On May 9, 2022 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported it has entered into a research collaboration and exclusive option license agreement with Astellas Pharma Inc (Press release, Twist Bioscience, MAY 9, 2022, View Source [SID1234613958]). Under the terms of the agreement, the companies will jointly conduct research activities to identify and optimize proprietary Twist antagonist antibodies, targeting an undisclosed checkpoint inhibitor pathway in the tumor microenvironment (TME), as potential therapeutic development candidates. Ligands in this pathway are found in relatively high concentrations in the tumor microenvironment. Blocking the receptor’s activation has the potential to markedly enhance anti-tumor immunity with other Astellas therapies including chimeric antigen receptor-based (CAR) technologies combined with Universal Donor Cells. Astellas will have the exclusive option to license any development candidates generated as part of the collaboration.

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"Our robust antibody discovery and optimization capabilities uniquely position us to develop antibodies with high affinity and specificity for historically difficult targets, such as those mediating immune suppression in the TME," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "This out-licensing agreement validates the capabilities of Twist-generated antibodies to enable the discovery and advancement of next generation therapies. As the first out-licensing agreement for Twist Biopharma, this deal will serve as an initial base that we intend to build on as we pursue increasingly larger and later stage out-licensing opportunities with additional partners and targets."

Targeting this pathway with antibody therapeutics is a novel approach with no antibodies in clinical development. Developing next-generation checkpoint inhibitor immunotherapies using new modalities is promising as an innovative healthcare solution. Through this collaboration we expect to stimulate a highly specific and targeted attack on cancer cells by optimizing these development candidates, and leveraging Astellas’ flexible convertibleCAR cell therapy technology.

Under the terms of the agreement, Twist will receive an upfront payment from Astellas as well as an additional payment upon the exercise of the licensing option. Twist will receive payments connected to success-based clinical milestones as well as royalty payments on product sales for each licensed product. Astellas will be responsible for the development, manufacturing and commercialization of any licensed products.

On May 9, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in cell-free, enzymatic DNA production, reported that it will report fiscal 2022 second quarter financial results after market close on Thursday, May 12, 2022 (Press release, Applied DNA Sciences, MAY 9, 2022, View Source;id=230827&p=2228311&I=1206939-c7Z3G6f3m8 [SID1234613957]). The Company’s management will discuss the results during a conference call and simultaneous webcast at 4:30 p.m. ET that same day. Presentation slides will also be posted to the ‘Company Events’ sub-page of the Company’s Investor Relations website and embedded into the live webcast.

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A telephonic replay of the conference call will be available for one week beginning one hour after the end of the live conference call.

On May 9, 2022 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, reported that it plans to host a conference call on Monday, May 16, 2022, at 8:30 a.m. ET to discuss its financial results for the quarter ended March 31, 2022 and provide a corporate update (Press release, Synthetic Biologics, MAY 9, 2022, View Source/news-media/press-releases/detail/326/synthetic-biologics-to-host-conference-call-and-webcast-to [SID1234613956]).

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Individuals may participate in the live call via telephone by dialing (877) 451-6152 (domestic) or (201) 389-0879 (international) and using the conference ID: 13729717. Participants are asked to dial in 15 minutes before the start of the call to register. Investors and the public can access the live and archived webcast of this call via the "News & Media" section of the company’s website, View Source, under "Events" or by clicking here, for 90 days after the call.

On May 9, 2022 Bavarian Nordic A/S (OMX: BAVA) reported the initiation of a new share buy-back program, under which the Company intends to buy back up to 71,562 of its own shares (Press release, Bavarian Nordic, MAY 9, 2022, View Source [SID1234613955]). The purpose of the share buy-back program is to meet the Company’s obligations arising from the share-based incentive programs for the Board of Directors and Executive Management, in accordance with the Company’s remuneration policy.

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The share buy-back program is initiated pursuant to the authorization granted at the annual general meeting on April 5, 2022, according to which the Company may purchase up to 10 % of the Company’s share capital for the time being.

The share buy-back program will be executed in accordance with Regulation (EU) No. 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse and supplementing Regulation (EU) 2016/1052 of 8 March 2016, which together constitute the Safe Harbour Regulation.

Bavarian Nordic A/S has appointed Danske Bank A/S Lead Manager of the program. Danske Bank A/S will buy back shares on behalf of Bavarian Nordic A/S and make decisions on trading with Bavarian Nordic A/S’ shares independently and without influence of Bavarian Nordic A/S.

The program will be implemented in accordance with the authorization within the following scope:

A maximum of 71,562 shares will be purchased within the duration of the program.
The maximum consideration for Bavarian Nordic A/S-shares purchased within the duration of the program is DKK 20 million. However, based on the closing price of Bavarian Nordic’s share on Nasdaq Copenhagen A/S on May 6, 2022, the total consideration is expected to be in the level of DKK 9.5 million.
The program terminates at the latest on May 18, 2022.
The maximum number of shares, which may be purchased per trading day, shall not exceed 25% of the average daily volume of shares in the Company traded on Nasdaq Copenhagen A/S in the preceding 20 trading days.
The shares may not be purchased at a price which is higher than the higher of the following:
The price of the last independent trade.
The highest current independent purchase bid on Nasdaq Copenhagen A/S.
Bavarian Nordic A/S may terminate the program at any time. If the Company determines to terminate the program, the Company will give notice hereof.

On May 9, 2022 Bavarian Nordic A/S (OMX: BAVA) reported its interim financial results and business progress for the first three months of 2022 (Press release, Bavarian Nordic, MAY 9, 2022, View Source [SID1234613954]).

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Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: "We have reported strong progress in our pipeline during the first quarter with additional Phase 2 results for our COVID-19 vaccine candidate, confirming its potential as a universal booster vaccine and we look forward to initiating the Phase 3 trial later this year. Furthermore, our RSV program was granted a Breakthrough Therapy Designation by the FDA, underlining the importance of the development of a vaccine to fulfil this high unmet medical need and to that end we initiated a Phase 3 program that will read out next year. In line with our RSV commercialization strategy, we were also pleased to enter a license and supply agreement covering selected Asian markets for RSV. Our rabies business demonstrated a stronger than expected performance in both US and Germany that off sets a slower than expected start of the TBE market during Q1. Based on current financial performance and current assessment of uncertainties and risks we maintain our full year financial guidance on revenue, EBITDA and cash."

Financial highlights from the first quarter

Revenue was DKK 320 million comprised of DKK 230 million from product sales, DKK 83 million in milestone payments from our RSV partner Nuance Pharma and DKK 7 million from contract work.
EBITDA was a loss of DKK 94 million.
Strong cash position of DKK 2,947 million at end of the period
Financial guidance for the full year is maintained at revenues between DKK 1,100 and 1,400 million, EBITDA with a loss between DKK -1,300 and -1,000 million and cash and cash equivalents at year-end unchanged between DKK 1,000 and 1,200 million.

* Repo pledged securities deducted.

Other highlights

In January, Bavarian Nordic announced the appointment of Russell Thirsk as new EVP and Chief Operating Officer to replace Henrik Birk, who has chosen to seek challenges outside Bavarian Nordic. Mr. Thirsk joined Bavarian Nordic in April from GSK, where he served as Head of Operations at GSK Vaccines in Belgium.
In February, the U.S. Food and Drug Administration (FDA) granted a Breakthrough Therapy Designation for the Company’s vaccine candidate, MVA-BN RSV, for the prevention of respiratory syncytial virus (RSV) in older adults. A Breakthrough Therapy Designation is designed to expedite the development and regulatory review of medicines that are intended to treat a serious condition.
In February, Bavarian Nordic announced additional results from the Phase 2 trial of its COVID-19 booster vaccine candidate, ABNCoV2. The results confirmed the ability of ABNCoV2 to boost neutralizing antibodies to levels reported to be highly efficacious (>90%) against SARS-CoV-21 both when used for primary vaccination and when used as a booster in subjects previously vaccinated with mRNA or Adeno-based vaccines.
In March, Bavarian Nordic entered into a license and supply agreement with Nuance Pharma on the development and commercialization of MVA-BN RSV for adults in China and selected Asian markets. Under the terms of the agreement, Bavarian Nordic could receive up to USD 225 million in upfront and milestone payments in addition to tiered, double-digit royalties. Nuance Pharma obtains rights to commercialize MVA-BN RSV in Chinese Mainland, Hong Kong, Macau, Taiwan, South Korea and Southeast Asia and will be responsible for all material costs, including development and regulatory.
Events after the reporting date

In April, Bavarian Nordic initiated a global Phase 3 clinical trial of MVA-BN RSV against RSV in older adults. The Phase 3 trial is planned to enroll approximately 20,000 adults, aged 60 years or older across approximately 115 sites in the U.S. and Germany. The trial is designed to run through the RSV season 2022/2023 with topline results expected mid 2023, if the pre-defined number of lower-respiratory tract disease events has occurred.
In May, Bavarian Nordic reported additional Phase 2 results for ABNCoV2, demonstrating that vaccination with ABNCoV2 induced a significant boost to the neutralizing antibodies against the Omicron variant in the majority of subjects (87%), who were previously vaccinated with approved mRNA or adenoviral vaccines. Neutralizing antibodies reached levels reported to be associated with a high level of protection (>90%).
Conference call and webcast

The management of Bavarian Nordic will host a conference call today at 2 pm CET (8 am ET) to present the interim results followed by a Q&A session. A listen-only version of the call can be accessed via View Source To join the Q&A session, use one of the following dial-in numbers: Denmark: +45 32 72 04 17, UK: +44 (0) 844 481 9752, USA: +1 646-741-3167. Participant code is 7179801.