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.
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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.

On March 29, 2022 Royalty Pharma plc (Nasdaq: RPRX) reported a charitable commitment totaling $7.5 million to The Leukemia & Lymphoma Society (LLS), a global leader in the fight against blood cancer (Press release, Royalty Pharma , MAR 29, 2022, View Source;lymphoma-society-lls-to-advance-initiatives-that-address-healthcare-disparities-in-blood-cancer-care-and-treatment-301512545.html [SID1234611151]). Through this five-year alliance, Royalty Pharma will support initiatives focused on reducing healthcare disparities in blood cancer care and treatment. Royalty Pharma is a founding donor of the LLS IMPACT grant program (Influential Medicine Providing Access to Clinical Trials) which awards funding to major cancer research and treatment centers to expand access to clinical trials for underserved and minority populations. Royalty Pharma plc will not receive any economic benefit in exchange for any aspect of these donations.

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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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Royalty Pharma is supporting initiatives focused on reducing healthcare disparities in blood cancer care and treatment.

"Despite many advances in blood cancer care and treatment, barriers exist in many communities to prevent patients from accessing new, more effective therapies and protocols that can lead to better outcomes," said Pablo Legorreta, founder and Chief Executive Officer of Royalty Pharma. "The gift awarded through Royalty Pharma’s alliance with The Leukemia & Lymphoma Society is intended to propel the work LLS is doing in underserved communities through three key initiatives that will help break down these barriers and ensure that everyone has access to the care they need to treat their blood cancer."

Blood cancer does not discriminate, affecting people of every age, gender, race and ethnicity. But not all people have equal access to care and treatments. LLS exists to ensure that all patients get the care they need. Royal Pharma’s annual contribution of $1.5 million over five years will be equally distributed to the following LLS initiatives that address disparities:

Equity in Access Research Program is a grantmaking program designed to generate evidence that will guide changes in healthcare policy and practice to ensure that all blood cancer patients and survivors achieve access to the cancer care and services they need throughout their lives. This new and novel program is based on the concept of health equity as the principle underlying a commitment to reduce—and ultimately, eliminate—disparities in health.
LLS IMPACT* Research Grants initiative has been established to improve access to clinical trials for underrepresented patients, including Black, Indigenous and People of Color (BIPOC) patients and people from rural communities. Through this initiative, LLS has awarded funding to three major cancer centers located in New York, Tennessee, and Minnesota to partner with community-based hospitals and clinics on creating networks of clinical trial sites in their regions. Additional sites will be selected in the coming months. More information, including participating sites, the communities they serve and the need to address disparities in these areas can be found here.
Myeloma Link is carried out by LLS staff and volunteers in 13 Black communities across the country. It is an education and outreach initiative that raises community awareness about myeloma and connects Black patients and caregivers to trusted, free myeloma information and support and enhances access to care and the latest treatments. Black Americans have at least double the incidence of myeloma as any other racial or ethnic group, and recent studies show they experience less optimal care. To learn more, including the cities where Myeloma Link is active, please visit this site.
"The Leukemia & Lymphoma Society has a long-standing commitment to serving all blood cancer patients and reaching underserved communities where there are barriers to access and equitable care," said Louis J. DeGennaro, Ph.D., President and Chief Executive Officer of The Leukemia & Lymphoma Society. "Royalty Pharma’s generous contribution to these three important initiatives will bring us closer to achieving our goal to ensure a future of expanded access and better outcomes for all blood cancer patients and their families."