Huahui Health Closed Series A+ Financing

On October 18, 2021 Huahui Health reported completion of its Series A+ financing round back in March 2021, raising approximately CNY 500 million (Press release, Huahui Health, OCT 18, 2021, View Source [SID1234642183]). The A+ round was led by GL Ventures and joined by existing investors including Hankang Capital and Matrix Partners China. Raised fund will be used to support clinical development of its pipeline products, establishing pilot scale manufacturing for biologics, and building research platform for small molecules.

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"This financing round will fuel and further expedite the growth and expansion of Huahui, " said Dr. Wenhui Li, founder of Huahui. "We are pleased with the recognition and support from our partners. We will continue building and advancing our internal competence and capabilities in order to meet the needs of patients across the globe."

Emergent BioSolutions to Release Third Quarter 2021 Financial Results and Conduct a Conference Call on November 4, 2021

On October 18, 2021 Emergent BioSolutions Inc. (NYSE: EBS) reported that it will host a conference call on Thursday, November 4, 2021 at 5:00 pm eastern time to discuss the financial results for the third quarter of 2021, recent business developments, and financial outlook for full year 2021 (Press release, Emergent BioSolutions, OCT 18, 2021, View Source [SID1234591444]).

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This conference call can be accessed live by telephone or by webcast:

Webcast Information:
Visit View Source for the live webcast.

A replay of the call can be accessed from the Emergent website.

Entry into a Material Definitive Agreement

On October 18, 2021, Thermo Fisher Scientific (Finance I) B.V. ("Thermo Fisher International"), an indirect, wholly-owned finance subsidiary of Thermo Fisher Scientific Inc. (the "Company"), reported that issued €1,750,000,000 aggregate principal amount of 0.800% Senior Notes due 2030 (the "2030 Notes"), €1,500,000,000 aggregate principal amount of 1.125% Senior Notes due 2033 (the "2033 Notes"), €1,250,000,000 aggregate principal amount of 1.625% Senior Notes due 2041 (the "2041 Notes") and €750,000,000 aggregate principal amount of 2.000% Senior Notes due 2051 (the "2051 Notes", and, together with the 2030 Notes, the 2033 Notes and the 2041 Notes, the "Notes") in a public offering (the "Offering") pursuant to a registration statement on Form S-3 (File No. 333-229951) and a preliminary prospectus supplement and prospectus supplement related to the offering of the Notes, each as previously filed with the Securities and Exchange Commission (the "SEC") (Filing, 8-K, Thermo Fisher Scientific, OCT 18, 2021, View Source [SID1234591460]). The Company has fully and unconditionally guaranteed the Notes on a senior unsecured basis (the "Guarantee" and, together with the Notes, the "Securities").

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The Securities were issued under an indenture, dated as of August 9, 2016 (the "Base Indenture"), and the Third Supplemental Indenture, dated as of October 18, 2021 (the "Supplemental Indenture" and, together with the Base Indenture, the "Indenture"), among Thermo Fisher International, as issuer, the Company, as guarantor, and The Bank of New York Mellon Trust Company, N.A., as trustee.

Prior to July 18, 2030, in the case of the 2030 Notes, July 18, 2033, in the case of the 2033 Notes, April 18, 2041, in the case of the 2041 Notes and April 18, 2051, in the case of the 2051 Notes (each such date, a "Par Call Date"), Thermo Fisher International may redeem the Notes of any such series, in whole at any time or in part from time to time, at a redemption price equal to the greater of (1) 100% of the principal amount of the Notes to be redeemed and (2) the sum of the present values of the remaining scheduled payments of principal and interest in respect of the Notes being redeemed (not including any portion of the payments of interest accrued but unpaid as of the date of redemption and assuming that such Notes to be redeemed matured on their applicable Par Call Date), discounted to the date of redemption on an annual basis (ACTUAL/ACTUAL (ICMA)), using a discount rate equal to the Comparable Bond Rate (as defined in the Indenture) plus 20 basis points, in the case of the 2030 Notes, 20 basis points, in the case of the 2033 Notes, 25 basis points, in the case of the 2041 Notes and 30 basis points, in the case of the 2051 Notes, plus in each case, accrued and unpaid interest on the Notes being redeemed, if any, to, but excluding, the date of redemption.

In addition, on and after the applicable Par Call Date, the Company may redeem the Notes of any series, in whole at any time or in part from time to time, at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the date of redemption.

Upon the occurrence of a change of control (as defined in the Indenture) of the Company and a contemporaneous downgrade of the Notes below an investment grade rating by at least two of Moody’s Investors Service, Inc., S&P Global Ratings, a division of S&P Global, Inc., and Fitch Ratings Limited, Thermo Fisher International will, in certain circumstances, be required to make an offer to purchase the Notes at a price equal to 101% of the principal amount of the Notes, plus accrued and unpaid interest, if any, to, but excluding, the date of repurchase.

The Notes are general unsecured obligations of Thermo Fisher International. The Notes rank equally in right of payment with existing and any future unsecured and unsubordinated indebtedness of Thermo Fisher International and rank senior in right of payment to any existing and future indebtedness of Thermo Fisher International that is subordinated to the Notes. The Notes are also effectively subordinated to any existing and future secured indebtedness of Thermo Fisher International to the extent of the assets securing such indebtedness, and are structurally subordinated to all existing and any future indebtedness and any other liabilities of its subsidiaries.

The Guarantee is a general unsecured obligation of the Company. The Guarantee ranks equally in right of payment with existing and any future unsecured and unsubordinated indebtedness of the Company and will rank senior in right of payment to any existing and future indebtedness of the Company that is subordinated to the Guarantee. The Guarantee is also effectively subordinated to any existing and future secured indebtedness of the Company to the extent of the assets securing such indebtedness, and is structurally subordinated to all existing and any future indebtedness and any other liabilities of its subsidiaries (other than, with respect to Thermo Fisher International, the Notes).

The Indenture contains limited affirmative and negative covenants of the Company and Thermo Fisher International. The negative covenants restrict the ability of the Company and its subsidiaries to incur debt secured by liens on Principal Properties (as defined in the Indenture) or on shares of stock of the Company’s Principal Subsidiaries (as defined in the Indenture) and engage in sale and lease-back transactions with respect to any Principal Property. The Indenture also limits the ability of each of the Company and Thermo Fisher International to merge or consolidate or sell all or substantially all of their respective assets.

Upon the occurrence of an event of default under the Indenture, which includes payment defaults, defaults in the performance of affirmative and negative covenants, bankruptcy and insolvency related defaults and failure to pay certain indebtedness, the obligations of Thermo Fisher International under the Notes may be accelerated, in which case the entire principal amount of the Notes would be immediately due and payable.

Wilmer Cutler Pickering Hale and Dorr LLP, U.S. counsel to the Company and Thermo Fisher International, has issued an opinion to the Company and Thermo Fisher International, dated October 18, 2021, regarding the legality of the Securities, and Linklaters LLP, Dutch counsel to Thermo Fisher International, has issued an opinion to Thermo Fisher International, dated October 18, 2021, regarding the Notes. Copies of these opinions are filed as Exhibits 5.1 and 5.2 hereto, respectively.

The foregoing description of certain of the terms of the Indenture does not purport to be complete and is qualified in its entirety by reference to the full text of each of the Base Indenture and the Supplemental Indenture, which are filed with this report as Exhibits 4.1 and 4.2 hereto, respectively. Each of the foregoing documents is incorporated herein by reference.

Isofol Medical AB (publ) publishes prospectus and new financial information in connection with listing on Nasdaq Stockholm

On October 18, 2021 Isofol Medical AB (publ), (Nasdaq First North Premier Growth Market: ISOFOL), ("Isofol" or the "Company"), reported that the prospectus prepared by the Company in connection with the listing on Nasdaq Stockholm has been approved and registered by the Swedish Financial Supervisory Authority (Finansinspektionen) (Press release, Isofol Medical, OCT 18, 2021, View Source [SID1234591478]). The prospectus contains updated financial information, due to regulatory requirements, attributable to the Company’s equity and liabilities as well as net indebtedness as of July 31, 2021. The prospectus is available on Isofol’s website, www.isofolmedical.com and on the Swedish Financial Supervisory Authority’s website, www.fi.se.

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Prospectus and new financial information

On October 15, 2021 Isofol announced that Nasdaq Stockholm’s listing committee made the assessment that Isofol fulfills the applicable listing requirements and will approve an application for admission to trading of the Company’s shares on Nasdaq Stockholm, provided that certain customary conditions are fulfilled, including approval and registration of a prospectus by the Swedish Financial Supervisory Authority. The prospectus that has been prepared in connection with the listing was approved and registered today by the Swedish Financial Supervisory Authority and is now available on Isofol’s website, www.isofolmedical.com and on the Swedish Financial Supervisory Authority’s website, www.fi.se.

The prospectus contains previously unpublished financial information attributable to Isofol’s equity and liabilities and net indebtedness as of July 31, 2021. The financial information, which is also outlined below, is presented due to regulatory requirements, according to which financial information regarding the capital structure must not be older than 90 days at the time of the prospectus’ publication. Note that only interest-bearing liabilities are reported in the tables below. The information has not been reviewed by the Company’s auditor.

Additional information about the listing

The first day of trading on Nasdaq Stockholm’s Main Market is planned to take place on Thursday, October 21, 2021 and the final day of trading on Nasdaq First North Premier Growth Market is expected to be Wednesday, October 20, 2021.

The Company’s shares will be traded with unchanged ticker ISOFOL and ISIN-code (SE0009581051). No new shares will be issued in connection with the shares being admitted to trading on Nasdaq Stockholm and the Company’s shareholders do not need to take any action in connection with the listing.

Advisors

Isofol has engaged Advokatfirman Vinge KB as legal advisor and Carnegie Investment Bank AB (publ) as financial advisor in connection with the listing on Nasdaq Stockholm.

The information was submitted for publication, through the agency of the contact person set out above, at 13:00 CEST on October 18, 2021.

About arfolitixorin

Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase III study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit more patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

Avelas Makes Senior Appointments and Provides Update on Pegloprastide Phase III Clinical Program

On October 18, 2021 Avelas Biosciences, Inc. ("Avelas" or "the Company"), a clinical-stage drug-device company pioneering the field of fluorescence imaging for real-time cancer detection, reported that additions to its senior management team and Board of Directors and provides an update on the pegloprastide Phase III clinical program, due to start in 1H22 (Press release, Avelas Biosciences, OCT 18, 2021, View Source [SID1234591424]).

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Corporate Update

Avelas is pleased to announce it has strengthened its management team with the appointment of Ambareen "Amber" Sheriff as Vice President, Regulatory and Quality and further bolstered its Board of Directors with the appointment of Robin Stevens as a Non-Executive Director of the Company.

Ms. Sheriff is an expert in global regulatory strategies with more than 32 years of regulatory affairs and product development experience. Throughout her career, Ms. Sheriff has led US, EMEA and rest of the world regulatory and quality strategies supporting development and preparation of drug products, investigational studies and marketing authorisations. Prior to joining Avelas, Ms. Sheriff was the VP, Regulatory Affairs and Quality Assurance at Celerity Pharmaceuticals, where she obtained ten regulatory approvals in over six years in the role. Ms. Sheriff previously held roles at Marathon Pharmaceuticals, Winston Laboratories, Akorn, and Baxter Healthcare. Ms. Sheriff holds a B.S. in Pharmacy from the University of Karachi and a B.S. in Chemistry from Northeastern Illinois University.

Mr. Stevens has over 30 years’ experience advising private and public companies in a variety of functions, including corporate finance, capital markets and previously as an international audit partner, in a wide range of industries, operating in the UK and overseas. In addition to his role at Avelas, he is a Senior Advisor and Capital Markets Lead at MHA MacIntyre Hudson.

Jay Lichter, Ph.D., Chairman, President, and Chief Executive Officer of Avelas, added: "As Avelas accelerates towards commencement of our Phase III clinical study for pegloprastide, I am delighted to be strengthening our team both at the management and Board level with the addition of Amber and Robin. We look forward to working closely with them."

Clinical Update

Avelas also announces that it is the Company’s intent to commence its registrational confirmatory Phase III trial for pegloprastide, its novel, best-in-class agent for visualizing breast cancer margins, in the first half of 2022, having received constructive and helpful feedback from the US Food and Drug Administration (the "FDA").

Avelas is developing pegloprastide (AVB-620), a novel fluorescent imaging agent used in combination with a fluorescence camera system, which has FDA Breakthrough Therapy Designation, for the intraoperative detection and visualization of positive margins during breast cancer surgery.

The goal of intraoperative image-guided surgery with pegloprastide is to increase the precision of cancer surgery and improve treatment outcomes for patients by fluorescently identifying cancer, in real-time during surgery, on the surfaces of excised tissue or residual cancer in the tumour bed not otherwise detected by surgeons and potentially left behind in a patient during an operation. Avelas has already demonstrated in prior studies that the use of pegloprastide, a fluorescent cancer marker, during surgery correctly identified cancer in up to 75% of patients who may have otherwise been candidates for a repeat (re-excision) surgery.

Through the benefits of Breakthrough Therapy Designation, Avelas has continued to collaborate with the FDA on the design of the Company’s registrational confirmatory Phase III trial. The design and protocol of the Phase III study will now be finalized in preparation for commencement of patient enrolment in the first half of 2022. Jay Lichter, Ph.D., Chairman, President, and Chief Executive Officer of Avelas said "We believe that pegloprastide is a best-in-class novel agent for visualising breast cancer margins in real time during surgery. Following this constructive dialogue with the FDA, we are excited to continue the clinical development of this exciting candidate."