On March 29, 2022 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, reported its financial and operating results for the year ended December 31, 2021 (Press release, AEterna Zentaris, MAR 29, 2022, View Source [SID1234611162]). The Company also provided an update on progress in its pre-clinical and clinical development programs.

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"With the in-licensing of six new pre-clinical development programs, 2021 was a transformational year for Aeterna Zentaris. As we work to make a positive impact across multiple therapeutic areas with unmet needs, our team is executing on all fronts to advance these pre-clinical assets toward in-human clinical studies," commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna. "Since the start of 2022, we have continued to build momentum and position ourselves to unlock the full potential of our pipeline and value for all stakeholders. Bolstered by our cash position, which provides us with the funding for operations through 2023, we are laser focused on our development and strategic priorities."

Recent Highlights

●Expanded research program with Julius-Maximilians-University Wuerzburg aimed to accelerate development of vaccine programs on COVID-19 and Chlamydia
●Announced Notice of Allowance for U.S. patent covering AEZS-150 for the potential treatment of chronic hypoparathyroidism.
●Appointed Giuliano La Fratta as Chief Financial Officer.

Pre-Clinical and Clinical Programs Update:

Therapeutics Development Pipeline

AIM Biologicals: Targeted, highly specific autoimmunity modifying therapeutics for the potential treatment of neuromyelitis optica spectrum disorder ("NMOSD") and Parkinson’s disease (PD)

In January 2021, Aeterna entered into an exclusive patent license and research agreement with the University of Wuerzburg, Germany, for worldwide rights to develop, manufacture, and commercialize AIM Biologicals for the potential treatment of NMOSD. Additionally, the Company has engaged Prof. Dr. Joerg Wischhusen from the University Hospital in Wuerzburg as well as neuro-immunologist Dr. Michael Levy from the Massachusetts General Hospital in Boston as consultants for scientific support and advice in the field of inflammatory CNS disorders, autoimmune diseases of the nervous system, and NMOSD. In September 2021, the Company entered into an additional exclusive license with the University of Wuerzburg for early pre-clinical development towards the potential treatment of Parkinson’s disease.

AIM Biologicals (Auto-Immunity Modifying Biologicals) is based on a natural process during pregnancy, which induces immunogenic tolerance of the maternal immune system to the partially foreign fetal antigens. Fetal proteins are processed and presented on certain immunosuppressive major histocompatibility complex class I molecules to induce this tolerance. In an autoimmune disease is the immune system misdirected and targeting the body’s own protein. With AIM Biologicals, the Company aims to restore the tolerance against such proteins to treat autoimmune diseases.

For the development of AIM Biologicals as potential PD therapeutics, Aeterna plans to utilize, among others, an innovative animal model on neurodegeneration by α-synuclein-specific T cells in AAV-A53T-α-synuclein Parkinson’s disease mice, which has recently been published by University of Wuerzburg researchers.

Next Steps – NMOSD

Conduct in-vitro and in-vivo assessments to select an AIM Biologicals-based development candidate.
●Manufacturing process development for selected candidate.

Next Steps – Parkinson’s Disease

●Design and produce antigen-specific AIM Biologics molecules for the potential treatment of Parkinson’s disease.
●Conduct in-vitro and in-vivo assessments in relevant Parkinson’s disease models.

Delayed Clearance Parathyroid Hormone ("DC-PTH") Fusion Polypeptides: Potential treatment for primary hypoparathyroidism

In March 2021, Aeterna entered into an exclusive patent and know-how license agreement and research agreement with The University of Sheffield, United Kingdom, for the intellectual property relating to DC-PTH fusion polypeptides with delayed clearance for all human uses. In consultation with The University of Sheffield, Aeterna has selected AEZS-150 as the lead candidate in its DC-PTH program. AEZS-150 is being developed with the goal of providing a potential new treatment option of primary hypoparathyroidism in adults.

Next Steps

●Work with The University of Sheffield to conduct in depth characterization of development candidate (in-vitro and in-vivo).
●Develop manufacturing process.
●Formalize pre-clinical development of AEZS-150 in preparation for a potential IND filing for conducting the first in-human clinical study.

Macimorelin Therapeutic: Ghrelin agonist in development for the treatment of ALS (Lou Gehrig’s disease)

In January 2021, the Company entered into a material transfer agreement with the University of Queensland, Australia, to provide macimorelin for the conduct of pre-clinical and subsequent clinical studies evaluating macimorelin as a potential therapeutic for the treatment of ALS (Lou Gehrig’s disease). The University of Queensland researchers have filed for supportive grants and aim to conduct pre-clinical studies in multiple pre-clinical models to demonstrate the therapeutic potential of macimorelin to slow disease progression and disease-specific pathology.

Macimorelin, a potent ghrelin agonist, is an orally active small molecule that stimulates the secretion of growth hormone from the pituitary gland. Acting via this mechanism, which was established during the development as a diagnostic test for growth hormone deficiency, it is believed that macimorelin may slow the progression of certain neurodegenerative diseases like ALS.

Apart from already available pre-clinical and clinical data on macimorelin for the development as a diagnostic, Aeterna may utilize the established supply chain to support this development. Alternative formulations are currently also under development, as a further option in addition to the existing oral solution already approved for the diagnostic use in adult growth hormone deficiency (AGHD).

Next Steps

●Work with The University of Queensland to conduct proof-of-concept studies with macimorelin in disease-specific animal models.
●Assess alternative formulations.
●Formalize pre-clinical development plan.

Diagnostics Development Pipeline

Macimorelin Diagnostic: Ghrelin agonist in development for diagnostic use in childhood-onset growth hormone deficiency ("CGHD")

Aeterna is currently conducting its pivotal Phase 3 safety and efficacy study AEZS-130-P02 (the "DETECT-trial") evaluating macimorelin for the diagnosis of CGHD.

Children and adolescents from two to less than 18 years of age with suspected growth hormone deficiency are to be included. The study is expected to include approximately 100 subjects in Europe and North America, with at least 40 subjects in pre-pubertal and 40 subjects in pubertal status. Macimorelin growth hormone stimulation test ("GHST") will be performed twice for repeatability data and two standard GHSTs will be used as controls: arginine (i.v.) and clonidine (p.o.).

On April 22, 2021, the U.S. FDA Investigational New Drug Application associated with this clinical trial became active.

The first clinical sites in the U.S. and in Europe are open for patient recruitment. In Europe, national clinical trial approval procedures and site initiation activities are ongoing. Site activation and patient enrollment continues to be impacted by the ongoing COVID-19 pandemic. The Company is actively monitoring delays to mitigate potential impact of COVID-19 on estimated trial completion dates. Additionally, clinical trial sites originally planned in the Ukraine and Russia are being halted due to the conflict in Ukraine intensifying following the Russian invasion. As a result, further delays with enrollment are expected as the DETECT-trial planned to recruit at least 25% (25 subjects) within those countries. Due to these circumstances and the resulting feasibility data from the Company’s CRO on potential options, Aeterna believes recruitment for the DETECT-trial may now continue until later into 2023.

The Company continues to advance its ongoing business development discussions to secure commercialization partners for macimorelin in additional markets. In addition to its previously established agreements, Aeterna recently entered into a license agreement with NK Meditech Ltd., for the development and commercialization of macimorelin in the Republic of Korea, and a distribution agreement with Er-Kim Pharmaceuticals Bulgaria EOOD for the commercialization of macimorelin in Turkey and some Balkan countries.

Vaccine Development Pipeline

Bacterial Vaccine Platform: Orally active, live-attenuated bacterial vaccine platform with potential application against viruses and bacteria, such as coronavirus types, including COVID-19 (SARS-CoV-2) and Chlamydia

In February 2021, Aeterna entered into an exclusive option agreement with the University of Wuerzburg to evaluate a pre-clinical, potential COVID-19 vaccine developed at the University of Wuerzburg. In March 2021, the Company exercised its option and entered into a license agreement where the Company was granted an exclusive, world-wide, license to certain patent applications and know-how owned by the University of Wuerzburg to research and develop, manufacture, and sell a potential COVID-19 vaccine. The Company’s vaccine platform is currently undergoing pre-clinical studies for the prevention of coronavirus diseases, including COVID-19 (SARS-CoV-2) with the planned start of clinical development targeted for H1 2023.

In September 2021, the Company exercised its option under the agreement with the University of Wuerzburg on a then undisclosed field, now known to be Chlamydia. Chlamydia trachomatis is a sexually transmitted bacterium infecting over 130 million subjects annually. Asymptomatic disease can spread to the reproductive tract eventually inducing infertility, miscarriage, or ectopic pregnancy, which is a life-threatening condition. Ocular infections can lead to inclusion conjunctivitis or trachoma, which is the primary source of visual impairment or infectious blindness. Additionally, Prof. Dr. Thomas Rudel of the University of Wuerzburg was engaged by the Company in September 2021 as a scientific consultant to support development of the salmonella-based vaccine platform for the coronavirus and Chlamydia vaccines.

Recently, the Company expanded its research agreement with the University of Wuerzburg to conduct supplementary research activities and pre-clinical development studies on the potential vaccines, the results of which are covered within the scope of the license agreements. Under the expanded research program, the University of Wuerzburg will validate and utilize innovative human 3D intestinal tissue models to study the infection biology of Salmonella strains towards clinical development.

Next Steps – Coronavirus Vaccine

●Evaluate administration route, dose and immunization scheme.
●Initiate in-vivo immunology experiments with antigen variant candidates in relevant mice models.
●Conduct virus challenge experiments in immunized transgenic animals.
●Start manufacturing process assessment / development.
●Conduct pre-clinical safety and toxicology assessment.

Next Steps – Chlamydia Vaccine

●Design and prepare candidate vaccine strains.
Evaluate administration route, dose and immunization scheme.
●Conduct In-vivo immunology experiments with candidate strains in relevant mouse models.

Summary of Fourth Quarter and Full Year 2021 Financial Results

All amounts are in U.S. dollars

Cash and cash equivalents

The Company had $65.3 million in cash and cash equivalents at December 31, 2021.

Results of operations for the three-month period ended December 31, 2021

For the three-month period ended December 31, 2021, we reported a consolidated net loss of $2.9 million, or $0.02 loss per common share (basic and diluted), as compared with a consolidated net loss of $1.3 million, or $0.02 loss per common share (basic and diluted) for the three-month period ended December 31, 2020. The $1.6 million increase in net loss is primarily from a $0.5 million increase in total operating expenses and a $1.4 million decrease in revenues, offset by a $0.4 million reduction in income tax expense.

Revenues

●Our total revenue for the three-month period ended December 31, 2021 was $1.0 million as compared with $2.4 million for the same period in 2020, representing a decrease of $1.4 million, primarily due to $1.4 million decline in product sales of macimorelin to its licensees, $0.5 million decline in license fees offset by $0.5 million increase in development services.

Operating Expenses

●Our total operating expenses for the three-month period ended December 31, 2021 was $4.1 million as compared with $3.6 million for the same period in 2020, representing an increase of $0.5 million. This increase arises primarily from a $1.3 million increase in research and development expenses, a $0.5 million increase in general and administrative expenses and $0.1 million in costs incurred in 2020 and not incurred in 2021 (comprised of $0.1 million in reversal of impairment of other asset), offset by a decline of $1.4 million in cost of sales.

Net Finance Income

●For the three-month period ended December 31, 2021, our net finance income was $0.3 million as compared to $0.3 million for the three-month period ended December 31, 2020.

Results of operations for the year ended December 31, 2021

For the twelve-month period ended December 31, 2021, we reported a consolidated net loss of $8.4 million, or $0.07 loss per common share (basic and diluted), as compared with a consolidated net loss of $5.1 million, or $0.12 loss per common share (basic and diluted), for the year ended December 31, 2020. The $3.3 million increase in net loss is primarily from a $4.5 million increase in operating expenses and a $0.8 million decline in net finance income, partially offset by an increase of $1.6 million in total revenues and a change in income tax recovery of $0.5 million

Revenues

●Our total revenue for the twelve-month period ended December 31, 2021 was $5.3 million as compared with $3.7 million for the same period in 2020, representing an increase of $1.6 million, primarily due to $3.3 million increase in development services with Novo and $0.8 million increase in license fees related to the partial recognition of the €5 million up front payment received from Novo in 2020. Offset by a decrease in product sales by $2.5 million.

Operating Expenses

●Our total operating expenses for the twelve-month period ended December 31, 2021 was $13.9 million as compared with $9.4 million for the same period in 2020, representing an increase of $4.5 million. This increase arises primarily from a $5.1 million increase in research and development expenses, $1.1 million increase in general and administration expenses, $0.3 million in increase in selling expenses and $0.3 million in costs incurred in 2020 and not incurred in 2021 (comprised of $0.2 million in gain on modification of building lease and $0.1 million in reversal of impairment of other asset), offset by a $2.2 million decrease in cost of sales.

Net Finance Income

●Our net finance income for the twelve-month period ended December 31, 2021, was $0.2 million as compared with $1.0 million for the same period in 2020, representing a decrease of $0.8 million. This is primarily due to a $1.1 million change in fair value of warrant liability, a $0.4 million decline in gain due to change in foreign currency, offset by a $0.7 million decline in other finance costs. During the prior year, the Company registered the common shares underlying certain warrants which allowed the Company to reclassify such warrants from liability to shareholders’ equity in the condensed interim consolidated statements of financial position. As such the change in fair value of such warrants liabilities was classified as a finance cost in the consolidated statements of loss in 2020; there was no such change in fair value in 2021.

Consolidated Financial Statements and Management’s Discussion and Analysis

For reference, the Management’s Discussion and Analysis of Financial Condition and Results of Operations for the fourth quarter and full year 2021, as well as the Company’s unaudited consolidated interim financial statements as of December 31, 2021, will be available on the Company’s website (www.zentaris.com) in the Investors section or at the Company’s profile at www.sedar.com and www.sec.gov.

March 29, 2022 Pyxis Oncology, Inc. (Nasdaq: PYXS), a multi-asset, multi-modality company focused on developing next-generation therapeutics for difficult to treat cancers, reported financial results for the full year ended December 31, 2021 (Press release, Pyxis Oncology, MAR 29, 2022, View Source [SID1234611160]).

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"We have had a highly productive start to 2022, advancing our lead programs toward first-in-human clinical trials while executing our strategy of identifying the most promising scientific breakthroughs and therapeutics in the treatment of cancers," said Lara Sullivan, M.D., Chief Executive Officer of Pyxis Oncology. "The in-licensing of Biosion’s anti-Siglec-15 (PYX-106) and the introduction of our first internally developed candidate anti-KLRG1 (PYX-102) further validate our approach to portfolio and pipeline expansion by identifying and progressing some of the most promising scientific and clinical advances from either our internal discovery engines or external sources."

"We are excited to partner with Pyxis Oncology and its experienced management team for the development of this promising asset," said Hugh M. Davis, Ph.D., Chief Operating Officer, Biosion, Inc. and President, Biosion USA, Inc. "While immunotherapies have improved the lives of many patients, only a fraction respond to treatment, suggesting that our understanding of how cancer is able to evade the immune system is incomplete. We believe that anti-Siglec-15 may represent a breakthrough and that targeting siglec-15 could extend the benefits of immunotherapies to broader patient populations, including those who have failed PD-(L)1 targeting therapies."

Corporate Development Highlights

•License agreement with Biosion adds anti-Siglec-15 to Pyxis Oncology’s IO pipeline: Pyxis Oncology announced today it has in-licensed anti-Siglec-15,now referred to as PYX-106, a potentially best-in-class monoclonal antibody which is a novel immune checkpoint. In pre-clinical studies, PYX-106 is broadly expressed across a range of solid tumors among difficult-to-treat cancers. The American Academy for Cancer Research (AACR) (Free AACR Whitepaper) has accepted an abstract submitted by Biosion for PYX-106. The poster will be made available at the start of the AACR (Free AACR Whitepaper) Annual Meeting on April 8, 2022. Pyxis Oncology expects to file an IND for PYX-106 in the second half of 2022.
•Pipeline expansion with the addition of Company’s first internally developed candidate: Pyxis Oncology announced today the declaration of its first internally developed candidate, an anti-KLRG1 monoclonal antibody program now referred to as PYX-102. PYX-102 originated as part of the Company’s proprietary IO target catalog and work out of Pyxis Oncology founder Tom Gajewski’s lab at the University of Chicago. The Company expects to provide further updates closer to the planned IND submission for PYX-102 in the second half of 2023.
•Additional GLP study underway for PYX-202: Pyxis Oncology’s anti-DLK1 ADC, PYX-202, was licensed in from LegoChem Biosciences, Inc. in December 2020. In preparation for an IND filing and based on observation of the Company’s GLP studies to date, management has decided to conduct additional GLP and non-GLP toxicity studies to determine whether PYX-202 is a viable clinical candidate. The Company will continue to monitor the progress of its PYX-202 program and expects to provide an update about PYX-202 in mid-2022.
•Advancing programs toward the clinic with near-term catalysts: Pyxis Oncology expects to file INDs for anti-EDB, PYX-201, and anti-CD123, PYX-203, in the second half of 2022 and in the second half of 2023, respectively.
1

Financial Update

•As of March 29, 2022, Pyxis Oncology had cash and cash equivalents of approximately $253 million (preliminary, unaudited), which is expected to fund operations into the third quarter of 2024.
"With a solid balance sheet and cash runway sufficient to deliver multiple catalysts through the third quarter of 2024, we remain focused on building and advancing our pipeline through a multi-asset, multi-modality approach that we believe will unlock benefits for patients," said Pam Connealy, Chief Financial Officer.

•Research and development expenses for the full year ended December 31, 2021 were $51.1 million, compared to $9.1 million for the full year ended December 31, 2020. The increase in research and development expenses was primarily attributed to increased expenses associated with the addition of three antibody-drug conjugates to the Company’s portfolio and an increase in employee headcount to support research and development activities.
•General and administrative expenses for the full year ended December 31, 2021 were $18.6 million, compared to $3.8 million for the year ended December 31, 2020. The increase was primarily attributed to higher personnel-related expenses (including stock-based compensation), and costs incurred to support the growth and expansion of the business, overhead and facilities.
•Net loss for the full year ended December 31, 2021 was $76.0 million ($8.95 per common share), compared to $12.8 million ($12.45 per common share) for the year ended December 31, 2020. The increase in net loss is primarily attributed to the addition of three antibody-drug conjugates to the Company’s portfolio and the Company’s preparations to initiate human clinical trials for PYX-201.
•As of March 25, 2022, the outstanding number of shares of Common Stock of Pyxis Oncology was 32,841,747.
Conference Call and Webcast Details

Pyxis Oncology management will host a conference call and live webcast on Tuesday, March 29, 2022, at 8:00 a.m. ET to discuss recent corporate updates. The live call can be accessed by dialing (833) 945-2461 (domestic) or (520) 809-9726 (international) using the conference ID 5458057. A live webcast can be accessed at View Source or on the Investors section of the Pyxis Oncology website at ir.pyxisoncology.com. A replay of the webcast will be available approximately two hours after completion of the call and will be archived on the Company’s website for up to 45 days.

On March 29, 2022 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision oncology biopharmaceutical company, reported that it intends to offer and sell shares of its common stock, warrants to purchase shares of its common stock, and pre-funded warrants in an underwritten public offering (Press release, Calithera Biosciences, MAR 29, 2022, View Source [SID1234611159]). All of the shares of common stock, warrants and pre-funded warrants are being offered by Calithera.

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SVB Leerink and H.C. Wainwright & Co. are acting as joint book-running managers for the offering.

The offering is subject to market conditions, as well as Nasdaq approval, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

A shelf registration statement relating to the offered securities was filed with the Securities and Exchange Commission (SEC), and was declared effective. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website, located at www.sec.gov. Copies of the prospectus related to the offering may be obtained, when available, from SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at 1-800-808-7525, ext. 6105 or by email at [email protected], or from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, Attention: Placement, by telephone at 212-856-5711 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On March 29, 2022 Mursla, a novel multi-omics exosome characterisation company, reported that it has secured mentorship support from Roche Diagnostics Ltd for a new liquid biopsy prospective pilot study for liver cancer surveillance through MedCity’s Collaborate to Innovate: London Diagnostics programme (Press release, Mursla, MAR 29, 2022, View Source [SID1234611153]). Liver cancer is the third most common cause of premature cancer death worldwide and its incidence has increased significantly over other forms of cancer in the last three decades.

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Mursla’s aim is to develop a blood test that can detect early-stage hepatocellular carcinoma (HCC) more effectively than the current standard of care. To this end, the primary objective of the prospective pilot study is to select and confirm the relevance of novel HCC biomarkers for a larger longitudinal study demonstrating high clinical performance in a more tailored cohort. A secondary objective is the assessment of Mursla’s tissue-specific and multi-omics exosome approach as proof of concept for the development of other related cancer liquid biopsy tests.

To enable the pilot study, Mursla will leverage its proprietary multi-omics exosome characterisation platform technology for the discovery and profiling of exosome phenotypes, ExoPheno. It consists of proprietary and patented technologies, which integrate wet lab (validated exosome tissue-of-origin markers, pre-analytical multi-omics sequencing workflow and ultrasensitive exosome marker detection systems) and dry lab analysis via machine learning.

Hundreds of blood samples will be prospectively collected by Tissue Access for Patient Benefit (TAPB), a University of College London (UCL) and NHS initiative based at the Royal Free Hospital in London, UK, and by Biobanco-IMM Lisbon Academic Medical Center Portugal in collaboration with Gastroenterology Service at Hospital de Santa Maria in Lisbon, Portugal. The samples will then be characterised by ExoPheno to establish differences in the multi-omics cargo of specific exosome sub-populations between patients with various chronic liver diseases and cancer at various stages. In addition, Roche Diagnostics Ltd will support Mursla in bringing its solution to the clinic by sharing its expertise and best practice in evidence generation, scaling up and market access.

First generation liquid biopsy tests measure circulating tumor DNA (ctDNA) mutations and/or epigenetic markers (such as ctDNA methylation or fragmentation patterns) with low positive predictive value (PPV) for early-stage cancer detection, potentially leading to millions of distressing false positives. Mursla intends to improve PPV with its novel ExoPheno platform which:

Uses tissue-of-origin markers to capture tissue-specific exosomes in blood.
Detects specific multi-omics disease markers (including DNA, RNA, proteins, lipids and metabolites) contained in exosomes, mirroring the parental cell with disease.
Focuses on dynamic information released by living cells in exosomes, not by dying cells in the case of ctDNA.
Gerard Harkin, Head of Innovation UK & Ireland, Roche Diagnostics Ltd commented: "We are delighted to support the MedCity programme that encourages innovations in diagnostics and to provide in-kind mentorship to Mursla. In the field of cancer, we see the potential for new technologies to significantly improve the existing standard of care."

Pierre Arsène, Founder and CEO, Mursla added: "We are very pleased to receive the support of Roche’s UK team for the application of our novel exosome characterisation platform in early-stage liver cancer detection and beyond. We believe that the specific multi-omics information carried by blood exosomes from the tumor and its microenvironment will enable the next generation of liquid biopsy tests."

The collaboration has been enabled via Collaborate to Innovate: London Diagnostics, a MedCity programme, which is part grant-funded by the London Economic Action Partnership (LEAP). Collaborate to Innovate is an initiative that streamlines the process for building effective collaborations between SMEs and academia, commercial and non-profit partners, by helping SMEs to refine and validate their promising early-stage innovative scientific developments in their journey to provide established commercial solutions.

Mursla is one of nine successful SMEs to be selected to proceed with its study having been chosen by a panel comprising leading experts from Cancer Research UK, NHS England, BIVDA, LifeArc and world leading London academic institutions. Mursla will retain full intellectual and economic rights.

On March 29, 2022 XNK Therapeutics AB ("XNK") reported it has secured a private placement of SEK 132 million, to existing and new investors, led by Flerie Invest AB (Press release, XNK Therapeutics, MAR 29, 2022, View Source [SID1234611152]). The purpose of the issue is primarily to finance the company’s clinical development in multiple myeloma and other indications.

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XNK is at the global forefront of the development of autologous NK cell-based products using its proprietary technology platform. The company’s lead investigational candidate drug is currently being evaluated in combination with Sanofi’s anti-CD38 antibody Sarclisa (Isatuximab) in a Phase II clinical study in multiple myeloma.

Flerie Invest led the SEK 132 million financing by placing SEK 100 million and thus gains approximately 22 percent of the total number of shares and votes in the company becoming XNK’s largest owner. Ted Fjällman, partner at Flerie Invest, will as a result of the investment join the board of directors.

"This substantial fundraising is an important milestone for XNK. It allows us to accelerate our global growth initiatives and invest in the further development of our product portfolio in multiple myeloma and other cancer indications, such as our ongoing proof of concept study in acute myeloid leukemia (AML) using patient samples from The University of Texas MD Anderson Cancer Center. We are thankful for the continued support of our current shareholders and excited to further strengthen our specialist investor base with Flerie Invest and welcome them as a new shareholder." said Johan Liwing, CEO of XNK Therapeutics.

"XNK Therapeutics and the innovation ecosystem around Karolinska University Hospital in Stockholm have long been at the forefront of clinical cell therapy development" said Ted Fjällman. "We’re excited to lead this round and use our network to further commercialise the company and in so doing bring cell therapies to more patients."

XNK has engaged ABG Sundal Collier AB as financial adviser. The private placement is subject to approval by an extraordinary general meeting, which is scheduled to be held on April 5, 2022.