Aravive Announces Approximately $41.5 Million Private Placement Financing

On October 25, 2022 Aravive, Inc. (Nasdaq: ARAV) ("Company"), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, reported that it has entered into definitive agreements with new biotechnology investors, existing investors, Company management and Company Directors for the issuance and sale of an aggregate of 45,178,811 shares of its common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to an aggregate of 45,178,811 shares of common stock in a private placement offering priced at-the-market under Nasdaq rules (Press release, Aravive, OCT 25, 2022, View Source [SID1234622334]). The purchase price per share and accompanying warrant was $0.9199 for all investors who participated in the deal (or $0.9198 per pre-funded warrant and accompanying warrant). Fifty percent of the warrants have an exercise price of $0.7949 per share and will expire on the date that is the later of: (i) 15 months from the date an increase in the number of authorized shares of common stock is effected, or (ii) one month after the public announcement of the topline Phase 3 platinum-resistant ovarian cancer (PROC) data. The remaining 50% of the warrants will have an exercise price of $0.7949 per share and will expire 30 months from the date an increase in the number of authorized shares of common stock is effected. All of the warrants other than the pre-funded warrants are exercisable for cash only.

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Investors in the transaction include new biotech-focused investors: BVF Partners L.P., and other institutions, as well as existing investors including Eshelman Ventures, LLC, Invus, and Company directors and senior management of the Company.

The private placement is expected to close on October 27th, subject to the satisfaction of customary closing conditions. The private placement is being conducted in accordance with applicable Nasdaq rules and was priced to satisfy the "Minimum Price" requirement (as defined in the Nasdaq rules). In connection with the PIPE, the Company has agreed to convene a special meeting of its stockholders no later than 120 days following the closing to seek approval for an increase in the number of its authorized shares of common stock. The gross proceeds of approximately $41.5 million, before deducting placement agent fees and other expenses, will be used to provide funding to get beyond the topline readout of the pivotal Phase 3 trial in PROC, incremental data read outs from the Phase 1b/2 trial in clear cell renal cell cancer and expanded Phase 1b pancreatic adenocarcinoma studies anticipated in 2023.

Gail McIntyre, Ph.D., DABT, Chief Executive Officer, said, "We are honored to have the continued support from insiders, as well as new support from a strong and respected syndicate of leading biotech investors. Together, we will continue to advance batiraxcept towards our pivotal Phase 3 platinum-resistant ovarian cancer readout expected in mid-2023, as well as continued development of batiraxcept in clear cell renal cell cancer and pancreatic adenocarcinoma with the potential for the drug to be a first-in-class oncology agent with an accompanying predictive biomarker."

MTS Securities, LLC, an affiliate of MTS Health Partners L.P., acted as the exclusive placement agent in the financing.

The securities sold in this financing are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Aravive has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock and the shares of its common stock underlying the pre-funded warrants and accompanying warrants sold in this financing.
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 the registration or qualification under the securities laws of any such state or other jurisdiction.

Symeres acquires Exemplify BioPharma, further strengthening its strategic foothold in the US

On October 25, 2022 Symeres reported the acquisition of Exemplify BioPharma, a US based CRO that provides integrated drug development services in Process & Analytical Chemistry and Formulation Development to pharmaceutical and biotech partners (Press release, Symeres, OCT 25, 2022, View Source [SID1234622333]).

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Exemplify BioPharma, based in Cranbury, New Jersey (US), is a provider of high-quality integrated end-to-end small molecule Chemistry Manufacturing and Controls (CMC) services to pharmaceutical and biotech partners. The company offers functional expertise and consultancy services in Process Chemistry, Analytical Chemistry, and Formulation Development for a successful transition of programs from late-stage lead optimization through candidate selection to first-in-human. Exemplify employs 20 people, of which the majority are Ph.D-level scientists. The company will remain under the current management of co-founders: Yadan Chen, Chief Executive Officer, and Dr. Paul O’Shea, Chief Scientific Officer.

This acquisition further strengthens Symeres’ strategic foothold in the US, where the company already generates about 50% of its revenues. Exemplify operates from its new state-of-the-art 18,600 sq. ft. facility in New Jersey. Its functional expertise in Process & Analytical Chemistry and Formulation Development represents a highly synergistic combination with Symeres capabilities and service offering.
Exemplify BioPharma is Symeres’ second acquisition in the US this year, following the acquisition of Organix Inc., an organic chemistry services provider based in the Boston area specialized in lipids addressing the mRNA therapeutics and vaccines market.

Yadan Chen, CEO of Exemplify BioPharma, stated: "We are proud to see Exemplify BioPharma’s scientific expertise and strategic location in North America recognized and become part of the Symeres family. Symeres is a trusted partner that shares our values and business philosophy of strong customer focus. Exemplify BioPharma’s recent move to our new and larger state-of-the-art facility, and the combination with a global business like Symeres, will allow us to better serve our clients under one roof. We look forward to accelerating our growth together."

Dr. Eelco Ebbers, Co-founder and CEO of Symeres, stated: "We are pleased to welcome Exemplify BioPharma into the group. Exemplify has an excellent track record of supporting the development needs of North American biotech companies through their experience and outstanding laboratory-based science. This acquisition, following the addition of Organix earlier this year and our investment plans for all of our R&D facilities, is a further tangible demonstration of Symeres’ strategy of building a leading mid-sized transatlantic pharmaceutical R&D service provider for our clients around the world."

Amit Karna, Partner at Keensight Capital, added: "Following the recent acquisition of Organix in the Boston area, the addition of Exemplify BioPharma in New Jersey marks another milestone in Symeres’ strategy to build a truly transatlantic business, serving the biopharma industry globally. The scientific and cultural fit of Exemplify BioPharma within the group is excellent. Keensight Capital is delighted to support Symeres in this exciting acquisition."

Evotec enters partnership with Hannover Medical School to create molecular patient database in autoimmune diseases

On October 25, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported that the Company has entered a partnership with Hannover Medical School ("MHH"), one of the leading German universities, to generate a molecular patient database for Sjögren’s syndrome ("SjS") and systemic lupus erythematosus ("SLE") (Press release, Evotec, OCT 25, 2022, View Source [SID1234622330]).

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The strategic partnership between Evotec and MHH aims at achieving a better disease understanding of SjS and SLE by creating a unique longitudinal PanOmics database from the analysis of patient material. Biospecimens from several hundred SjS and SLE patients will be collected by MHH and analysed on Evotec’s PanOmics platform, which includes genomics, transcriptomics, proteomics, and metabolomics as well as single-cell sequencing technologies. Together with supplementary pseudonymised patient data, these PanOmics data will feed into Evotec’s proprietary translational molecular patient data platform E.MPD, which serves as the central data repository for molecular patient data.

For academic research, MHH will receive access to the data generated within the partnership by working with Evotec’s AI-driven analytics software PanHunter. Evotec has the exclusive right to exploit the data commercially with its unique capabilities in the field of data-driven precision medicine. No financial terms of the collaboration were disclosed.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "We are excited to enter this partnership with MHH and expand Evotec’s E.MPD database into autoimmune diseases. The conventional symptomatic description of many diseases stands in the way of both diagnosis and effective treatment. By leveraging PanOmics data, we are taking a deeper dive into underlying disease mechanisms. A better understanding of molecular disease mechanisms guides the identification of key disease drivers and ultimately supports the identification of new targets and the development of effective medicine."

Prof. Dr Torsten Witte, Professor of Rheumatology and Head of the Department of Rheumatology and Immunology at MHH, added: "So far, there are no efficacious anti-inflammatory therapies for Sjögren’s syndrome and only few for SLE. The identification of inflammatory pathways contributing to the pathogenesis of the disorders would help to establish novel therapies. Since these pathways may differ interindividually, the research project by MHH and Evotec may even pave the road to individualised treatments of Sjögren’s syndrome and SLE. We are therefore excited about the possibilities of the collaboration that combines the expertise of the partners from MHH in the exact clinical characterisation of the patients and from Evotec in the application of multi-omics technologies."

Celaid Therapeutics, developer of novel cell therapies, announces 500 million yen Series A financing

On October 24, 2022 Celaid Therapeutics Inc. (Head office: Bunkyo-ku, Tokyo; President: Nobuyuki Arakawa) reported a third-party allotment of new shares with The University of Tokyo Edge Capital Partners Co., Ltd. as the lead investor, Tsukuba Institute of Research, Ltd. and SBI Regional Revitalization Support Corporation, and Techno Science Co (Press release, Celaid Therapeutics, OCT 24, 2022, View Source [SID1234649813]). The total amount of funds raised is approximately 500 million yen.

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With this financing, Celaid will further accelerate the development of cell therapy products for blood cancers such as acute leukemia.

Sauvie Inc. Enters into an Exclusive Worldwide License Agreement to Develop and Commercialize a Nanobody-based NK Cell Engager

On October 24, 2022 Sauvie Inc., a mission-driven biopharmaceutical company focused on sustainably building an immuno-oncology company, reported Sauvie’s subsidiary, Sauvie BiKE LLC, has entered into an exclusive license agreement with Rutgers, The State University of New Jersey ("Rutgers") for the development and worldwide commercialization rights of a bi-specific natural killer (NK) cell engager technology in the field of oncology (Press release, Sauvie, OCT 24, 2022, View Source [SID1234627526]).

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The licensed technology is based on discoveries and invention by Arash Hatefi, PhD, Professor, Department of Pharmaceutics at Rutgers’ Ernest Mario School of Pharmacy, who has over 20 years of experience in developing new cancer therapeutics and more than 50 original, peer-reviewed publications in this field.

"As an emerging biopharma organization focused on developing and commercializing critical cancer therapies, Sauvie is truly honored and excited to have this opportunity to advance the primary inventor, Dr. Hatefi’s discovery to offer great hope for people with cancer and position Sauvie to be a key player in the NK cell area," said Ken Suh, CEO of Sauvie Inc.

"We are excited by the broad potential the NK cell engager platform can offer to fight multiple tumors and help many people throughout the world," said Dr. Brian E. Jahns, Chief Operating Officer of Sauvie Inc.

"I am thrilled with the agreement and collaboration between Rutgers and Sauvie to advance my research into new nanobody formats such as bispecific natural killer cell engagers that are capable of stimulating the NK cells, amplifying not only their direct role in tumor eradication, but also their function in inducing multicellular immune responses ultimately resulting in enduring tumor control," said Dr. Arash Hatefi.

The exclusive license granted to the Company relates to a camelid nanobody that has demonstrated high affinity and high specificity to NK cells and has the potential to target multiple antigens of solid and hematologic tumors. NK cell engagers are designed to harness the power of NK cells that are present within the innate immune system and link the NK cells to receptors specific to a tumor. Several clinical research programs around the world have demonstrated the potential effectiveness of safely harnessing the NK cells to attack tumor cells.