On May 27, 2020 Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, reported the closing of its previously announced underwritten public offering of 16,100,000 shares of its common stock, including the exercise in full by the underwriters of their option to purchase an additional 2,100,000 shares, at a price to the public of $5.00 per share (Press release, Dynavax Technologies, MAY 27, 2020, View Source [SID1234558545]). The gross proceeds to Dynavax from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Dynavax, were approximately $80.5 million.

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Cowen, Evercore ISI and William Blair acted as joint book-running managers for the offering. H.C. Wainwright & Co. acted as co-manager for the offering.

Dynavax anticipates using the net proceeds from the offering to fund activities associated with the ongoing commercialization of HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted], to advance its CpG 1018 vaccine platform, including any scale up efforts in support of a potential COVID-19 vaccine by Dynavax and its collaborators, and for general corporate purposes, including working capital.

The securities described above were offered by Dynavax pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed with and became effective by rule of the Securities and Exchange Commission (SEC) on April 30, 2020. A final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 Attention: Prospectus Department, by telephone at (833) 297-2926, or by email at [email protected]; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, New York, NY 10055, by telephone at (888) 474-0200 or by email at [email protected]; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at (800) 621-0687 or by email at [email protected].

This press release shall not constitute an offer to sell or the 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 the registration or qualification under the securities laws of any such state or other jurisdiction.

On May 27, 2020 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported initial data from pivotal Cohort 4 and updated long-term data from Cohort 2 in the C-144-01 study of lifileucel in advanced melanoma (Press release, Iovance Biotherapeutics, MAY 27, 2020, View Source [SID1234558544]).

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"We are very pleased to announce our pivotal Cohort 4 early data from the C-144-01 clinical study in advanced melanoma today," said Maria Fardis, Ph.D., President and Chief Executive Officer of Iovance Biotherapeutics. "The data from the first 68 patients in Cohort 4, with a 32.4% overall response rate (ORR) at 5.3 months of median study follow up, is highly consistent with what we have observed in Cohort 2 with comparable study follow up. For Cohort 2, median duration of response has not been reached at 18.7 months of study follow up. Available care for metastatic melanoma patients enrolled into our program is chemotherapy, which has been reported to offer a 4-10% response rate with a very short median duration of response. Together, these early data continue to support the potential benefit of the one-time administration of lifileucel TIL therapy in advanced melanoma patients."

Interim Pivotal Cohort 4 Results

Initial results from the pivotal Cohort 4 in the C-144-01 clinical study is available for 68 patients with two radiological assessments, as determined by investigator. Primary endpoint for the C-144-01 Cohort 4 study is ORR by independent review committee and secondary endpoint is ORR by investigator. Lifileucel shows a 32.4% overall response rate (1 complete response and 21 partial responses, 2 of which are yet to be confirmed with follow up visits) and a disease control rate of 72.1% as of the data cut off of 16 Mar 2020. This data is consistent with what was noted in Cohort 2 at 6 months of median study follow up. The ORR was 33% as reported in SITC (Free SITC Whitepaper) 2018 abstract.

The Cohort 4 metastatic melanoma patients have a similar patient characteristic profile to Cohort 2 with high baseline disease burden. They have progressed on multiple prior therapies, including anti-PD-1 and BRAF/MEK inhibitors. The adverse event profile was consistent with Cohort 2 and with the underlying advanced disease, lymphodepletion and IL-2 regimens. Cohort 4 dosed a total of 89 patients, and additional updates on Cohort 4 will be presented at upcoming medical meetings. Iovance remains on track to submit a biologics licensing application (BLA) for lifileucel in late 2020.

Updated Cohort 2 Results

Updated results from Cohort 2 will be presented at the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program during an oral abstract session titled, "Long-term follow up of lifileucel (LN-144) cryopreserved autologous tumor infiltrating lymphocyte therapy in patients with advanced melanoma progressed on multiple prior therapies." In this Cohort 2 data, lifileucel shows a 36.4% overall response rate (2 complete responses and 22 partial responses) and a disease control rate of 80% (n=66) as assessed by investigators. Median duration of response (DOR) was not reached at 18.7 months of median study follow up (2.2 to 26.9+ months). Durable responses have been observed across a wide age range in metastatic melanoma patients who have received prior anti-CTLA-4 and BRAF targeted treatments, regardless of BRAF mutation status, and equally in patients with PD-L1 high and low status.

The Cohort 2 melanoma patients are heavily pretreated with high baseline disease burden. They have progressed on multiple prior therapies (3.3 mean prior therapies), including anti-PD-1 and BRAF/MEK inhibitors. The adverse event profile was consistent with the underlying advanced disease, lymphodepletion and IL-2 regimens.

The oral abstract session at ASCO (Free ASCO Whitepaper)20 will be available on demand in the ASCO (Free ASCO Whitepaper) Meeting Library at View Source Details of the presentation are as follows:

Title: Long-term follow up of lifileucel (LN-144) cryopreserved autologous tumor infiltrating lymphocyte therapy in patients with advanced melanoma progressed on multiple prior therapies

Authors: Amod Sarnaik, et al.

Session Title: Melanoma/Skin Cancers

Session Type: Oral Abstract Session

Abstract Number: 10006

Location: ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program at View Source

Date/Time: available for on-demand viewing starting at 8:00am ET on May 29, 2020

Furthermore, Iovance will provide results from Cohort 4 as well as Cohort 2 of the C-144-01 study in metastatic melanoma as part of the BLA package. Based on the pooled analysis of Cohort 2 plus 4 (n=134), the overall response rate was 34.3%, including three complete responses, 43 partial responses (two of which are yet to be confirmed with follow up visits) and a disease control rate of 76.1%. Median DOR was not reached at 10.6 months of median study follow up.

On May 27, 2020 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that it is offering to sell $100 million of its common stock and, in lieu of common stock, to offer and sell to certain investors pre-funded warrants to purchase shares of its common stock in an underwritten public offering (Press release, BioCryst Pharmaceuticals, MAY 27, 2020, https://biocryst.gcs-web.com/news-releases/news-release-details/biocryst-commences-public-offering-common-stock-and-pre-funded [SID1234558543]). As part of this offering, BioCryst intends to grant the underwriters a 30-day option to purchase additional shares of common stock in an amount equal to up to 15% of the securities offered in the public offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

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J.P. Morgan and Piper Sandler are acting as joint book-running managers for the offering.

All of the securities to be sold in the offering are being sold by BioCryst, with the proceeds to be used for general corporate purposes, which may include, but are not limited to, worldwide development, manufacturing, regulatory, pre-launch and commercial activities for the prophylactic berotralstat (BCX7353) program in the United States and European Union; advancement of the worldwide development, manufacturing, regulatory and clinical activities for BCX9930 for complement-mediated diseases; post-approval commitments for RAPIVABTM/ALPIVABTM; and capital expenditures and other general working capital needs.

A shelf registration statement on Form S-3 relating to the securities being offered by BioCryst has been previously filed with and declared effective by the U.S. Securities and Exchange Commission (SEC). This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

This offering is being made by means of a prospectus supplement and related prospectus. A preliminary prospectus supplement relating to the offering will be filed with the SEC and will be available on its website at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-866-803-9204, or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924, or by email at [email protected].

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."