BioNTech Announces Closing of $512 Million Underwritten Offering of American Depositary Shares

On June 27, 2020 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported the closing of its previously announced underwritten offering (the "Underwritten Offering") of 5,500,000 American Depositary Shares ("ADSs"), each representing one of its ordinary shares, at a public offering price of $93.00 per ADS, for gross proceeds of approximately $512 million, before deducting underwriting discounts and commissions and other offering expenses payable by BioNTech (Press release, BioNTech, JUL 27, 2020, View Source [SID1234562402]). In addition, a selling shareholder granted the underwriters a 30-day option to purchase up to 825,000 additional ADSs at the same public offering price, which has not yet been exercised. BioNTech would not receive any of the proceeds from such a sale of ADSs by the selling shareholder.

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"We would like to thank our existing shareholders for their continued support and welcome our new shareholders. With the proceeds from this financing, we have strengthened our position to execute our strategy to advance a diverse pipeline of novel immunotherapies toward the market, including multiple oncology and infectious disease candidates. We look forward to updating the investment community on our continued progress," said Ryan Richardson, Chief Strategy Officer at BioNTech.

J.P. Morgan, BofA Securities and Berenberg acted as lead joint book-running managers for the Underwritten Offering. UBS Investment Bank acted as joint book-running manager and Canaccord Genuity acted as lead manager for the Underwritten Offering. COMMERZBANK, Wolfe Capital Markets and Advisory and Bryan, Garnier & Co. acted as co-managers for the Underwritten Offering.

A registration statement on Form F-1 relating to the securities offered in the Underwritten Offering was filed with the United States Securities and Exchange Commission (the "SEC") and was declared effective on July 22, 2020. The Underwritten Offering was made only by means of a prospectus, copies of which may be obtained, when available, for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, copies of the prospectus, when available, may be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by telephone at +1 (866) 803-9204, or by e-mail at [email protected]; BofA Securities, Inc., NC1-004-03-43; 200 North College Street, 3rd Floor, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department, or by e-mail at [email protected]; or Berenberg Capital Markets LLC, Attention: Investment Banking, 1251 Avenue of the Americas, 53rd Floor, New York, New York 10020, or by telephone at +1 (646) 949-9000, or by e-mail at [email protected].

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 other 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 other jurisdiction.

Champions Oncology Reports Quarterly Revenue of $8.8 Million

On July 27, 2020 Champions Oncology, Inc. (Nasdaq: CSBR), engaged in an end-to-end range of research and development technology solutions and services to improve the development and use of oncology drugs, reported its financial results for the year and fourth fiscal quarter ended April 30, 2020 (Press release, Champions Oncology, JUL 27, 2020, View Source [SID1234562401]).

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Fourth Quarter and Fiscal Year 2020 Financial and Recent Business Highlights:

Record annual revenue of $32.1 million, an increase of 18.7% year-over-year

Record annual bookings

Expanded lab space and capacity

Forecast revenue growth of 15% – 20% in FY 2021

Ronnie Morris, CEO of Champions, commented, "We’ve successfully completed another year executing our strategy to enhance our existing services and expand product lines to fuel top line revenue growth. We’ve recently added an additional 10,000 square ft of lab space, significantly increasing our capacity and enabling us to meet expected demand as we plan for future growth. We’ve successfully navigated the business during this unprecedented time and are well positioned to extend our growth over the course of the new fiscal year."

David Miller, CFO of Champions added, "Our record annual revenue and solid bookings highlights the continued strength in our business and efforts to expand our product lines. While our recent expenses were higher than expected, we’re projecting another year of 15% – 20% revenue growth as demand for existing and new services continues to grow."

Fourth Fiscal Quarter Financial Results

For the fourth quarter of fiscal 2020, revenue increased 13.4% to $8.8 million compared to $7.7 million for the fourth quarter of fiscal 2019. The overall increase in revenue is due to increased sales, both in number and size of studies, the growth of our platform, and an expansion of our product lines. Total costs and operating expenses for the fourth quarter of fiscal 2020 were $10.7 million compared to $7.8 million for the fourth quarter of fiscal 2019, an increase of $2.8 million or 36.1%.

For the fourth quarter of fiscal 2020, Champions reported a loss from operations of $1.9 million, which includes $163,000 in stock-based compensation, $246,000 in depreciation, and goodwill impairment of $335,000 compared to a loss from operations of $117,000, inclusive of $143,000 in stock-based compensation and $174,000 depreciation expense, in the fourth quarter of fiscal 2019. Excluding stock-based compensation, depreciation, and goodwill impairment, Champions

Exhibit 99.1

reported a loss from operations for the quarter of $1.2 million, a decrease of $1.4 million compared to income from operations of $200,000 in the prior year period.

Cost of oncology solutions was $4.9 million for the three months ended April 30, 2020, an increase of $620,000, or 14.0% compared to $4.3 million for the three months ended April 30, 2019. The increase in cost of sales was primarily due to an increase in work outsourced to our strategic partners and immediate recognition of invoiced costs. For the three months ended April 30, 2020, gross margin was 43.7% compared to 44.3% for the three months ended April 30, 2019.

Research and development expense was $1.8 million for the three months ended April 30, 2020 an increase of $571,000, or 45.8% compared to $1.2 million in the prior year. The increase was due to costs associated with expanding existing services, new product development, and investing in our TumorBank. Sales and marketing expense for the three months ended April 30, 2020 was $1.1 million, an increase of $170,000, or 18.5% compared to $918,000 for the three months ended April 30, 2019. The increase was mainly due to an expansion of our sales force and related increase in compensation. General and administrative expense was $2.5 million for the three months ended April 30, 2020 compared to $1.4 million for the three months ended April 30, 2019, an increase of $1.1 million or 82.6%. The increase was mainly due to a bonus payment to the CEO. Goodwill impairment was $335,000 for the three months ended April 30, 2020, resulting from an annual goodwill assessment and the ensuing Company decision to write-off the goodwill allocated to the declining POS business unit.

Net cash provided by operations was $2.0 million for the three months ended April 30, 2020. The increase in cash from operations is primarily the result of our sales growth. Additionally approximately 700,000 warrants were exercised, generating $4.0 million from financing activities. The company ended the quarter, and year, in a strong cash position with 8.3 million and no debt.

Year-to-Date Financial Results

For the twelve months of fiscal 2020, revenue increased 18.7% to $32.1 million, as compared to $27.1 million for the twelve months of fiscal 2019. The overall increase in revenue is due to increased sales, both in number and size of studies, a rising demand for our services, an expansion of our customer base, the growth of our platform, and expansion of our product line. For the twelve months of fiscal 2020, total operating expenses increased 26.6% to $33.9 million, as compared to $26.8 million for the twelve months of fiscal 2019.

For the twelve months ended April 30, 2020, Champions reported a net loss from operations of $1.8 million, which includes $600,000 in stock-based compensation, $825,000 in depreciation, and goodwill impairment of $335,000, compared to income from operations of $270,000, inclusive of $649,000 in stock-based compensation and $606,000 depreciation, for the twelve months ended April 30, 2019. Excluding stock-based compensation, depreciation, and goodwill impairment, Champions reported an operating loss of $43,000 for the twelve months ended April 30, 2020.

Cost of oncology solutions was $16.9 million for the twelve months ended April 30, 2020 compared to $14.3 million for the twelve months ended April 30, 2019, an increase of $2.6 million or 18.2%. The increase in cost of oncology services was mainly due to an increase in compensation, supply, and outsourced, strategic partner lab service expenses. Gross margin was 47.4% for the twelve months ended April 30, 2020 compared to 47.3% for the twelve months ended April 30, 2019.

Research and development expense was $5.9 million for the twelve months ended April 30, 2020 an increase of $1.1 million, or 22.0% compared to $4.8 million for the twelve months ended April 30,

Exhibit 99.1

2019. The increase was due to increased compensation and mice and lab supply expenses as we replenished the models in our Bank and continued to develop new service capabilities and endpoint analysis testing. Sales and marketing expense for the twelve months ended April 30, 2020 was $4.2 million, an increase of $1.2 million, or 38.8% compared to $3.1 million for the twelve months ended April 30, 2019. The increase was mainly due to compensation expense driven by the continued expansion of our sales force and commissions earned. General and administrative expense was $6.6 million for the twelve months ended April 30, 2020, an increase of $1.9 million or 41.4% compared to $4.7 million for the twelve months ended April 30, 2019. The increase was mainly due to an increase in salary expenses. Goodwill impairment was $335,000 for the twelve months ended April 30, 2020, resulting from an annual goodwill assessment and subsequent determination to write-off compared to nil for the same period in the prior year.

Net cash provided by operations was $2.9 million for the twelve months ended April 30, 2020 compared to the net cash provided by operations of $1.9 million for the twelve months ended April 30, 2019, an increase of $1.0 million. The increase in cash from operations is the result of our sales growth.

Conference Call Information:

The Company will host a conference call today at 4:30 p.m. EDT (1:30 p.m. PDT) to discuss its fourth quarter financial results. To participate in the call, please call 877-407-8035 (domestic) or 201-689-8035 (international) ten minutes ahead of the call and give the verbal reference "Champions Oncology."

Full details of the Company’s financial results will be available on, or before, Wednesday July 29, 2020 in the Company’s Form 10-K at www.championsoncology.com.

* Non-GAAP Financial Information

See the attached Reconciliation of GAAP to non-GAAP Net Income (Loss) (Unaudited) for an explanation of the amounts excluded to arrive at non-GAAP net income (loss) and related non-GAAP net income (loss) per share amounts for the three and twelve months ended April 30, 2020 and 2019. Non-GAAP financial measures provide investors and management with supplemental measures of operating performance and trends that facilitate comparisons between periods before and after certain items that would not otherwise be apparent on a GAAP basis. Certain unusual or non-recurring items that management does not believe affect the Company’s basic operations do not meet the GAAP definition of unusual or non-recurring items. Non-GAAP net income (loss) and non-GAAP income (loss) per share are not, and should not be viewed as a substitute for similar GAAP items. Champions’ defines non-GAAP dilutive income (loss) per share amounts as non-GAAP net income (loss) divided by the weighted average number of diluted shares outstanding. Champions’ definition of non-GAAP net income (loss) and non-GAAP diluted income (loss) per share may differ from similarly named measures used by others.

Spectrum Pharmaceuticals Announces Positive Topline Results in HER2 Exon20 Insertion Mutations from Cohort 2 of the Poziotinib ZENITH20 Trial

On July 27, 2020 Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that it met the pre-specified primary endpoint in the ZENITH20 Phase 2 clinical trial evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with HER2 exon 20 insertion mutations (Cohort 2) (Press release, Spectrum Pharmaceuticals, JUL 27, 2020, View Source [SID1234562400]).

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"The positive results of Cohort 2 are a significant milestone and we are looking forward to meeting with the FDA," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "We believe that poziotinib is a significant advancement for patients with this deadly disease in an area of high unmet medical need."

Cohort 2 of the ZENITH20 clinical trial enrolled a total of 90 patients who received an oral, once daily dose of 16 mg of poziotinib. All the patients had failed at least one line of prior systemic therapy with 60 patients (67%) having failed two or more prior therapies, including chemotherapy and immunotherapy. All responses were read independently and confirmed by a central imaging laboratory using RECIST criteria. The intent-to-treat analysis demonstrated a confirmed objective response rate (ORR) of 27.8% (95% Confidence Interval (CI) 18.9%-38.2%). Based on the pre-specified statistical hypothesis for the primary endpoint, the observed lower bound of 18.9% exceeded the pre-specified lower bound of 17% in this heavily pre-treated population.

The median duration of response was 5.1 months (range 1 to >12.3), with a median follow up of 8.3 months. The disease control rate (DCR) was 70% and the median progression free survival was 5.5 months. The safety profile was in-line with the type of adverse events (AEs) seen with other second-generation EGFR tyrosine kinase inhibitors and similar to Cohort 1. Grade 3 treatment related rash was 30% and diarrhea was 26%. In Cohort 2, no pneumonitis was reported (0/90).

"We are pleased with the results of Cohort 2," said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. "There are currently no approved therapies for HER2 patients with exon 20 insertion mutations in NSCLC and we are looking forward to reviewing this data with the FDA to determine the path forward."

Cohort 2 was designed to be a registrational study. The company is in the process of requesting a meeting with the U.S. Food and Drug Administration (FDA) to discuss the data and its plans for a New Drug Application (NDA) submission. The company plans to present additional study results for Cohort 2 at an upcoming medical meeting.

The ZENITH20 trial is comprised of 7 independent cohorts. Cohorts 1 – 4 are each independently powered for a pre-specified statistical hypothesis with a primary endpoint of ORR. Cohorts 5 – 7 are exploratory. In December 2019, the company reported that the primary endpoint for Cohort 1 (EGFR) was not met but clinical activity was seen. Based on the results of Cohort 1, the company has amended the protocol for ZENITH20 to explore additional twice daily dosing regimens as well as lower single daily dosage amounts. This amendment did not impact Cohorts 2 and 3 as these cohorts were fully enrolled. Results from Cohort 3 are expected in the second half of the year.

Conference Call and Webcast

The company’s management will host a webcast and conference call today, July 27, 2020, at 4:30 p.m. ET / 1:30 p.m. PT to discuss the clinical trial results. The live call may be accessed by dialing (877) 837-3910 for domestic callers and (973) 796-5077 for international callers and entering the conference ID#: 2516797. A live webcast of the call will be available from the Investor Relations section of the company’s website at View Source and will be archived there shortly after the live event.

About Poziotinib

Poziotinib is a novel, oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. The company holds an exclusive license from Hanmi Pharmaceuticals to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China. Poziotinib is currently being investigated by the company and Hanmi in several mid-stage trials in multiple solid tumor indications.

Avidity Biosciences Appoints Jae Kim, M.D. as Chief Medical Officer

On July 27, 2020 Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company pioneering a new class of oligonucleotide-based therapies called Antibody Oligonucleotide Conjugates (AOCs), reported the appointment of Jae Kim, M.D. as Chief Medical Officer (Press release, Avidity Biosciences, JUL 27, 2020, View Source [SID1234562399]). In his new role, Dr. Kim will be responsible for leading and expanding Avidity’s AOC pipeline and will serve as a key member of its executive management team.

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"We are very pleased that Jae is joining Avidity as we continue to build a leading RNA-targeted therapeutics company," said Sarah Boyce, President and CEO of Avidity. "His extensive experience developing monoclonal antibodies and oligonucleotides for a range of serious diseases, including orphan indications, will be invaluable as we progress our AOCs for muscle diseases and other tissue types toward the clinic."

Dr. Kim joins Avidity from Alnylam Pharmaceuticals, Inc., where he served as Clinical Research Head, Chair of the Clinical Trial Review Board, and Vice President of Clinical Development. He oversaw the development of multiple clinical assets across several therapeutic areas and played a key role in the development and approval of Givlaari (givosiran) for acute hepatic porphyria. Prior to Alnylam, he served in roles of increasing responsibility in global development at MyoKardia, Inc. and Amgen. Dr. Kim received his Bachelor of Arts in Neurobiology Magna Cum Laude from Cornell University and his M.D. from Cornell University Medical College. He completed his post-doctoral fellowship in Genetics at Harvard Medical School and his clinical training in cardiovascular disease at the Brigham and Women’s Hospital and Massachusetts General Hospital. Dr. Kim is a board-certified cardiologist, was an NIH-funded Principal Investigator, and served on the Faculty of Medicine at Harvard Medical School and the Brigham and Women’s Hospital before joining industry.

"The advent of conjugation methods to expand the therapeutic application of oligonucleotides is an important step forward in the field of RNA-targeted therapeutics," said Dr. Kim. "Avidity’s AOC therapeutics could have broad utility by accessing previously undruggable tissue and cell types, which give us the potential to transform the lives of patients living with serious diseases, who currently have no available treatment options. Avidity has made great progress on its technology and I look forward to joining the team to advance a meaningful portfolio of AOCs through clinical development."

Aurinia Closes US$200 Million Public Offering of Common Shares

On July 27, 2020 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, reported the closing of its previously announced underwritten public offering of 13,333,334 common shares (the "Offering") (Press release, Aurinia Pharmaceuticals, JUL 27, 2020, View Source [SID1234562398]). The shares were sold at a public offering price of US$15.00 per share. The gross offering proceeds to the Company from this Offering are approximately US$200 million, before deducting underwriting discounts and commissions and other offering expenses.

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Jefferies and SVB Leerink acted as joint book-running managers for the Offering. Cantor acted as lead manager and Oppenheimer & Co. and H.C. Wainwright & Co. acted as co-managers for the Offering. The Company has granted the underwriters an option exercisable, in whole or in part, in the sole discretion of the underwriters, to purchase 2,000,000 additional common shares, for a period of up to 30 days.

For the purposes of the TSX approval, the Company relied 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 Company intends to use the net proceeds of the Offering for pre-commercialization and launch activities, research and development, as well as working capital and general corporate purposes.

The Offering was made pursuant to a U.S. registration statement on Form F-10, declared effective by the U.S. Securities and Exchange Commission (the "SEC") on June 19, 2020 (the "Registration Statement"), and the Company’s existing Canadian short form base shelf prospectus (the "Base Shelf Prospectus") dated June 17, 2020. The prospectus supplements relating to the Offering (together with the Base Shelf Prospectus and the Registration Statement, the "Offering Documents") have been filed with the securities commissions in the provinces of British Columbia, Alberta and Ontario in Canada, and with the SEC in the United States. The Offering Documents contain important detailed information about the securities being offered. Before you invest, you should read the Offering Documents and the other documents the Company has filed for more complete information about the Company and the Offering. Copies of the Offering Documents are available for free by visiting the Company’s profiles on the SEDAR website maintained by the Canadian Securities Administrators at www.sedar.com or the SEC’s website at www.sec.gov, as applicable. Alternatively, copies of the prospectus supplement are available upon request in the United States by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022; by phone at (877) 821-7388; or by e-mail at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6218, or by email at [email protected]; and in Canada by contacting Jefferies Securities, Inc., attention: Steven Latimer, 161 Bay Street, Suite 2700 Toronto, Ontario M5J 2S1, by telephone at 416-572-2215.

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.