolizumab) in patients with a range of solid tumors.

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Lars Prestegarden, MD, PhD, CEO of Cytovation, commented: "We are very pleased to report the dosing of our first patient with CyPep-1 in combination with MSD’s leading anti-PD-1 therapy KEYTRUDA. This marks a further important milestone in our journey to bring this exciting potential new therapy to patients, where preclinical data suggest its mode of action is highly synergistic with checkpoint inhibitors. We believe CyPep-1 could have broad utility in treating a range of solid tumors and we look forward to reporting further data as we progress this study."

This new part of the planned expansion phase follows the successful conclusion of the initial monotherapy trial (Part 1) previously announced on September 23rd, 2021 and aims to evaluate the safety of CyPep-1 in combination with KEYTRUDA in 15 patients with a variety of advanced solid tumors.

Upon successful completion of this Phase I tranche of patients, the combination trial will move to a three arm, Phase II open-label, multi-center trial of CyPep-1 in combination with KEYTRUDA to evaluate the efficacy and safety of intratumoral CyPep-1 in patients with advanced HNSCC (head and neck squamous cell carcinoma), melanoma, or TNBC (triple negative breast cancer) receiving prior standard of care.

Initial results from Phase 1 of the combination arm safety study are expected early in 2022 with the Phase II combination trial scheduled to start shortly thereafter.

Previously in Part 1 of the CICILIA trial 12 patients were recruited with a range of solid tumors, each patient having received a minimum of three intra-tumoral injections of CyPep-1. Safety and tolerability in this first part of the monotherapy study were encouraging with no serious adverse events or dose-limiting toxicities, while early efficacy signals were positive and remain consistent with the preclinical proof-of-concept data previously generated.

Both the Phase I part of the combination program with KEYTRUDA and the three Phase II arms are part of a clinical trial collaboration and supply agreement with MSD.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About CyPep-1

CyPep-1 is a proprietary first-in-class targeted tumor membrane immunotherapy engineered to selectively target tumor cell membranes based on their altered molecular composition relative to normal cells. CyPep-1 eliminates cancer cells by forming pores in the plasma membrane, releasing cancer specific antigens to the immune system, promoting an inflammatory microenvironment, and inducing a tumor-specific immune response by in situ vaccination.

Preclinical data suggest this mode of action is highly synergistic with checkpoint inhibitors.

On November 15, 2021 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported financial results for the third quarter ended September 30, 2021 and provided a financial and business update on recent corporate, clinical and regulatory developments (Press release, Protalix, NOV 15, 2021, View Source [SID1234595548]).

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"We are pleased with the progress we have made over the past few weeks with respect to the regulatory path forward with PRX-102 for the treatment of Fabry disease with both the U.S. Food and Drug Administration and the European Medicines Agency," stated Dror Bashan, Protalix’s President and Chief Executive Officer. "Following our Type A meeting with the FDA, we believe there is now an established pathway to resubmit the PRX-102 BLA. We remain focused on our mission to bring to the market another important potential alternative treatment for all adult Fabry patients. We are grateful for the continued support from our team members, advocates and external partners who remain as steadfast and focused as ever; they see the value of having an alternative treatment for patients, especially one with our profile. Following the note exchange agreement we completed in August, we now have additional financial flexibility and sufficient capital to fund our operations through important milestones in 2022. We are committed to executing our strategy and are looking forward to converting the momentum of the last quarter into a successful 2022."

2021 Third Quarter and Recent Business Update

Regulatory Updates

On October 11, 2021, the Company, together with its development and commercialization partner, Chiesi Farmaceutici S.p.A., or Chiesi, provided a regulatory update regarding PRX-102, which included the announcement of the receipt of the official Type A (End-of-Review) meeting minutes from the U.S. Food and Drug Administration (FDA) regarding the Complete Response Letter (CRL) received in April 2021 for the biologics license application (BLA) for PRX–102 for the treatment of adult patients with Fabry disease, and confirming the pathway for resubmission of a BLA for PRX–102. The PRX–102 biologics license application (BLA) resubmission to the FDA is anticipated in the second half of 2022.
On October 8, 2021, the Company, together with Chiesi, held a meeting with the Rapporteur and Co-Rapporteur of the European Medicines Agency (EMA) regarding PRX-102. At the meeting, Chiesi and the Company discussed the scope of the anticipated Marketing Authorization Application (MAA) submission for the European Union, and the Rapporteur and Co-Rapporteur were generally supportive of a planned MAA submission for PRX-102. This is an important step in the necessary pre-submission activities leading up to a MAA submission. The Company and Chiesi expect to submit an MAA to the EMA for PRX-102 during the first quarter of 2022.
Clinical Advancements

On October 15, 2021, the Company, together with Chiesi, announced the final dosing of the last patient in the Company’s phase III BALANCE clinical trial, or the BALANCE study, for the proposed treatment of Fabry disease. The BALANCE study is a 24-month, randomized, double blind, active control study of PRX-102 in Fabry patients with impaired renal function. Unblinded final data is anticipated to be released in the second quarter of 2022 after all remaining patients have completed the 24-month treatment period.
Given the changed regulatory landscape in the United States, the planned data package for the PRX-102 BLA resubmission will include the final two-year analyses of the BALANCE study.
Corporate & Financial Developments

On August 25, 2021, the Company completed exchanges, or the Exchanges, of a substantial majority of the Company’s outstanding 7.50% Senior Secured Convertible Notes due 2021, or the 2021 Notes, with institutional note holders. In the Exchanges, an aggregate of $54.65 million principal amount of outstanding 2021 Notes were exchanged for an aggregate of $28.75 million principal amount of newly issued 7.50% Senior Secured Convertible Notes due 2024, $25.90 million in cash, and approximately $1.1 million in cash representing accrued and unpaid interest through the closing date of the Exchanges.
The maturity date of the 2021 Notes is November 15, 2021, on which date the Company is required to settle all of the remaining 2021 Notes then outstanding, and pay all accrued but unpaid interest thereon. On November 9, 2021, the Company delivered the necessary funds under the indenture governing the 2021 Notes to effectively discharge the remaining outstanding 2021 Notes.
Third Quarter 2021 Financial Highlights

The Company recorded revenues from selling goods of $4.5 million during the three months ended September 30, 2021, an increase of $1.2 million, or 36%, compared to revenues of $3.3 million for the same period of 2020.
Revenues from license and R&D services for the three months ended September 30, 2021 and September 30, 2020 were $7.5 million. Revenues from license and R&D services are comprised primarily of revenues the Company recognized in connection with its license and supply agreements with Chiesi. A revenue increase of $1.0 million recognized from the Kirin feasibility study was offset by a $1.0 million decrease in revenue generated under the Company’s license and supply agreements with Chiesi.
Cost of goods sold for the three months ended September 30, 2021 was $3.7 million, an increase of $0.8 million, or 28%, compared to $2.9 million for the same period in 2020. The increase resulted primarily from higher sales.
Research and development expenses for the three months ended September 30, 2021 were $7.3 million, a decrease of $0.4 million, or 5%, compared to $7.7 million for the same period of 2020. The decrease was primarily the result of the completion of two out of the three phase III clinical trials of PRX–102 and reduced costs related to the BALANCE study. The Company expects research and development expenses to continue to be its primary expense as it enters into a more advanced stage of preclinical and clinical trials for certain product candidates.
Selling, general and administrative expenses were $3.0 million, an increase of $0.2 million, or 7%, for the three months ended September 30, 2021 compared to $2.8 million for the same period in 2020. The increase is primarily the result of an increase of $0.4 million in corporate costs mainly related to insurance and a $0.2 million increase in sales and marketing costs, partially offset by a decrease of $0.5 million in share-based compensation.
Financial expenses, net, were $2.3 million for the three months ended September 30, 2021 and $1.9 million for the three months ended September 30, 2020. The increase resulted primarily from loss on extinguishment related to the Exchanges of the Company’s 2021 Notes.
Cash, cash equivalents and short-term bank deposits were approximately $48.7 million at September 30, 2021.
Net loss for the three months ended September 30, 2021 was approximately $4.2 million, or $0.09 per share, basic and diluted, compared to a net loss of $4.4 million, or $0.14 per share, basic and diluted, for the same period in 2020.
Conference Call and Webcast Information

The Company will host a conference call today, November 15, 2021, at 8:30 am Eastern Standard Time, to review the corporate, clinical and regulatory developments, which will also be available by webcast. To participate in the conference call, please dial the following numbers prior to the start of the call:

Webcast Details:

Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

The conference call will be available for replay for two weeks on the Events Calendar of the Investors section of the Company’s website, at the above link.

On November 15, 2021 MimiVax LLC, a clinical-stage biotechnology company in Buffalo, NY, USA, developing immunotherapeutics for cancer and autoimmune diseases, reported that the company has received a "Study May Proceed" notification from the United States Food and Drug Administration (FDA) to begin a Phase 2b trial, for SurVaxM in newly diagnosed glioblastoma entitled "SURVIVE (Press release, MimiVax, NOV 15, 2021, View Source;utm_medium=rss&utm_campaign=mimivax-llc-receives-fda-approval-to-initiate-a-new-phase-2b-clinical-study-for-the-treatment-of-newly-diagnosed-glioblastoma [SID1234595591])." MimiVax has been operating through Covid related delays but is excited to now be able to launch a new clinical trial in 2021. The "SURVIVE" trial will evaluate SurVaxM in a randomized, blinded, placebo-controlled, multi-center study designated to compare standard of care (temozolomide) with or without the addition of SurVaxM. The primary objective and endpoint for the study will be overall survival. Additional objectives will evaluate molecular predictors of response, including MGMT methylation status, IDH1 mutation and survivin-specific responses.

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About Glioblastoma

Glioblastoma is the most deadly and unfortunately the most common adult brain tumor affecting approximately 14,000 people/year in the USA. Only 25% of patients generally survive 1 year and less than 5% survive longer than 5 years, while standard of care has remained largely unchanged over the last 15 years.

About SurVaxM

SurVaxM is the first of its kind patented peptide vaccine, developed at Roswell Park Comprehensive Cancer Center. SurVaxM targets survivin, a cell-survival protein present in glioblastoma and many other cancers. A multi-center Phase 2a open label study in newly diagnosed glioblastoma was completed in 2020 (NCT02455557). Data from this study indicated a median overall survival of 25.8 months with a range of 19.5 to 43.5+ mos. Those survival statistics compare favorably with current standard of care, where patients are expected to have a median overall survival of 16 months, with a range of 14-18.4 mos.

MimiVax is collaborating and partnering for SurVaxM in several other indications; multiple myeloma in combination with Revlimid (BMS) (fully enrolled); recurrent glioblastoma in combination with Keytruda (Merck) (fully enrolled); and Neuro-endocrine Tumors (NET) (recruiting at Roswell Park).

The SurVaxM project has been graciously supported by donations to the Roswell Park Comprehensive Cancer Center and by private investors, including Buffalo Capital Partners and Varia Ventures.