On May 27, 2020 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, Zytiga-resistant prostate cancer and leukemia, reported it has entered into a definitive securities purchase agreement with biotech-focused fundamental investor, Acorn Bioventures, LP, for $2.5 million (Press release, Cardiff Oncology, MAY 27, 2020, View Source [SID1234558542]).

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Under the agreement, Acorn Bioventures has agreed to purchase in a registered direct offering 1,205,400 shares of common stock at market price for $2.074 per share. In a concurrent private placement, Acorn agreed to purchase warrants to purchase 482,160 shares of common stock. The warrants will be exercisable six months following the date of issuance, will expire on the five year anniversary of the initial exercise date and have an exercise price of $2.024 per share.
Cardiff intends to use the net proceeds from the registered direct offering and concurrent private placement to rapidly advance its onvansertib clinical development programs and to provide additional working capital.

"We are very pleased to support Cardiff Oncology as they continue to progress clinical development of onvansertib for second-line treatment of patients with KRAS-mutated metastatic colorectal cancer, Zytiga-resistant metastatic castration-resistant prostate cancer and acute myeloid leukemia," commented Isaac Manke, PhD, and Anders Hove, MD, of Acorn Bioventures.

"We believe this investment by Acorn Bioventures is validation of the positive impact we are seeing in patients treated with onvansertib," said Dr. Mark Erlander, Chief Executive Officer of Cardiff Oncology. "Acorn Bioventures is well recognized for their long-term investing in companies that are bringing novel innovative medicines to patients. We are excited to embark on this important partnership."

The common stock is being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-232321), previously filed with the Securities and Exchange Commission ("SEC") on June 25, 2019 and declared effective on July 1, 2019. Such shares of common stock are being offered only by means of a prospectus supplement. A prospectus supplement and the accompanying prospectus relating to the registered direct offerings may be obtained, when available, on the SEC’s website at View Source or by contacting Cardiff Oncology, Inc.

The warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Rule 506(b) of Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from registration requirements of the Act and such applicable state securities laws.

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 these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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."

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.

On May 27, 2020 Gilead Sciences, Inc. (NASDAQ: GILD) and Arcus Biosciences, Inc. (NYSE: RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapeutics, reported that the companies have entered into a 10-year partnership to co-develop and co-commercialize current and future therapeutic product candidates in Arcus’s pipeline (Press release, Gilead Sciences, MAY 27, 2020, View Source [SID1234558539]). The agreement will also provide ongoing funding to support Arcus’s research and development programs.

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Arcus is building an extensive and diverse portfolio of investigational products that target important mechanisms involved in tumor evasion of the immune system, as well as developing drug candidates that target cell-intrinsic pathways important for cancer growth and metastasis. In addition to small molecule products, Arcus is also advancing antibody products that target immune checkpoint receptors, including PD-1 and TIGIT. Arcus currently has a clinical-stage pipeline of four immuno-oncology programs, as well as an active oncology discovery pipeline with six preclinical compounds that target critical biological pathways. A core component of Arcus’s strategy is the development of intra-portfolio combinations that include small-molecule and antibody product candidates. Arcus has 10 ongoing clinical studies of molecules in its portfolio, including a randomized Phase 2 study in first-line non-small cell lung cancer evaluating combinations of three Arcus product candidates: AB154, an investigational anti-TIGIT monoclonal antibody; AB928, an investigational A2aR/A2bR antagonist; and zimberelimab (AB122), an investigational anti-PD-1 monoclonal antibody.

"We are very pleased to build on Gilead’s growing presence in immuno-oncology with this important new strategic collaboration with Arcus," said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. "Gilead is committed to accessing the world’s best innovation in immuno-oncology and our agreement with Arcus further demonstrates that commitment. By gaining access to its broad, diverse pipeline and Arcus’s clear strengths in discovery and development, we believe that our partnership with Arcus will significantly accelerate our progress in developing transformative new therapies for cancer."

"We believe Gilead is an ideal partner for Arcus with its focus on thoughtful and purposeful science, vision to provide transformational therapies in the oncology setting and deeply experienced scientific leadership," said Terry Rosen, PhD, Chief Executive Officer, Arcus. "This collaboration will allow us to act as one team to maximize the clinical and commercial potential of Arcus’s therapeutic development candidates, greatly amplifying and expediting the opportunities in our pipeline and discovery programs. At the same time, this partnership structure facilitates Arcus’s path to becoming an independent, fully integrated biopharmaceutical company."

Terms of the Partnership

Under the terms of the agreement, Arcus will receive $375 million upon closing, consisting of a $175 million upfront payment and a $200 million equity investment from Gilead. Arcus is eligible to receive up to $1.225 billion in opt-in and milestone payments with respect to its current clinical product candidates. Gilead will gain access to Arcus’s current and future investigational immuno-oncology products through the agreement, as Gilead continues to expand its presence in the field. This includes immediate rights to zimberelimab, as well as the right to opt-in to all other current Arcus clinical candidates, which include AB154, AB928 and AB680, upon payment of an opt-in fee that ranges from $200 million to $275 million per program, after delivery of a qualifying data package. If Gilead opts-in to the AB154 program, Arcus is eligible to receive up to $500 million in potential future U.S. regulatory approval milestones.

Gilead will receive the right to opt-in to all other programs that emerge from Arcus’s research portfolio over the next 10 years, upon payment of an opt-in fee of $150 million per program after Arcus’s delivery of a qualifying data package.

Upon Gilead’s exercise of its option for a program, unless Arcus opts out according to terms of the agreement, the companies will co-develop and share global development costs and will co-commercialize and share profits in the United States. Gilead will obtain exclusive rights to commercialize any optioned programs outside of the U.S., subject to any rights of Arcus’s existing partners, and for which Gilead will pay to Arcus tiered royalties ranging from high-teens to low twenties. Gilead will further provide ongoing research and development support of up to $400 million over the collaboration term.

Gilead will have the right to appoint two individuals to Arcus’s Board of Directors upon closing of the transaction.

Terms of the Equity Investment

Gilead’s $200 million equity investment will be at a price per share of $33.54. Additionally, Gilead will have the right to purchase additional shares from Arcus, up to a maximum of 35% of the outstanding voting stock of Arcus over the course of the next five years, at a 20% premium at the time Gilead exercises such option, or, if greater, at the initial purchase price per share.

This transaction, which is expected to close in the third quarter of 2020, is subject to applicable antitrust clearance under the Hart-Scott Rodino Antitrust Improvements Act and other customary closing conditions.

Cowen and Morgan Stanley & Co. LLC are acting as financial advisors to Gilead. Citi is acting as financial advisor to Arcus. Covington & Burling LLP, Skadden, Arps, Slate, Meagher & Flom LLP and Venable LLP are serving as legal counsel to Gilead and Cooley is serving as legal counsel to Arcus.

Zimberelimab, AB928, AB680 and AB154 are investigational and not approved anywhere globally. Their efficacy and safety have not been established. More information about clinical trials with zimberelimab, AB928, AB680 and AB154 is available at www.clinicaltrials.gov.

Arcus Conference Call

At 5:00 a.m. Pacific Time/8:00 a.m. Eastern Time today, Arcus’s management will host a conference call and a simultaneous webcast to discuss the transaction. A live webcast of the call can be accessed by visiting the "Investors" section of Arcus’s website at www.arcusbio.com. Please connect to the website at least 15 minutes prior to the start of the call to allow adequate time for any software download that may be required. Alternatively, please call (877) 209-6698 (U.S.) or (825) 312-2373 (International) and dial the conference ID 1827008 to access the call. A replay of the webcast will be available approximately two hours after the call through 14 days following the live event.

On May 27, 2020 Synlogic (Nasdaq: SYBX) reported that will host its first Virtual R&D Event which will include presentations from members of the Synlogic executive team providing an in-depth review of Synlogic’s Synthetic Biotic platform and programs for the treatment of metabolic diseases, inflammatory and immune disorders, and cancer (Press release, Synlogic, MAY 27, 2020, View Source [SID1234558538]). In addition, guest speaker David S. Goldfarb, M.D., Professor of Medicine and Physiology, NYU School of Medicine, Clinical Chief, Nephrology Division, NYU Langone Health, Chief, Nephrology Section, New York VA Medical Center, will present an overview of enteric hyperoxaluria and a patient perspective.

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Registration information for the event can be accessed under "Event Calendar" in the Investors & Media section of the Synlogic website. The R&D Event presentations are scheduled to begin at 12:30 pm ET today, May 27, 2020. A live audio webcast of the presentation and a slide deck will be available via the company’s Investor Relations website. Following the live webcast, an archived version will be available on the website for 90 days.