On November 9, 2022 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, reported financial results for the third quarter ended September 30, 2022 (Press release, Nkarta, NOV 9, 2022, View Source [SID1234623546]).

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"The third quarter marked significant progress as we continue to treat patients across our two lead clinical programs," said Paul J. Hastings, President and CEO of Nkarta. "We recently completed the first cycle of treatment for patients in the NKX019 monotherapy dose escalation cohort and look forward to announcing new clinical data by year-end, including data from responding patients reported in the last update. We’ve also opened enrollment in multiple dose expansion cohorts, where we intend to build on our prior experience with NKX019 in patients with autologous CAR T naïve, relapsed/refractory (r/r) LBCL, while simultaneously investigating activity in patients with LBCL who have previously received autologous CAR T. We will also explore NKX019 in combination with rituximab, regardless of prior CAR T treatment. NKX101 continues to enroll patients in monotherapy dose escalation, and we have updated the timing of NKX101 data in r/r AML to the first half of next year. We are continuing our mission to bring our allogeneic, off-the-shelf cell therapies to patients in outpatient and community oncology settings, enabling convenient multi-cycle treatment and broad access."

Anticipated Clinical Milestones

Nkarta plans to present additional clinical data from its ongoing Phase 1 clinical trial of NKX019 by year-end 2022 as part of a company-hosted announcement.
Nkarta plans to present additional clinical data from its ongoing Phase 1 clinical trial of NKX101 in the first half of 2023. Nkarta updated this timing from year-end 2022 in order to collect a more robust and interpretable data set from a heavily pre-treated and heterogenous patient population.
The data updates for NKX019 and NKX101 are expected to include safety and activity data from patients in the dose escalation cohorts who receive the 3-dose monotherapy treatment at the higher 1.5 billion CAR NK cell dose, durability of response in patients who were in response as of the April 2022 data cut-off, and safety and activity data from patients in the dose escalation cohorts who may have received one or more additional cycles of CAR NK cell therapy, including consolidation therapy.
NKX019 Dose Expansion Cohorts

Nkarta recently opened enrollment in the dose expansion portion of its Phase 1 clinical trial of NKX019. This dose expansion will investigate for the first time NKX019 as combination therapy with rituximab, an anti-CD20 monoclonal antibody, in patients with r/r non-Hodgkin lymphoma, as well as NKX019 as monotherapy in patients with large B-cell lymphoma (LBCL) who previously received autologous CD19 CAR T therapy. The dose expansion will also further investigate NKX019 as monotherapy in patients with LBCL who have not previously received autologous CD19 CAR T therapy.
Owing to the recent start of patient enrollment, data from the dose expansion cohorts are not expected to be announced in the NKX019 clinical update planned for 2022.
NKX101 Clinical Data – April 2022

On April 25, 2022, Nkarta reported preliminary data from its Phase 1 clinical trial evaluating NKX101, an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses NK cells engineered to target NKG2D ligands on cancer cells, as a multi-dose, multi-cycle monotherapy in patients with r/r acute myeloid leukemia (AML) and higher-risk myelodysplastic syndrome (MDS). As of data cut-off on April 21, 2022, 21 patients had been enrolled and dosed.
Three of five patients with heavily pre-treated AML treated at the higher dose levels in a three-dose regimen achieved a complete response (60% CR) with hematologic recovery, with two of the three responses MRD (measurable residual disease) negative.
NKX101 was well tolerated. No dose-limiting toxicities were observed. No cytokine release syndrome (CRS), graft-versus-host disease (GvHD), or immune effector cell-associated neurotoxicity syndrome (ICANS) was observed. The most common higher-grade adverse events were myelosuppression and infection, which are common in this patient population following lymphodepletion.
NKX019 Clinical Data – April 2022

On April 25, 2022, Nkarta reported preliminary data from its Phase 1 clinical trial evaluating NKX019, an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses NK cells engineered to target the B-cell antigen CD19, as a multi-dose, multi-cycle monotherapy in patients with r/r B-cell malignancies. As of data cut-off on April 21, 2022, 13 patients had been enrolled and dosed.
Three of six patients treated at the higher dose level in a three-dose regimen showed a complete response (50% CR), including one patient with aggressive large B cell lymphoma (LBCL) and one patient with mantle cell lymphoma (MCL).
NKX019 was well tolerated. No dose-limiting toxicities were observed. No CRS, GvHD, or neurotoxicity (ICANS) was observed. The most common higher-grade adverse events were myelosuppression, which is common in this patient population following lymphodepletion.
SITC 2022

In November 2022, Nkarta presented preclinical data from its engineered NK cell platform in two posters at the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper).
Poster #902, "NKX019, an Off-the-Shelf CD19 CAR-NK Cell, Mediates Improved Anti-Tumor Activity and Persistence in Combination with CD20-Directed Therapeutic mAbs," presents preclinical data on the improved anti-tumor activity demonstrated by the combination of NKX019 and a CD20-directed monoclonal antibody (mAb). This combination showed superior tumor cell killing compared to that of NKX019 and either mAb alone. Each agent was capable of direct killing of tumor cells, and when combined they further acted through ADCC, or antibody dependent cellular cytotoxicity. ADCC is a mechanism of immune defense whereby immune cells such as NK cells can recognize and kill tumor cells whose surface antigens are coated with antibodies. ADCC is one of several mechanisms by which NK cells are known to kill tumor cells.
Poster #381, "Large-Scale Expansion and Engineering of Human NK Cells Sourced from Peripheral Blood Versus Umbilical Cord Blood," presents data on the use of Nkarta’s proprietary NKSTIM cell line to expand NK cells in support of potential large-scale commercial production of therapeutic CAR NK cells. NK cells derived from the healthy-donor peripheral blood were expanded over 250 billion-fold while maintaining chromosomal integrity and potency against multiple tumor cell models, and compared favorably to NK cells derived from cord blood. Cell populations capable of superior expansion and native potency could be identified in adult donor-derived NK cells, allowing the potential selection of optimal donors and cell populations for enhanced CAR NK cell production.
Other Corporate Highlights

In August 2022, Nkarta signed amended lease agreements for its future cell therapy manufacturing facility and company headquarters and for its existing facilities. The amendments provide for approximately $15 million of additional tenant improvement allowances for the future facility, increase the rent for the future facility, and increase the rent and term of the lease for some of Nkarta’s existing facilities. These allowances are in addition to the tenant improvement allowances of $25.2 million included in the original lease agreement for the future facility. Nkarta’s facilities are located in South San Francisco, California.
Third Quarter 2022 and Recent Financial Highlights

Cash and Cash Equivalents: As of September 30, 2022, Nkarta had cash, cash equivalents, restricted cash, and short-term investments of $395.1 million.
R&D Expenses: Research and development (R&D) expenses were $23.4 million for the third quarter of 2022. Non-cash stock-based compensation expense included in R&D expense was $1.9 million for the third quarter of 2022.
G&A Expenses: General and administrative (G&A) expenses were $6.8 million for the third quarter of 2022. Non-cash stock-based compensation expense included in G&A expense was $2.4 million for the third quarter of 2022.
Net Loss: Net loss was $28.3 million, or $0.58 per basic and diluted share, for the third quarter of 2022. This net loss includes non-cash charges of $5.9 million that consisted primarily of share-based compensation of $4.4 million.
Financial Guidance

Nkarta expects its current cash and cash equivalents will be sufficient to fund its current operating plan into 2025.
About NKX101
NKX101 is an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy donors. It is engineered with a chimeric antigen receptor (CAR) targeting NKG2D ligands on tumor cells. NKG2D, a key activating receptor found on naturally occurring NK cells, induces a cell-killing immune response through the detection of stress ligands that are widely expressed on cancer cells. NKX101 is also engineered with membrane-bound form of interleukin-15 (IL15) for greater persistence and activity without exogenous cytokine support. To learn more about the NKX101 clinical trial in adults with AML or MDS, please visit ClinicalTrials.gov.

About NKX019
NKX019 is an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed CAR for enhanced tumor cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal and malignant B cells, and it is a validated target for B cell cancer therapies. To learn more about the NKX019 clinical trial in adults with advanced B cell malignancies, please visit ClinicalTrials.gov.

On November 9, 2022 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported financial results for the third quarter ended September 30, 2022 and provided a corporate update (Press release, Celldex Therapeutics, NOV 9, 2022, View Source [SID1234623545]).

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"Celldex continued to execute towards our clinical and corporate milestones, making strong progress across multiple programs; importantly, this includes the initiation of our Phase 2 studies in chronic spontaneous and chronic inducible urticaria this past summer. As we near the close of 2022 and look to 2023, we anticipate a consistent stream of data readouts from the barzolvolimab program, starting in December with additional data from our Phase 1 study in chronic inducible urticaria," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "We are also enthusiastic about the potential of our bispecific platform and believe our strategic updates including the development of CDX-585, our ILT4 and PD-(L)1 bispecific antibody, which is expected to enter the clinic in 2023, will drive value for this platform."

"In summary, our recent advances of the barzolvolimab program, development of our bispecific platform, and strong balance sheet continue to position us very well to execute across our upcoming key clinical milestones. We look forward to continued momentum across the company for the rest of the year and providing updates in the coming months," concluded Mr. Marucci.

Recent Program Highlights

Barzolvolimab – KIT Inhibitor Program

Barzolvolimab is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival and activity of mast cells.

In June and July 2022, Celldex announced that the first patients have been dosed in the Phase 2 clinical studies of barzolvolimab for the treatment of Chronic Spontaneous Urticaria (CSU) and the two most common forms of chronic inducible urticaria (CIndU) – cold urticaria (ColdU) and symptomatic dermographism (SD). These randomized, double-blind, placebo-controlled, parallel group Phase 2 studies are evaluating the efficacy and safety profile of multiple dose regimens of barzolvolimab in patients who remain symptomatic despite antihistamine therapy, to determine the optimal dosing strategies.

On June 30, Celldex reported interim data from the barzolvolimab multiple dose Phase 1b study in CSU which were presented as a late-breaking electronic poster presentation as part of the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress 2022. The Company has since completed enrollment to the 3 and 4.5 mg/kg dose groups and plans to present 12-week treatment data from these dose groups in February 2023.

EAACI 2022 Data Summary:

Barzolvolimab was well tolerated with a favorable safety profile; effects of multiple dose administration were consistent with observations in single dose studies. Barzolvolimab resulted in rapid, marked and durable responses in patients with moderate to severe CSU refractory to antihistamines, including patients with prior omalizumab treatment.
Mean reduction from baseline in urticaria activity (UAS7) of 66.6% in all patients in the 1.5 mg/kg dose group (n=8) at week 12 and 75.1% in all patients in the 3 mg/kg dose group (n=9) at week 8 (reflects only one dose), demonstrating clinically meaningful symptom improvements for patients.
Complete response (UAS7=0) of 57.1% in the 1.5 mg/kg dose group at week 12 and 44.4% at week 8 (reflects only one dose) in the 3 mg/kg dose group which is a key therapeutic goal.
75% well-controlled disease by Urticaria Control Test (UCT) in the 1.5 mg/kg dose group at week 12 and 83.3% in the 3 mg/kg dose group at week 8 (reflects only one dose).
Tryptase suppression paralleled symptom improvement, demonstrating the impact of mast cell depletion on CSU disease activity.

Celldex has completed enrollment in the barzolvolimab Phase 1b open label study in chronic inducible urticaria. The Company plans to present data from the 1.5 mg/kg cold urticaria cohort and long-term follow up from the 3 mg/kg symptomatic dermographism and cold urticaria cohorts in December. Patient follow up continues in the cholinergic cohort and is planned for presentation in mid-2023.

Celldex continues to enroll patients in the barzolvolimab Phase 1b multi-center, randomized, double-blind, placebo-controlled study in patients with prurigo nodularis (PN), a chronic skin disease characterized by the development of hard, intensely itchy (pruritic) nodules on the skin.

Celldex plans to initiate a Phase 2 international trial of barzolvolimab in eosinophilic esophagitis (EoE), the most common type of eosinophilic gastrointestinal disease, in the first half of 2023. The Company is finalizing clinical study design and completing the chronic toxicology study which will support study initiation in the United States.
Bispecific Antibody Platform

CDX-585 – Bispecific ILT4 & PD-(L)1

CDX-585 combines highly active PD-1 blockade with anti-ILT4 blockade to overcome immunosuppressive signals in T cells and myeloid cells. ILT4 is emerging as an important immune checkpoint on myeloid cells.

CDX-585 is currently completing CMC and IND-enabling activities and is expected to enter the clinic in 2023.
CDX-527 – Bispecific PD-L1 & CD27

CDX-527 utilizes the Company’s proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway.

The standard of care in ovarian cancer continues to evolve, making drug development in this indication more challenging. With multiple clinical trials actively recruiting in ovarian cancer, enrollment to the expansion cohort in patients with checkpoint naïve ovarian cancer (n=8) did not meet the Company’s internal timelines and a review of the results to date also did not meet internal hurdles for proceeding. Given the evolving environment and Celldex’s pipeline and resource priorities, the Company has decided to discontinue the program.
Third Quarter 2022 Financial Highlights and 2022 Guidance

Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2022 were $323.5 million compared to $356.8 million as of June 30, 2022. The decrease was primarily driven by third quarter cash used in operating activities of $35.2 million, which includes the $15.0 million payment to Shareholder Representative Services (SRS), the representative of the former stockholders of Kolltan Pharmaceuticals, Inc., pursuant to our settlement agreement. At September 30, 2022, Celldex had 47.1 million shares outstanding.

Revenues: Total revenue was $0.4 million in the third quarter of 2022 and $0.7 million for the nine months ended September 30, 2022, compared to $0.2 million and $4.3 million for the comparable periods in 2021. The decrease in revenue for the nine months ended September 30, 2022 compared to the nine months ended September 30, 2021 was primarily due to a decrease in services performed under our manufacturing and research and development agreements with Rockefeller University and Gilead Sciences.

R&D Expenses: Research and development (R&D) expenses were $21.6 million in the third quarter of 2022 and $59.4 million for the nine months ended September 30, 2022, compared to $13.6 million and $38.6 million for the comparable periods in 2021. The increase in R&D expenses was primarily due to an increase in barzolvolimab clinical trial, barzolvolimab contract manufacturing and personnel expenses.

G&A Expenses: General and administrative (G&A) expenses were $6.5 million in the third quarter of 2022 and $20.6 million for the nine months ended September 30, 2022, compared to $5.8 million and $14.2 million for the comparable periods in 2021. The increase in G&A expenses was primarily due to higher legal costs related to our settlement agreement with SRS, barzolvolimab commercial planning and stock-based compensation expenses.

Changes in Fair Value Remeasurement of Contingent Consideration: The Company recorded a $6.9 million gain on fair value remeasurement of contingent consideration for the nine months ended September 30, 2022, primarily due to the Company’s decision to deprioritize the CDX-1140 program in the second quarter of 2022.

Litigation Settlement Related Loss: The Company recorded a one-time loss of $15.0 million in the second quarter of 2022 related to the $15.0 million paid to SRS pursuant to our settlement agreement.

Net Loss: Net loss was $26.8 million, or ($0.57) per share, for the third quarter of 2022, and $85.8 million, or ($1.83) per share, for the nine months ended September 30, 2022, compared to a net loss of $20.5 million, or ($0.45) per share, for the third quarter of 2021 and $50.4 million, or ($1.21) per share, for the nine months ended September 30, 2021. The litigation settlement related loss had a ($0.32) impact on net loss per share for the nine months ended September 30, 2022. The gain on fair value remeasurement of contingent consideration had a $0.15 impact on net loss per share for the nine months ended September 30, 2022.

Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at September 30, 2022 are sufficient to meet estimated working capital requirements and fund planned operations through 2025.

On November 9, 2022 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported its business update and financial results for the third quarter ended September 30, 2022 (Press release, Curis, NOV 9, 2022, View Source [SID1234623543]).

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The Company plans to release updated data from its TakeAim Leukemia Phase 1/2 trial of emavusertib in relapsed or refractory (R/R) acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (hrMDS) during the upcoming 64th annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in New Orleans on December 10-13, 2022. The release includes data for 11 additional evaluable AML/hrMDS patients treated with monotherapy (total to date 24) in targeted populations (patients with U2AF1, SF3B1 or FLT3 mutations), as well as 5 AML/hrMDS patients treated with the combination of emavusertib and venetoclax.

To further advance the development of emavusertib based on these data, the Company is concentrating its resources to focus on and accelerate emavusertib. Resources will be reallocated to the emavusertib programs and resources dedicated to all other pipeline programs will be reduced. Deprioritization of other programs will enable a reduction of approximately 30% of the Company’s workforce and is expected to extend the Company’s cash runway into 2025.

"We believe emavusertib’s potential to address an area of high unmet need in R/R AML and R/R hrMDS sets it apart. To that end, we are dedicating the resources of the company to prioritize the acceleration of its regulatory path," said James Dentzer, President and Chief Executive Officer of Curis. "While we continue to believe in our entire pipeline, we recognize the unique potential of emavusertib and are fortunate that our existing cash will allow us to extend our runway into 2025 to advance its development," continued Mr. Dentzer.

Third Quarter 2022 and Recent Operational Highlights

Precision Oncology, Emavusertib (IRAK4 Inhibitor)

The Company announced in August that, after review of the comprehensive data packages submitted by the Company, the FDA has allowed enrollment to resume in the TakeAim Lymphoma study and in the monotherapy dose finding phase (Phase 1a) of the TakeAim Leukemia study.

Curis held the first annual IRAK4 in Cancer symposium virtually on October 7, 2022 where leaders from academia and industry gathered to present their cutting edge research on IRAK4, its biology and the role it could play as a target for therapeutic intervention.
Upcoming Milestones

The Company plans to report monotherapy and combination data from the TakeAim Leukemia studies during ASH (Free ASH Whitepaper) 2022.
Third Quarter 2022 Financial Results

For the third quarter of 2022, Curis reported a net loss of $13.3 million or $0.14 per share on both a basic and diluted basis, as compared to a net loss of $11.1 million, or $0.12 per share on both a basic and diluted basis for the same period in 2021. Curis reported a net loss of $45.3 million or $0.49 per share on both a basic and diluted basis, for the nine months ended September 30, 2022 as compared to a net loss of $31.8 million, or $0.35 per share on both a basic and diluted basis for the same period in 2021.

Revenues, net for the third quarter of 2022 and 2021 were $2.8 million and $3.0 million, respectively. Revenues, net for the nine months ended September 30, 2022 were $7.3 million as compared to $7.5 million for the same period in 2021. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge.

Operating expenses for the third quarter of 2022 were $15.4 million, as compared to $13.1 million for the same period in 2021. Operating expenses for the nine months ended September 30, 2022 were $50.1 million, as compared to $37.0 million for the same period in 2021, and comprised the following:

Cost of Royalty Revenues. Cost of royalty revenues, which represents amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $0.1 million for the third quarter of 2022 and $0.2 million for the same period in 2021. Cost of royalty revenues for the nine months ended September 30, 2022 were $0.2 million, as compared to $0.4 million for the same period in 2021.

Research and Development Expenses. Research and development expenses were $10.8 million for the third quarter of 2022 as compared to $8.6 million for the same period in 2021. The increase in research and development expenses for the quarter is primarily attributable to increased personnel and consulting costs, partially offset by decreased manufacturing and clinical development costs. Research and development expenses were $34.6 million for the nine months ended September 30, 2022 as compared to $24.1 million for the same period in 2021.

General and Administrative Expenses. General and administrative expenses were $4.6 million for the third quarter of 2022, as compared to $4.3 million for the same period in 2021. The increase in general and administrative expenses was driven primarily by the timing of costs. General and administrative expenses were $15.3 million for the nine months ended September 30, 2022, as compared to $12.5 million for the same period in 2021.

Other Expense. For the third quarter of 2022 and 2021, total other expense was $0.7 million and $1.0 million, respectively. Other expense primarily consisted of imputed interest expense related to future royalty payments partially offset by interest income. Other expense was $2.5 million for the nine months ended September 30, 2022, as compared to $2.3 million for the same period in 2021.

As of September 30, 2022, Curis’s cash, cash equivalents and investments totaled $98.7 million, and the Company had approximately 96.4 million shares of common stock outstanding. Curis expects its existing cash, cash equivalents and investments should enable it to maintain its planned operations into 2025.

Conference Call Information

Curis management will host a conference call today, November 9, 2022, at 4:30 p.m. ET, to discuss the business update and these financial results.

To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412-317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at in the Investors section.

On November 9, 2022 Selvita S.A. [WSE: SLV], one of the largest contract research organizations (CRO) in Europe, reported its financial results for Q3 2022* (Press release, Selvita, NOV 9, 2022, View Source [SID1234623542]). The Group continues its dynamic growth, exceeding the assumptions of the ambitious development strategy for 2022-2025 presented in March this year .

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In Q3 2022, Selvita Group generated EUR 22.7 million in revenues, indicating a 33% increase y/y. EBITDA profit amounted to EUR 6.2 million and was 31% higher than in the corresponding period in 2021. The net profit reached EUR 3.3 million, i.e., 50% more than in the previous year. This means that the EBITDA profitability will be maintained above 27%, and the net profitability will increase from 12.8% to 14.5% y/y.
In Q1-Q3 2022, the Group generated EUR 65.6 million in revenues, which means an increase of 38% y/y. The EBITDA profit in this period was EUR 18.3 million and was 48% higher than in the previous year. Net profit amounted to EUR 10.3 million (an increase of 68% y/y). Thus, the EBITDA profitability in Q1-Q3 2022 increased from 25.9% to 27.9%, and the net profitability from 12.9% to 15.8% y/y.
The Group’s backlog for 2022 exceeds EUR 83.1 million (as of 06/11/2022) and is 31% higher than the value reported a year earlier (as of 18/11/2021).
– We are happy to say that we are continuing our dynamic growth. The level of revenues generated in the first three quarters of 2022 was almost equal to the revenues generated in the whole of 2021, and what is worth noting is that the second half of last year constitutes a fairly high base for us. We also manage to maintain high profitability at all levels. Backlog for 2022 is approaching currently EUR 85 million, which shows that despite the demanding environment, we are pretty effective in resisting macro-economic factors – says Bogusław Sieczkowski, co-founder and Chief Executive Officer at Selvita.

In the period of Q1-Q3 2022, research and development services provided by Selvita generated EUR 56.3 million (an increase of 35% y/y) and accounted for 86% of the Group’s revenues. In Q3, the activities mentioned earlier generated EUR 19.3 million in revenues, indicating an increase of over 30% y/y. After nine months of 2022, EBITDA generated by research and development services exceeds EUR 17.2 million, which shows a rise of 54% y/y.

– We conduct very intensive business development activities. We have planned to participate in over 40 industry events between September and December this year. I am particularly pleased with the increasing sales of the regulatory research projects, which in the first three quarters of this year generated EUR 8.8 million in revenues, and the current backlog for this type of services amounts to over EUR 10.5 million, i.e., 57% more than a year earlier – comments Milosz Gruca, Vice President of the Management Board of Selvita and Chief Commercial Officer at Selvita.

The bioinformatics segment, i.e., Ardigen, generated EUR 7.4 million in external revenues in Q1-Q3 2022, which indicates a 60% increase y/y (over EUR 2.8 million in revenues in Q3 alone, i.e., 58% higher y/y). The EBITDA profit for this segment amounted to EUR 1.2 million at the end of Q3, and due to the Company’s intensive investments, it was at a level similar to last year’s. The bioinformatics backlog currently amounts to EUR 9.8 million, indicating an increase of 53% compared to the same period in 2021.

– Ardigen invests extensively in research and development, which is associated with increased expenses. However, the Company is fully profitable and finances itself. In the third quarter, Ardigen joined the "JUMP-Cell Painting Consortium" alongside companies such as Amgen, Astra Zeneca, Bayer, Eisai, Merck, Pfizer, and Takeda. Together, we create the world’s most extensive set of imaging data characterizing phenotypic cell changes caused by the activity of small molecule compounds. Joining the consortium will strengthen our credibility and recognition and significantly support our research work, says Janusz Homa, co-founder and Chief Executive Officer at Ardigen.

In the coming months, Selvita plans to complete the construction of its first laboratory building within the planned Selvita Research Center, which will allow adding additional 250 workplaces for scientists.

– We remain on track to launch the first of our Selvita Research Centre buildings in the first quarter of 2023. In the coming year, we also plan to commence the construction of a second similar building. We have acquired a plot of land that allows for the construction of four such buildings, where a total of over 1 000 workplaces will be created. We are also continuously looking for solutions that would allow us to increase the laboratory space in Poznan and Zagreb – adds Mirosława Zydron, Chief Operating Officer and Member of the Management Board at Selvita.

Implementation of the development strategy 2022-2025

At the end of Q1 2022, Selvita, having achieved the strategic goals set for the end of 2023 one year ahead, announced an updated development strategy for 2022-2025. During this period, the Company plans to triple its sales revenues (up to EUR 200 million) while maintaining high profitability. The Company will implement its strategy through organic growth and acquisitions. The implementation of the planned investments intends to allow Selvita to become the leading global preclinical CRO.

The Selvita Group Development Strategy for 2022-2025 is based on three key pillars:

Comprehensive drug discovery and development offer – supplementing the drug discovery offer and building the drug development segment
Focus on high-value services for the client – specialization in selected therapeutic areas and development of unique competencies
Development of the Group’s operations in the largest markets in the United States and Great Britain – increasing teams and potential new locations for laboratories
In the area of ​​acquisitions, in 2022-2025, Selvita intends to acquire at least two preclinical CROs in Europe or North America, providing services complementary to the Company’s offer or enabling the expansion of the scale of its operations.

– The financial results for 2022 reported to date show that the Company is currently organically growing faster than planned. At the same time, we are in numerous talks with selected potential acquisition targets, and we have every reason to believe that we are also heading in the right direction in this respect – sums up Bogusław Sieczkowski.

*The results do not include the accounting (non-cash) costs of the employee share incentive program.
Backlog as of November 6, 2022.

On November 9, 2022 Ipsen (Euronext: IPN; ADR: IPSEY) reoorted the Phase III NAPOLI 3 trial of Onivyde (irinotecan liposome injection) plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen) met its primary endpoint demonstrating clinically meaningful and statistically significant improvement in overall survival compared to nab-paclitaxel plus gemcitabine in 770 previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) and key secondary efficacy outcome of progression-free survival (PFS) also showed significant improvement over the comparator arm (Press release, Ipsen, NOV 9, 2022, View Source [SID1234623541]). The safety profile of Onivyde in the NAPOLI 3 trial was consistent with those observed in the previous phase I/II mPDAC study.

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Ipsen intends to file a supplemental New Drug Application with the U.S. Food and Drug Administration for Onivyde in combination with oxaliplatin plus 5- fluorouracil/leucovorin for the treatment of patients with previously untreated mPDAC following the Fast Track Designation granted in 2020. The clinical trial results will be presented at an upcoming medical conference.

"The positive results from the NAPOLI 3 trial demonstrate that compared with the standard-of-care, the investigational Onivyde treatment regimen extended the lives of people living with metastatic pancreatic ductal adenocarcinoma who were previously untreated," said Howard Mayer, Executive Vice President and Head of Research and Development for Ipsen. "The prognosis for people diagnosed with pancreatic cancer is extremely poor and we plan to submit these new findings to the regulatory authority as, if approved, we believe this regimen could offer up an important new treatment option for people living with an aggressive and hard-to-treat cancer. We thank the patients who participated in the study, their families and their healthcare teams."

PDAC is the most common type of cancer that forms in the pancreas with approximately 60,000 people diagnosed in the U.S. each year and nearly 500,000 people globally.1,2 Since there are no specific symptoms in the early stages, PDAC is often detected late and after the disease has spread to other parts of the body (metastatic or stage IV).3 Even in later stages, weight loss, abdominal pain and jaundice are the most common symptoms making PDAC difficult to detect.4 Currently, fewer than 20 percent of people diagnosed with PDAC survive longer than one year and overall, pancreatic cancer has the lowest five-year survival rate of all cancer types globally and in the U.S.1,2

Phase III NAPOLI 3 Study

NAPOLI 3 is a randomized, open-label Phase III trial of Onivyde treatment regimen (NALIRIFOX) in patients who have not previously received chemotherapy for metastatic pancreatic ductal adenocarcinoma. Onivyde plus oxaliplatin and 5 FU/LV was administered twice in a month (days 1 and 15 of 28 day cycle) compared to an injection of nab-paclitaxel and gemcitabine administered three times a month (days 1, 8, 15 of a 28 day cycle). Approximately 770 patients were enrolled in the trial with the primary outcome measure of overall survival. Secondary outcome measures included progression-free survival, objective response rate, quality of life assessment, incidence of treatment-emergent adverse events, serious adverse events and laboratory abnormalities. Adverse events and laboratory analyses were also analyzed.

Onviyde (irinotecan liposome injection)

Onivyde is a long-circulating, liposomal topoisomerase inhibitor designed to interrupt DNA replication in cancer cells. Onivyde enters cancer cells using a naturally occurring process (enhanced permeability and retention or EPR effect) and as macrophages unpack the liposomes, Onivyde is activated facilitating the release of the cytotoxic payload into the tumor, including irinotecan and its conversion into SN-38, its active metabolite. Ipsen has exclusive commercialization rights for the current and potential future indications for Onivyde in the U.S. Servier, an independent international pharmaceutical company with a strong international presence in 150 countries, is responsible for the commercialization of Onivyde outside of the U.S. and Taiwan. PharmaEngine is a commercial stage oncology company headquartered in Taipei and is responsible for the commercialization of Onivyde in Taiwan.

Onivyde is currently approved in most major markets including the U.S., Europe and Asia in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. Onivyde is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.

U.S. IMPORTANT SAFETY INFORMATION

BOXED WARNINGS: SEVERE NEUTROPENIA and SEVERE DIARRHEA

Fatal neutropenic sepsis occurred in 0.8% of patients receiving Onivyde. Severe or life-threatening neutropenic fever or sepsis occurred in 3% and severe or life-threatening neutropenia occurred in 20% of patients receiving Onivyde in combination with 5-FU and LV. Withhold Onivyde for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment.

Severe diarrhea occurred in 13% of patients receiving Onivyde in combination with 5-FU/LV. Do not administer Onivyde to patients with bowel obstruction. Withhold Onivyde for diarrhea of Grade 2–4 severity. Administer loperamide for late diarrhea of any severity. Administer atropine, if not contraindicated, for early diarrhea of any severity.

CONTRAINDICATION

Onivyde is contraindicated in patients who have experienced a severe hypersensitivity reaction to Onivyde or irinotecan hydrochloride.

Warnings and precautions

Severe neutropenia: see boxed WARNING. In patients receiving Onivyde/5-FU/LV, the incidence of Grade 3/4 neutropenia was higher among Asian (18/33 [55%]) vs White patients (13/73 [18%]). Neutropenic fever/neutropenic sepsis was reported in 6% of Asian vs 1% of White patients

Severe diarrhea: see boxed WARNING. Severe and life-threatening late-onset (onset >24 hours after chemotherapy [9%]) and early-onset diarrhea (onset ≤24 hours after chemotherapy [3%], sometimes with other symptoms of cholinergic reaction) were observed

Interstitial lung disease (ILD): Irinotecan HCl can cause severe and fatal ILD. Withhold Onivyde patients with new or progressive dyspnea, cough, and fever, pending diagnostic evaluation. Discontinue Onivyde in patients with a confirmed diagnosis of ILD

Severe hypersensitivity reactions: Irinotecan HCl can cause severe hypersensitivity reactions, including anaphylactic reactions. Permanently discontinue Onivyde in patients who experience a severe hypersensitivity reaction

Embryo-fetal toxicity: Onivyde can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during and for 1 month after Onivyde treatment

Adverse reactions

The most common adverse reactions (≥20%) were diarrhea (59%), fatigue/asthenia (56%), vomiting (52%), nausea (51%), decreased appetite (44%), stomatitis (32%), and pyrexia (23%)
The most common Grade 3/4 adverse reactions (≥10%) were diarrhea (13%), fatigue/asthenia (21%), and vomiting (11%)
Adverse reactions led to permanent discontinuation of Onivyde in 11% of patients receiving Onivyde/5- FU/LV; The most frequent adverse reactions resulting in discontinuation of Onivyde were diarrhea, vomiting, and sepsis
Dose reductions of Onivyde for adverse reactions occurred in 33% of patients receiving Onivyde/5 FU/LV; the most frequent adverse reactions requiring dose reductions were neutropenia, diarrhea, nausea, and anemia
Onivyde was withheld or delayed for adverse reactions in 62% of patients receiving Onivyde/5-FU/LV; the most frequent adverse reactions requiring interruption or delays were neutropenia, diarrhea, fatigue, vomiting, and thrombocytopenia
The most common laboratory abnormalities (≥20%) were anemia (97%), lymphopenia (81%), neutropenia (52%), increased ALT (51%), hypoalbuminemia (43%), thrombocytopenia (41%), hypomagnesemia (35%), hypokalemia (32%), hypocalcemia (32%), hypophosphatemia (29%), and hyponatremia (27%)

Drug Interactions

Avoid the use of strong CYP3A4 inducers, if possible, and substitute non-enzyme inducing therapies ≥2 weeks prior to initiation of Onivyde
Avoid the use of strong CYP3A4 or UGT1A1 inhibitors, if possible, and discontinue strong CYP3A4 inhibitors ≥1 week prior to starting therapy

Special Populations

Pregnancy and Reproductive Potential: See WARNINGS & PRECAUTIONS. Advise males with female partners of reproductive potential to use condoms during and for 4 months after Onivyde treatment
Lactation: Advise nursing women not to breastfeed during and for 1 month after Onivyde treatment