On September 10, 2020 Codiak BioSciences, a company developing therapies based on tiny bubbles secreted by cells, reported that it is lining up an IPO as it prepares for the first tests of its technology in humans later this year (Press release, Codiak Biosciences, SEP 10, 2020, View Source [SID1234564997]).

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In paperwork filed with securities regulators late Wednesday, Codiak set a preliminary $100 million goal for its stock market debut. The Cambridge, MA-based biotech has applied for a Nasdaq listing under the stock symbol "CDAK."

The research of Codiak focuses on exosomes, extracellular vesicles that carry proteins, genetic material, and other substances in and out of cells. Exosomes function as a messenger system between cells, transporting molecules that alter the function of a recipient cell, Codiak says in its filing. Because these vesicles evolved with humans naturally, they don’t trigger an immune response. Exosomes can also be engineered for selective targeting of particular cells, and they can carry an array of payloads.

Codiak produces its therapies by engineering exosomes to carry drug molecules, either on the surface or the inside of the vesicle. The company says that its proprietary technology, called engEx, can produce therapeutic exosomes at scale and according to pharmaceutical standards.

The lead Codiak program, exoSTING, is being developed as a treatment for solid tumors. This Codiak exosome is engineered to carry molecules inside the vesicle that are intended to elicit an anti-tumor immune response by hitting the stimulator of interferon genes (STING) pathway of the innate immune system. Other attempts to drug this pathway have run into problems delivering the therapy to a cell while also avoiding toxic effects to healthy cells, Codiak says in its filing. The company says its exosome drug could overcome those limitations.

The cancers that Codiak aims to treat with exoSTING include metastatic head and neck squamous cell cancer, triple-negative breast cancer, cutaneous squamous cell carcinoma, and anaplastic thyroid carcinoma. If a Phase 1/2 clinical trial begins later this year as expected, the company says preliminary data could become available by the middle of 2021.

The next program in Codiak’s pipeline is exoIL-12, an exosome that’s engineered with the cytokine interleukin 12 (IL-12) on the surface of the vesicle. Other companies are also pursuing therapies that incorporate IL-12. Codiak notes IL-12 has elicited an anti-tumor immune response in its preclinical research and the clinical studies of others. But the company adds that experimental IL-12 therapies have been hampered by the unwanted spread of the therapy’s effects throughout the body, particularly the liver. Codiak says its exosome-delivered IL-12 drug could avoid such problems.

Codiak is developing exoIL-12 to treat solid tumors for which the IL-12 pathway has been established. These cancers include melanoma, Merkel cell carcinoma, Kaposi sarcoma, glioblastoma, and triple-negative breast cancer. The initial focus for this drug is early-stage cutaneous T cell lymphoma. A Phase 1 study is planned to start later this year; preliminary data are expected by the end of 2020. Additional data, including efficacy results, could become available by the middle of next year.

Other companies developing exosome therapies include Aruna Bio, AstraZeneca (NYSE: AZN), Evox Therapeutics, and PureTech Health. Startups are also getting into the mix. Harvard University spinout Vesigen emerged in July with $28.5 million in Series A financing to fund the development of its extracellular vesicle-based therapies.

The Wednesday IPO filing is Codiak’s second attempt to join the public markets. The company initially filed to go public in April 2019 but withdrew those plans three months later. Codiak’s timeline for the start of clinical trials is unchanged from last year. But Codiak can now make its case to investors with some additional validation. In June, Codiak inked a two-year research deal with Sarepta Therapeutics (NASDAQ: SRPT), which agreed to pay its new partner $72.5 million in upfront and near-term milestone payments. Sarepta is interested in exploring Codiak’s exosome technology as a way to deliver genetic medicines for muscular disorders without triggering an immune response.

The Sarepta deal is Codiak’s second partnership with a larger biopharmaceutical company. Early last year, the company began an alliance with Jazz Pharmaceuticals (NASDAQ: JAZZ), which paid $56 million up front in a deal spanning five cancer therapies.

Codiak launched in 2015 with financial backing from an investor group that included Flagship Pioneering (known then as Flagship Ventures), Arch Venture Partners, and Fidelity Management & Research. Those firms are Codiak’s largest stockholders, owning 28.3 percent, 18.9 percent, and 14.1 percent of the company respectively, according to the filing.

Codiak reported that its cash holdings as of June 30 totaled $50.9 million. The company says it will use the IPO proceeds to fund clinical tests of its two lead exosome drug candidates, and to finance further development of programs in earlier stages of development.

On September 10, 2020 Trillium Therapeutics Inc. ("Trillium" or the "Company") (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported that it has priced its previously announced underwritten public offering of 10,000,000 common shares (the "Common Shares") of the Company (the "Offering") (Press release, Trillium Therapeutics, SEP 10, 2020, View Source [SID1234564996]). The Common Shares are being sold at a public offering price of US$13.00 per Common Share.

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In connection with the Offering, Trillium has granted the underwriters a 30-day option to purchase up to an additional 1,500,000 Common Shares.

The gross proceeds to the Company from the Offering are expected to be approximately US$130 million, before deducting underwriting discounts and commissions and other estimated offering expenses. The Offering is expected to close on or around September 16, 2020, subject to the satisfaction of customary closing conditions.

The Company intends to use the net proceeds of the Offering for its ongoing and planned clinical trials for its CD47 program, including drug supply and for working capital and general corporate purposes.

Cowen and Evercore ISI are acting as joint book-running managers for the Offering. JMP Securities is acting as the lead manager and Ladenburg Thalmann and JonesTrading are acting as co-managers for the Offering.

No Common Shares will be offered or sold in Canada as part of this Offering. The Offering is subject to market conditions, as well as a number of closing conditions, including Nasdaq Capital Market ("Nasdaq") and Toronto Stock Exchange ("TSX") approvals, and there can be no assurance as to whether or when the Offering may be completed. For the purposes of TSX approval, the Company intends to rely on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible inter-listed issuers on a recognized exchange, such as Nasdaq.

The Offering is being made to purchasers outside of Canada pursuant to a U.S. registration statement on Form F-3 (File No. 333-237810), declared effective by the United States Securities and Exchange Commission (the "SEC") on May 4, 2020. A preliminary prospectus supplement dated September 9, 2020 has been filed with SEC relating to the Offering and a final prospectus supplement relating to the Offering will be filed with the SEC.

Before you invest, you should read the final prospectus supplement and the other documents the Company has filed for more complete information about the Company and the Offering. Copies of the final prospectus supplement will be available for free by visiting the SEC’s website at www.sec.gov or the Company’s profiles on the SEDAR website maintained by the Canadian Securities Administrators at www.sedar.com. Alternatively, copies of the final prospectus supplement will be available upon request by contacting Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926 or by contacting Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, New York 10055, or by telephone at (888) 474-0200, or by email at [email protected].

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

On September 10, 2020 Selvita (WSE: SLV), one of the largest preclinical contract research organizations in Europe, reported its H1 2020 financial results and provided a corporate update (Press release, Selvita, SEP 10, 2020, View Source [SID1234564985]).

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For the H1 2020, Selvita reports consolidated revenues of EUR 15.2 million, up by 47% on a year-on-year basis. The EBITDA result reached EUR 3.6 million, compared to EUR 2.4 million a year earlier. The backlog for 2020, as of September 7, amounts to EUR 27.6 million and indicates an increase of 39%, as compared to the values reported a year ago.

The Company consistently develops its business activities and strengthens its position on the global preclinical CRO market, especially among the U.S. customer base, considered the world’s largest biotechnology market.

Commercial revenues in the Services Segment increased in H1 2020 to EUR 12.5 million, showing a 51% increase, compared to EUR 8.6 million in the corresponding period last year. The EBITDA result of the Services Segment amounted to EUR 3.2 million, which indicates a 23.8% profitability.

Revenues in the Bioinformatics segment (Selvita’s subsidiary – Ardigen S.A.) amounted to EUR 2.0 million in 1H 2020, indicating a 43% increase compared to the same period last year. The EBITDA result increased by 217% and amounted to EUR 0.4 million, with a margin of 20,1%.

The Company’s net profit in the first half of the year amounted to EUR 2.1 million, compared to EUR 1.1 million for a corresponding period last year.

The first half of 2020 was a very intensive period for Selvita in terms of corporate and business development. The Company announced a new development strategy for 2020-2023, successfully raised over EUR 20 million from the issue of C series shares, and consequently increased its scale of business.

– We’re consistently implementing the assumptions of the development strategy, which directly translate into strengthening of our market position, as well as a solid operational and financial result. The first half of 2020 confirms that the global preclinical CRO market continues to grow and diversify, despite the uncertainties caused by the COVID-19 pandemic. For Selvita, it was a very strong half-year, as, despite the global situation and instabilities, we managed to strengthen our position on international markets, especially among U.S. based customers – comments Boguslaw Sieczkowski, Chief Executive Officer at Selvita.

Revenues from the services commissioned by U.S. customers increased almost three times by 279% y/y, and already constitute nearly 28% of the entire Services Segment revenues. At the same time, revenues from the services commissioned by customers from the United Kingdom increased by 63% y/y. Increasing customer recognition is related to the high quality of services offered and highly competent teams of specialists, which results in further contracts.

Continuity of our business operations has been assured with numerous preventive measures across our entire organization that have been taken in order to keep our scientists safe and the Company fully operational. Despite the restrictions placed on international travel, we are keeping our sales and networking activities going, which has successfully translated into the signature of numerous new contracts, as evidenced by our record-breaking backlog – adds Boguslaw Sieczkowski.

At the end of April 2020, Selvita announced its new development strategy for 2020 – 2023, which assumes increasing revenues, maintaining a stable EBITDA margin, and over EUR 230 million of market cap in 2023. For this purpose, in 2020-2023, the Company intends to execute investments worth up to EUR 75-90 million, allocated to acquisitions and organic development. In order to complete the strategy, Selvita raised over EUR 20 million in its Follow-On public offering from the issue of C series shares. Approximately 80% of the proceeds will be allocated to acquisitions, on which the Company is currently intensively working on. One of the elements of the strategy execution will be the creation of the Selvita Research Center in order to secure its own research space necessary for further growth. The Company has already made the first step towards executing this goal and signed a contract to purchase a plot of land in the neighborhood of its current laboratories in August 2020 for the value of EUR 2,3 million.

* Percentage changes in the press release are calculated based on functional currency [PLN].

On September 10, 2020 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported that the Company will participate in a "fireside chat" presentation at the Morgan Stanley Virtual 18th Annual Global Healthcare Conference on Thursday, September 17, 2020 at 11:00am EDT (Press release, Fusion Pharmaceuticals, SEP 10, 2020, View Source [SID1234564984]). Presenting on behalf of Fusion will be Chief Executive Officer John Valliant, Ph.D., Chief Financial Officer John Crowley, and Chief Medical Officer James O’Leary, M.D.

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A live webcast of the event will be available on the "Events and Presentations" page in the "Investors & Media" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

On September 10, 2020 Universal Health Services, Inc. (NYSE: UHS) reported an offering of senior secured notes due 2030 (the "Notes") (Press release, Universal Health Services, SEP 10, 2020, View Source [SID1234564983]). The Company intends to use the net proceeds of the offering, together with cash on hand, to redeem all of the outstanding $700 million aggregate principal amount of its 4.750% Senior Secured Notes due 2022 (the "Existing 2022 Notes") on September 28, 2020, to pay accrued and unpaid interest on the Existing 2022 Notes to but excluding the date of redemption, to pay transaction expenses and for general corporate purposes.

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The Notes have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities law and, unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable state securities laws. The Notes will be offered only to persons reasonably believed to be qualified institutional buyers under Rule 144A of the Securities Act and outside the United States under Regulation S of the Securities Act.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the Notes in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. Any offers of the Notes will be made only by means of a private offering memorandum. This notice is being issued pursuant to and in accordance with Rule 135(c) under the Securities Act.

Certain statements in this release may constitute forward-looking statements and are subject to various risks and uncertainties as discussed in the Company’s filings with the Securities and Exchange Commission. The Company is not obligated to update these forward-looking statements even if the Company’s assessment of these risks and uncertainties changes.

Universal Health Services, Inc. ("UHS") is one of the nation’s largest providers of hospital and healthcare services. Through its subsidiaries, UHS operates acute care hospitals, behavioral health facilities, outpatient facilities and ambulatory care access points located throughout the United States, Puerto Rico and the United Kingdom.