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Avidity Biosciences to Present at the 39th Annual J.P. Morgan Healthcare Conference

On December 22, 2020 Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company pioneering a new class of oligonucleotide-based therapies called Antibody Oligonucleotide Conjugates (AOCs), reported that Sarah Boyce, President and Chief Executive Officer, reported to present at the 39th Annual J.P. Morgan Healthcare Conference on Thursday, January 14th, 2021 at 12:40pm PST (Press release, Avidity Biosciences, DEC 22, 2020, View Source [SID1234573219]). The conference is being held in a virtual format.

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A live webcast of the presentation will be available on the Company’s website at www.aviditybiosciences.com in the Investor Resources section. A replay of the presentation will be archived on the Company’s website for 30 days.

Inhibikase Therapeutics, Inc. Announces Pricing of its Initial Public Offering

On December 22, 2020 Inhibikase Therapeutics, Inc. (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics for Parkinson’s disease and related disorders that arise inside and outside of the brain, reported the pricing of its initial public offering of 1,800,000 shares of common stock at a public offering price of $10.00 per share, for gross proceeds of $18 million, before deducting underwriting discounts and commissions and other offering expenses payable by Inhibikase (Press release, Inhibikase Therapeutics, DEC 22, 2020, View Source [SID1234573218]). All of the shares are being offered by Inhibikase. In addition, Inhibikase has granted the underwriters a 45-day option to purchase up to an additional 270,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions.

The shares are expected to begin trading on the Nasdaq Capital Market on December 23, 2020 under the ticker symbol "IKT." The offering is expected to close on December 28, 2020, subject to the satisfaction of customary closing conditions.

ThinkEquity, a division of Fordham Financial Management, Inc., is acting as sole book-running manager for the offering.

A registration statement relating to the securities being sold in the offering was declared effective by the Securities and Exchange Commission (SEC) on December 22, 2020. This offering is being made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained, when available, from the offices of ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, or by email at [email protected]. These documents may also be obtained free of charge, when they are available, by visiting the SEC’s website at www.sec.gov.

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. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.

Transcenta Closes $105 Million in Crossover Financing

On December 22, 2020 Transcenta Holding Limited ("Transcenta"), a global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, reported the completion of a 105 million USD crossover financing (Press release, Transcenta, DEC 22, 2020, View Source [SID1234573217]). China Structural Reform Fund led the financing round, participated by new investors including Country Garden Venture Capital, Qatar Investment Authority, and other prominent institutional investors. Existing investors including CCT China Merchants Fund, Lilly Asia Ventures, Teng Yue Partners, Sequoia Capital China and others also participated in this round. China Renaissance acted as the lead financial advisor for this transaction, and Bank of China International as joint financial advisor.

The year 2020 has marked many significant milestones for Transcenta. Multiple senior clinical leaders joined the company during the last six months. With multiple assets in clinical stage, the Company has been pushing the robust pipeline forward aggressively. TST001, a CLDN18.2 targeting antibody and one of its leading programs, has been moving quickly in clinic in both US and China. Transcenta will also file IND soon for TST005, a second generation PDL1-TGFβ bifunctional molecule. Transcenta has also expanded its Hangzhou facility with a fill & finish line as well as 2000L bioreactors. Its perfusion biomanufacturing platform has achieved further breakthroughs including achieving industry leading productivity of more than 4 g/L per day for multiple cell lines and successful scale-up of perfusion process to 200L for GMP production for an in-house bispecific antibody. Within the past months, Transcenta has also sealed strategic partnership with international technology innovators such as Merck KG to advance its continuous manufacturing technology capabilities.

"Transcenta has been focusing on discovering, developing and delivering novel and high quality antibody therapeutics at affordable price. We appreciate the support of new and existing investors for their confidence in Transcenta. The proceeds from new funding will be used to accelerate our ongoing clinical programs and prepare for commercialization," commented Dr. Xueming Qian, Transcenta’s Co-Founder and CEO.

"We are excited to welcome new investors in this crossover financing. Joined by multiple long-term investors, including international funds, sovereign funds, as well as China mega funds, Transcenta is strategically positioned to sustain long-term growth, bringing quality and affordable biotherapeutics to patients worldwide," said Transcenta’s Co-Founder and Chairman Dr. Jonathan Y. Zhao.

Ran Wei, General Manager of Chengtong Fund Management, which manages China Structural Reform Fund commented, "As the next-generation leader in novel drug development and commercialization, Transcenta is a platform company with fully integrated capabilities focusing on biotherapeutics. We are pleased to join hands with the other new and existing shareholders to support Transcenta along its journey of bringing the best treatment to the market."

Kevin Xie, Managing Director of China Renaissance, commented, "We are fortunate to have witnessed all the milestones that Transcenta has accomplished since its merger, and pleased to have helped seal the 2 financing rounds. We look forward to more breakthroughs the Company is to bring and the successful story it continues to write."

Illumina to Webcast Upcoming Investor Conference Presentations

On December 22, 2020 Illumina, Inc. (NASDAQ:ILMN) reported that its executives will be speaking at the following investor conference and invited investors to participate via webcast (Press release, Illumina, DEC 22, 2020, View Source [SID1234573215]).

J.P. Morgan Virtual Healthcare Conference on Monday, January 11, 2021
Presentation at 11:00am Pacific Time immediately followed by a Q&A Session to begin at approximately 11:20am Pacific Time

The live webcasts can be accessed under the Investor Info section of the "company" tab at www.illumina.com. Replays will be posted on Illumina’s website as soon as possible after the event and will be available for at least 30 days following.

MaaT Pharma Announces First Positive DSMB Safety Review for Phase Ib CIMON Trial Testing Its Microbiome Ecosystem Therapy Capsule Formulation in AML Patients

On December 22, 2020 MaaT Pharma reported that an independent Data Safety and Monitoring Board (DSMB) completed its first analysis of the ongoing Phase Ib CIMON clinical trial with MaaT033, the company’s capsule formulation of its lead biotherapeutic, MaaT013, in patients with acute myeloid leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS) following intensive chemotherapy (Press release, MaaT Pharma, DEC 22, 2020, View Source [SID1234573214]). The DSMB reviewed safety data from the first patient cohort treated with the first dose of MaaT033 and confirmed the absence of safety issues during the trial and recommended that the trial continue without modifications.

Studies have shown that chemotherapy severely reduces the microbial species networks in the gut leading to disruption in its protective epithelial layer and immune system functionality, negatively impacting patient outcomes. MaaT033, which is characterized by high microbial species diversity and richness, has been designed to restore a functional gut microbiome and re-establish immune system homeostasis to improve outcomes for patients in an easy to administer capsule.

"The DSMB’s positive assessment supports our data compiled to date and our understanding of the safety of our microbiome ecosystem therapies in this patient population, and we look forward to continuing this trial with the next patient cohort and identifying a dose that will be utilized in the subsequent Phase II study," commented John Weinberg, MD, Chief Medical Officer at MaaT Pharma. "Our goal is to provide a convenient formulation that enables use in a broad group of patients and that complements our first product candidate MaaT013."

The CIMON trial (NCT04150393) is enrolling a total of 27 patients at 4 centers across France. It is an open-label Phase 1b study to investigate the maximum tolerated dose of MaaT033, over 7 or 14 days of therapy, that supports optimal gut microbiome colonization in patients with AML or high-risk MDS who underwent intensive chemotherapy. Overall safety, tolerability, and dose regimen will be evaluated, as will the impact on the gut microbiome, to identify a recommended Phase II dose. The CIMON Phase 1b trial is expected to be completed in the fourth quarter of 2021.

Prof. Christian Recher, PU-PH, Head of the Hematology Department at the University Hospital of Toulouse, France, and coordinator of the CIMON trial added: "The treatment of hematological malignancies such as acute myeloid leukemia and myelodysplastic syndrome result in substantial negative changes in the content of patients’ gut microbiota. These microbiome changes increase the risk of poor outcomes, by allowing for negative effects such as gut or systemic infections or GvHD in patients who do go on to receive a hematopoietic stem cell transplant. Therefore, we believe that reconstituting the microbiome with a rich and highly diverse microbial therapy such as MaaT033 offers an opportunity to improve outcomes for these patients."

About MaaT033

MaaT033 is an oral, full-ecosystem, off-the-shelf, standardized, pooled-donor, high-richness microbiome biotherapeutic. It is manufactured at MaaT Pharma’s centralized European cGMP production facility. MaaT033 is designed to restore the gut ecosystem to full functionality in order to improve clinical outcomes as well as control adverse events related to conventional treatments for cancer. The capsule formulation eases administration while maintaining the high and consistent richness and diversity of microbial species, including anti-inflammatory "Butycore" species, which characterize MaaT Pharma’s microbiome ecosystem therapies.