On December 15, 2021 Alethiomics, a drug discovery company focused on developing targeted therapies to treat a family of blood cancers called myeloproliferative neoplasms (MPNs), reported that launched, backed by £6m seed financing from Oxford Science Enterprises (Press release, Alethiomics, DEC 15, 2021, View Source [SID1234597257]).

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A spin-out from the University of Oxford, the company is based on world-leading discoveries in clinical haematology and single-cell multi-omics by its founders, Professor Adam Mead and Professor Beth Psaila. Mark Throsby Ph.D. has been appointed as Chairman and Edward Ainscow Ph.D. has joined as Chief Scientific Officer (CSO).

MPNs are a group of chronic blood cancers that begin with mutations occurring in cancer stem cells in the bone marrow. Currently available treatments, for example JAK2 inhibitors, provide symptomatic benefit, but do not tackle the underlying disease drivers meaning that many patients have a persistent burden of disease and remain at risk of disease progression.

Identifying new drug targets within these mutant cells is critical to developing targeted and curative therapies. Alethiomics’ founders have pioneered the use of single-cell multi-omic approaches to better understand the biology of mutant-positive stem cells in MPNs and to discover novel molecular targets as the basis for drug discovery. They have also developed bespoke platforms for target validation to accelerate successful translation to the clinic.

Prof. Mead said: "Despite tremendous advances in oncology, the quality of life and outcome for patients with many aggressive cancers remains poor. It is now clear that precision treatments targeted at specific driver mutations in cancer-initiating cells are required. Current approaches to single-cell tumour analysis are unable to resolve both cellular and mutational heterogeneity. The Alethiomics TARGET-seq platform simultaneously detects DNA mutations, the RNA transcriptome and cell surface proteins from individual cells to provide a holistic understanding of pathologies and more intelligent target identification.

Prof. Psaila added: "Our initial focus is on the most sinister MPNs, for which current treatments are really inadequate and many of our patients still suffer very poor outcomes. We are really excited to have founded Alethiomics and to be recruiting an experienced and dynamic team, enabling us to translate our discoveries in novel target identification into precision medicines to improve the lifespan and quality of life for the patients we care for in the clinic."

The breakthrough potential of the founders’ research is underlined by the fact that work using TARGET-seq, led by Professor Mead, was selected for the Plenary Session at one of most prestigious scientific presentations in haematology; the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting1.

The seed financing will be used to establish Alethiomics’ research operations at the Oxford BioEscalator, to advance its pipeline of programmes in MPNs, and to industrialise the company’s proprietary TARGET-seq drug discovery and target prioritisation platform.

Claire Brown, PhD, MBA, Life Sciences Partner at Oxford Science Enterprises said:
"We are tremendously impressed by the unparalleled expertise in haematological cancer of Prof. Mead and Prof. Psaila, and their passion for bringing new therapies to the clinic to benefit patients. We look forward to building on their foundational discoveries and to developing clinical programmes and new therapies that deliver on the early promise of the technology."

Co-founders, Adam and Beth, will act as consultants to Alethiomics and serve on the Scientific Advisory Board, whilst continuing to lead their research groups at the MRC Weatherall Institute of Molecular Medicine, Radcliffe Department of Medicine, University of Oxford alongside their clinical practices in the Department of Haematology at Oxford University Hospitals NHS Trust.

Chairman Dr Mark Throsby is a biopharmaceutical executive with extensive research experience and a track record of innovation and execution. He is an expert in antibody engineering and immunology with over two decades of commercial experience gained in pharma and biotech at Crucell NV and Merus NV. Alongside his role at Alethiomics he acts as COO/CSO of Gadeta BV and serves on the Board of Ona Therapeutics.

CSO Dr Ed Ainscow brings two decades of experience working on innovative approaches to early drug discovery in both pharma and biotech. He joins from Carrick Therapeutics Ltd where he has been Chief Technology Officer for the past five years.

Alethiomics foundational research has been supported by academic and charitable grants including the support of Cancer Research UK, which becomes a minority shareholder in the company.

1. ASH (Free ASH Whitepaper) Plenary Session Information

Title: Single-Cell Multi-Omics Reveals the Genetic, Cellular and Molecular Landscape of TP53 Mutated Leukemic Transformation in MPN
Plenary Scientific Session: Hematology Disease Topics & Pathways:
Fundamental Science, Genomics, Translational Research, Hematopoiesis, Biological Processes
Presenter: Dr Rodriguez-Meira
Timing: Presented on Sunday, December 12, 2021, 2:00 PM-4:00 PM EST
Paper: View Source

On December 15, 2021 Avenue Therapeutics, Inc. (or the "Company") (NASDAQ: ATXI), a company focused on the development of intravenous ("IV") tramadol for the U.S. market, reported the closing of its public offering of 1,910,100 shares of common stock at a public offering price of $1.07 (Press release, Avenue Therapeutics, DEC 15, 2021, View Source [SID1234597229]). The gross proceeds of the offering were approximately $2.0 million before deducting underwriting discounts, commissions and offering expenses. In addition, the Company has granted Aegis Capital Corp. a 45-day option to purchase up to an additional 286,430 shares of common stock to cover over-allotments, if any, at the public offering price, less the underwriting discount.

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The common stock is trading on The Nasdaq Capital Market under the symbol "ATXI".

Aegis Capital Corp. acted as the sole book-running manager for the offering.

A registration statement on Form S-3 relating to common stock being sold in this offering was declared effective by the Securities and Exchange Commission (the "SEC") on December 10, 2021. The offering was made only by means of a prospectus. Copies of the final prospectus may be obtained on the SEC’s website, www.sec.gov, or by contacting Aegis Capital Corp., Attention: Syndicate Department, 810 7th Avenue, 18th Floor, New York, NY 10019, by email at [email protected], or by telephone at (212) 813-1010.

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 December 15, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported that it has completed its previously announced initial public offering (STAR Offering) on the Science and Technology Innovation Board (STAR Market) of the Shanghai Stock Exchange (SSE) (Press release, BeiGene, DEC 15, 2021, View Source [SID1234597365]). The shares offered in the STAR Offering were issued to and subscribed for by permitted investors in the People’s Republic of China (PRC) in Renminbi (RMB Shares). The RMB Shares began trading on the STAR Market under the stock code "688235" on December 15, 2021, China time, making BeiGene the first triple-listed biotechnology company on NASDAQ, the Hong Kong Stock Exchange (HKEx), and the STAR Market.

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The total number of shares offered in the STAR Offering is 115,055,260 ordinary shares, par value $0.0001 per share, which represents 8.62% of BeiGene’s total outstanding ordinary shares as of October 31, 2021, after giving effect to the shares offered. The public offering price of the RMB Shares is RMB192.60 per ordinary share, which equates to HK$234.89 per ordinary share and US$391.68 per American Depositary Share (ADS), based on an assumed exchange rate of RMB0.81996 to HK$1.00 and RMB6.3924 to US$1.00. Each ADS represents 13 ordinary shares.

The gross proceeds to BeiGene from the STAR Offering, before deducting underwriting commissions and other estimated offering expenses, are approximately RMB22.2 billion, or approximately US$3.5 billion, based on an assumed exchange rate of RMB6.3924 to US$1.00.

China International Capital Corporation Limited and Goldman Sachs Gao Hua Securities Company Limited acted as joint sponsors and joint bookrunners for the STAR Offering. J.P. Morgan Securities (China) Company Limited, CITIC Securities Co., Ltd. and Guotai Junan Securities Co., Ltd. acted as joint bookrunners for the STAR Offering.

BeiGene has granted China International Capital Corporation Limited a 30-day overallotment option for up to 17,258,000 additional RMB Shares. If the over-allotment option is fully exercised, the total number of shares offered in the STAR Offering will be 132,313,260 Shares, which represents 9.79% of BeiGene’s total outstanding ordinary shares as of October 31, 2021, after giving effect to the shares offered.

BeiGene expects to use the net proceeds from the STAR Offering to fund its research and clinical development, construction of its research and development centers and a manufacturing plant in China, sales and marketing force expansion in China, and for working capital and general corporate purposes.

In accordance with applicable PRC laws and regulations, the STAR Offering is conducted solely within the PRC and only to permitted investors who are eligible to participate in the STAR Offering in accordance with applicable PRC securities laws and regulations, and rules promulgated by the SSE and the China Securities Regulatory Commission (CSRC). The STAR Offering is conducted pursuant to a prospectus and other offering materials prepared by BeiGene in Chinese language and as approved by and registered with the SSE and the CSRC, which are only permitted to be used within the PRC. No part of the STAR Offering is intended to involve a public offering or sale of the RMB Shares into or in the United States or any other jurisdiction outside of the PRC. In addition, although the RMB Shares are of the same class and have the same rights as the Company’s existing ordinary shares listed on the HKEx, the RMB Shares will not be fungible with the ordinary shares listed on the HKEx or the Company’s ADSs representing its ordinary shares listed on the NASDAQ Global Select Market (NASDAQ), and in no event will any RMB Shares be able to be converted into ordinary shares listed on the HKEx or ADSs listed on NASDAQ, or vice versa.

An automatically effective shelf registration statement on Form S-3 was filed with the Securities and Exchange Commission (SEC) on May 11, 2020. A prospectus supplement relating to and describing the key terms of the STAR Offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. The purpose of the prospectus supplement is to register all RMB Shares offered in the STAR Offering under the Securities Act of 1933, as amended (Securities Act) to ensure that the offer and sale of the RMB Shares, if any, to permitted investors who are U.S. persons (as defined in Regulation S under the Securities Act) in transactions outside the United States will not violate the registration requirements under Section 5 of the Securities Act.

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 offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. This press release is being issued pursuant to, and in accordance with, Rule 134 under the Securities Act.

On December 15, 2021 Bionaut Labs, a company focused on revolutionizing the treatment of central nervous system disorders (CNS) with its Bionaut precision medicine treatment modality, and Candel Therapeutics, Inc. (Nasdaq: CADL), a late clinical-stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported a strategic collaboration to investigate the use of Bionaut’s remote-controlled microscale robots for precision delivery of Candel’s oncolytic viral immunotherapy agents to specific brain tumors (Press release, Bionaut Labs, DEC 15, 2021, View Source [SID1234597181]).

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Bionaut Labs will apply its micro-robotic technology under the guidance of an integrated electro-magnetic control system to deliver Candel’s oncolytic viruses directly to brain tumors in a minimally invasive manner. The parties will jointly research the use of the Bionaut platform in the preclinical setting with an aim of advancing to clinical trials. The agreement enables both parties to retain unencumbered rights to their respective platforms, as well as rights for future clinical development together.

"With the goal of maximizing the benefit to patients, Candel continues to evaluate expansion of our clinically validated oncolytic viral immunotherapy approach into additional subsets of patients with high-grade glioma using novel methods, such as the Bionaut platform, to deliver our investigational medicines," said Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel Therapeutics. "We look forward to this collaboration with Bionaut Labs in the hope that it will ultimately lead to better outcomes for patients living with brain cancer."

"Bionaut Labs is excited to partner with Candel, a leader in developing oncolytic viruses for multiple cancers, to advance much-needed treatment options for brain cancer patients leveraging our transformative Bionaut platform technology," said Michael Shpigelmacher, co-founder and CEO, Bionaut Labs. "The research we plan to jointly undertake validates our approach and will enable advancement of our technology as we continue our mission of helping patients suffering from debilitating brain diseases who lack effective treatments. We look forward to working with Candel, as this collaboration has the potential to re-envision the standard of care for high-grade gliomas and make a meaningful difference in patients’ lives."

Terms of the agreement were not disclosed.

About Bionaut Treatment
A Bionaut is a novel treatment modality that uses remote-controlled microscale robots to deliver biologics, nucleic acids, small molecule, gene or cellular therapies locally to targeted CNS disease areas. Through precise targeting, Bionaut therapeutics could offer better efficacy and safety that cannot be achieved by other traditional treatment or delivery modalities.

Bionauts can be constructed in different designs with custom geometries and surface characteristics. Smaller than a millimeter, they contain moving parts controlled remotely by a magnetic controller, allowing them to safely reach the target and release a therapeutic payload from the cargo compartment. Engineering flexibility provides a broad foundation for designing Bionaut therapies for nearly any disease of interest.

Bionaut Labs has demonstrated safe and controlled navigation of its therapeutic Bionaut to and from the treatment locus in the brain, in a large animal in vivo model. Furthermore, the Company has successfully treated human glioma tumors established in mice, utilizing guided delivery of therapeutic cargos directly into these tumors to eliminate systemic toxicity. These results pave the way to the clinical trials of the Bionaut platform.

On December 15, 2021 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported that it has terminated the Stock Purchase Agreement that was executed on August 30, 2020 (Press release, Navidea Biopharmaceuticals, DEC 15, 2021, View Source [SID1234597201]).

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On August 30, 2020, the Company entered into a Stock Purchase Agreement with each of the investors named therein (the "Investors"), pursuant to which the Investors agreed to purchase from the Company up to $25.0 million in shares of the Company’s common stock, par value $0.001 per share ("Common Stock"). The initial closings of the sale and purchase of the Common Stock (collectively, the "Initial Closing") were to occur within forty-five (45) business days after the date on which the Company’s application to the NYSE American for the listing of the Common Shares for trading thereon was approved by the NYSE American. The Investors agreed to purchase an aggregate of 1,000,000 shares of Common Stock at the Initial Closing at a purchase price of $5.00 per share. To date, we have received only $25,000 of the $5.0 million that was due at the Initial Closing. On December 14, 2021, the Company notified the Investors that it was terminating the Stock Purchase Agreement in accordance with its terms.