Immunic, Inc. Announces $60.0 Million Oversubscribed Private Placement Equity Financing

On October 10, 2022 Immunic, Inc. (Nasdaq: IMUX) ("Immunic" or the "Company"), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, reported it has entered into a securities purchase agreement (the "Purchase Agreement") with select accredited investors and certain existing investors to issue and sell an aggregate of 8,696,552 shares of its common stock ("Common Stock") at a price of $4.35 per share, reflecting a 10% premium to the closing price on October 7, 2022 on NASDAQ, and pre-funded warrants ("Pre-Funded Warrants") to purchase up to an aggregate of 5,096,552 shares of Common Stock at a purchase price of $4.34 per pre-funded warrant share, through a private investment in public equity ("PIPE") financing (Press release, Immunic, OCT 10, 2022, View Source [SID1234621872]). The Pre-Funded Warrants will have an exercise price of $0.01 per share of Common Stock, to be immediately exercisable and remain exercisable until exercised in full. Immunic anticipates the gross proceeds from the PIPE to be approximately $60.0 million, before deducting any offering related expenses. The financing is expected to close on October 12, 2022, subject to customary closing conditions.

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SVB Securities is acting as lead placement agent and Piper Sandler is acting as placement agent in connection with the financing.

The oversubscribed financing includes participation from new and existing institutional investors, including Deep Track Capital, Commodore Capital, BVF Partners LP, RTW Investments, LP, Great Point Partners, Logos Capital, Vivo Capital, Invus, Adage Capital Partners LP, Parkman Healthcare Partners, and Sphera Healthcare.

"We are highly pleased that this group of renowned, high-quality investors has participated in the financing to support our clinical-stage development pipeline targeting chronic inflammatory and autoimmune diseases," commented Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "Most notably, later this month, we eagerly await the initial clinical activity data from part C of our phase 1 clinical trial of IMU-935, our highly potent and selective oral IL-17 inhibitor, in moderate-to-severe psoriasis patients."

The Company intends to use net proceeds from the financing to fund the ongoing clinical development of its three lead product candidates, vidofludimus calcium (IMU-838), IMU-935 and IMU-856, and for other general corporate purposes. The proceeds from this PIPE financing, combined with current cash, cash equivalents and marketable securities, is expected to fund operating and capital expenditures into the fourth quarter of 2024.

The securities to be sold in this PIPE financing, including the shares of Common Stock underlying the Pre-Funded Warrants, have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. Pursuant to the Purchase Agreement, Immunic has agreed to file a registration statement with the U.S. Securities and Exchange Commission registering the resale of the shares of Common Stock sold in the PIPE financing and the shares of Common Stock issuable upon exercise of the Pre-Funded Warrants. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

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

Immune-Onc Therapeutics Enters into Clinical Collaboration with BeiGene in China

On October 10, 2022 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, reported it has entered into a clinical trial collaboration and supply agreement with BeiGene to evaluate Immune-Onc’s first-in-class myeloid checkpoint inhibitors, IO-108 and IO-202, in combination with BeiGene’s anti-PD-1 antibody, tislelizumab, as part of its clinical development programs in China (Press release, Immune-Onc Therapeutics, OCT 10, 2022, View Source [SID1234621871]).

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"We are delighted to partner with BeiGene. The preclinical and clinical data to date of our first-in-class LILRB antagonists IO-108 and IO-202 have shown that there is great potential in combining our myeloid checkpoint inhibitors with T cell checkpoint inhibitors, such as tislelizumab, to potentially improve clinical outcomes," said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. "By expanding our reach with BeiGene in China, we have an opportunity to treat a broader array of patients with significant unmet medical needs."

"We are thrilled to partner with Immune-Onc to evaluate the combination of tislelizumab with their novel myeloid checkpoint inhibitors IO-108 and IO-202," added Lai Wang, Ph.D., Global Head of R&D of BeiGene. "Based on strong preclinical and emerging clinical data, we believe there is good synergy between PD-1 and LILRB antagonists for the treatment of solid tumors. We look forward to working with Immune-Onc to explore the possibility of combination therapy with our products, which may bring more treatment options to cancer patients in China."

Under the terms of the collaboration, Immune-Onc will sponsor and fund the IO-108 and IO-202 clinical trials in China, and BeiGene will provide tislelizumab. Immune-Onc retains global development and commercial rights to IO-108 and IO-202.

ABOUT IO-108

IO-108 is a fully human IgG4 monoclonal antibody with high affinity and specificity towards LILRB2 (also known as ILT4). It blocks the interaction of LILRB2 with multiple ligands that are involved in cancer-associated immune suppression, including HLA-G, ANGPTLs, SEMA4A and CD1d. Preclinical data presented at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s annual meeting and the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting demonstrate that IO-108 functions as a myeloid checkpoint inhibitor and promotes innate and adaptive anti-cancer immunity.

The ongoing Phase 1 study of IO-108 in adult cancer patients in the U.S. (NCT05054348) has completed dose escalation. To date, IO-108 has been well tolerated with demonstrated clinical activity in multiple tumor types, both as a monotherapy and in combination with pembrolizumab, an anti-PD-1 antibody. The company is actively enrolling a Phase 1 clinical trial in China to evaluate IO-108 in solid tumors.

ABOUT IO-202

IO-202 is a humanized IgG1 monoclonal antibody with high affinity and specificity towards LILRB4 (also known as ILT3). It blocks the interaction of LILRB4 with multiple ligands, including ApoE and Fibronectin, and has broad potential as an immunotherapy in both blood cancers and solid tumors. In hematologic malignancies, preclinical studies showed that IO-202 converts a "don’t kill me" to a "kill me" signal by activating T cell killing and converts a "don’t find me" to a "find me" signal by inhibiting infiltration of blood cancer cells. In the context of solid tumors, preclinical data presented at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting demonstrate that IO-202 enhances dendritic cell function and T cell activation in vitro and inhibits tumor growth in an immune competent model in vivo.

IO-202 has two ongoing clinical studies in the U.S.: Its first Phase 1 trial is currently enrolling patients with acute myeloid leukemia (AML) or chronic myelomonocytic leukemia (CMML) as a monotherapy and in combination with azacitidine (NCT04372433). The U.S. Food and Drug Administration granted IO-202 Orphan Drug designation for treatment of AML in 2020 and Fast Track designation for relapsed or refractory AML in 2022. The second Phase 1 trial of IO-202 is currently enrolling patients with advanced solid tumors to evaluate IO-202 as a monotherapy and in combination with an anti-PD-1 (NCT05309187).

Rocket Pharmaceuticals to Present at the 2022 Cell & Gene Meeting on the Mesa

On October 10, 2022 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a leading late-stage biotechnology company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders with high unmet need, reported that Raj Prabhakar, M.B.A., Chief Business Officer, will deliver an in-person company presentation at the 2022 Cell & Gene Meeting on the Mesa on Tuesday, October 11, at 2:30 p.m. PT in Carlsbad, CA (Press release, Rocket Pharmaceuticals, OCT 10, 2022, View Source [SID1234621870]).

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A live audio webcast of the presentation will be available to registered attendees within the conference virtual platform and the video will be available for on-demand viewing within 24 hours of the Rocket presentation.

Guardant Health to Report Third Quarter 2022 Financial Results on November 3, 2022

On October 10, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported it will report financial results for the third quarter 2022 after market close on Thursday, November 3, 2022 (Press release, Guardant Health, OCT 10, 2022, View Source [SID1234621869]). Company management will be webcasting a corresponding conference call beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time.

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Live audio of the webcast will be available on the "Investors" section of the company website at: www.guardanthealth.com. The webcast will be archived and available for replay after the event.

Bluestar Genomics Receives CAP Accreditation for Its Clinical Laboratory

On October 10, 2022 Bluestar Genomics, Inc., an early cancer detection company leading the development and commercialization of next-generation liquid biopsy tests focused on non-invasive detection of high-mortality cancers in high-risk patient populations, reported it received accreditation for its clinical laboratory from the College of American Pathologists (CAP) (Press release, Bluestar Genomics, OCT 10, 2022, View Source [SID1234621868]). The certification enables the company to serve physicians and patients globally as it works towards broad commercialization of its first test for the detection of pancreatic cancer.

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CAP Accreditation is an internationally recognized program that awards laboratories that meet stringent requirements of quality, accuracy, and consistency. This milestone further solidifies Bluestar Genomics’ commitment to providing the highest standards of testing results. The company’s proprietary approach to detecting cancer early is anchored in epigenomic process of tracking dynamic changes in cells in the body by measuring levels of the biomarker 5-hydroxymethylcytosine (5hmC) in a person’s blood.

"This accreditation—on the heels of our CLIA certification and combined with our growing body of scientific evidence supporting the utility of our 5hmC-based epigenomic testing—positions us to become the first cancer detection company to offer non-invasive epigenomic blood-based testing for early pancreatic cancer detection," said David Mullarkey, chief executive officer of Bluestar Genomics. "These milestones are a testament to our focus on preparing our company to serve customers around the world, helping millions of patients avoid late-stage, untreatable cancer diagnosis."

Bluestar Genomics’ pancreatic cancer early detection test has been analytically validated and previously received FDA Breakthrough Device Designation. It is designed to analyze a person’s changing biology and uses novel 5hmC-based epigenomic analysis to detect when cells become cancerous. The company has a prospective, large clinical validation study underway to further study its test.