On May 14, 2024 Eagle Pharmaceuticals, Inc. reported the company entered into a Third Amendment to Third Amended and Restated Credit Agreement (the "Third Amendment Agreement") with JPMorgan Chase Bank, N.A., as administrative agent (the "Agent"), and the lenders party thereto (the "Lenders"), with an effective date of May 13, 2024, which amends the terms of (i) the Company’s Third Amended and Restated Credit Agreement, dated as of November 1, 2022 (as amended by the First Amendment Agreement (defined below), the "Original Credit Agreement") and (ii) the Limited Waiver and First Amendment to Third Amended and Restated Credit Agreement, dated as of January 12, 2024 (as amended by the Second Amendment Agreement (defined below), the "First Amendment Agreement") (Press release, Eagle Pharmaceuticals, MAY 15, 2024, View Source [SID1234643301]). The Original Credit Agreement as amended by that certain Second Amendment to Third Amended and Restated Credit Agreement, dated as of February 29, 2024 (the "Second Amendment Agreement"), is referred to herein as the "Credit Agreement," and the Credit Agreement as amended by the Third Amendment Agreement is referred to herein as the "Amended Credit Agreement."

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As previously disclosed (i) in the Company’s Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission (the "SEC") on January 16, 2024, incorporated by reference herein, the Company, the Agent and the Lenders entered into the First Amendment Agreement, which provided a waiver of defaults and events of default that occurred and were continuing under the Original Credit Agreement at such time and (ii) in the Company’s Current Report on Form 8-K filed with the SEC on March 1, 2024, incorporated by reference herein, the Company, the Agent and the Lenders entered into the Second Amendment Agreement, which amended certain terms of the Original Credit Agreement and the First Amendment Agreement.

Pursuant to the Credit Agreement and the First Amendment Agreement, (i) the Company is required to deliver to the Agent and the Lenders, by not later than May 13, 2024, (a) annual audited financial statements for the fiscal year ended December 31, 2023, reported on by the Company’s independent public accountant (without a "going concern" or like qualification or exception and without any qualification or exception as to the scope of such audit) to the effect that such consolidated financial statements present fairly in all material respects the financial condition and results of operations of the Company and its consolidated subsidiaries in accordance with GAAP (the "Annual Financial Statement Requirement"), (b) restated quarterly financial statements for the fiscal quarter ended June 30, 2023 and (c) quarterly financial statements for the fiscal quarter ended September 30, 2023, (ii) the Company is required to deliver to the Agent and the Lenders, by not later than June 3, 2024, quarterly financial statements for the fiscal quarter ended March 31, 2024, (iii) the Company is required to deliver to the Agent and the Lenders, concurrently with delivery of the financials statements referred to in the foregoing clauses (i)(b), (i)(c) and (ii), a certificate by one of its officers that such financial statements present fairly in all material respects the financial condition and results of operations of the Company and its consolidated subsidiaries in accordance with GAAP for the respective quarter (clauses ((i)(b), (i)(c) and (ii), the "Quarterly Financial Statement Requirement" and together with the Annual Financial Statement Requirement, the "Financial Statement Requirement") and (iv) until the Quarterly Financial Statement Requirement has been satisfied, (a) availability under the revolving facility under the Credit Agreement is reduced from $100 million to $50 million (the "Availability Restriction"), (b) the Company is not permitted to utilize any negative covenant flexibility that is based on a pro forma compliance with any of the Fixed Charge Coverage Ratio, Senior Secured Net Leverage Ratio and/or the Total Net Leverage Ratio test (each as defined in the Credit Agreement), which restricts the Company’s flexibility to, among other things, incur certain additional indebtedness, complete certain corporate transactions, including certain acquisitions and dispositions, or make certain additional restricted payments (the "Covenant Flexibility Restriction") and (c) compliance with the minimum liquidity covenant is waived (the "Liquidity Covenant Waiver").

Pursuant to the terms of the Third Amendment Agreement, (i) the delivery deadline with respect to each Financial Statement Requirement has been extended to July 31, 2024, (ii) the Availability Restriction has been superseded by a permanent reduction of availability under the revolving facility under the Amended Credit Agreement from $100 million to $50 million, (iii) the Covenant Flexibility Restriction has been revised to continue until the Company has satisfied each Financial Statement Requirement, (iv) the Liquidity Covenant Waiver has been terminated and (v) the minimum liquidity covenant in the Amended Credit Agreement has been reduced from $50 million to $10 million.

Pursuant to the terms of the Amended Credit Agreement, failure to timely satisfy the Financial Statement Requirement will result in an event of default. During the continuance of an event of default, the Agent may, with the consent of the required lenders, and shall, at the request of the required lenders, by notice to the Company, terminate undrawn commitments, declare the loans then outstanding to be due and payable in full and/or exercise other remedies available to it, among other things. In addition, the Company’s obligations under the Amended Credit Agreement are secured by a pledge of substantially all of the Company’s assets. If the Company is unable to pay its obligations, the Agent on behalf of the lenders could proceed to protect and enforce their rights under the Amended Credit Agreement, including by foreclosure on the assets securing the Company’s obligations under the Amended Credit Agreement. The foregoing would materially and adversely affect the Company’s business and financial condition. There can be no assurance that the Company will be able to satisfy the Financial Statement Requirement on the required timing or at all, or comply with the terms of the Third Amendment Agreement and the Amended Credit Agreement.

The foregoing descriptions of the Third Amendment Agreement, the Second Amendment Agreement, the First Amendment Agreement and the Original Credit Agreement are not intended to be complete and are qualified in their entirety by reference to the full text of the Third Amendment Agreement, the Second Amendment Agreement, the First Amendment Agreement and the Original Credit Agreement, which are filed as Exhibit 10.1 to this Current Report on Form 8-K, Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on March 1, 2024, Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on January 16, 2024, and Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on November 3, 2022, respectively.

On May 15, 2024 Novartis reported the company will present data from more than 60 abstracts, including investigator-initiated trials at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the European Hematology Association (EHA) (Free EHA Whitepaper) 2024 Hybrid Congress (Press release, Novartis, MAY 15, 2024, View Source [SID1234643329]). The primary results from ASC4FIRST, a pivotal Phase III study of Scemblix (asciminib) versus standard of care tyrosine kinase inhibitors (imatinib, nilotinib, dasatinib, and bosutinib) in newly diagnosed patients with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) will be shared at the ASCO (Free ASCO Whitepaper) official Press Program and at the EHA (Free EHA Whitepaper) Plenary Session.

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"Despite progress, people with CML continue to struggle to find treatment that is both efficacious and tolerable for them at diagnosis and beyond. We look forward to sharing the primary analysis from the pivotal Phase III ASC4FIRST trial, which builds on our over 20-year legacy to transform care for people diagnosed with CML," said Jeff Legos, Executive Vice President, Global Head of Oncology, Novartis. "With these promising data, a new analysis of the NATALEE trial in patients with node-negative early breast cancer and additional updates from our RLT portfolio, we further our efforts to reimagine medicine for those with cancer in partnership with the scientific community."

Key highlights of data accepted by ASCO (Free ASCO Whitepaper) include:

Medicine     Abstract Title     Abstract Number/ Presentation Details     
Scemblix ASC4FIRST, a pivotal phase 3 study of asciminib (ASC) vs investigator-selected tyrosine kinase inhibitors (IS TKIs) in newly diagnosed patients (pts) with chronic myeloid leukemia (CML): Primary results

Abstract #LBA6500
Oral presentation
Friday, May 31
2:45 – 5:45pm CDT

Kisqali (ribociclib)

Baseline (BL) characteristics and efficacy endpoints for patients (pts) with node-negative (N0) HR+/HER2− early breast cancer (EBC): NATALEE trial

Abstract #512
Rapid oral presentation
Friday, May 31
2:45 – 4:15pm CDT
Kisqali

On-treatment (tx) dynamic circulating tumor DNA changes (∆ctDNA) associated with progression-free survival (PFS) and overall survival (OS) of patients (pts) with HR+/HER2− advanced breast cancer (ABC) in MONALEESA-3 (ML-3)

Abstract #1012
Clinical Science Symposium
Sunday, June 2
4:30 – 6:00pm CDT

Kisqali

Short-term risk of recurrence in patients (pts) with HR+/HER2− early breast cancer (EBC) treated with endocrine therapy (ET) in randomized clinical trials (RCTs): A meta-analysis

Abstract #541
Poster presentation
Sunday, June 2
9:00am – 12:00pm CDT
Kisqali     Real-world (RW) risk recurrence among patients (pts) diagnosed with stage II-III HR+/HER2- early breast cancer (EBC) treated with endocrine therapy (ET) in the US
  Abstract #e12533
Online publication

Pluvicto (INN: lutetium (177Lu) vipivotide tetraxetan / USAN: lutetium Lu 177 vipivotide tetraxetan)

Health-related quality of life and pain in a phase 3 study of [177Lu]Lu-PSMA-617 in taxane-naïve patients with metastatic castration-resistant prostate cancer (PSMAfore)

Abstract #5003
Oral presentation
Saturday, June 1
3:00 – 6:00pm CDT

Pluvicto Baseline ctDNA analyses and associations with outcomes in taxane-naive patients with mCRPC treated with 177Lu-PSMA-617 versus change of ARPI in PSMAfore

Abstract #5008
Oral presentation
Saturday, June 1
3:00 – 6:00pm CDT

Pluvicto Real-world clinical outcomes and economic burden of early discontinuation of taxane therapy among patients with metastatic castration-resistant prostate cancer

Abstract #e17043
Online publication

Pluvicto Patient characteristics, treatment patterns and early trends of lutetium Lu 177 vipivotide tetraxetan (177Lu-PSMA-617) use by US urologists and oncologists

Abstract #e17048
Online publication
Lutathera (INN: lutetium (177Lu) oxodotreotide / USAN: lutetium Lu 177 dotatate)

Safety and time to response of [177Lu]Lu-DOTATATE in patients with newly diagnosed advanced grade 2 and grade 3, well-differentiated gastroenteropancreatic neuroendocrine tumors: Sub-analysis of the phase 3 randomized NETTER-2 study

Abstract #4131
Poster presentation
Saturday, June 1
1:30 – 4:30pm CDT

At the ASCO (Free ASCO Whitepaper) Annual Meeting, Novartis will also address health equity at the company’s booth on the meeting floor, with the More Than Just Words virtual reality experience. Meeting attendees will have the opportunity to immerse themselves in scenarios inspired by real-life microaggressions Black patients face due to bias in care, and explore resources co-created with leading multidisciplinary experts to help foster productive, nonbiased conversations about breast cancer risk, diagnosis, and care.

Key highlights of data accepted by EHA (Free EHA Whitepaper) include:  

Medicine   Abstract Title Abstract Number/ Presentation Details     
Scemblix Asciminib (ASC) provides superior efficacy and excellent safety and tolerability vs tyrosine kinase inhibitors (TKI) in newly diagnosed chronic myeloid leukemia (CML) in the pivotal ASC4FIRST study

Abstract #S103
Plenary oral presentation
Saturday, June 15
2:45 – 4:15pm CEST

Scemblix Asciminib (ASC) is well tolerated in pediatric patients with chronic myeloid leukemia in chronic phase (CML-CP): interim pharmacokinetics and safety results from ASC4KIDS 

Abstract #P1865
e-Poster presentation

Fabhalta (iptacopan)

Effects of oral iptacopan monotherapy, including increased paroxysmal nocturnal hemoglobinuria red blood cell clone size, are sustained in anti-c5-treated patients with anemia: final APPLY-PNH data Abstract #P829
Poster presentation
Friday, June 14
9:00am CEST
Fabhalta

Effects of oral iptacopan monotherapy, including increased paroxysmal nocturnal hemoglobinuria red blood cell clone size, are maintained in complement inhibitor-naïve patients: final APPOINT-PNH data

Abstract #P822
Poster presentation
Friday, June 14
9:00am CEST

Fabhalta

Patient experience of iptacopan in three clinical trials for paroxysmal nocturnal hemoglobinuria

Abstract #P1918
e-Poster presentation
Product Information 
For full prescribing information, including approved indications and important safety information about marketed products, please visit View Source

On May 15, 2024) – Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, reported financial results and business updates for the first quarter ended March 31, 2024 (Press release, Adaptimmune, MAY 15, 2024, View Source [SID1234643361]). The Company will host a live webcast at 8:00 a.m. EDT (1:00 p.m. BST) today.

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Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer: "Support from the sarcoma community continues to highlight the high unmet medical need for new therapies for synovial sarcoma and we are making great progress preparing for the commercial launch of afami-cel on approval. Behind afami-cel, we plan to launch lete-cel for synovial sarcoma and MRCLS in 2026 with projected peak US sales of $400 million for our sarcoma franchise."

Sarcoma Franchise with afami-cel and lete-cel

U.S. FDA accepted the BLA for afami-cel for the treatment of advanced synovial sarcoma with priority review and a PDUFA date of August 4th, 2024
The BLA mid-cycle review meeting was held with FDA in April
FDA GCP Bioresearch Monitoring Program (BIMO) inspections have been conducted at Adaptimmune and at selected clinical sites that participated in the pivotal
SPEARHEAD-1 trial
FDA GMP Pre-license inspections (PLI) have taken place at the Company’s Navy Yard facility and at the lentiviral vector contract manufacturer’s facility
Preliminary plans for confirmatory evidence for afami-cel’s full approval were previously agreed with FDA, including Cohort 2
Adaptimmune expects to discuss post-marketing requirements and commitments at the late-cycle meeting which is scheduled for the second half of May
To date, the FDA has not requested an Advisory Committee meeting or a REMS program
The marketing application for the companion diagnostic for MAGE-A4 is currently under FDA review and is expected to be approved contemporaneously with the BLA
Adaptimmune is preparing to launch afami-cel on approval in the U.S. Initially, launch will be focused on 6-10 selected treatment centers ("Authorized Treatment Centers" or "ATCs") and will expand to up to ~30 ATCs.
100% of the customer facing commercial and medical affairs teams is now in place
Company launched www.Tcrtcell.com: an unbranded website aimed at educating healthcare providers about TCR T-cell therapy in solid tumors, including synovial sarcoma, and the role of biomarkers and testing to determine future treatments
The second product in Adaptimmune’s sarcoma franchise, lete-cel, is being investigated in the pivotal IGNYTE-ESO trial (NCT03967223), which at a planned interim analysis exhibited response in 18/45 of patients (ORR 40%). The primary efficacy endpoint requires 16/60 patients have responses, so this trial has met its primary endpoint for efficacy. The full pivotal analyses are anticipated in late 2024.
Lete-cel will enable Adaptimmune to expand its addressable synovial sarcoma patient population by targeting the NY-ESO cancer antigen, in addition to MAGE-A4 targeted by afami-cel, as well as treating Myxoid Round Cell Liposarcoma (MRCLS) patients.
Sarcoma franchise of afami-cel and lete-cel leverages same development and commercial footprint with US peak year sales projected to be up to $400 million
Data presentations
Data from pivotal SPEARHEAD-1 trial with afami-cel published in The Lancet: article entitled "Afamitresgene autoleucel for advanced synovial sarcoma and myxoid round cell liposarcoma (SPEARHEAD-1): an international, open-label, phase 2 trial"
Data from the planned interim analysis of the pivotal IGNYTE-ESO trial with lete-cel to be presented by Dr. Sandra P. D’Angelo, M.D., Sarcoma Medical Oncology, Memorial Sloan Kettering Cancer Center, in an oral presentation at ASCO (Free ASCO Whitepaper) entitled "Lete-cel in patients with synovial sarcoma or myxoid/round cell liposarcoma: Planned interim analysis of the pivotal IGNYTE-ESO trial" during the Developmental Therapeutics-Immunotherapy session in Hall D2 on June 3, 2024 at 11:30 a.m. CDT
Clinical pipeline

Uzatresgene autoleucel ("uza-cel", formerly ADP-A2M4CD8) is being investigated in the SURPASS-3 Phase 2 clinical trial (NCT05601752) for the treatment of platinum-resistant ovarian cancer. Uza-cel received FDA RMAT designation in 2022 for the treatment of patients with platinum resistant ovarian cancer. The SURPASS-3 trial is currently enrolling patients.
Cohorts in the Phase 1 SURPASS trial are ongoing for people with head & neck and urothelial (bladder) cancers with uza-cel in combination with standard of care checkpoint inhibitor therapy.
Preclinical pipeline

IND-enabling studies are underway for ADP-600 (PRAME) and ADP-520 (CD70) programs.
Wholly owned allogeneic pipeline advancing; process development in progress at Adaptimmune’s allogeneic manufacturing facility in Milton Park, UK.
Data presentation
Poster presented by George Pope, Ph.D., Associate Director Preclinical Safety at Adaptimmune, entitled "Development and Preclinical Characterization of an Engineered T-Cell Therapy Targeting PRAME-Expressing Solid Tumors" at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual meeting
Corporate news

As announced earlier today, Adaptimmune has secured up to $125 million in debt financing with Hercules Capital with the first tranche of $25 million available upon closing; and an additional $25 million available upon afami-cel approval
Cash runway into late 2025 which includes current cash on hand, anticipated revenues from the launch of afami-cel, expected future income from partners and other non-dilutive capital sources including the Company’s new debt facility with Hercules Capital
Company announced that its strategic collaboration with Genentech was terminated
Financial Results for the three months ended March 31, 2024

Cash / liquidity position: As of March 31, 2024, Adaptimmune had cash and cash equivalents of $140.7 million and Total Liquidity[1] of $143.7 million, compared to $144.0 million and $146.9 million respectively, as of December 31, 2023.
Revenue: Revenue for the three months ended March 31, 2024, was $5.7 million compared to $47.6 million for the same period in 2023. Revenue has decreased in 2024, compared to the same period in 2023 primarily due to the termination of the Astellas collaboration in the first quarter of 2023, resulting in the remaining deferred income for the collaboration being recognized as revenue in March 2023.
Research and development (R&D) expenses: R&D expenses for the three months ended March 31, 2024, were $35.2 million compared to $25.5 million for the same period in 2023. R&D expenses in the three months ended March 31, 2024 increased in employee-related costs and additional costs associated with lease properties following the acquisition of TCR2 in June 2023 and a decrease in offsetting reimbursements receivable for research and development tax and expenditure credits.
General and administrative (G&A) expenses: G&A expenses for the three months ended March 31, 2024, were $19.7 million compared to $20.4 million for the same period in 2023. G&A expenses in the three months ended March 31, 2024 decreased due to restructuring and charges recognised in the first quarter of 2023 and a decrease in other corporate costs due to an increase in accounting, legal and professional fees incurred in relation to the TCR2 Therapeutics, Inc merger agreement that were not repeated in 2024, offset by an increase in depreciation due to leasehold improvements capitalised in 2023.
Net loss/profit: Net loss attributable to holders of the Company’s ordinary shares for the three months March 31, 2024, was $48.5 million ($(0.03) per ordinary share), compared to a profit of $1.0 million ($0.00 per ordinary share), for the same periods in 2023.
Financial Guidance
The Company believes that its existing cash, cash equivalents and marketable securities, together with anticipated revenues from the launch of afami-cel, expected future income from partners and other non-dilutive capital sources including the Company’s new debt facility with Hercules Capital announced earlier today, will fund the Company’s current operations into late 2025, as further detailed in the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2024, to be filed with the Securities and Exchange Commission following this earnings release.

On May 15, 2024 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that four abstracts with Innate’s drug candidates have been accepted for the European Association of Hematology (EHA) (Free EHA Whitepaper) 2024 Congress, taking place June 13-16, 2024 in Madrid, Spain (Press release, Innate Pharma, MAY 15, 2024, View Source [SID1234643377]).

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Two abstracts are related to SAR443579 (IPH6101), an investigational trifunctional anti-CD123 NKp46xCD16 NK cell engager from a joint research collaboration between Innate Pharma and Sanofi and currently being evaluated as a monotherapy in a Sanofi-sponsored Phase 1/2 clinical trial for the treatment of blood cancers with high unmet needs.
Two abstracts are related to IPH6501, Innate’s second generation ANKET for the treatment of relapsed or refractory CD20-expressing B-cell Non-Hodgkin’s Lymphoma, currently in Phase 1/2 clinical trial.
"We’re pleased to see a continued momentum around our ANKET platform assets, SAR443579 and IPH6501," said Dr. Sonia Quaratino, Chief Medical Officer of Innate Pharma. "With their innovative format, we believe that NK Cell Engagers will benefit for patients who are in high unmet medical need, and we look forward to continue the studies with these assets."

EHA abstract details:

SAR443579 / IPH6101 (under development by Sanofi)

Abstract: S146
Abstract Title: Completed dose-escalation from the First-in-Human, Phase 1/2 Study of CD123 NK Cell Engager SAR443579 in Relapsed or Refractory Acute Myeloid Leukemia or High Risk-Myelodysplasia
Abstract type: Oral Presentation

Abstract: P475
Abstract Title: Exploring Dose-response Relationship of a Novel CD123 NK Cell Engager SAR443579 in Acute Myeloid Leukemia (AML) Models
Abstract type: Poster Presentation

IPH6501

Abstract: P1251
Abstract Title: Preclinical assessment of IPH6501, a first-in-class IL2V-armed tetraspecific NK Cell Engager directed against CD20 for R/R B-NHL, in comparison with a CD20-targeting T Cell Engager
Abstract type: Poster Presentation
This abstract is embargoed until 23.05.2024 23:00 CEST, until publication by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), Inc. for their 2024 ASCO (Free ASCO Whitepaper) Annual Meeting.

The Abstract PB3041, "A Phase 1/2 trial investigating safety, tolerability, and preliminary antitumor activity of IPH6501, a first-in-class NK Cell Engager, in patients with R/R CD20-expressing NHL" will be available in the EHA (Free EHA Whitepaper) abstracts book.

About ANKET

ANKET (Antibody-based NK cell Engager Therapeutics) is Innate’s proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer. This versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer.

About IPH6501

IPH6501 is the first Antibody-based NK cell Engager Therapeutic to co-engage activating receptors on NK cells (NKp46 and CD16), IL-2R (but not α subunit) through a variant of human IL-2, and a tumor antigen (CD20) via a single molecule, hence providing proliferation and activation signals targeted to NK cells and promoting their cytotoxic activity against CD20 expressing malignant cells. IPH6501 has shown better anti-tumor efficacy than approved benchmark antibodies in preclinical tumor models (Demaria, EHA (Free EHA Whitepaper) 2023).

About the Innate-Sanofi research collaboration and licensing agreements

The Company has a research collaboration and license agreement with Sanofi to apply Innate’s proprietary technology to the development of innovative multi-specific antibody formats engaging NK cells through the activating receptors NKp46 and CD16 to kill tumor cells.

Under the terms of the 2016 research collaboration and license agreement, Sanofi is responsible for the development, manufacturing and commercialization of products resulting from the research collaboration, which includes SAR443579/IPH6101 (Trifunctional anti-CD123 NKp46xCD16 NK cell engager) and SAR445514/IPH6401 (Trifunctional anti-BCMA NKp46xCD16 NK cell engager). As part of the 2016 agreement, Innate Pharma is eligible to up to €400m in development and commercial milestone payments as well as royalties on net sales.

As part of the license agreement entered in December 2022, Sanofi licensed IPH62 and IPH67 and has the option for one additional target. Under the terms of the 2022 agreement, Innate Pharma is eligible to up to €1.35bn in development and commercial milestone payments as well as royalties on net sales.

On May 15, 2024 Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the first quarter of 2024 and recent corporate progress (Press release, Abeona Therapeutics, MAY 15, 2024, View Source [SID1234643313]).

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"We are grateful to our existing as well as new investors who have demonstrated their support through the recent financing, which has extended our cash runway into 2026, well beyond anticipated regulatory milestones," said Vish Seshadri, Chief Executive Officer of Abeona. "We now remain focused on working with the FDA to address the CMC deficiencies noted in the CRL and making the BLA resubmission to bring pz-cel to RDEB patients as soon as possible."

First Quarter and Recent Progress

Corporate highlights

● On May 7, 2024, Abeona closed a $75 million underwritten securities offering with participation from both new and existing investors.
● In January 2024, Abeona entered into a $50 million credit facility and received the first tranche of $20 million.

Pz-cel for RDEB

● In April 2024, Abeona received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Company’s Biologics License Application (BLA) for prademagene zamikeracel (pz-cel) for recessive dystrophic epidermolysis bullosa (RDEB), based on the need for additional Chemistry Manufacturing and Controls (CMC) information. In the CRL, the FDA noted that certain additional information needed to satisfy CMC requirements must be resolved before the application can be approved. The information needed to satisfy the CMC requests in the CRL pertains to validation requirements for certain manufacturing and release testing methods. The CRL did not identify any deficiencies related to the clinical efficacy or clinical safety data in the BLA, and the FDA did not request any new clinical trials or clinical data to support the approval of pz-cel. The Company anticipates completing the BLA resubmission in the second half of 2024.
● New pz-cel data will be presented at upcoming medical meetings. At the Society for Investigative Dermatology (SID) Annual Meeting, being held on May 15-18, 2024, new long-term safety data with up to 11 years of follow-up has been accepted as a late-breaking presentation.

U.S. commercial launch preparations for pz-cel

● Abeona continues to advance key commercial activities in preparation for a potential U.S. launch for pz-cel, including onboarding discussions with epidermolysis bullosa treatment sites, conducting medical and payer engagement, as well as building supply chain and enterprise capabilities to support the Company’s transition to a commercial stage company.

First Quarter Financial Results and Cash Runway Guidance

Cash, cash equivalents, restricted cash and short-term investments totaled $62.7 million as of March 31, 2024, compared to $52.6 million as of December 31, 2023. Net cash used in operating activities was $14.5 million for the three months ended March 31, 2024.

Abeona estimates that its current cash and cash equivalents, restricted cash and short-term investments, as well as the credit facility, combined with the net proceeds from the underwritten securities offering, are sufficient resources to fund operations into 2026, before accounting for any potential revenue from commercial sales of pz-cel, if approved, or proceeds from the sale of a Priority Review Voucher or PRV, if awarded by the FDA.

Research and development expenses for the three months ended March 31, 2024 were $7.2 million, compared to $8.0 million for the same period of 2023. General and administrative expenses were $7.1 million for the three months ended March 31, 2024, compared to $4.0 million for the same period of 2023. Net loss was $31.6 million for the first quarter of 2024, or $1.16 loss per common share, including a change in the fair value of warrant liabilities due to remeasurement of the Company’s issued stock purchase warrants. Net loss in the first quarter of 2023 was $9.1 million, or $0.54 loss per common share.

Conference Call Details

The Company will host a conference call and webcast on Wednesday, May 15, 2024, at 8:30 a.m. ET, to discuss the first quarter results. To access the call, dial 888-506-0062 (U.S. toll-free) or 973-528-0011 (international) and Entry Code: 496484 five minutes prior to the start of the call. A live, listen-only webcast and archived replay of the call can be accessed on the Investors & Media section of Abeona’s website at View Source The archived webcast replay will be available for 30 days following the call.