On May 2, 2024 Moderna Therapeutics reported financial results and provided business updates for the first quarter of 2024 (Press release, Moderna Therapeutics, MAY 2, 2024, View Source/news/news-details/2024/Moderna-Reports-First-Quarter-2024-Financial-Results-and-Provides-Business-Updates/default.aspx" target="_blank" title="View Source/news/news-details/2024/Moderna-Reports-First-Quarter-2024-Financial-Results-and-Provides-Business-Updates/default.aspx" rel="nofollow">View Source [SID1234644823]).

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"As we anticipate the launches of our Spikevax 2024-2025 formula and RSV vaccine, we are exercising financial discipline and have intensified our focus on building and utilizing AI technologies to further streamline operations and enhance productivity," said Stéphane Bancel, Chief Executive Officer of Moderna. "With 10 late-stage programs, and additional new programs advancing toward pivotal studies, we continue to expect numerous product milestones this year across our vaccines and therapeutics portfolio. This is the start of a banner year for our vaccine platform as we continue to advance mRNA medicines for patients. This is just the beginning."

Recent progress includes:

Commercial Updates

COVID-19: The Company reported $167 million in Spikevax (COVID-19 vaccine) sales in the first quarter of 2024, which includes $100 million of U.S. sales and $67 million of international sales.

In the U.S., the Company is reaffirming its 2024 product sales outlook as it enters the second year of the commercial endemic COVID market. Moderna’s focus is on working with public health officials, health care providers and pharmacies to increase vaccination coverage rates to reduce the substantial burden of COVID-19. Moderna is also working with the U.S. FDA and regulators to align the timing of flu and COVID-19 vaccine approvals, which is expected to result in higher vaccination uptake if vaccines are available sooner and offered at the same time as the flu shot.

In the European Union, Moderna is participating in the EU Health Emergency and Response Authority’s tendering procedure for up to 36 million doses of mRNA COVID-19 vaccines per year for up to four years.

In the Rest of World, the Company is prioritizing markets for greater commercial focus and in April announced a contract with the Ministry of Health in Brazil (Ministério da Saúde) to supply 12.5 million mRNA COVID-19 vaccines as an integral part of Brazil’s 2024 national vaccination campaign against COVID-19.

RSV: The Company anticipates initial regulatory approvals of its RSV vaccine (mRNA-1345) beginning in the first half of 2024.

Moderna is targeting fall 2024 for its U.S. RSV vaccine launch, which will build upon the success of its commercial efforts in the fall COVID-19 market. The Company is encouraged by early indications of widespread consumer awareness and established demand in the RSV market, which Moderna will enter with a strong competitive profile with robust clinical efficacy data, a well-established safety and tolerability profile for its mRNA technology, and as the only pre-filled syringe (PFS) product available.

The PFS ready-to-use formulation will save pharmacists and clinicians time, potentially alleviating wait times and reducing the burden on pharmacy staff. In a study funded by Moderna, the PFS presentation was three to four times more efficient than vaccines requiring reconstitution, measured in doses per hour and based on mean time of preparation.

First Quarter 2024 Financial Results

Revenue: Total revenue for the first quarter of 2024 was $167 million, compared to $1.9 billion in the same period in 2023. The decline was primarily due to reduced sales of the Company’s COVID-19 vaccine. Net product sales for the first quarter of 2024 were $167 million, representing a 91% decline compared to the same period in 2023. This decline aligns with the anticipated transition to a seasonal COVID-19 vaccine market; in the prior year period, the Company recognized revenue primarily from delivered doses deferred from 2022.

Cost of Sales: Cost of sales for the first quarter of 2024 totaled $96 million, which included third-party royalties of $8 million, inventory write-downs of $30 million, and unutilized manufacturing capacity and winddown costs of $27 million. Cost of sales for the first quarter of 2024 decreased by $696 million, or 88%, compared to the same period in 2023. Cost of sales as a percentage of net product sales was 58% for the first quarter of 2024, compared to 43% for the first quarter of 2023. The decrease in cost of sales in 2024 was primarily driven by lower sales volume coupled with reduced unutilized manufacturing capacity, inventory write-downs and losses on firm purchase commitments and related cancellation fees. Conversely, the increase in cost of sales as a percentage of net product sales in 2024 was driven by the lower sales level compared to the prior year.

Research and Development Expenses: Research and development expenses for the first quarter of 2024 decreased by 6% to $1.1 billion, compared to the same quarter of 2023. This reduction was primarily due to the absence of upfront collaboration payments being made in 2024. The upfront payments made in the first quarter of 2023 were related to the Company’s strategic collaborations with Generation Bio and Life Edit Therapeutics. Additionally, there was a decrease in clinical development and manufacturing expenses, driven by lower spending on clinical trials for the Company’s COVID-19, RSV and seasonal flu programs, which aligns with its planned trial schedules. These decreases were partially offset by higher personnel-related costs, resulting from an increased headcount in the research and development functions.

Selling, General and Administrative Expenses: Selling, general and administrative expenses for the first quarter of 2024 decreased by 10% to $274 million, compared to the first quarter of 2023. This decrease is a result of cost discipline and the efficiencies resulting from investments the Company made in foundational capabilities over the last year, which allowed for a significant reduction of purchased services and the use of external consultants. The Company continues to invest in digital and commercial capabilities and has intensified its focus on building and utilizing AI technologies to further streamline operations and enhance productivity.

Income Taxes: Income tax expense for the first quarter of 2024 was $10 million, in contrast to an income tax benefit of $384 million in the same period last year. The shift primarily resulted from the continued application of a valuation allowance on the majority of the Company’s deferred tax assets, first established in the third quarter of 2023. The Company only maintained a valuation allowance on certain state deferred tax assets prior to the third quarter of 2023.

Net Income (Loss): Net loss was $(1.2) billion for the first quarter of 2024, compared to net income of $79 million for the first quarter of 2023.

Earnings (Loss) Per Share: Diluted loss per share was $(3.07) for the first quarter of 2024, compared to diluted earnings per share of $0.19 for the first quarter of 2023.

Cash Position: Cash, cash equivalents and investments as of March 31, 2024, were $12.2 billion, compared to $13.3 billion as of December 31, 2023. The decrease in the Company’s cash position during the first quarter of 2024 was largely attributable to research and development expenses and operating activities.

2024 Financial Framework

Expectations for full year 2024 remain consistent with prior expectations.

Revenue: The Company reaffirms its 2024 expected revenue of approximately $4 billion from its respiratory franchise, and now expects approximately $0.3 billion in net sales in the first half of the year, reflecting the seasonality of the respiratory business.

Cost of Sales: Cost of sales is expected to be approximately 35% of product sales for the year.

Research and Development Expenses: Full-year 2024 research and development expenses are anticipated to be approximately $4.5 billion.

Selling, General and Administrative Expenses: Selling, general and administrative expenses for 2024 are projected to be approximately $1.3 billion.

Income Taxes: The Company continues to expect its full-year tax expense to be negligible.

Capital Expenditures: Capital expenditures for 2024 are expected to be approximately $0.9 billion.

Cash and Investments: Year-end cash and investments for 2024 are projected to be approximately $9 billion.

Recent Progress and Upcoming Late-Stage Pipeline Milestones

With 10 late-stage programs, and additional new programs advancing toward pivotal studies, Moderna continues to advance its pipeline and expects numerous product milestones in 2024 across its vaccines and therapeutics portfolio. Late-stage includes eight programs that have progressed to Phase 3 clinical studies and two rare disease programs that are moving toward registrational studies.

Respiratory vaccines:

Respiratory syncytial virus (RSV) vaccine: Moderna’s RSV vaccine candidate (mRNA-1345) is in an ongoing Phase 2/3 clinical trial, ConquerRSV. Based on positive data from the study, Moderna has filed for regulatory approvals for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease (ARD) in adults over 60 years of age. As mentioned above, the Company is awaiting regulatory approvals and the U.S. ACIP recommendation in 2024.

At its Vaccines Day event in March, Moderna announced the initiation of multiple Phase 3 expansion studies of its RSV vaccine in adults over 50 years of age to evaluate co-administration and revaccination. Additional trials (Phase 1 – Phase 3) have been initiated for high-risk adults, as well as maternal and pediatric populations. Interim data from these studies could be available as early as 2024.
Seasonal flu vaccine: Moderna’s seasonal flu vaccine (mRNA-1010) demonstrated consistently acceptable safety and tolerability across three Phase 3 trials. In the most recent Phase 3 trial (P303), mRNA-1010 met all immunogenicity endpoints, demonstrating higher titers compared to a currently licensed standard-dose flu vaccine. In an older adult extension study of P303, mRNA-1010 is being studied against high dose Fluzone HD; the trial is fully enrolled. The Company is in ongoing discussions with regulators and intends to file in 2024.
Next-generation COVID-19 vaccine: A recent announcement of positive interim results from the NEXTCove Phase 3 trial showed that Moderna’s next-generation COVID-19 vaccine (mRNA-1283) elicited a higher immune response against both the Omicron BA.4/BA.5 and original virus strains of SARS-CoV-2 compared to Moderna’s licensed COVID-19 vaccine (mRNA-1273.222). The next-generation vaccine is designed to be refrigerator-stable and paves the way for a combination vaccine against influenza and COVID-19 (mRNA-1083). This is Moderna’s fourth infectious disease vaccine program with positive Phase 3 data. The Company is engaging with regulators on next steps.
Seasonal flu + COVID vaccine: Moderna’s Phase 3 trial of its combination vaccine against seasonal flu and COVID-19 (mRNA-1083) is fully enrolled. The Company anticipates data from the study in 2024.
Latent and other vaccines:

Cytomegalovirus (CMV) vaccine: The pivotal Phase 3 study of Moderna’s CMV vaccine candidate (mRNA-1647) is fully enrolled and accruing cases, evaluating its efficacy, safety and immunogenicity in the prevention of primary infection in women of childbearing age. The first interim analysis for the evaluation of vaccine efficacy is expected as early as the end of 2024.
Epstein-Barr virus (EBV) vaccine: Moderna’s EBV vaccine candidate for the prevention of infectious mononucleosis (mRNA-1189) showed positive immunogenicity and safety data in a Phase 1 study. The Company is advancing this candidate toward pivotal development.
Varicella-Zoster virus (VZV) vaccine: In a Phase 1/2 trial, Moderna’s VZV vaccine candidate for the prevention of shingles (mRNA-1468) elicited comparable or higher T cell responses relative to Shingrix. The Company is advancing toward a pivotal Phase 3 trial.
Herpes simplex virus (HSV) vaccine: The Phase 1/2 study of Moderna’s HSV vaccine candidate (mRNA-1608) is fully enrolled.
Norovirus vaccine: Moderna’s vaccine candidate for the prevention of norovirus (mRNA-1403) showed positive immunogenicity and safety data in a Phase 1 study. The Company is advancing toward a pivotal Phase 3 trial.
Oncology therapeutics:

Individualized Neoantigen Therapy (INT): Moderna continues to demonstrate the potential clinical benefit of its INT program (mRNA-4157). In partnership with Merck, two Phase 3 trials in resected high-risk (stage III/IV) melanoma and completely resected stage II, IIIA or IIIB non-small cell lung cancer are ongoing.

Moderna and Merck have initiated three new randomized clinical studies in additional tumor types in 2024, including a Phase 2 adjuvant treatment in patients with renal cell carcinoma, or kidney cancer; a Phase 2 adjuvant treatment in patients with high-risk muscle-invasive bladder cancer; and a Phase 2/3 neoadjuvant and adjuvant treatment in patients with cutaneous squamous cell carcinoma, the second most common form of skin cancer.
Rare disease and other therapeutics:

Propionic acidemia (PA) & methylmalonic acidemia (MMA) therapeutics: Interim data for a first-in-human, Phase 1/2, open-label, dose optimization study and extension study, evaluating the safety and efficacy of an investigational mRNA therapy for PA (mRNA-3927), was published in Nature. The Company expects to advance its PA and MMA (mRNA-3705) programs into registrational studies in 2024.
PD-L1 therapeutic: Following a strategic review, and as a result of its decision to prioritize investments in other programs, Moderna is discontinuing development of its preclinical PD-L1 program (mRNA-6981), and is no longer evaluating other mRNA candidates in this area.
Moderna Corporate Updates

Announced the advancement of multiple vaccine programs to late-stage clinical trials at its fifth Vaccines Day Investor Event on March 27, 2024.
Announced a development and commercialization funding agreement on March 27, 2024, with Blackstone Life Sciences for up to $750 million to advance Moderna’s flu program.
Announced a new collaboration with OpenAI to advance mRNA medicine using generative AI.
Entered into a non-exclusive intellectual property licensing agreement with an upfront payment and low double-digit royalty on the net sales of a COVID-19 product from a pharmaceutical company in the territory of Japan.
Agreed with Metagenomi to terminate gene editing collaboration as Moderna continues to strategically prioritize its research and development investments.
The Moderna Annual Meeting of Shareholders will be held on May 6, 2024, at 8:00 a.m. ET.
Company Accolade

Moderna was named for the first time to the LinkedIn Top Companies list of the best workplaces to grow a career in the U.S.
Key 2024 Investor and Analyst Event Dates

ASCO Investor Event: June 3
R&D Day: September 12
Investor Call and Webcast Information

Moderna will host a live conference call and webcast at 8:00 a.m. ET on May 2, 2024. To access the live conference call via telephone, please register at the link below. Once registered, dial-in numbers and a unique pin number will be provided. A live webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website.

Telephone: https://register.vevent.com/register/BI4b70dc922b874480847b6928c1fb9579
Webcast: View Source
The archived webcast will be available on Moderna’s website approximately two hours after the conference call and will be available for one year following the call.

On May 2, 2024 Ingenium Therapeutics reported the FDA granted an orphan drug designation to IGNK001 for the treatment of patients with acute myeloid leukemia (AML) (Press release, Ingenium Therapeutics, MAY 2, 2024, View Source [SID1234643523]).

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"We are delighted to have received orphan drug designation for IGNK001 from the FDA, recognizing the potential of our innovative [natural killer (NK)] cell therapy technology," said Ko Jin-ok, chief executive officer of Ingenium Therapeutics, in a press release. "[IGNK001] has already received approval from the Korean Ministry of Food and Drug Safety for phase 2 clinical trials, and we are preparing to initiate clinical trials in the US targeting 80 subjects with the goal of completing the studies by December 2027."

IGNK001 is an allogeneic NK cell therapy.2 While traditional methods for NK cell therapy use feeder cells to cultivate small numbers of isolated NK cells, this manufacturing process for IGNK001 leads to memory NK cells with higher expression of activating receptors. The novel method expands NK cells through targeted differentiation of other immune cells. This feeder cell-free process yields large quantities of healthy NK cells while avoiding exhaustion.

In addition to memory NK cells that have higher expression of activating receptors, the IGNK001 manufacturing process results in higher granzyme B and perforin 1 production compared with normal NK cells. These cells have also shown to have increased production of IFN-γ.

The mass-produced, allogeneic NK cell therapy has already demonstrated potent anticancer effects with high purity and activity.1 Its safety and efficacy have also been evaluated in a number of clinical trials.

Most recently, a single-center, open-label, random comparison, phase 2b study (NCT02477787) evaluated haploidentical hematopoietic cell transplantation and subsequent donor NK cell infusion in patients with high-risk, refractory AML and myelodysplastic syndromes.3 Patients were required to be aged 19 years or older with a Karnofsky performance status of at least 70.

In the experimental arm (n = 40), patients were given donor-derived NK cell infusions twice on days 13 and 20 after haploidentical hematopoietic cell transplantation. On day 13, the donor NK cell infusion was given at a dose which ranged from 1 x 108/kg to 2 x 108/kg, and on day 20, the donor NK cell infusion was given at a cell dose of up to 5 x 108/kg. The control arm included 36 patients who underwent haploidentical hematopoietic cell transplantation alone.

Investigators assessed the primary end point of the number of patients who experienced AML progression or recurrence after hematopoietic cell transplantation. Secondary end points explored in the study included the number of patients who achieved engraftment after hematopoietic cell transplantation, the number of patients who developed acute graft-vs-host disease (GVHD) and chronic GVHD, the number of patients who experienced donor NK cell infusion-associated toxicity, and the number of patients who died after hematopoietic cell transplantation without AML progression.

Findings from the intention-to-treat analysis showed that there was lower 30-month cumulative incidence of disease progression among those in the NK group vs the control group. These rates were 35% vs 61%, respectively (subdistribution HR, 0.50; P = .040).4

Three months post hematopoietic cell transplantation, those who received NK cells had a 1.8- and 2.6-fold higher median absolute blood count of NK cells and T cells compared with those who received hematopoietic cell transplantation alone. Looking at a single-cell RNA sequencing analysis in 7 patients, findings showed there to be an increase in memory-like NK cells among those given the NK cell infusion. This in turn expanded the CD8-positive effector memory T cells.

These findings, which led to IGNK001’s approval from the Korean Ministry of Food and Drug Safety for phase 2 clinical trials, now also are leading to the initiation of a sponsored clinical trial to support the conditional marketing approval of IGNK001.

On May 2, 2024 Galapagos NV (Euronext & NASDAQ: GLPG) reported its first quarter 2024 financial results and provided a business update and outlook for the remainder of 2024 (Press release, Galapagos, MAY 2, 2024, View Source [SID1234642637]).

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"We are moving forward with a renewed focus, a differentiated and expanding R&D pipeline, and competitive technology platforms to bring innovation to patients around the world. We continue to build a strong team of global leaders and we expanded our U.S. footprint," said Dr. Paul Stoffels1, CEO and Chairman of the Board of Directors of Galapagos. "As we look forward to the year ahead, we strive to make important progress in our clinical programs, achieving regulatory milestones to initiate clinical development of our CAR-T programs in the U.S., and expanding our decentralized CAR-T network in the U.S. and Europe. In parallel, we will continue to build our early-stage pipeline of cell therapy and small molecule investigational medicines in oncology and immunology, both internally and through external partnerships."

Thad Huston, CFO and COO of Galapagos, concluded: "We are committed to investing in our internal R&D pipeline, while we continue to actively pursue business development opportunities. We are broadening our oncology and immunology portfolio and will capitalize on opportunities that are aligned with our strategic objectives."

First quarter 2024 and recent business update

At the Annual and Extraordinary Shareholders’ Meetings held on 30 April 2024, all proposed resolutions were approved (see: press release of 30 April 2024).
Presented our innovative decentralized CAR-T manufacturing and 7-day vein-to-vein approach to hematological cancer care at the EBMT-EHA and EBMT annual meetings with new preliminary translational and previously published encouraging clinical data of our CD19 CAR-T candidates. The data support the promise of GLPG5101 in relapsed/refractory non-Hodgkin lymphoma (NHL) and GLPG5201 in relapsed/refractory chronic lymphocytic leukemia (CLL) and Richter transformation (RT), in addressing the critical needs of patients facing poor prognosis.
Discontinued the development of CD19 CAR-T candidate in refractory systemic lupus erythematosus.
Transferred the Jyseleca business to Alfasigma per 31 January 2024.
Signed a strategic collaboration and license agreement with BridGene Biosciences to further strengthen our growing early-stage oncology precision medicine pipeline.
Entered into a strategic collaboration agreement with Thermo Fisher Scientific for decentralized CAR-T manufacturing in the San Francisco area.
Participated with an investment of $40.0 million in the Series C financing round of precision oncology pioneer Frontier Medicines.
Financial performance
First quarter 2024 key figures (consolidated)
(€ millions, except basic & diluted income per share)

Three months ended 31 March % Change

2024 2023
Total net revenues 62.4 58.6 +7%
Cost of sales (2.5) –
R&D expenses (71.6) (52.5) +36%
G&Aii and S&Miii expenses (30.8) (27.1) +14%
Other operating income 9.4 6.8 +37%
Operating loss (33.1) (14.2)
Fair value adjustments and net exchange differences 30.6 (9.7)
Net other financial result 25.4 12.5
Income taxes 0.6 0.2
Net profit/loss (-) from continuing operations 23.5 (11.2)
Net profit from discontinued operations, net of tax 66.7 34.4
Net profit of the period 90.2 23.2
Basic and diluted earnings per share (€) 1.4 0.4
Current financial investments, cash & cash equivalents 3,557.9 4,005.5 (*)
(*) Including €15.4 million of net accrued interest income

DETAILS OF THE FINANCIAL RESULTS OF THE FIRST THREE MONTHS OF 2024
As a consequence of the transfer of our Jyseleca business to Alfasigma, the revenues and costs related to Jyseleca for the first quarter of 2024 are presented separately from the results of our continuing operations in the line ‘Net profit from discontinued operations, net of tax’ in our consolidated income statement. The comparative first quarter of 2023 has been restated accordingly for the presentation of the results related to the Jyseleca business.

Results from our continuing operations
Total operating loss from continuing operations for the three months ended 31 March 2024 was €33.1 million, compared to an operating loss of €14.2 million for the three months ended 31 March 2023.

Total net revenues for the three months ended 31 March 2024 amounted to €62.4 million, compared to €58.6 million for the three months ended 31 March 2023. The revenue recognition related to the exclusive access rights granted to Gilead for our drug discovery platform amounted to €57.6 million for the first three months of both 2024 and 2023. Our deferred income balance at 31 March 2024 includes €1.2 billion allocated to our drug discovery platform that is recognized linearly over the remaining period of our 10-year collaboration.
Cost of sales for the three months ended 31 March 2024 amounted to €2.5 million and related to the supply of Jyseleca to Alfasigma under the transition agreement. The related revenues are booked in total net revenues.
R&D expenses in the first three months of 2024 amounted to €71.6 million, compared to €52.5 million for the first three months of 2023. This increase was primarily explained by higher costs for CAR-T and small molecule programs in oncology.
G&A and S&M expenses amounted to €30.8 million in the first three months of 2024, compared to €27.1 million in the first three months of 2023. This increase was primarily due to an increase in legal and professional fees, mainly related to business development activities.
Other operating income amounted to €9.4 million in the first three months of 2024, compared to €6.8 million for the same period last year. This increase is mainly due to €2.2 million of recharges for transition services to Alfasigma for the months of February and March 2024.
Net financial income in the first three months of 2024 amounted to €56.0 million, compared to net financial income of €2.8 million for the first three months of 2023.

Fair value adjustments and net currency exchange gains in the first three months of 2024 amounted to €30.6 million, compared to fair value adjustments and net currency exchange losses of €9.7 million for the first three months of 2023, and were primarily attributable to €12.4 million of unrealized currency exchange gains on our cash and cash equivalents and current financial investments at amortized cost in U.S. dollars, and to €17.6 million of positive changes in fair value of current financial investments.
Net other financial income in the first three months of 2024 amounted to €25.4 million, compared to net other financial income of €12.5 million for the first three months of 2023, and was primarily attributable to €25.2 million of interest income, which increased significantly due to the increase in interest rates.
Net profit from continuing operations for the first three months of 2024 was €23.5 million, compared to a net loss from continuing operations of €11.2 million for the first three months of 2023.

Results from discontinued operations

(€ millions)

Three months ended 31 March % Change

2024 2023
Product net sales 11.3 26.7 -58%
Collaboration revenues 26.0 93.6 -72%
Total net revenues 37.3 120.3 -69%
Cost of sales (1.9) (3.6) -47%
R&D expenses (13.4) (51.0) -74%
G&A and S&M expenses (9.2) (31.1) -71%
Other operating income 53.9 1.5
Operating profit 66.7 36.1
Net financial result 0.1 (1.3)
Income taxes (0.1) (0.4)
Net profit from discontinued operations 66.7 34.4
Total operating profit from discontinued operations amounted to €66.7 million in the first three months of 2024, compared to an operating profit of €36.1 million in the same period last year.

Product net sales of Jyseleca in Europe were €11.3 million for the first three months of 2024 consisting of sales to customers in January 2024. Product net sales to customers for the first three months of 2023 amounted to €26.7 million. As from 1 February 2024, all economics linked to the sales of Jyseleca in Europe are to the benefit of Alfasigma.
Collaboration revenues for the development of filgotinib with Gilead amounted to €26.0 million for the first three months of 2024, compared to €93.6 million for the same period last year. The sale of the Jyseleca business to Alfasigma on 31 January 2024 led to the full recognition in revenue of the remaining deferred income related to filgotinib.
Cost of sales related to Jyseleca net sales were €1.9 million for the first three months of 2024. Cost of sales related to Jyseleca net sales for the first three months of 2023 amounted to €3.6 million.
R&D expenses for the development of filgotinib for the first three months of 2024 amounted to €13.4 million, compared to €51.0 million in the first three months of 2023. As from 1 February 2024, all filgotinib development expenses are recharged to Alfasigma.
G&A and S&M expenses related to the Jyseleca business amounted to €9.2 million in the first three months of 2024, compared to €31.1 million in the first three months of 2023. As from 1 February 2024, all remaining G&A and S&M expenses relating to Jyseleca are recharged to Alfasigma.
Other operating income for the first three months of 2024 amounted to €53.9 million (€1.5 million for the same period last year) and comprised €53.2 million related to the preliminary calculation of the gain on the sale of the Jyseleca business to Alfasigma. This preliminary result at 31 March 2024 of the transaction is considering the following elements:
€50.0 million of upfront payment received at closing of the transaction of which €40.0 million was paid on an escrow account. This amount will be kept in escrow for a period of one year after the closing date of 31 January 2024. We gave customary representations and warranties which are capped and limited in time (at 31 March 2024, this €40.0 million is presented as "Escrow account" in our balance sheet).
€13.2 million of cash received at closing of the transaction from Alfasigma for preliminary settlement for net cash and working capital and an additional adjustment estimated at €1.1 million related to settlement for completion accounts.
€47.0 million of estimated fair value on 31 January 2024 of the future earn-outs payable by Alfasigma to us (the fair value of these future earn-outs at 31 March 2024 is presented on the lines "Non-current contingent consideration receivable" and "Trade and other receivables").
€40.0 million of liability towards Alfasigma on 31 January 2024 for R&D cost contributions of which €5.0 million was paid in the first quarter of 2024 (at 31 March 2024, €35.0 million of liabilities for R&D cost contribution is presented in our balance sheet in "Other non-current liabilities" for €10.0 million and on the line "Trade and other liabilities" for €25.0 million).
Net profit from discontinued operations related to Jyseleca amounted to €66.7 million for the first three months of 2024, compared to a net profit amounting to €34.4 million for the first three months of 2023.

Cash, cash equivalents and current financial investments totaled €3,557.9 million as of 31 March 2024, as compared to €3,684.5 million as of 31 December 2023. Total net decrease in cash and cash equivalents and current financial investments amounted to €126.6 million during the first three months of 2024, compared to a net decrease of €88.6 million during the first three months of 2023. This net decrease was composed of (i) €125.2 million of operational cash burn, (ii) €36.9 million for the acquisition of financial assets held at fair value through profit or loss, (iii) €38.7 million of net cash in related to the sale of the Jyseleca business to Alfasigma of which €40.0 million has been transferred to an escrow account, offset by (iv) €36.8 million of positive exchange rate differences, positive changes in fair value of current financial investments and variation in accrued interest income.

Outlook 2024

Financial outlook
For the full year 2024, we reconfirm our cash burn guidance of €280 million to €320 million (compared to €414.8 million for the full year 2023), not including future potential business development opportunities.

R&D Outlook
We are progressing three CAR-T Phase 1/2 studies in hemato-oncology:
GLPG5101 in relapsed/refractory NHL;
GLPG5201 in relapsed/refractory CLL, and RT; and
GLPG5301 in relapsed/refractory multiple myeloma.
We are progressing two Phase 2 studies with TYK2 inhibitor GLPG3667, in systemic lupus erythematosus and in dermatomyositis.
We plan to file Investigational New Drug applications in the U.S. to progress clinical development of our CAR-T programs in hemato-oncology.
We will further upscale our CAR-T network and operations in the U.S. and Europe.
Business development
We will continue to evaluate business development opportunities that fit our strategy to accelerate and expand our pipeline of potential best-in-class investigational medicines in our therapeutic focus areas of oncology and immunology.

Conference call and webcast presentation
We will host a conference call and webcast presentation on 3 May 2024, at 14:00 CET / 8:00 am ET. To participate in the conference call, please register in advance using this link. Dial-in numbers will be provided upon registration. The conference call can be accessed 10 minutes prior to the start of the call by using the conference access information provided in the email received after registration, or by selecting the "call me" feature.

The live webcast is available on glpg.com or via the following link. The archived webcast will be available for replay shortly after the close of the call on the investor section of the website.

On May 2, 2024 Sonnet BioTherapeutics Holdings, Inc., a Delaware corporation (the "Company") entered into a ChEF Purchase Agreement (the "Purchase Agreement") and a Registration Rights Agreement (the "Registration Rights Agreement"), each with Chardan Capital Markets LLC ("Chardan") related to a "ChEF," Chardan’s committed equity facility (the "Facility") (Filing, 8-K, Sonnet BioTherapeutics, MAY 2, 2024, View Source [SID1234642635]). Pursuant to the Purchase Agreement, the Company has the right from time to time at its option to sell to Chardan up to the lesser of (i) $25,000,000 in aggregate gross purchase price of newly issued shares of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), and (ii) the Exchange Cap (as defined below), subject to certain conditions and limitations set forth in the Purchase Agreement. The Company is under no obligation to sell any securities to Chardan under the Purchase Agreement.

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While there are distinct differences, the Facility is structured similarly to a traditional at-the-market equity facility, insofar as it allows the Company to raise primary equity capital on a periodic basis outside the context of a traditional underwritten follow-on offering. From and after the Commencement (as defined below), sales of Common Stock to Chardan under the Purchase Agreement, and the timing of any sales, will be determined by the Company from time to time in its sole discretion and will depend on a variety of factors including, among other things, market conditions, the trading price of the Common Stock and determinations by the Company regarding the use of proceeds of such Common Stock. The net proceeds from any sales under the Purchase Agreement will depend on the frequency with, and prices at, which the shares of Common Stock are sold to Chardan. The Company expects to use the proceeds from any sales of shares of our Common Stock to Chardan under the Facility, together with our existing cash and cash equivalents, for research and development, including clinical trials, working capital and general corporate purposes.

Upon the satisfaction of the conditions to Chardan’s purchase obligation set forth in the Purchase Agreement (the "Commencement" and the date of initial satisfaction of all of such conditions, the "Commencement Date"), including that a registration statement registering the resale by Chardan of shares of Common Stock issued to it by the Company under the Purchase Agreement (the "Initial Resale Registration Statement") under the Securities Act of 1933, as amended (the "Securities Act"), which the Company agreed to file with the Securities and Exchange Commission (the "SEC") pursuant to the Registration Rights Agreement, is declared effective by the SEC (the date of such effectiveness, the "Effective Date") and a final prospectus relating thereto is filed with the SEC, the Company will have the right, but not the obligation, from time to time at the Company’s sole discretion over the 36-month period from and after the Effective Date, to direct Chardan to purchase up to an amount of shares of Common Stock (the "VWAP Purchase Share Amount") not to exceed certain limitations set forth in the Purchase Agreement (each, a "VWAP Purchase") by delivering a written notice (a "VWAP Purchase Notice") to Chardan after 6:00 a.m., New York City time, but prior to 9:00 a.m., New York City time on any trading day (the "Purchase Date"), so long as all shares of Common Stock subject to all prior VWAP Purchases and Intraday VWAP Purchases (as defined below) theretofore required to have been received by Chardan have been received by Chardan in accordance with the Purchase Agreement and certain other conditions have been satisfied. The purchase price of the shares of Common Stock that the Company elects to sell to Chardan pursuant to the Purchase Agreement will be determined by reference to the volume weighted average price of the Common Stock ("VWAP") during the applicable Purchase Date on which the Company has timely delivered a VWAP Purchase Notice (and/or Intraday VWAP Purchase Notice (as defined below), as applicable), less a fixed 4.0% discount.

In addition to the regular VWAP Purchases described above, after the Commencement, the Company will also have the right, but not the obligation, subject to the continued satisfaction of the conditions set forth in the Purchase Agreement, from time to time at the Company’s sole discretion over the 36-month period from and after the Effective Date, to offer to Chardan the right to or, in certain circumstances, to direct Chardan, to purchase, on any trading day, including the same Purchase Date on which a regular VWAP Purchase is effected, up to an amount of shares of Common Stock (the "Intraday VWAP Purchase Share Amount") not to exceed certain limitations set forth in the Purchase Agreement that are similar to those that apply to a regular VWAP Purchase (each, an "Intraday VWAP Purchase"), by delivering a written notice (each, an "Intraday VWAP Purchase Notice") to Chardan prior to 3:00 p.m., New York City time, on such Purchase Date.

The Purchase Agreement provides that the number of shares of Common Stock issuable pursuant to any VWAP Purchase Notice (and, if applicable, the number of shares of Common Stock issuable pursuant to any Intraday VWAP Purchase Notice delivered on the same Purchase Date that such VWAP Purchase Notice is delivered) shall not, without Chardan’s express written agreement, exceed the lesser of: (i) the number of shares of Common Stock which, when aggregated with all other shares of Common Stock then beneficially owned by Chardan and its affiliates, would exceed the Beneficial Ownership Limitation (as defined below), (ii) the number of shares of Common Stock which would cause the total aggregate purchase price to be paid by Chardan in any VWAP Purchase together with, if applicable, all Intraday VWAP Purchases, made on one Purchase Date, to exceed $5.0 million, (iii) the number of shares of Common Stock that equals 20% of the total number (or volume) of shares of Common Stock traded on The Nasdaq Capital Market ("Nasdaq") (or a successor Principal Market (as defined in the Purchase Agreement)) during the applicable purchase period on such Purchase Date and (iv) the VWAP Purchase Share Amount (for a VWAP Purchase) or the Intraday VWAP Purchase Share Amount (for an Intraday VWAP Purchase).

Under the applicable rules and regulations of Nasdaq, in no event may the Company issue to Chardan under the Purchase Agreement more than 622,168 shares of Common Stock, which number of shares is equal to 19.99% of the shares of the Common Stock outstanding immediately prior to the execution of the Purchase Agreement (the "Exchange Cap"), unless the Company’s stockholders have approved the issuance of Common Stock pursuant to the Purchase Agreement in excess of the Exchange Cap in accordance with the applicable rules and regulations of Nasdaq or such approval is not required in accordance with the applicable rules and regulations of Nasdaq or otherwise. The Exchange Cap is not applicable to issuances and sales of Common Stock pursuant to VWAP Purchases and Intraday VWAP Purchases that the Company may effect pursuant to the Purchase Agreement to the extent such shares of Common Stock are sold in such VWAP Purchases or Intraday VWAP Purchases (as applicable) at a weighted average price (when taking into account prior purchases under the Facility) equal to or in excess of the applicable "minimum price" (as defined Nasdaq Listing Rule 5635(d)) of the Common Stock, calculated at the time such VWAP Purchases or Intraday VWAP Purchases (as applicable) are effected by the Company under the Purchase Agreement, if any, as adjusted as necessary for compliance with the rules of Nasdaq to take into account certain fees and expenses payable and/or reimbursable by the Company to Chardan. Moreover, the Company may not issue or sell any shares of Common Stock to Chardan under the Purchase Agreement which, when aggregated with all other shares of Common Stock then beneficially owned by Chardan and its affiliates (as calculated pursuant to Section 13(d) of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and Rule 13d-3 promulgated thereunder), would result in Chardan beneficially owning more than 4.99% of the outstanding shares of Common Stock (the "Beneficial Ownership Limitation").

There are no restrictions on future financings, and no rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement or Registration Rights Agreement, as applicable, other than a prohibition on entering (with certain limited exceptions) into a Specified Transaction (as defined in the Purchase Agreement), as further described in the Purchase Agreement. At no time prior to the date of the Purchase Agreement has Chardan engaged in or effected, in any manner whatsoever, directly or indirectly for its own principal account, any (i) "short sale" (as such term is defined in Rule 200 of Regulation SHO of the Exchange Act) of the Common Stock or (ii) hedging transaction, which establishes a net short position with respect to the Common Stock that remains in effect as of the date of the Purchase Agreement.

The Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, conditions and indemnification obligations of the parties. The representations, warranties and covenants contained in such agreements were made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements, and may be subject to limitations agreed upon by the contracting parties.

The Purchase Agreement will automatically terminate on the earliest to occur of (i) the 36-month anniversary of the Effective Date of the Initial Resale Registration Statement (such term being subject to extension by the parties to the Purchase Agreement), (ii) the date on which Chardan shall have purchased $25,000,000 of shares of Common Stock pursuant to the Purchase Agreement, (iii) the date on which the Common Stock shall have failed to be listed or quoted on Nasdaq or a successor Principal Market, and (iv) the commencement of certain bankruptcy proceedings or similar transactions with respect to the Company or all or substantially all of its property.

The Company has the right to terminate the Purchase Agreement at any time after Commencement, at no cost or penalty, upon ten (10) trading days’ prior written notice to Chardan. Chardan also has the right to terminate the Purchase Agreement upon ten (10) trading days’ prior written notice to us, but only upon the occurrence of certain customary events as listed in the Purchase Agreement. Neither the Company nor Chardan may assign or transfer its rights and obligations under the Purchase Agreement or the Registration Rights Agreement.

As consideration for Chardan’s commitment to purchase shares of Common Stock at the Company’s direction upon the terms and subject to the conditions set forth in the Purchase Agreement, (i) on the Effective Date, the Company shall pay to Chardan a non-refundable commitment fee of $100,000 (the "Initial Commitment Fee"), and (ii) prior to or on the 6-moth anniversary of the Purchase Agreement, the Company shall pay to Chardan a non-refundable commitment fee of $150,000. The Company also paid Chardan a documentation fee, consisting of $25,000 in connection with the preparation of the Purchase Agreement. Further, the Company agreed to reimburse Chardan for its fees and expenses (including fees and disbursements of its counsel) (i) for initial diligence and documentation related to the Facility in an amount up to $75,000, provided, however, that any amount of reimbursement exceeding $75,000 will reduce, on a dollar-for-dollar basis, the Initial Commitment Fee, and (ii) up to $20,000 per fiscal quarter during which the Facility is active and not suspended for its reasonable and documented fees and expenses related to ongoing diligence of the Company except for any quarter in which additional diligence is reasonably required because of a material amendment or restatement to the registration statement, in which such amount shall not exceed $25,000 per quarter, absent unusual circumstances, provided, that such amount is not to exceed $300,000 in the aggregate during the term of the Purchase Agreement

The foregoing descriptions of the Purchase Agreement and the Registration Rights Agreement do not purport to be complete and are qualified in their entirety by reference to, and incorporate herein by reference, the full text of the Purchase Agreement and the Registration Rights Agreement, which are filed herewith as Exhibit 10.1 and Exhibit 10.2, respectively.

This Current Report on Form 8-K shall not constitute an offer to sell or a solicitation of an offer to buy any securities, nor shall there be any sale of securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On May 2, 2024 Delphia Therapeutics, Inc. (Delphia), reported its launch today to pioneer a new area of cancer biology – activation lethality – which targets cancer’s surprising vulnerability to oncogene overactivation (Press release, Delphia Therapeutics, MAY 2, 2024, View Source [SID1234642617]). Leveraging this next-generation approach, Delphia is advancing highly differentiated first-in-class targeted cancer medicines with the potential for significant anti-tumor activity and more durable patient benefit across multiple prevalent cancer types. Delphia completed a $67 million Series A financing led by premier early life sciences investors including GV (Google Ventures), Nextech Invest, Polaris Innovation Fund and Alexandria Venture Investments.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Despite dramatic advances in the understanding and drugging of key driver mutations and oncogenic pathways, cancer remains a tremendous global health challenge, as tumors rapidly develop resistance to targeted therapy in the vast majority of patients," said Kevin Marks, Ph.D., co-founder, president and CEO of Delphia. "Our activation lethality platform offers the potential for new cancer medicines that are effective on their own while also combating the emergence of resistance to classic targeted therapies. These medicines hold the potential to address significant cancer patient populations and may mark a disruptive paradigm shift in how cancer is treated, leading to more sustained disease control and longer patient survival. We are thrilled to launch Delphia to lead this exciting new area of cancer biology."

Activation Lethality: Unlocking the Next Wave in Oncology Therapeutics

The problem of cancer drug resistance

Mutations in oncogenes drive cancer by boosting activity of key pathways that drive cell/tumor growth. Targeted therapies that inhibit oncogenes block pathway activity and typically lead to an initial response.
However, tumors are heterogeneous. Under the selective pressure of inhibitor therapy, drug resistance rapidly emerges – often pushing pathway activity even higher, leading to increased tumor growth and further disease progression.
Activation lethality

Breakthrough research led by Delphia’s founders has revealed that many oncogenic pathways are also highly vulnerable to overactivation1. Oncogene overactivation leads to an overload on cell stress pathways and is selectively lethal to cancers with mutations that put them close to the upper bounds of tolerable pathway activity (‘activation lethality’).
Activation lethal medicines

Critical cellular pathways have multiple layers of regulation to ensure optimal activity. Oncogenic mutations boost pathway activity and disable much of this regulation. In cells with oncogenic mutations, the remaining regulators are vulnerable – a ‘last line of defense’ from overactivation.
These key, vulnerable regulatory nodes represent unique therapeutic targets to drive overactivation and selective killing of tumor cells.
Delphia’s next-generation platform

Delphia integrates tumor genetics, novel functional genomic approaches, and studies of inhibitor drug resistance to identify targets that drive activation lethality.
Through its activation lethality platform, Delphia is advancing a pipeline of first-in-class cancer medicines that aim to better control oncogenic pathways.
"Delphia is advancing multiple strategies to hyperactivate oncogene pathways; I am enthusiastic about the potential of this new class of medicines, which also may open up avenues to alternate between pathway activation and inhibition as a way to durably keep tumor growth in check," said Bill Sellers, M.D., director of the cancer program of the Broad Institute of MIT and Harvard and co-founder and board member of Delphia. "I am excited to work alongside the Delphia team to leverage the company’s activation lethality platform to advance potential paradigm-shifting cancer medicines."

Delphia Co-Founders

Delphia was founded by industry leading oncology drug developers who have collectively been involved in the discovery, development and commercialization of more than 15 approved drugs.

Bill Sellers, M.D., director of the cancer program of the Broad Institute of MIT and Harvard
Mike Dillon, Ph.D., former chief scientific officer of IDEAYA Biosciences and former global head of discovery chemistry for oncology at Novartis Institutes for BioMedical Research (NIBR)
Kevin Marks, Ph.D., president and CEO of Delphia, entrepreneur-in-residence at GV, and former oncology drug discovery site head at NIBR
"Delphia’s activation lethality platform is one of the most innovative approaches in cancer drug development and offers an excellent foundation to build a differentiated oncology company," said David Schenkein, M.D., general partner and co-lead of the life sciences team at GV and Delphia board observer. "This opens up a new category of cancer genetics and therapeutic targets that have the potential to lead to better medicines for patients. We are thrilled to continue supporting Dr. Kevin Marks and the Delphia team after the company was incubated at GV through our entrepreneur-in-residence program, and we are excited to see this team of experienced cancer drug developers make major impacts on the lives of cancer patients."