Araris Biotech Closes $24 Million Financing Round

On October 4, 2022 Araris Biotech AG ("Araris" or "the Company"), a company pioneering a proprietary antibody-drug conjugate (ADC)-linker technology, reported the closing of a $24 million financing round, bringing the total funds raised to $40 million to date (Press release, Araris Biotech, OCT 4, 2022, View Source [SID1234651279]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The round was co-led by 4BIO Capital and Pureos Bioventures, with participation from new investors, including Wille AG and the Institute for Follicular Lymphoma Innovation. The round also included participation from existing investors VI Partners, Schroders Capital, btov Partners and Redalpine. Damir Illich, Ph.D. from Wille AG and Sophie Allauzen, Ph.D. from the Institute for Follicular Lymphoma Innovation will also be joining the Araris team as board observers.

Proceeds from the financing will be used to support the further development and advancement of Araris’ antibody-drug conjugate (ADC) candidates, created using the Company’s proprietary linker technology, as Araris moves closer towards clinical development.

"We’re thrilled to have support from this group of investors who recognize the potential of our linker technology in this exciting and growing ADC field and look forward to using these proceeds to support our efforts in advancing our ADC candidates toward the clinic," said Philipp Spycher, Ph.D., chief executive officer at Araris Biotech. "Our linker technology has enabled us to create ADCs in a single conjugation step. The resulting ADCs have shown a significantly improved therapeutic index and favorable biophysical properties in preclinical studies to date, and an ability to address the limitations of current ADCs on the market. This fundraising will allow us to move closer to our goal of bringing these therapies to patients in need of better treatment options."

Dmitry Kuzmin, Ph.D., managing partner at 4BIO Capital, added, "Araris continues to make waves in the industry with its pioneering linker technology, enabling fast and precise production of ADCs. Having invested in Araris’ seed round, we are now delighted to co-lead the latest round to ensure that Araris can unlock the potential of its differentiated technology and bring highly effective therapies to patients across the world."

Dominik Escher, Ph.D., founding partner at Pureos Bioventures stated, "We are pleased to continue our support for Araris in this financing round as the company advances the next generation of antibody-drug conjugates with the potential to help cancer patients in the future."

Sibylla Biotech Raises €23 Million Series A to Advance Protein Degradation by Folding Interference Pipeline and Expand Technology Platform

On October 4, 2022 Sibylla Biotech reported the successful close of its €23 million Series A financing round to fund the further development of its Pharmacological Protein Inactivation by Folding Intermediate Targeting (PPI-FIT) approach, which provides access to a new class of pharmacological targets that transiently appear during the process of protein folding, and to advance its proprietary pipeline programs through preclinical evaluation (Press release, Sibylla Biotech, OCT 4, 2022, View Source [SID1234641501]). The financing from an international syndicate of specialized life science investors was led by V-Bio Ventures with participation from Seroba Life Sciences, 3B Future Health Fund, Claris Ventures, CDP Venture Capital with Evolution Fund, VI Partners, Indaco Venture Partners, as well as the company’s seed investor, Vertis SGR. Concurrent with the close of the fundraising, Ward Capoen from V-Bio, Bruno Montanari from Seroba, Ciro Spedaliere from Claris Ventures, and Marianne Bjordal from 3B Future Health Fund will join Sibylla’s Board of Directors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Sibylla Biotech is developing small molecule degraders designed to interfere with the folding process of a selected protein by binding to the folding intermediate states, bringing a highly differentiated approach to the protein degradation field that can access a range of targets previously considered undruggable," commented Lidia Pieri, PhD, Co-Founder and Chief Executive Officer of Sibylla Biotech.

"We have gained the support of a strong group of expert investors and the capital to advance our small molecule pipeline, expand our protein folding simulation technology platform and bring additional expertise to our team. I would like to thank all Sibylla employees, founders, and supporters for enabling our achievements so far."

Through the PPI-FIT approach, Sibylla Biotech designs Folding Interfering Degraders (FIDs), classical small molecules that target specific proteins, including proteins that lack druggable pockets in their native state. The company’s lead candidate degrades Cyclin D1, a protein that is amplified and overexpressed in a range of cancers and which is currently considered an undruggable target. The proceeds of the Series A will allow the company to build out its pipeline of therapeutics by exploiting the protein folding simulation platform, as well as to further expand the potentiality of its technology.

"Sibylla’s novel approach has already demonstrated that it can unlock a new category of targets with the potential to translate these into a robust pipeline of small molecule candidates for an unlimited range of indications. We are excited to support Sibylla Biotech’s vision to transform the protein degradation landscape," added Ward Capoen, PhD, Partner at V-Bio Ventures.

"Lidia and her team came together from a group of cross-disciplinary experts with the goal of developing the PPI-FIT technology. Sibylla Biotech has distinguished itself by applying ground-breaking science to solve therapeutic challenges and now they have the further validation from a group of highly experienced investors. Vertis congratulates the team on achieving this next step in their development," said Roberto Della Marina, PhD, Operating Partner at Vertis SGR.

CIDARA THERAPEUTICS RECEIVES $11.1 MILLION MILESTONE PAYMENT FROM MUNDIPHARMA

On October 4, 2022 Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases, reported receipt of an $11 million milestone payment from Mundipharma under the licensing agreement established between the two companies in September 2019 (Press release, Cidara Therapeutics, OCT 4, 2022, View Source [SID1234636985]). The payment was made in association with the European Medicines Agency (EMA) acceptance of the marketing authorization application (MAA) for rezafungin for the treatment of candidemia and invasive candidiasis in adult patients.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"With the $11 million milestone payment from Mundipharma, Cidara remains eligible to receive additional non-dilutive capital of up to approximately $108 million in development and regulatory milestones from our existing partnerships based on successful completion of activities planned for the next two years," said Jeffrey Stein, Ph.D., President and Chief Executive Officer of Cidara. "If received, these payments have the potential to significantly bolster the Company’s financial position to more rapidly advance our key Cloudbreak programs and complete the ongoing Phase 3 ReSPECT trial and are in addition to any commercial milestones or royalties that Cidara is eligible to receive from these partnerships over the same time period."

Cidara retains the rights to rezafungin in Japan and has licensed the commercial rights to Melinta Therapeutics in the U.S. and Mundipharma Medical in all other geographies.

About Rezafungin
Rezafungin is a novel once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as candidemia and invasive candidiasis. The structure and properties of rezafungin are specifically designed to improve upon a clinically validated mechanism intended to enhance its efficacy and safety potential for patients. Cidara has completed a Phase 3 clinical trial with rezafungin for the treatment of candidemia and/or invasive candidiasis (ReSTORE trial) and is currently conducting a second Phase 3 clinical trial of rezafungin for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (ReSPECT trial). Rezafungin has been designated a QIDP with Fast Track status by the FDA, and has been granted Orphan Drug Designation for its use in the treatment of invasive candidiasis in both the U.S. and EU.

Valneva Announces Closing of Upsized €102.9 Million Global Offering

On October 4, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (the "Company"), a specialty vaccine company, reported the closing of its previously announced global offering to specified categories of investors of an aggregate 21,000,000 new ordinary shares, consisting of a public offering of 375,000 American Depositary Shares ("ADSs"), each representing two ordinary shares, in the United States at an offering price of $9.51 per ADS (the "U.S. Offering"), and a concurrent private placement of 20,250,000 ordinary shares in Europe (including France) and other countries outside of the United States at the corresponding offering price of €4.90 per ordinary share (the "European Private Placement", and, together with the U.S. Offering, the "Global Offering") (Press release, Valneva, OCT 4, 2022, View Source [SID1234621777]). Aggregate gross proceeds of the Global Offering, before deducting underwriting commissions and estimated expenses payable by the Company, were approximately €102.9 million ($99.9 million).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Valneva’s ordinary shares are listed on Euronext Paris under the symbol "VLA" and its ADSs are listed on the Nasdaq Global Select Market under the symbol "VALN".

Goldman Sachs, Jefferies, Guggenheim Securities and Bryan, Garnier & Co. acted as joint bookrunners for the Global Offering.

The Company has filed a shelf registration statement on Form F-3 relating to the ADSs and ordinary shares sold in the Global Offering with the U.S. Securities and Exchange Commission ("SEC") on August 12, 2022, which was declared effective on August 19, 2022. The offering was made by means of a prospectus and copies of the prospectus relating to and describing the terms of the Global Offering may be obtained from Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, New York 10282, telephone: 866-471-2526, facsimile: 212-902-9316, e-mail: prospectus-ny@ny.email.gs.com or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at +1 877 821 7388 or by email at Prospectus_Department@Jefferies.com.

Application was made to list the new ordinary shares issued pursuant to the Global Offering on Euronext Paris pursuant to a listing prospectus (the "Listing Prospectus") which was approved by the Autorité des Marchés Financiers ("AMF") on September 30, 2022 under number 22-405. The Listing Prospectus comprises (i) the 2021 universal registration document filed with the AMF on March 23, 2022 (document d’enregistrement universel 2021) under number D. 22-0140 (the "2021 URD"), as completed by an amendment to the 2021 universal registration document filed with the AMF on September 30, 2022 under number D. 22-0140-A01 (the "Amendment") and (ii) a securities note (Note d’opération) (the "Securities Note"), including (iii) a summary of the prospectus. Copies of the Company’s 2021 URD, as amended, is available free of charge on the Company’s website. The Listing Prospectus has been published on the Company’s website and on the AMF’s website (www.amf-france.org).

Pluristyx, panCELLa, and Implant Therapeutics Announce Definitive Merger Agreement

On October 4, 2022 Pluristyx, panCELLa, and Implant Therapeutics management reported their corporate merger, pending shareholder approval (Press release, panCELLa, OCT 4, 2022, View Source [SID1234621763]). The merged company will combine complementary portfolios to offer end-to-end customer support and provide increased access to a wide range of induced pluripotent stem cell (iPSC)-related products and services. The integrated technological and service offerings will greatly accelerate the development and delivery of revolutionary cell therapies to patients.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This merger announcement follows their successful partnership in January 2022 which enables streamlined access to the next generation of safe, universal, cost-effective, "off-the-shelf" iPSCs. Pluristyx/panCELLa’s iPSCs are generated through a proprietary mRNA-based technology and are conveniently available in a ‘try-before-you-buy’ research evaluation model requiring low up-front licensing fees. Packaged in Pluristyx’s Ready-to-Differentiate format, iPSCs containing panCELLa’s FailSafe and hypoimmunogenic technologies offer customers, at any stage of product development, the ability to rapidly assess and select lines for further development and manufacturing. Since Plurisytx/panCELLa iPSC’s are sourced from clinical-grade material, commercial partners can readily transition from development to therapeutic manufacturing.

Regarding this merger, Mahendra Rao, Co-Chairman of the Board at panCELLa and CEO of Implant Therapeutics, commented, "We are extremely excited to be joining forces with Pluristyx. From the start of our collaboration, it was clear that the expertise and strong track record in cell therapy development within the Pluristyx team was the perfect fit to maximize the customer benefit from our technologies. By coming together, we can offer clients an industry-leading suite of technologies and services for the next generation of cell therapies."

Benjamin Fryer, Chief Executive Officer, Pluristyx said: "In discussions with customers, it became evident that panCELLa’s hypoimmune and FailSafe technologies are seen as industry gold-standards. This merger takes us one step farther in our journey to become the leading provider of iPSC and cell therapy solutions for research, diagnostic, and clinical applications. Together with the expertise and technology portfolio of panCELLa, we can now provide a full suite of tools and provide the fastest path to gene-edited iPSC-based therapies."

The merged companies will retain the Pluristyx name with panCELLa becoming a wholly owned subsidiary of Pluristyx. Benjamin Fryer will continue as the Chief Executive Officer and Mahendra Rao will take on the role of Chief Science Officer. Current Pluristyx and panCELLa executives will maintain their roles with Jason Carstens as the Chief Operating Officer, Brian Hawkins as the Chief Technology Officer, Kaye Reiter as General Counsel, Jake Krembil as VP of Business Development/Toronto Site Lead, and James Laing as VP of Finance.