Tetraphase Announces Amendment to Merger Agreement with AcelRx Pharmaceuticals for Increased Consideration

On May 27, 2020 Tetraphase Pharmaceuticals, Inc. (Nasdaq:TTPH), a biopharmaceutical company focused on commercializing its novel tetracycline XERAVA (eravacycline for injection) to treat serious and life-threatening infections, reported that it has entered into an amendment to the Agreement and Plan of Merger, dated March 15, 2020, to which the Company is a party with AcelRx Pharmaceuticals, Inc. ("AcelRx") and its merger subsidiary (the "Merger Agreement"), to increase the consideration payable to Tetraphase shareholders (Press release, Tetraphase, MAY 27, 2020, View Source [SID1234558540]).

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Under the amended Merger Agreement, Tetraphase stockholders will receive, for each share of Tetraphase common stock, (1) $0.2434 in cash and 0.7217 of a share of AcelRx common stock, representing approximately $1.43 in upfront per share value, based on the closing price of AcelRx’s common stock as of the close of trading on May 26, 2020, in each case subject to downward adjustment in the event that the Company’s closing net cash is less than $5.0 million, and (2) one contingent value right ("CVR"), which would entitle the holders to receive potential aggregate payments of up to $14.5 million in cash upon the achievement of certain future XERAVA net sales milestones starting in 2021. Under the terms of the Merger Agreement prior to the amendment, upon the consummation of the transaction, Tetraphase stockholders were entitled to receive for each share of Tetraphase common stock, 0.6303 of a share of AcelRx common stock, subject to downward adjustment in the event that the Company’s closing net cash is less than $5.0 million, and one CVR, which would have entitled the holders to receive potential aggregate payments of up to $12.5 million in cash or AcelRx stock, at AcelRx’s option upon the achievement of future XERAVA net sales milestones starting in 2021.

AcelRx proposed the amendment to the Merger Agreement in response to a proposal from Melinta Therapeutics, Inc. ("Melinta"), on May 21, 2020, to acquire Tetraphase for $27.0 million in cash (or $1.21 per share of Tetraphase common stock), plus an additional $12.5 million in cash potentially payable under CVRs upon the achievement of certain future XERAVA net sales milestones starting in 2021.

The boards of directors of Tetraphase and AcelRx have each approved the amendment to the Merger Agreement. Tetraphase’s board of directors has determined that as a result of the amendment to the Merger Agreement with AcelRx, Melinta’s proposal is not superior and recommends the Merger Agreement, as amended by the amendment, to its stockholders.

Based on the closing price of AcelRx stock on May 26, 2020, the total upfront consideration to be received by Tetraphase equityholders is valued at approximately $31.9 million, with approximately $16.5 million of this amount allocated to the Company’s outstanding common stock warrants. In the merger, Tetraphase stockholders would also be entitled to receive, for each share of Tetraphase common stock, one non-tradeable CVR, the holders of which will be entitled to receive potential payments of up to an additional $14.5 million in cash in the aggregate upon the achievement of net sales of XERAVA in the United States, payable as follows: (i) $2.5 million upon annual net sales of $20.0 million during 2021, (ii) $4.5 million upon annual net sales of $35.0 million during any year ending on or before December 31, 2024 and (iii) $7.5 million upon annual net sales of $55.0 million during any year ending on or before December 31, 2024.

Tetraphase continues to plan to hold its special meeting of stockholders to approve the pending transaction on June 8, 2020. The transaction is expected to close in June 2020, subject to specified closing conditions, including Tetraphase having a minimum amount of net cash as of the closing and approval by Tetraphase stockholders. Upon the closing of the transaction, Tetraphase will become a privately held company and shares of Tetraphase’s common stock will no longer be listed on any public market. Subject to certain limited exceptions, the CVRs will be non-transferable.

Janney Montgomery Scott LLC is acting as financial advisor to Tetraphase and Wilmer Cutler Pickering Hale and Dorr LLP is acting as legal advisor.

Maverick Therapeutics to Participate at 2020 Jefferies Virtual Healthcare Conference

On May 27, 2020 Maverick Therapeutics Inc., a private biopharmaceutical company pioneering conditionally active bispecific T cell targeted immunotherapies, reported it will share company and pipeline updates at the Jefferies Virtual Healthcare Conference being held from June 2 to June 4, 2020 (Press release, Maverick Therapeutics, MAY 27, 2020, View Source [SID1234558576]). Chief Executive Officer Jim Scibetta is scheduled to participate in a live presentation on June 3, 2020 at 3:30 p.m. Eastern Time.

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Following the conference, the presentation will be available on the events & presentations section of the Maverick website at: View Source

Medidata Announces New Research Published at American Society for Clinical Oncology Annual Meeting

On May 27, 2020 Medidata, the global leader in creating end-to-end solutions to support the entire clinical trial process, and a Dassault Systèmes company, reported the online publication of four abstracts at the ASCO (Free ASCO Whitepaper) 2020 Annual Meeting, being held virtually May 29 – 31 (Press release, Medidata, MAY 27, 2020, View Source [SID1234558592]).

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Acorn AI, by Medidata, and its partners – Friends of Cancer Research, Guardian Research Network, Donald and Barbara Zucker School of Medicine of Hofstra/Northwell, Memorial Sloan Kettering Cancer Center, New York-Presbyterian/Weill Cornell Medical Center and Weill Cornell Medicine, and New York Medical College – collaborated on research studies that highlight the importance of integrating multiple sources of data to provide insights into clinical oncology.

"Our research findings demonstrate the value of generating new clinical insights by collecting, combining, and analyzing data in innovative ways," said Glen de Vries, co-founder and co-CEO, Medidata. "We are proud to be working with outstanding research partners, who help bring meaningful contributions to the field and hope to millions of patients."

The published abstracts include use cases that combine omic and clinical data, use real-world data and pooled clinical trial data, and that expand on Medidata’s pioneering work in synthetic control arms. The following are a summary of these abstracts:

Exploring the validity of a synthetic control arm (SCA) for augmentation or replacement of a randomized control in difficult-to-study indications – a case study in relapsed or refractory multiple myeloma (R/R MM) (Abstract e20521)
The study demonstrated that the treatment effect based on a synthetic control arm can mimic the treatment effect from a randomized clinical trial in a study involving patients with relapsed or refractory multiple myeloma; this may have significant implications in speeding drug development and reducing patient burden
Evaluating progression free survival in black and white women with triple negative breast cancer in pooled clinical trials from a Synthetic Control Database (SCD) and real-world electronic medical records (EMR) (Abstract e13102)
A representative pool of cross trial triple negative breast cancer patients demonstrated lower progression free survival in Black patients compared to their non-Black counterparts by using a Synthetic Control Database and real-world EMR data, underscoring the necessity of diversity in clinical trials
Assessing the relationship in relapsed-refractory multiple myeloma between response, progression, and survival between pooled clinical trial subjects and a real-world electronic medical record data source (Abstract e20525)
The study revealed that using pooled clinical trial analyses, together with real-world data, can overcome individual trial sample size limitations and biases; this can expand the range of populations and allow a more comprehensive understanding of the complex oncology treatment landscape
Error-free, automated data integration of exosome cargo protein data with extensive clinical data in an ongoing, multi-omic translational research study (Abstract e16743)
The automatic, efficient, and reliable integration of clinical and omic data was demonstrated in a clinical trial for pancreatic ductal adenocarcinoma (PDAC), an aggressive, difficult to treat malignancy; much-needed diagnostic biomarkers for early detection may now be found in a more expedited, less-resource intensive manner
The Acorn AI/Medidata team invites the oncology community to learn more about these studies at the ASCO (Free ASCO Whitepaper) Industry Expert Theater, which are available starting May 29. This is an opportunity to dive deeper into how the company is bringing data, expertise and technology to the frontlines of decision-making in clinical oncology:

Making Precision Medicine a Reality in Clinical Development, Discovery and Beyond with Bryant Fields, Senior Director, Integrated Evidence Commercial Lead, Acorn AI
Clinical Trial Data meets the Real World: Bridging the Experimental and Post-Launch Worlds with Aaron Galaznik, Head, Acorn AI Labs Boston, Real-World Evidence (RWE)
Medidata is a wholly-owned subsidiary of Dassault Systèmes, which with its 3DEXPERIENCE platform is positioned to lead the digital transformation of life sciences in the age of personalized medicine with the first end-to-end scientific and business platform, from research to commercialization.

Bicycle Therapeutics to Present at Upcoming Investor Conferences

On May 27, 2020 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that management will participate in fireside chats at the following virtual investor conferences in June (Press release, Bicycle Therapeutics, MAY 27, 2020, View Source [SID1234558525]):

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Jefferies Global Healthcare Conference on Wednesday, June 3, 2020 at 3:00 p.m. ET
Goldman Sachs 41st Annual Global Healthcare Conference on Thursday, June 11, 2020 at 1:20 p.m. ET
A live webcast of each presentation will be accessible in the Investors & Media section of Bicycle’s website at www.bicycletherapeutics.com. Archived replays of the webcasts will be available for 90 days following the presentation dates.

Zionexa USA and PETNET Solutions announce FDA approval of Cerianna™ (fluoroestradiol F18)

On May 27, 2020 Zionexa USA, a wholly owned subsidiary of Zionexa SAS, and PETNET Solutions, Inc., a wholly owned subsidiary of Siemens Medical Solutions, Inc., reported the Food and Drug Administration (FDA) has approved Cerianna (fluoroestradiol F 18) injection for intravenous use (Press release, Zionexa, MAY 27, 2020, View Source;utm_medium=rss&utm_campaign=zionexa-usa-and-petnet-solutions-announce-fda-approval-of-cerianna-fluoroestradiol-f18 [SID1234558541]). Cerianna (fluoroestradiol F 18) is a molecular imaging agent indicated for use in positron emission tomography (PET) imaging for the detection of estrogen receptor-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer. Cerianna (fluoroestradiol F 18) is the first FDA-approved F-18 PET imaging agent specifically indicated for use in patients with recurrent or metastatic breast cancer.

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Cerianna (fluoroestradiol F 18) will be commercially available beginning in late 2020/early 2021 through PETNET Solutions, Inc., Zionexa USA’s manufacturer and exclusive commercial distributor in the U.S. Additional manufacturing sites will be added as each site receives regulatory approval to commence manufacturing.

"Zionexa is pleased to be able to make Cerianna (fluoroestradiol F 18) commercially available through the extensive manufacturing network of PETNET Solutions, Inc.," said Peter Webner, Chief Executive Officer of Zionexa USA. "PETNET has been a great partner to Zionexa and has surpassed our expectations as a contract manufacturer. Cerianna (fluoroestradiol F 18) will provide clinicians with additional, previously unavailable data on the estrogen receptor status of tumors across the patient’s entire body, providing additional data to enhance therapeutic decision-making."

"PETNET Solutions, Inc., is proud to work with Zionexa USA as the exclusive U.S. commercial supplier making Cerianna (fluoroestradiol F 18) accessible to imaging centers and their breast cancer patients," said Barry Scott, head of PETNET Solutions, Inc. "Our extensive network of radiopharmacies enables us to increase access to cutting-edge radiotracers such as Cerianna (fluoroestradiol F 18), helping healthcare facilities address the challenge of recurrent and metastatic breast cancer."