Immune Response Data for INO-3107 to be Presented as a Poster at American Association for Cancer Research Immuno-Oncology (AACR-IO) Conference

On February 10, 2025 INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, reported that an abstract describing the immunological activity of INO-3107 will be presented as a poster at the following scientific conference (Press release, Inovio, FEB 10, 2025, View Source [SID1234650134]):

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American Association for Cancer Research – Immuno-Oncology
Discovery and Innovation in Cancer Immunology: Revolutionizing Treatment through Immunotherapy (February 23-26, 2025)
Poster entitled: "Loss of Detectable HPV-6 Following Induction of Emergent T cells in Patients with Durable Complete Clinical Response to Treatment for Recurrent Respiratory Papillomatosis using INO-3107"

The abstract will be made available on INOVIO’s website following the conference.

Incyte Reports 2024 Fourth Quarter and Year-End Financial Results, Provides 2025 Financial Guidance and Highlights 2025 R&D Milestones

On February 10, 2025 Incyte (Nasdaq:INCY) reported financial results for the fourth quarter and full year ended December 31, 2024 and provided full year 2025 financial guidance (Press release, Incyte, FEB 10, 2025, View Source [SID1234650133]).

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"2024 was an important year for Incyte, with a 15% increase in total revenues, driven by strong growth from both Jakafi and Opzelura, as well as significant progress across our R&D pipeline," said Hervé Hoppenot, Chief Executive Officer, Incyte. "Looking ahead to 2025, we anticipate a year of continued strong revenue growth and diversification, as well as several defining milestones that will serve as an inflection point for Incyte. A year ago, we set the goal to achieve more than 10 impactful product launches by 2030. In 2025, a number of key catalysts across the entire portfolio will bring that goal closer to reality."
2025: A Year of Defining Catalysts
Incyte expects to deliver at least 18 key milestones in 2025. These include:
•Four new product launches: Niktimvo in 3L+ chronic graft-versus-host disease (GVHD), ruxolitinib cream in pediatric atopic dermatitis (AD), tafasitamab in relapsed/refractory follicular lymphoma (FL), and retifanlimab in squamous cell anal carcinoma (SCAC).
•At least three Phase 3 study initiations: BET inhibitor in 2L myelofibrosis (MF), ruxolitinib cream in mild to moderate hidradenitis suppurativa (HS) and CDK2 inhibitor in ovarian cancer.
•Four pivotal readouts: Povorcitinib in moderate to severe HS, ruxolitinib cream in prurigo nodularis (PN), tafasitamab in 1L diffuse large B-cell lymphoma (DLBCL), and ruxolitinib XR for MF, polycythemia vera (PV), and GVHD.
•Seven proof of concept readouts: Povorcitinib in chronic spontaneous urticaria (CSU) and asthma, mutCALR in MF and essential thrombocythemia (ET), JAK2V617F mutant-specific inhibitor in MF, and both KRASG12D and TGFβR2xPD-1 in solid tumors.

Key Recent Company Updates
•A bioequivalence study of ruxolitinib extended-release (XR) has been completed. These data are anticipated to be submitted to the U.S. Food and Drug Administration (FDA) by year-end 2025 once the stability studies are complete.

•In January 2025, Incyte and Syndax Pharmaceuticals announced that the FDA approved Niktimvo (axatilimab-csfr) in 9 mg and 22 mg vial sizes. Niktimvo is now commercially available in the U.S. and the commercial launch is underway.

•In December 2024, additional results from the pivotal Phase 3 inMIND trial evaluating treatment with tafasitamab (Monjuvi), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, in combination with lenalidomide and rituximab compared with placebo plus lenalidomide and rituximab in patients with relapsed or refractory follicular lymphoma were featured in the late-breaking session at the 2024 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. The study met its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) by investigator assessment in 548 patients with relapsed or refractory FL. Tafasitamab was generally well-tolerated, and safety was consistent with other CD19 and immunotherapy combination regimens. These data have been submitted to the FDA and approval for this indication is expected in the second half of 2025.

•In December 2024, Incyte shared additional data from its BET inhibitor (INCB057643) in patients with relapsed or refractory myelofibrosis and other advanced myeloid neoplasms at the 2024 ASH (Free ASH Whitepaper) Annual Meeting. These results showed treatment with INCB057643 was generally well tolerated and improvements in anemia, spleen size, and symptom burden were observed in patients receiving INCB057643 monotherapy and in combination with ruxolitinib. Incyte plans to initiate a Phase 3 monotherapy study in the post Jakafi patient population in 2025.

•In December 2024, the supplemental Biologics License Application (sBLA) submission for retifanlimab (Zynyz) in advanced/metastatic squamous cell anal carcinoma was filed with the FDA with approval anticipated in the second half of 2025.

•In October 2024, the sNDA submission for ruxolitinib cream (Opzelura) in pediatric atopic dermatitis was filed with the FDA with approval anticipated in the second half of 2025.
Jakafi:
Net product revenues for the fourth quarter of 2024 of $773 million; 2024 full year net product revenues of $2.79 billion
▪Fourth quarter 2024 net product revenues increased 11% compared to the fourth quarter of 2023 and 8% for the full year 2024 when compared to 2023.
▪Net product revenues were primarily driven by paid demand, which increased 14% in the fourth quarter of 2024 and 9% for the full year 2024 when compared to the same periods in 2023, with growth across all indications.
▪Channel inventory at the end of the fourth quarter of 2024 was within the normal range.
Opzelura:
Net product revenues for the fourth quarter of 2024 of $162 million; 2024 full year net product revenues of $508 million:
▪Fourth quarter 2024 net product revenues increased 48% compared to the fourth quarter of 2023 and 50% for the full year 2024 when compared to 2023.
▪Net product revenues were primarily driven by patient demand and refills for both atopic dermatitis and vitiligo and increased contribution from Europe.

Additional Pipeline Updates
Myeloproliferative Neoplasms (MPNs) and Graft-Versus-Host Disease (GVHD) – key highlights
▪The Phase 1 studies evaluating mutCALR in myelofibrosis (MF) and essential thrombocythemia (ET) and JAK2V617Fi in MF are ongoing and enrolling patients. Initial proof of concept data for both studies are anticipated in 2025.
▪A Phase 2 trial evaluating the safety and efficacy of axatilimab (Niktimvo) in combination with ruxolitinib (Jakafi) in patients with newly diagnosed chronic GVHD was initiated in the fourth quarter of 2024 and is enrolling patients.
▪A Phase 3, randomized, double-blind, placebo-controlled, multi-center trial that will investigate the use of axatilimab in combination with corticosteroids as initial treatment for chronic GVHD has been initiated and is enrolling patients.
MPN and GVHD Programs Indication and Phase
Ruxolitinib XR (QD)
(JAK1/JAK2) Myelofibrosis, polycythemia vera and GVHD
Ruxolitinib + INCB57643
(JAK1/JAK2 + BETi) Myelofibrosis: Phase 2
Ruxolitinib + axatilimab1
(JAK1/JAK2 + anti-CSF-1R)
Chronic GVHD: Phase 2
Steroids + axatilimab1
(Steroids + anti-CSF-1R)
Chronic GVHD: Phase 3
INCA33989
(mutCALR) Myelofibrosis, essential thrombocythemia: Phase 1
INCB160058
(JAK2V617Fi) Myelofibrosis: Phase 1

1 Clinical development of axatilimab in GVHD conducted in collaboration with Syndax Pharmaceuticals.
Other Hematology/Oncology – key highlights
▪Incyte plans to initiate Phase 3 studies for its potentially first-in-class CDK2 inhibitor (INCB123667), in ovarian cancer in 2025 and is also evaluating INCB123667 in combination with other treatments.
▪The Phase 3 study evaluating tafasitamab in first-line DLBCL is ongoing. The Phase 3 data are anticipated in the first half of 2025.
▪The Phase 1 studies evaluating KRASG12D and TGFßR2×PD-1 in solid tumors are ongoing and enrolling patients. Initial proof of concept data for both studies are anticipated in 2025.

Heme/Oncology Programs Indication and Phase
Tafasitamab (Monjuvi/Minjuvi)
(CD19)
Relapsed or refractory diffuse large B-cell lymphoma (DLBCL): Phase 3 (B-MIND)
First-line DLBCL: Phase 3 (frontMIND)
Relapsed or refractory follicular lymphoma (FL): Phase 3 (inMIND)
Retifanlimab (Zynyz)1
(PD-1)
Squamous cell anal cancer (SCAC): Phase 3 (POD1UM-303)
Non-small cell lung cancer (NSCLC): Phase 3 (POD1UM-304)
MSI-high endometrial cancer: Phase 2 (POD1UM-101, POD1UM-204)
INCB123667
(CDK2i) Solid tumors with CCNE1 amplification/Cyclin E overexpression: Phase 1
INCB161734
(KRASG12D) Advanced metastatic solid tumors with a KRASG12D mutation: Phase 1
INCA33890
(TGFßR2×PD-1)2
Advanced or metastatic solid tumors: Phase 1

1 Retifanlimab licensed from MacroGenics.
2 Development in collaboration with Merus.
Inflammation and Autoimmunity (IAI) – key highlights
Ruxolitinib Cream
▪Two Phase 3 trials (TRuE-PN1 and TRuE-PN2) evaluating ruxolitinib cream in prurigo nodularis (PN) are fully enrolled. Data from the Phase 3 studies are anticipated in the first half of 2025.
▪The Phase 3 trial for ruxolitinib cream in mild to moderate hidradenitis suppurativa (HS) is on track to initiate in the first half of 2025 following achieving alignment on the study design with FDA.
▪In February 2025, Opzelura was granted approval by the Swiss Agency for Therapeutic Products (Swissmedic) for the treatment of non-segmental vitiligo with facial involvement in patients 12 years of age and older.
▪In October 2024, Opzelura was granted a Notice of Compliance by Health Canada for the topical treatment of both mild to moderate atopic dermatitis and nonsegmental vitiligo in patients 12 years of age and older.
Povorcitinib (INCB54707)
▪In October 2024, two Phase 3 studies (STOP-PN1 and STOP-PN2) evaluating povorcitinib in patients with PN versus placebo were initiated and are enrolling.
▪The Phase 3 studies of povorcitinib in patients with HS (STOP-HS1 and STOP-HS2) are fully enrolled. Data from both pivotal studies are anticipated in the first half of 2025.
▪Two Phase 2 trials evaluating povorcitinib in asthma and chronic spontaneous urticaria (CSU) are enrolling. Data for CSU are anticipated in the first half of 2025 and data in asthma are anticipated in the second half of 2025.
4

IAI and Dermatology Programs Indication and Phase
Ruxolitinib cream (Opzelura)1
(JAK1/JAK2)
Atopic dermatitis: Phase 3 pediatric study (TRuE-AD3)
Hidradenitis suppurativa: Phase 2; Phase 3 expected to initiate in 2025
Prurigo nodularis: Phase 3 (TRuE-PN1, TRuE-PN2)
Povorcitinib
(JAK1) Hidradenitis suppurativa: Phase 3 (STOP-HS1, STOP-HS2)
Vitiligo: Phase 3 (STOP-V1, STOP-V2)
Prurigo nodularis: Phase 3 (STOP-PN1, STOP-PN2)
Chronic spontaneous urticaria: Phase 2
Asthma: Phase 2
INCA034460
(anti-CD122) Vitiligo: Phase 1

1 Novartis’ rights to ruxolitinib outside of the United States under our Collaboration and License Agreement with Novartis do not include topical administration.
Other
Other Program Indication and Phase
Zilurgisertib
(ALK2) Fibrodysplasia ossificans progressiva: Pivotal Phase 2

2024 Fourth Quarter and Year-end Financial Results
The financial measures presented in this press release for the quarter and year ended December 31, 2024 and 2023 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"), unless otherwise identified as a Non-GAAP financial measure. Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte’s GAAP disclosures. Management uses such information internally and externally for establishing budgets, operating goals and financial planning purposes. These metrics are also used to manage the Company’s business and monitor performance. The Company adjusts, where appropriate, for expenses in order to reflect the Company’s core operations. The Company believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the Company’s core operations. The metrics have been adopted to align the Company with disclosures provided by industry peers.
Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used in conjunction with and to supplement Incyte’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry.
As changes in exchange rates are an important factor in understanding period-to-period comparisons, Management believes the presentation of certain revenue results on a constant currency basis in addition to reported results helps improve investors’ ability to understand its operating results and evaluate its performance in comparison to prior periods. Constant currency information compares results between periods as if exchange rates had remained constant period over period. The Company calculates constant currency by calculating current year results using prior year foreign currency exchange rates and generally refers to such amounts calculated on a constant currency basis as excluding the impact of foreign exchange or being on a constant currency basis. These results should be considered in addition to, not as a substitute for, results reported in accordance with GAAP. Results on a constant currency basis, as the Company presents them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with GAAP.

Financial Highlights
Financial Highlights
(unaudited, in thousands, except per share amounts)
Three Months Ended December 31, Twelve Months Ended December 31,
2024 2023 2024 2023
Total GAAP revenues $ 1,178,698 $ 1,013,341 $ 4,241,217 $ 3,695,649
Total GAAP operating income 301,513 187,270 61,366 620,525
Total Non-GAAP operating income 376,265 267,702 413,883 892,783
GAAP net income 201,212 201,079 32,615 597,599
Non-GAAP net income 281,353 239,124 227,591 795,449
GAAP basic EPS $ 1.04 $ 0.90 $ 0.16 $ 2.67
Non-GAAP basic EPS $ 1.46 $ 1.07 $ 1.10 $ 3.56
GAAP diluted EPS $ 1.02 $ 0.89 $ 0.15 $ 2.65
Non-GAAP diluted EPS $ 1.43 $ 1.06 $ 1.08 $ 3.52

Revenue Details
Revenue Details
(unaudited, in thousands)
Three Months Ended December 31, %
Change
(as reported)
%
Change
(constant currency)1
Twelve Months Ended December 31, %
Change
(as reported)
%
Change
(constant currency)1
2024 2023 2024 2023
Net product revenues:
Jakafi $ 773,114 $ 695,127 11 % 11 % $ 2,792,107 $ 2,593,732 8 % 8 %
Opzelura 161,602 109,243 48 % 48 % 508,293 337,864 50 % 50 %
Iclusig 27,369 27,130 1 % 1 % 114,319 111,623 2 % 2 %
Pemazyre 23,142 20,653 12 % 12 % 81,748 83,642 (2 %) (2 %)
Minjuvi/ Monjuvi 32,807 8,994 265 % 265 % 119,236 37,057 222 % 222 %
Zynyz 1,373 582 136 % 136 % 3,185 1,250 155 % 155 %
Total net product revenues 1,019,407 861,729 18 % 18 % 3,618,888 3,165,168 14 % 14 %
Royalty revenues:
Jakavi 114,187 103,892 10 % 13 % 418,840 367,583 14 % 16 %
Olumiant 38,485 40,359 (5 %) (3 %) 135,572 136,138 — % 2 %
Tabrecta 6,286 4,678 34 % NA 22,746 17,793 28 % NA
Pemazyre 333 683 NM NM 2,171 1,967 NM NM
Total royalty revenues 159,291 149,612 6 % 579,329 523,481 11 %
Total net product and royalty revenues 1,178,698 1,011,341 17 % 4,198,217 3,688,649 14 %
Milestone and contract revenues — 2,000 — % — % 43,000 7,000 514 % 514 %
Total GAAP revenues $ 1,178,698 $ 1,013,341 16 % $ 4,241,217 $ 3,695,649 15 %

NM = not meaningful
NA = not applicable
1.Percentage change in constant currency is calculated using 2023 foreign exchange rates to recalculate 2024 results.
6

Product and Royalty Revenues Total net product and royalty revenues for the quarter and year ended December 31, 2024 increased 17% and 14%, respectively, over the prior year comparative periods, primarily driven by the following:
•For the quarter ended December 31, 2024, Jakafi net product revenue increased 11% primarily driven by a 14% increase in paid demand. Channel inventory at the end of the fourth quarter of 2024 was within the normal range. For the year ended December 31, 2024, Jakafi net product revenue increased 8% primarily driven by a 9% increase in paid demand.
•For the quarter and year ended December 31, 2024, Opzelura net product revenue increased 48% and 50%, respectively, driven by continued growth in new patient starts and refills in the U.S. and increased contribution from Europe. Opzelura net product revenues included $24 million and $61 million ex-U.S. revenue for the fourth quarter and full year, respectively.
•For the quarter and year ended December 31, 2024, Minjuvi/Monjuvi net product revenue increased 265% and 222%, respectively, as we recognize all revenue from sales of Monjuvi in the United States following the acquisition of exclusive global rights for tafasitamab in February 2024.
•For the quarter and full year ended December 31, 2024, total royalty revenues increased by 6% and 11%, respectively, primarily driven by growth in Jakavi royalty revenues.
Operating Expenses
Operating Expense Summary
(unaudited, in thousands)
Three Months Ended December 31, %
Change Twelve Months Ended December 31, %
Change
2024 2023 2024 2023
GAAP cost of product revenues $ 88,485 $ 69,751 27 % $ 312,068 $ 254,990 22 %
Non-GAAP cost of product revenues1
82,427 63,575 30 % 288,266 230,308 25 %
GAAP research and development 466,034 444,494 5 % 2,606,848 1,627,594 60 %
Non-GAAP research and development2
420,297 408,488 3 % 2,423,167 1,500,897 61 %
GAAP selling, general and administrative 326,710 293,865 11 % 1,242,157 1,161,293 7 %
Non-GAAP selling, general and administrative3
299,709 270,673 11 % 1,116,926 1,069,616 4 %
GAAP (gain) loss on change in fair value of acquisition-related contingent consideration (4,044) 15,058 (127 %) 19,803 29,202 (32 %)
Non-GAAP (gain) loss on change in fair value of acquisition-related contingent consideration — — — % — — — %
GAAP (profit) and loss sharing under collaboration agreements — 2,903 — % (1,025) 2,045 (150 %)

1 Non-GAAP cost of product revenues excludes the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the cost of stock-based compensation.
2 Non-GAAP research and development expenses exclude the cost of stock-based compensation, MorphoSys transition costs, and Escient acquisition related compensation expense related to cash settled unvested Escient equity awards and severance payments.
3 Non-GAAP selling, general and administrative expenses exclude the cost of stock-based compensation, MorphoSys transition costs, Escient acquisition related compensation expense related to cash settled unvested Escient equity awards and severance payments, and asset impairments.
Cost of product revenues GAAP and Non-GAAP cost of product revenues for the quarter and year ended December 31, 2024 increased 27% and 30%, and 22% and 25%, respectively, compared to the same periods in 2023 primarily due to growth in net product revenues, increased royalty expense and increased manufacturing related costs.

Research and development expenses GAAP and Non-GAAP research and development expense for the quarter ended December 31, 2024 increased 5% and 3%, respectively, compared to the same period in 2023, primarily driven by continued investment in our late-stage development assets and timing of certain expenses. GAAP and Non-GAAP research and development expense for the year ended December 31, 2024 increased 60% and 61%, respectively, compared to the same period in 2023, primarily due to the Escient acquisition upfront consideration and related compensation expense and severance payments, and other milestone payments. For the year ended December 31, 2024, excluding the Escient acquisition upfront payment, related compensation expense and severance payments and other milestone payments, research and development expense increased 14% compared to the same period in 2023 as a result of continued investment in our late-stage development assets and timing of certain expenses.
Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the quarter ended December 31, 2024 increased 11% compared to the same period in 2023, primarily due to the timing of consumer marketing activities and of certain other expenses. GAAP and Non-GAAP selling, general and administrative expenses for the year ended December 31, 2024 increased 7% and 4%, respectively, compared to the same period in 2023, primarily due to $22.1 million of Escient acquisition related compensation expense including severance payments, and timing of consumer marketing activities and of certain other expenses. Excluding the Escient acquisition related compensation expense and severance payments, selling, general and administrative expenses for the year ended December 31, 2024 increased 5% compared to the prior year.

Other Financial Information

Change in fair value of acquisition-related contingent consideration The change in fair value of contingent consideration during the quarter and year ended December 31, 2024, compared to the same periods in 2023, was primarily due to fluctuations in foreign currency exchange rates impacting future revenue projections of Iclusig.
Operating income GAAP and Non-GAAP operating income for the quarter ended December 31, 2024 increased 61% and 41%, respectively, compared to the same period in 2023, primarily driven by growth in total revenues and stable operating expenses. GAAP and Non-GAAP operating income for the year ended December 31, 2024 decreased 90% and 54%, respectively, compared to the same period in 2023, primarily driven by the $679.4 million of expense relating to the IPR&D assets acquired in the Escient acquisition, $38.0 million of Escient acquisition related compensation expense and severance payments, and the $100.0 million milestone payment made to MacroGenics. Excluding upfront and milestone payments and the Escient acquisition related compensation expense and severance payments, operating income for the year ended December 31, 2024 increased 34% compared to the prior year primarily driven by growth in net product revenue.
Cash, cash equivalents and marketable securities position As of December 31, 2024 and 2023, cash, cash equivalents and marketable securities totaled $2.2 billion and $3.7 billion, respectively. The decrease in cash, cash equivalents and marketable securities during 2024 was driven primarily by the $2.0 billion share repurchase completed in June 2024, and the total cash consideration paid to Escient shareholders of $783 million, partially offset by proceeds of sales of equity investments and operating cash flows during the year ended December 31, 2024.

2025 Financial Guidance
Incyte’s guidance for the fiscal year 2025 is summarized below. Guidance for Opzelura includes net product revenue for pediatric atopic dermatitis which has an anticipated approval in the second half of 2025. Guidance for other oncology net product revenues include net product revenue for Monjuvi in follicular lymphoma and Zynyz in squamous cell anal carcinoma. Approvals for these indications are anticipated in the second half of 2025.
Current
Jakafi net product revenues $2,925 – $2,975 million
Opzelura net product revenues $630 – $670 million
Other oncology net product revenues(1)
$415 – $455 million
GAAP Cost of product revenues 8.5% – 9.0% of net product revenues
Non-GAAP Cost of product revenues(2)
7.5% – 8.0% of net product revenues
GAAP Research and development expenses $1,930 – $1,960 million
Non-GAAP Research and development expenses(3)
$1,780 – $1,805 million
GAAP Selling, general and administrative expenses $1,280 – $1,310 million
Non-GAAP Selling, general and administrative expenses(3)
$1,160 – $1,185 million

1Pemazyre in the U.S., EU and Japan; Niktimvo, Monjuvi and Zynyz in the U.S.; and Iclusig and Minjuvi in the EU.
2Adjusted to exclude the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the estimated cost of stock-based compensation.
3 Adjusted to exclude the estimated cost of stock-based compensation.
Conference Call and Webcast Information
Incyte will hold a conference call and webcast this morning at 8:00 a.m. ET. To access the conference call, please dial 877-407-3042 for domestic callers or 201-389-0864 for international callers. When prompted, provide the conference identification number, 13751174.
If you are unable to participate, a replay of the conference call will be available for 90 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference identification number, 13751174.
The conference call will also be webcast live and can be accessed at investor.incyte.com.

iBio Reports Fiscal Second Quarter 2025 Financial Results

On February 10, 2025 iBio, Inc. (NYSEA:IBIO), reported financial results for the second quarter ended Dec. 31, 2024, and provided a corporate update on its progress (Press release, iBioPharma, FEB 10, 2025, View Source [SID1234650132]).

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"In our second fiscal quarter we further strengthened our leadership with key Board appointments, reinforcing our commitment to innovation and execution as we work to develop next-generation therapeutics," said CEO and Chief Scientific Officer Dr. Martin Brenner, Ph.D. "Following more recent developments, we also want to highlight the significant strides we have made in advancing our preclinical pipeline with the in-licensing of potentially best-in-class IBIO-600, the notable discovery of a novel Activin E antibody, and the launch of a bispecific antibody program targeting myostatin/activin A. We are excited by the momentum we have built through these results and remain focused on leveraging our AI-driven platform as we aim to transform the treatment landscape for patients with cardiometabolic diseases and obesity, offering hope for more effective, targeted therapies addressing the underlying causes of these conditions while improving overall metabolic health and quality of life."

Fiscal Second Quarter 2025 & Recent Corporate Updates:

Discovered a novel antibody targeting activin E in collaboration with AstralBio, leveraging iBio’s Machine-Learning Antibody Engine to overcome significant technical challenges, demonstrating the platform’s ability to engineer innovative therapeutics potentially for cardiometabolic disease and obesity.

Expanded iBio’s cardiometabolic and obesity program with IBIO-600, the long-acting anti-myostatin antibody in-licensed from AstralBio in January. IBIO-600 was discovered by AstralBio through the use of iBio’s Machine-Learning Antibody Engine and was designed for subcutaneous administration with the potential for an extended half-life.

Initiated a bispecific antibody program targeting myostatin/activin A to promote weight loss, muscle preservation, and prevent weight regain with plans for clinical investigation in obesity and cardiometabolic disorders in 2026. The program leverages iBio’s Machine-Learning Antibody Engine as well as the technology of IBIO-600.
Strengthened the Board of Directors with the appointments of biotech industry veterans David Arkowitz and António Parada on November 25, 2024.
In January we further extended our cash runway with the closing of a private placement offering with members of our Board of Directors and Officers, underscoring their confidence and support in our strategy to advance as a clinical-stage biotech.

Fiscal Second Quarter 2025 Financial Results:

Revenue of $0.2 million was reported for services provided to a collaborative partner during the quarter ended Dec. 31, 2024.

R&D and G&A expenses for the second quarter of fiscal 2025 totaled approximately $4.6 million as compared to $4.5 million in the same period of fiscal year 2024, an increase of approximately 3%. This slight increase is a result of additional spending on consumables supplies and research related activities offset by lower G&A personnel related costs, consulting fees and outside services spending. Net loss from continuing operations for the second quarter ended Dec. 31, 2024, was approximately $4.4 million, or $0.48 per share, compared to a net loss of approximately $4.5 million, or $2.42 per share, in the same period of fiscal 2024.

Cash, cash equivalents and restricted cash as of Dec. 31, 2024, was approximately $7.2 million, inclusive of $0.2 million of restricted cash.

Greenwich LifeSciences Provides Update on Open Label HLA Data from FLAMINGO-01

On February 10, 2025 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported the following update on FLAMINGO-01 open label HLA data (Press release, Greenwich LifeSciences, FEB 10, 2025, View Source [SID1234650131]).

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Analysis of the open label data from FLAMINGO-01 has commenced and has been conducted in a manner that maintains the study blind. A preliminary review of FLAMINGO-01 HLA data in both the HLA-A*02 treated and placebo arms and the third open label arm with all other HLA types, shows that approximately 46% of all screened patients have at least one HLA-A*02 allele from either parent.

The main purpose of the open label arm is to investigate the safety and efficacy of GLSI-100 vaccination in patients who do not have an HLA-A*02 allele. It is possible that the open label arm may be large enough to draw immune response and efficacy conclusions. As discussed below, the HLA type can be analyzed by race and ethnicity in those patients who self-reported such information.

CEO Snehal Patel commented, "The review of open label data and the ability to look at multiple patient populations in the Phase III trial will be much greater than was possible in the Phase IIb trial. The HLA-A*02 prevalence of 46% in all screened patients meets our expectations of 40-50% prevalence and supports our sample size estimates for the trial and the interim analysis. We are also interested in studying the 8% of patients who have received HLA-A*02 alleles from both parents, as the mechanism of action in these double HLA-A*02 patients could lead to greater immune response and efficacy."

Mr. Patel further added, "There may be other subgroups of HLA types that can be analyzed in addition to the main arms. Approximately 92% of the patients that are in the HLA-A*02 arms have a second HLA-A type from the other parent that is not HLA-A*02 and could be any of 6 or more other prevalent HLA-A types. We can compare these HLA combinations against each other for immune response and clinical outcome, which could allow for subgroup analysis of HLA-A combinations. The prevalence of various HLA-A types by race or ethnicity may also help to inform the Company in its initial commercial development strategy by suggesting those markets where the most efficacious HLA patient populations may reside."

Background on FLAMINGO-01 Trial Design and HLA Testing

The design of the Phase III trial can be seen here. The trial is a prospective, randomized, double-blinded, multi-center study. The patient population is defined by major screening criteria and is stratified to balance the patient population between the treated and placebo arms of the trial.

As currently designed, approximately 500 patients with the HLA-A*02 allele will be randomized to receive GLSI-100 (GP2 and GM-CSF) or placebo control in the first two pivotal arms of the trial with a planned interim analysis.

In addition, patients without the HLA-A*02 allele will be enrolled in the third open label arm where all patients will receive GLSI-100 and where all endpoints will be open label. This non-HLA-A*02 arm was recently expanded from 100 to 250 patients based on recommendation of the steering committee and review/approval by the FDA and EMA.

HLA-A*02 blinded arms: A patient has 2 HLA-A genes, one from each parent, thus a single HLA-A*02 patient has received the HLA-A*02 allele from one parent. A double HLA-A*02 patient has received the HLA-A*02 allele from both parents. Both single and double HLA-A*02 patients are enrolled in the HLA-A*02 treated and placebo arms, which are blinded. Those patients who have a single HLA-A*02 allele will also have a second HLA-A gene of any other type.
Double HLA-A*02 Potential Mechanism of Action: Theoretically, a double HLA-A*02 patient may have double the amount of HLA-A*02-GP2 complex presented to the immune system to create cancer killing T-cells during the GLSI-100 vaccinations, and as a cancer cell recurs, the HER2 positive recurring cancer cells may have double the amounts HLA-A*02-GP2 complex for the trained T-cells to target and kill. It may be interesting to investigate immune or clinical response differences between single and double HLA-A*02 patients.
Open Label non-HLA-A*02 Third Arm: If a patient has no HLA-A*02 alleles, they will have 2 different or identical non-HLA-A*02 alleles. These non-HLA-A*02 patients are enrolled in the open label arm, where the immune or clinical response can be assessed as a group or by each HLA-A type, including double HLA-A types, providing the number of patients is sufficiently high to draw conclusions or trends.
Additional Information: A central laboratory in the US is sequencing the DNA of patients to determine both HLA-A allele types. The technology is available to sequence the HLA-B and HLA-C alleles, in addition to the HLA-A allele, to further assess other HLA types that may associate with GP2 to create a positive therapeutic effect. GP2 prediction binding algorithms may suggest that some HLA-B or HLA-C alleles may associate similarly to or stronger than HLA-A*02.
Phase IIb Clinical Trial Results

A variety of HLA types are predicted to associate with GP2 based on binding algorithms, and such binding can be tested in preclinical experiments. However, HLA-A*02 is the most common HLA type, thus it was studied first, and all patients in the Phase IIb trial had at least one HLA-A*02 allele. The HLA data collected did not identify if a patient was double HLA-A*02, nor were any other non-HLA-A*02 alleles identified.

Preliminary Review of FLAMINGO-01 HLA Data

Estimates of HLA prevalence by race are available in literature. As there are many sources and population studies to reference, a general consensus is that HLA-A*02 is prevalent in about 40-50% of the Caucasian population, which is the majority of the population in the US and Europe where the study is being conducted. To assess the prevalence of various HLA-A alleles by race, we have been collecting race and ethnicity data on all patients screened. We have summarized the preliminary data available to date in a blinded manner and have observed the results below. It is important to note that this preliminary summary may not reflect results at the end of the study.

Across all screened patients, HLA-A*02 prevalence is about 46%. The double HLA-A*02 prevalence, in patients who have received HLA-A*02 alleles from both parents, is about 8%. Because there are 2 HLA-A genes, one from each parent, the total of all prevalence percentages exceeds 100% and is less than 200% because of double HLA-A types. The HLA-A*03, HLA-A*24, and HLA-A*01 prevalences are about 20-25% for each allele. The HLA-A*11, HLA-A*68, HLA-A*29, and HLA-A*30 prevalences are about 9-12% for each allele.
In those screened patients who self-report as White, at least single or double HLA-A*02 genes are prevalent in approximately 50% of the patients. The double HLA-A*02 alleles are prevalent in 10% of these patients screened. The next most prevalent HLA-A types in the White populations are HLA-A*01 (29%), HLA-A*03 (21%), HLA-A*24 (19%), HLA-A*68 (10%), HLA-A*29 (13%), and HLA-A*11 (9%).
In those screened patients who self-report as Hispanic or Latino, at least single or double HLA-A*02 alleles are prevalent in approximately 50% of the patients. The double HLA-A*02 genes are prevalent in 7% of these patients screened. The next most prevalent HLA-A types in the Hispanic or Latino populations are HLA-A*01 (20%), HLA-A*24 (22%), HLA-A*68 (22%), HLA-A*30 (18%), HLA-A*29 (13%), and HLA-A*11 (13%).
In those screened patients who self-report as Black or African-American, at least single or double HLA-A*02 alleles are prevalent in approximately 40% of the patients. The next most prevalent HLA-A types in the Black or African-American populations are HLA-A*68 (33%), HLA-A*03 (27%), HLA-A*30 (27%), HLA-A*24 (13%), HLA-A*29 (13%), and HLA-A*23 (13%).
In those screened patients who self-report as Asian, at least single or double HLA-A*02 alleles are prevalent in approximately 17% of the patients. The other prevalent HLA-A types are HLA-A*24 (42%), HLA-A*33 (42%), HLA-A*11 (25%), and HLA-A*03 (25%).
The above preliminary Flamingo-01 open label data on HLA-A alleles by race and ethnicity is similar to the data available in literature. If any of the non-HLA-A*02 alleles have a strong association to GP2, it may be interesting to study the immune response and efficacy of GLSI-100 in patients with one allele of that type and one allele that is HLA-A*02 in addition to in patients with the double HLA-A*02 alleles.

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US clinical sites from university-based hospitals and cooperative networks with plans to expand into Europe and to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

Clarity expands pipeline in breast cancer with Cu-64/67 SAR-trastuzumab: Pre-clinical data published and trastuzumab supply agreement in place

On February 10, 2025 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported the addition of a new asset, 64/67Cu-SAR-trastuzumab, into the Targeted Copper Theranostic (TCT) portfolio (Press release, Clarity Pharmaceuticals, FEB 10, 2025, View Source [SID1234650130]). Pre-clinical data on SAR-trastuzumab has recently been published and Clarity has signed a Supply Agreement with EirGenix, Inc. ("EirGenix") for the clinical development and future commercial supply of clinical-grade GMP trastuzumab biosimilar, EG12014. The supply enables the development of a radiolabelled product using Clarity’s SAR Technology.

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Trastuzumab is an antibody that targets HER2, which is expressed in many cancers, including some types of lung, gastric and breast cancers4. This novel theranostic asset will initially focus on breast cancer and, combined with SAR-Bombesin, SARTATE and SAR-bisPSMA, bolster Clarity’s renewed focus on this important indication.

Through pioneering work in collaboration with the University of Melbourne, the trastuzumab antibody was combined with Clarity’s proprietary SAR chelator and radiolabelled with copper-64 (Cu-64 or 64Cu) for diagnostic imaging and copper-67 (Cu-67 or 67Cu), forming an RIT3. 64Cu-SAR-trastuzumab was shown to target HER2-positive cancer cells to a very high level pre-clinically. 67Cu-SAR-trastuzumab was shown to significantly reduce the growth of HER2-expressing tumours in a dose-dependent manner, as well as to improve the survival of mice treated with the product.

Clarity intends to conduct a Phase 1/2a theranostic study with 64/67Cu-SAR-trastuzumab in HER2-positive breast cancer patients to address a significant unmet clinical need. This subtype of breast cancer is characterised as being aggressive and has a poor prognosis5. Despite recent advances in the treatment of patients with early HER2-positive breast cancer, relapse still occurs in up to 25% of patients within 10 years6.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "The antibody revolution over the last few decades has transformed the treatment of many diseases and has also led to the development of the antibody-drug conjugate (ADC) market. However, the application of antibodies in radiopharmaceuticals, despite many potential benefits of radiation compared to the cytotoxic payloads used in ADCs, has been limited with the current strategies being sub-optimal, particularly in comparison with peptides. At Clarity, we continue to strive for excellence when it comes to science and treatment outcomes, working to firstly open up a broad range of targeting technologies for radiopharmaceuticals in a safe and effective manner, and secondly, broaden the use of radiopharmaceuticals outside of prostate cancer when looking at large cancer indications.

"We have been investigating a number of antibody strategies for many years, including the use of whole antibodies, antibody fragments and antibody pre-targeting in combination with our SAR Technology to develop a new class of treatments when combined with antibodies in RIT. The 64/67Cu-SAR-trastuzumab product is a result of this R&D process.

"The pre-clinical results we generated so far are very exciting and highlight the potential benefit of 64/67Cu-SAR-trastuzumab to image and treat patients with HER2-positive cancers. This is an area of high unmet need, as a considerable proportion of patients, most of whom are women, will relapse or develop resistance to standard treatments, and metastatic disease remains incurable. We are also committed to progressing our SAR-Bombesin, SARTATE and SAR-bisPSMA products in breast cancer, complementing the existing focus on prostate cancer, neuroblastoma and neuroendocrine tumours.

"We are uniquely placed at Clarity to address large markets, firstly with the proven background of using great science to make novel products, and secondly with the commercialisation of the "perfect pairing" of copper isotopes. Those factors combined have myriad advantages in relation to efficacy, supply and manufacturing. With regards to supply, particularly of copper-67, the simple manufacturing process on basic linear accelerators and plentiful precursor means that large markets can be served in a modular format, instead of the reliance on the small number of research reactors around the world and rare earth materials as feedstock in the case of lutetium-177 supply. The supply chains of chelatable alpha radioisotopes, that are yet to show safety and efficacy, are still in their infancy with many hurdles to overcome. Having abundant supply of diagnostic and therapeutic isotopes and finished products made under the one roof to treat large populations of patients in the same country the isotopes and products are made in is an ideal scenario quickly becoming reality and made possible with the perfect pairing of copper.

"We are excited to have entered into the Supply Agreement for trastuzumab with EirGenix, given their excellent capabilities to produce an approved biosimilar product, and progress to the next step in our RIT program. Having a reliable and secure supply of 67Cu-SAR-trastuzumab for future trials in breast cancer is essential as we continue to build a commanding pipeline of radiopharmaceuticals in order to reach our ultimate goal of better treating children and adults with cancer."

EirGenix’s Chairman & President, Dr. Liu, commented, "We are very pleased to be working with Clarity on this important program to develop a novel treatment option for breast cancer patients. At EirGenix we believe that RIT using copper-67 is a promising avenue for the next generation of antibody therapies, and we are thrilled to be contributing to the development of this unique product."

About SAR Technology
Clarity’s proprietary copper-chelating technology, called "sarcophagine" or SAR Technology, has enabled the Company to advance the TCT product pipeline into a range of theranostic clinical trials that use copper-64 for diagnostic imaging and copper-67 for therapy. Clarity is currently progressing three key product areas, SAR-bisPSMA, SAR-Bombesin and SARTATE, with three theranostic and four diagnostic clinical trials with a focus on prostate cancer indications.

64Cu-SAR-trastuzumab and 67Cu-SAR-trastuzumab are unregistered products. The data outlined in this announcement has not been assessed by health authorities such as the US Food and Drug Administration (FDA) or the Therapeutic Goods Administration (TGA). Outcomes from human clinical trials may differ from pre-clinical findings. A clinical development program is currently undergoing feasibility assessment. There is no guarantee that these products will become commercially available.

About Breast Cancer
Breast cancer is the most common cancer in women in the US, excluding skin cancers, although it can also affect some men. It accounts for about 30% of all new cancer diagnoses in women each year7. In 2025 in the US, an estimated 319,750 individuals are projected to be diagnosed with invasive breast cancer, with 316,950 of them being women1. Breast cancer remains the second leading cause of cancer death in women, after lung cancer. It is estimated that 42,170 women will die from breast cancer in 2025 in the US1. The lifetime risk of a woman developing breast cancer is about 13%, or 1 in 87. Incidence rates have increased slightly in recent years, especially in women under 507. Approximately up to 20% of breast cancers are HER2-positive, meaning they have higher levels of the HER2 protein, which promotes faster growth of the cancer.