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Iovance Biotherapeutics Reports Third Quarter and Year-to-Date 2022 Financial Results and Corporate Updates

On November 3, 2022 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor infiltrating lymphocyte, TIL, and peripheral-blood lymphocyte, PBL), reported third quarter and year-to-date 2022 financial results and corporate updates (Press release, Iovance Biotherapeutics, NOV 3, 2022, View Source [SID1234622954]).

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Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "Iovance has made tremendous progress year-to-date. With our rolling BLA submission for lifileucel and six active clinical trials of TIL therapy underway, we are executing our mission to innovate, develop and deliver TIL therapy for patients with cancer. We are on track to complete our BLA submission in the fourth quarter. As we prepare for our first potential FDA approval and commercial launch and advance our pipeline and technology platforms, we believe we have multiple opportunities to create significant value for patients with cancer as well as for our shareholders."

Third Quarter 2022 Highlights and Recent Corporate Updates

Regulatory and Clinical Updates for Iovance TIL Therapy (Lifileucel) in Advanced Melanoma

BLA Submission: A rolling BLA submission for lifileucel in advanced melanoma (post-anti-PD-1 therapy) commenced in August 2022 and is anticipated to complete in the fourth quarter of 2022.

C-144-01 Trial Presentation and Poster at Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper): Iovance reported positive topline clinical data from Cohorts 2 and 4 of the C-144-01 clinical trial in advanced melanoma in the second quarter of 2022. A pooled analysis and additional results for Cohorts 2 and 4 will be presented during SITC (Free SITC Whitepaper)’s 37th Annual Meeting as well as a Webcast on November 10, 2022.

Phase 3 trial in frontline advanced melanoma: Iovance remains on track to begin the Phase 3 trial of lifileucel in combination with pembrolizumab in frontline advanced melanoma in late 2022. The Phase 3 trial is intended to expand the opportunity for lifileucel as an earlier treatment and serve as a confirmatory study.

Poster at European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022: A poster at ESMO (Free ESMO Whitepaper) highlighted the potential for lifileucel in advanced melanoma patients who progress after anti-LAG-3 and anti-PD-1 combination therapy. Lifileucel response rates were consistent between the overall C-144-01 study population and a C-144-01 subgroup analysis of patients treated with prior anti-LAG-3 containing therapy.
Manufacturing and Commercial Preparations

The Iovance Cell Therapy Center (iCTC) is currently operating flex suites for clinical manufacturing and core suites for activities to support BLA submission and review, including pre-approval inspections, in preparation for commercial supply.

The iCTC facility as currently built has annual capacity to supply TIL therapies for 2,000+ patients, with flexibility to build out existing shell space to supply 5,000+ patients.

Contract manufacturers provide additional flexibility and capacity for Iovance to meet potential commercial and clinical demand, including a new agreement for two cGMP manufacturing suites for commercial manufacturing and supply.

Iovance is executing several initiatives ahead of potential commercialization in 2023, including on-boarding and personnel training at authorized treatment centers (ATCs), education and awareness, and other launch readiness activities.
Clinical Pipeline

Iovance TIL therapy (LN-145) in mNSCLC: Enrollment is ongoing at more than 40 active clinical sites in the U.S., Canada and Europe for the IOV-LUN-202 trial of LN-145 in patients with mNSCLC. Iovance is engaged in discussions with the FDA about the potential for IOV-LUN-202 to serve as a registrational trial for LN-145 in mNSCLC and intends to execute an updated regulatory strategy based on this dialogue and feedback.

Iovance PD-1 inactivated TIL therapy (IOV-4001) in previously treated advanced melanoma or mNSCLC: the first patient was dosed, and completed the safety observation period, in the IOV-GM1-201 trial of IOV-4001, Iovance’s first genetically modified TIL therapy. To inactivate the gene coding for the PD-1 protein, IOV-4001 utilizes the gene editing TALEN technology licensed from Cellectis.

Lifileucel in advanced cervical cancer: Iovance expanded Cohort 2 of the ongoing C-145-04 trial to enroll additional patients. Following FDA discussions and feedback, Cohort 2 is intended to support a BLA in cervical cancer following progression on chemotherapy and pembrolizumab.
Research Programs for Next-Generation TIL Therapies and Related Technologies

Additional research and preclinical studies focused on optimizing TIL therapy consist of several targets for genetic modification using the gene-editing TALEN technology, including double genetic knock-out programs, as well as approaches to increase TIL potency using CD39/69 double negative TILs and gene knock-in targets that incorporate enhancements such as tethered cytokines.

A novel interleukin-2 (IL-2) analog (IOV-3001) is in IND-enabling studies supporting its use as part of the TIL treatment regimen following TIL infusion.
Corporate

Cash position of $366.6 million at September 30, 2022 is expected to be sufficient into 2024.

Iovance currently owns at least 60 granted or allowed U.S. and international patents for TIL compositions and methods of treatment and manufacturing in a broad range of cancers, with Gen 2 patent rights expected to provide exclusivity into 2038. More information on Iovance’s patent portfolio can be found on the Intellectual Property page on www.iovance.com.
Third Quarter and Year-to-Date 2022 Financial Results

Iovance had $366.6 million in cash, cash equivalents, investments and restricted cash at September 30, 2022, compared to $602.1 million at December 31, 2021. The cash position is expected to be sufficient to fund current and planned operations into 2024.

Jean-Marc Bellemin, Chief Financial Officer of Iovance, said, "As a late-stage oncology company approaching potential commercialization, our cash position continues to support our prudent investments in commercial launch preparations, internal manufacturing and pipeline expansion into several milestones to create value for patients and shareholders."

Net loss for the third quarter ended September 30, 2022, was $99.6 million, or $0.63 per share, compared to a net loss of $86.1 million, or $0.55 per share, for the third quarter ended September 30, 2021. Net loss for the nine months ended September 30, 2022, was $290.6 million, or $1.85 per share, compared to a net loss of $242.9 million, or $1.60 per share, for the same period ended September 30, 2021.

Research and development expenses were $72.5 million for the third quarter ended September 30, 2022, an increase of $7.1 million compared to $65.4 million for the same period ended September 30, 2021. Research and development expenses were $214.2 million for the nine months ended September 30, 2022, an increase of $30.8 million compared to $183.4 million for the same period ended September 30, 2021.

The increases in research and development expenses in the third quarter and year-to-date 2022 over the prior year periods were primarily attributable to growth of the internal research and development team, including stock-based compensation expense, as well as facility-related and internal research program costs, which were partially offset by lower clinical and manufacturing costs driven by completion of enrollment of pivotal clinical trials.

General and administrative expenses were $27.9 million for the third quarter ended September 30, 2022, an increase of $7.0 million compared to $20.9 million for the same period ended September 30, 2021. General and administrative expenses were $77.6 million for the nine months ended September 30, 2022, an increase of $17.8 million compared to $59.8 million for the same period ended September 30, 2021.

The increase in general and administrative expenses in the third quarter and year-to-date 2022 compared to the prior year periods were primarily attributable to growth of the internal general and administrative and commercial teams, including stock-based compensation expense, and facility-related costs associated with the build-out of the new corporate headquarters, as well as costs associated with pre-commercial activities.

For additional information, please see the Company’s Selected Condensed Consolidated Balance Sheet and Statement of Operations below.

Webcast and Conference Call

To participate in the conference call, please register at https://register.vevent.com/register/BI4721983fb77a4615b46f4ab97c051712. The live and archived webcast can be accessed in the Investors section of the Company’s website, IR.Iovance.com. The archived webcast will also be available for one year.

Gossamer Bio Announces Third Quarter 2022 Financial Results and Provides Business Update

On November 3, 2022 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported its financial results for the third quarter ended September 30, 2022 and provided a business update (Press release, Gossamer Bio, NOV 3, 2022, View Source [SID1234622953]).

"It has been a productive quarter as we eagerly await topline results from the Phase 2 TORREY Study," said Faheem Hasnain, Chairman, Co-Founder and CEO of Gossamer Bio. "Additionally, our team continues to enroll the dose escalation portion of the STAR CNS Study of GB5121, our CNS-penetrant BTK inhibitor for the treatment of CNS lymphomas."

Product Candidate Updates

Seralutinib (GB002): Inhaled PDGFR, CSF1R and c-KIT Inhibitor for Pulmonary Arterial Hypertension (PAH)

Ongoing TORREY Study is a Phase 2 clinical trial in patients with PAH whose disease has progressed despite standard-of-care therapy. The primary endpoint is change in pulmonary vascular resistance from baseline at week 24.
Topline data from the Phase 2 TORREY Study are expected in the second half of November or first half of December.
Ahead of these data, Gossamer has commenced investment in operational activities to enable the commencement of a registrational PAH Phase 3 clinical program in the third quarter of 2023.
GB5121: Oral, CNS-Penetrant BTK Inhibitor for Primary CNS Lymphoma (PCNSL) and other Rare CNS Malignancies

Enrollment ongoing in Phase 1b/2 STAR CNS Study in relapsed / refractory PCNSL and other rare CNS malignancies.
Results from the STAR CNS study to be presented at relevant medical conferences, as data become available.
GB7208: Oral, CNS-Penetrant BTK Inhibitor for Multiple Sclerosis

Program highlighted in two poster presentations at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS; October 2022):
P556: GB7208 is a CNS-Penetrant BTK Inhibitor Demonstrating Potent Activity on Pathogenic Pathways Implicated in Multiple Sclerosis
P690: GB7208 is a Novel, Highly Potent and Selective CNS-Penetrant BTK Inhibitor for Neuroinflammatory and Neurodegenerative Diseases
Posters are available online at: View Source
Preclinical Pipeline Updates

Data generated for two internally developed preclinical programs presented at recent medical conferences:
10th Annual Meeting of the International Cytokine & Interferon Society (September 2022):
P109: Identification of Novel Inhibitor(s) Targeting NLRP3 Inflammasome Activation
34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium (October 2022):
P350: An Orally Bioavailable ENPP1-Selective Inhibitor Demonstrates Superior Immune Preservation Effects over STING Agonists and Confers Anti-Tumor Efficacy in Combination with Other Therapies in Syngeneic Tumor Models
Poster highlighting a third internally developed program to be presented at the upcoming 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), or SITC (Free SITC Whitepaper), in Boston from November 8-12, 2022:
P855: Diacylglycerol Kinase Alpha and Zeta Dual Inhibitors Enhance T Cell Responses and Promote Robust and Durable Anti-Tumor T Cell Immunity
Posters are available, or will be available, online at: View Source
Financial Results for Quarter Ended September 30, 2022

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of September 30, 2022, were $304.4 million. The Company expects the combination of current cash, cash equivalents and marketable securities, and access to its debt facility, will be sufficient to fund its operating and capital expenditures into the second quarter of 2024.
Research and Development (R&D) Expenses: For the quarter ended September 30, 2022, R&D expenses were $44.5 million, compared to $43.2 million for the same period in 2021.
General and Administrative (G&A) Expenses: For the quarter ended September 30, 2022, G&A expenses were $11.5 million, compared to $12.5 million for the same period in 2021.
Net Loss: Net loss for the quarter ended September 30, 2022, was $59.4 million, or $0.65 per share, compared to a net loss of $60.2 million, or $0.80 per share, for the same period in 2021.

Cerus Corporation Announces Third Quarter Financial Results

On November 3, 2022 Cerus Corporation (Nasdaq: CERS) reported financial results for the third quarter ended September 30, 2022 (Press release, Cerus, NOV 3, 2022, View Source [SID1234622952]).

Recent developments and highlights include:

Third quarter 2022 total revenue of $46.3 million, reflecting a 10% increase over the third quarter of 2021. Total revenue was composed of (in thousands, except %):
Awarded $9.1 million contract by the U.S. Department of Defense (DoD) Industrial Base Analysis and Sustainment (IBAS) program for development of pathogen reduced, lyophilized cryoprecipitate ("LyoCryo") to treat bleeding due to trauma.
Received Health Canada approval for 7-day shelf life for INTERCEPT platelets.
Receipt of feedback from and close-out of all modules by our notified body, TUV, related to our INTERCEPT Red Blood Cells CE Mark submission; review by the competent authority is ongoing.
Third quarter 2022 net loss attributable to Cerus Corporation of $8.5 million, or $0.05 per basic and diluted share, reflecting an improvement of $3.9 million over the prior year period of $12.4 million, or $0.07 per basic and diluted share, led by strength of growing INTERCEPT platelet business in North America coupled with continued financial discipline.
Non-GAAP Adjusted EBITDA for the third quarter of 2022 was negative $2.7 million, compared to negative $5.6 million during the prior year period. For additional information, please see definitions and the reconciliation of this non-GAAP measure to net loss attributable to Cerus Corporation accompanying this release.
Narrowing full-year product revenue guidance to a range of $160 million to $162 million, given foreign exchange rate headwinds anticipated for the rest of the year.
Cash, cash equivalents, and short-term investments were $103.8 million at September 30, 2022.
"We continue to execute in this challenging environment on our mission to make INTERCEPT the standard of care in transfusion medicine and have progressed on our manufacturing expansion efforts," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "Despite the 6% FX headwind, the resiliency in our business of safeguarding the global blood supply is evident in our results, even in the face of continued macroeconomic and geopolitical challenges over the balance of this year."

"We expect to see continued strong demand for INTERCEPT platelets as we close out the year, and at the same time, we see expanded adoption of our IFC product, which we believe has the potential to impact patient’s lives meaningfully. Given the global nature of our business coupled with expectations for strength of the dollar going forward, we are narrowing our 2022 product revenue guidance range to $160-162 million for the full year," Greenman continued. "Importantly, with this growth and our continued financial discipline, we have been progressing towards our goal of cashflow breakeven."

Revenue

Product revenue during the third quarter of 2022 was $39.6 million, compared to $36.1 million during the prior year period. The 10% year-over-year growth in product revenue during the quarter comes despite ongoing headwinds associated with unfavorable foreign exchange rates, primarily with respect to average EUR:USD rates, resulting in a top-line impact of 6% year-over-year. The reported revenue growth was once again led by continued demand for our platelet products in North America.

Third quarter 2022 government contract revenue was $6.8 million, compared to $6.0 million during the prior year period. Reported government contract revenue is comprised of funding associated with research and development (R&D) activities related to the INTERCEPT Blood System for Red Blood Cells and sponsored efforts related to the development of next-generation pathogen reduction technology for whole blood.

Product Gross Profit & Margin

Product gross profit for the third quarter of 2022 was $21.9 million, increasing by $3.4 million over the prior year period. Product gross margin for the third quarter of 2022 was 55.4% compared to 51.3% for the third quarter of 2021, up more than 300 basis points compared to the second quarter of 2022.

Operating Expenses

Total operating expenses for the third quarter of 2022 were $36.1 million compared to $35.6 million for the same period of the prior year. Ongoing financial discipline during the quarter continues to position the Company for reaching cashflow breakeven in the near term.

Selling, general and administrative (SG&A) expenses for the third quarter of 2022 totaled $19.9 million, compared to $20.4 million for the third quarter of 2021, reflecting ongoing leverage of the Company’s expense structure with ramping product sales.

R&D expenses for the third quarter of 2022 were $16.2 million, compared to $15.3 million for the third quarter of 2021. In the third quarter, the increase in Company’s R&D expenses on a year-over-year basis were related to the development of next generation product and LED illuminator, partially offset by the completion of the Phase IV PIPER study in 2021.

Net Loss Attributable to Cerus Corporation

Net loss attributable to Cerus Corporation for the third quarter of 2022 was $8.5 million, or $0.05 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $12.4 million, or $0.07 per basic and diluted share, for the third quarter of 2021.

Non-GAAP Adjusted EBITDA

Non-GAAP Adjusted EBITDA for the third quarter of 2022 was negative $2.7 million, compared to non-GAAP Adjusted EBITDA of negative $5.6 million for the third quarter of 2021. For additional information, please see definitions and the reconciliation of this non-GAAP measure to net loss attributable to Cerus Corporation accompanying this release.

Balance Sheet & Cash Use

At September 30, 2022, the Company had cash, cash equivalents and short-term investments of $103.8 million, compared to $107.0 million at June 30, 2022.

As of September 30, 2022, the Company carried $55.0 million of notes due and a balance on its revolving line of credit of $14.9 million. The Company continues to have access to an additional $5 million under its revolving line of credit.

For the third quarter, net cash used in operating activities totaled $2.1 million as compared to $6.6 million during the prior year period. For the first nine months of 2022, net cash used in operating activities totaled $23.9 million as compared to $32.7 million during the prior year period. In both instances, increased product sales and their gross profit contribution, as well as strong working capital management, drove the improvements versus the prior year period.

2022 Product Revenue Guidance

The Company is narrowing its previously stated product revenue guidance range. The Company expects full-year 2022 product revenue to be in the range of $160 million to $162 million, compared to its previous guidance range of $160 million to $165 million, representing anticipated continued strong demand for our products and expectations for continued strength of the U.S. dollar versus the Euro.

Quarterly Conference Call

The Company will host a conference call at 4:30 P.M. EDT this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at View Source

A replay will be available on Cerus’ website approximately three hours after the call through November 17, 2022.

Ichnos Sciences Data Selected for Presentation at the 64th ASH Annual Meeting

On November 3, 2022 Ichnos Sciences Inc., a global clinical-stage biotechnology company developing innovative multispecific immune cell engager antibodies in oncology, reported that four abstracts highlighting data on its pipeline assets have been selected for presentation at the upcoming 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, Ichnos Sciences, NOV 3, 2022, View Source [SID1234622951]). The meeting will be held December 10-13, 2022, in New Orleans, Louisiana.

These abstracts discuss three assets – ISB 1342, ISB 1442 and ISB 2001 – two of which are currently in Phase 1 clinical studies in relapsed/refractory multiple myeloma. The data to be presented will highlight the potential of the company’s proprietary BEAT platform1 and its growing momentum toward providing curative therapies that may extend and improve lives.

"Our work is grounded in the notion that cure is possible and the understanding that there is room for novel thinking in the pursuit of effective, disease-centric therapies for oncology," said Cyril Konto, M.D., President and Chief Executive Officer of Ichnos Sciences. "Ichnos is focused on harnessing the power of the immune system in the fight against cancer, and we are pleased to have been selected to present data supporting this approach at the ASH (Free ASH Whitepaper) Annual Meeting."

The full ASH (Free ASH Whitepaper) 2022 Annual Meeting abstracts are available for review at: View Source
Visit the Ichnos Sciences booth (#3127) to learn more about Ichnos’ proprietary BEAT platform, expanding pipeline of oncology assets, partnership opportunities and more.

Follow Ichnos on LinkedIn for more updates throughout the conference.

November 3, 2022: MaaT Pharma Announces Oral and Poster Presentations at the 64th American Society of Hematology (ASH) Annual Meeting

On November 3, 2022 MaaT Pharma (EURONEXT: MAAT – the "Company"), a French clinical-stage biotech and a pioneer in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, reported that extended results from its Early Access Program (EAP) of MaaT013 in patients with GI-aGvHD have been selected for oral presentation at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting held from December 10-13, 2022, in New-Orleans, Louisiana, U.S.A (Press release, MaaT Pharma, NOV 3, 2022, View Source [SID1234622950]). Additionally, detailed results of the Phase 1b trial of MaaT033 in patients with acute myeloid leukemia (AML) were selected for presentation in a poster session. This is the sixth year in a row that the Company’s clinical data are selected for presentation at the ASH (Free ASH Whitepaper) Conference, the world-leading event in malignant and non-malignant hematology, and the third year in a row for an oral presentation.

In line with the conference embargo policy, MaaT Pharma will detail the presented results through a press release on Saturday, December 10, 2022. The Company will also host an investor webcast on Monday, December 12th, 2022, at 6:00pm CET (additional details will be provided at a later date).

The EAP results include data from 81 patients treated with MaaT013, with steroid-resistant or steroid-dependent aGvHD with GI involvement, who had previously failed 1 to 6 lines (median: 2) of systemic therapy; MaaT Pharma provided the MET product to hospitals under a compassionate access program in France. In parallel, MaaT013 is currently being evaluated in a pivotal open-label, single-arm Phase 3 trial in Europe (n=75) in GI-aGvHD patients refractory to corticosteroids and ruxolitinib; a first data review is expected in the first half of 2023. As of today, MaaT013 has been safely administered to more than 160 patients in Europe in clinical trials and in the Expanded Access Program in France.

Oral Presentation:

Title: Pooled Fecal Allogenic Microbiotherapy for Refractory Gastrointestinal Acute Graft-Versus-Host Disease: Results from the Early Access Program in France
Presenter: Professor Mohamad Mohty, hematology professor and Head of the Hematology and Cellular Therapy Department at the Saint-Antoine Hospital and Sorbonne University
Publication Number: 112
Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Clinical Studies Exploring the Immunobiology of HCT
Session Date/Time: Saturday, December 10, 2022; 10:15am EST
Room: 252-254 (Ernest N. Morial Convention Center)
Poster:

Title: Restoration Of Gut Microbiota Diversity With Oral Pooled Fecal Microbiotherapy In Acute Myeloid Leukemia Patients After Intensive Chemotherapy: The Phase 1b CIMON Trial
Presenter: Professor Mohamad Mohty, hematology professor and Head of the Hematology and Cellular Therapy Department at the Saint-Antoine Hospital and Sorbonne University
Poster number: 2765
Session: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies
Session Date/Time: Sunday, December 11, 2022: 6:00pm -8:00pm EST
Room: Hall D (Ernest N. Morial Convention Center)

Upcoming scientific conferences participations

November 8-10, 2022 – 9th International Human Microbiome Consortium (IHMC) Congress: Poster and oral presentation
November 9-11, 2022 – 21st Société Francophone de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC) Congress – Booth #10 – poster and oral presentation
December 10-13, 2022 - 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting: Poster and oral presentation
About MaaT013

MaaT013 is a full-ecosystem, off-the-shelf, standardized, pooled-donor, enema Microbiome Ecosystem TherapyTM for acute, hospital use. It is characterized by a consistently high diversity and richness of microbial species and the presence of ButycoreTM (group of bacterial species known to produce anti-inflammatory metabolites). MaaT013 aims to restore the symbiotic relationship between the patient’s functional gut microbiome and their immune system to correct the responsiveness and tolerance of immune functions and thus reduce steroid-resistant, gastrointestinal-predominant aGvHD. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

About MaaT033

MaaT033 is an oral, full-ecosystem, off-the-shelf, standardized, pooled-donor, high-richness Microbiome Ecosystem TherapyTM. MaaT033 is designed to restore the gut ecosystem to full functionality to improve clinical outcomes as well as to control adverse events related to conventional treatments for liquid tumors. The capsule formulation facilitates administration and allows the potential to treat larger patients’ population while maintaining the high and consistent richness and diversity of microbial species, including anti-inflammatory ButycoreTM species.