Celyad Oncology Announces $32.5 Million Private Placement with Fortress Investment Group

On December 3, 2021 Celyad Oncology SA (Euronext & Nasdaq: CYAD) ("Celyad" or the "Company"), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, reported that it has entered into a subscription agreement with an affiliate of Fortress Investment Group (such affiliate "Fortress") for the private placement of 6,500,000 ordinary shares for gross proceeds of USD 32.5 million (about EUR 28.7 million) (Press release, Celyad, DEC 3, 2021, View Source [SID1234596436]). The subscription will take place within the framework of the authorized capital and it is expected to close on or about December 8, 2021, subject to satisfaction of customary closing conditions.

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!

Pursuant to the terms of the private placement, the Company will issue the ordinary shares at a price of USD 5.00 (about EUR 4.42) per share, which represents a 18.5% premium to the 30-day volume weighted average price ("VWAP"). The Company intends to use net proceeds from the private placement to fund research and development expenses, including the clinical development of its allogeneic CAR T candidates CYAD-101 and CYAD-211, to advance the current pipeline of preclinical CAR T candidates, to discover and develop additional preclinical product candidates using its proprietary non-gene edited short hairpin RNA (shRNA) technology platform, as well as for working capital, other general corporate purposes, and the enhancement of the Company’s intellectual property.

As a result of the transaction, Fortress will hold 28.8% of the Company’s shares.

Filippo Petti, CEO of Celyad Oncology, commented, "This transformative investment provides an important springboard for the Company and further strengthens our corporate initiatives to advance our novel allogeneic CAR T product candidates. In addition, Fortress’s expertise in the intellectual property domain further validates our robust patent portfolio and emphasizes our position within the allogeneic CAR T field. The growth financing will be essential for us to expand our current allogeneic CAR T pipeline by continuing to exploit our differentiated, non-gene edited technologies and armored CAR T franchise."

"Celyad Oncology offers a unique optionality around its technology and intellectual property," said Christopher LiPuma, Director at Fortress. "In particular, the Company’s strong IP position around allogeneic CAR T stands out as a key asset that we believe will provide the foundation for the Company to strategically develop both novel cell therapy candidates and potential partnerships within the exciting off-the-shelf cell therapy landscape."

SVB Leerink acted as the exclusive placement agent for the private placement, Goodwin Procter LLP and Harvest acted as legal counsel to the Company. Skadden, Arps, Slate, Meagher & Flom LLP and Eubelius acted as legal counsel to Fortress.

The Company believes that following the close of the private placement, its existing cash and cash equivalents combined with access to the equity purchase agreement established with Lincoln Park Capital Fund, LLC should be sufficient, based on the current scope of activities, to fund operating expenses and capital expenditure requirements into the first half of 2023.

In the framework of this investment, Fortress and the Company have entered into a shareholders’ rights agreement. Pursuant to this agreement, Fortress will be subject to a customary lock-up obligation and standstill obligation, in each case for nine months following the closing of the private placement. Furthermore, as long as Fortress holds 10% of the shares of the Company, it will benefit from a right of first offer on any new indebtedness to be incurred by Celyad and on any new equity securities to be issued, pro-rata its shareholding, as well as of the right to nominate two individuals to Celyad’s board of directors. In addition, as long as Fortress holds 15% or more of the outstanding shares of the Company, certain intellectual property transactions will be subject to a 90% board majority for approval. Celyad will propose an amendment to its articles of association to reflect this qualified right.

The securities to be issued in the private placement have not been registered under the Securities Act of 1933 or applicable state securities laws and may not be offered or sold in the United States absent registration under the Securities Act or an applicable exemption from such registration requirements. The Company has agreed to customary registration rights covering the resale of the ordinary shares (in the form of American Depositary Shares) sold in the private placement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

SCYNEXIS Reports the Exercise of Warrants Totalling $7.9 Million

On December 3, 2021 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, reported the exercise of warrants to purchase 1.2 million shares of SCYNEXIS common stock by Federated Hermes Kaufmann Small Cap Fund and Dafna Lifescience LP for which SCYNEXIS accepted a reduced exercise price (Press release, Scynexis, DEC 3, 2021, View Source [SID1234596435]). Proceeds to SCYNEXIS are approximately $7.9 million. The exercised warrants were issued in SCYNEXIS’s December 2019 financing. The remaining warrants issued in the December 2019 financing covering approximately 3.2 million shares of common stock expired unexercised on December 2, 2021.

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!

"We believe the exercise of warrants by two of our largest stockholders provides a significant sign of confidence in the future of SCYNEXIS, after a year that included the approval and launch of our first U.S. commercial product and continued progress in our clinical development programs to treat serious fungal infections in the hospital setting," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "This additional cash influx strengthens our balance sheet and supports our important mission."

Lupin and Biomm Enter into a Distribution and Marketing Agreement for Pegfilgrastim in Brazil

On December 3, 2021 Global pharma major, Lupin Limited (Lupin) reported that they have entered into an exclusive distribution and marketing agreement with Biomm SA in Brazil (Press release, Lupin, DEC 3, 2021, View Source [SID1234596434]). Under the terms of agreement, Biomm will distribute and market biosimilar Pegfilgrastim in Brazil.

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!

Lupin had earlier received the U.S. FDA acceptance of the Biologics License Application (BLA) for its proposed biosimilar to Neulasta (pegfilgrastim) through a filing using the 351(k) pathway.

Pegfilgrastim is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients receiving chemotherapy.

Aqilion strengthens the company’s pipeline through the acquisition of a phase-1 ready anti-inflammatory program from LEO Pharma

On December 3, 2021 AQILION AB (publ) reported that it has strengthened its pipeline with an innovative development program in the field of chronic inflammation (Press release, Aqilion, DEC 3, 2021, View Source [SID1234596433]). With this acquisition, Aqilion is taking over all rights to the program, now under the name Regulus, from LEO Pharma. The project is ready for clinical trials and Aqilion plans to begin clinical development in 2022.

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!

Aqilion has acquired all rights to Regulus from LEO Pharma, who developed the project from early internal discovery research. Under the terms of the agreement, Aqilion will make an upfront payment that is a combination of cash and equity and LEO Pharma will become a shareholder of Aqilion. Furthermore, Aqilion will make additional payments from either product sales or through out-licensing revenues.

Regulus is a novel next-generation selective JAK1 inhibitor previously developed as LEO 142397, now AQ280. Drugs with a similar mechanism of action have shown clinical efficacy in autoimmune and inflammatory diseases. Aqilion will initially investigate AQ280 as a potential therapy for eosinophilic esophagitis (EoE), an inflammatory disease of the esophagus. To date, no drugs with the same mechanism of action have been developed for EoE and there is a high unmet medical need. Aqilion will conduct the Regulus project in-house with the aim of starting a Phase 1 safety study in healthy volunteers in 2022, followed by a Phase 2a study in patients.

"It is both gratifying and inspiring for us at Aqilion to be able to expand our chronic inflammation pipeline with such an innovative, high quality and exciting program as Regulus. Expanding our pipeline with a project in early clinical development has been a priority and we now look forward to advancing Regulus, while benefiting from synergies with our pipeline of preclinical projects," says Sarah Fredriksson, CEO of Aqilion.

"We are always excited to see our R&D operations bring forward new compounds that has the potential to help patients in any indication. In this case EoE where Aqilion is the right partner to pursue the potential of LEO 142397 – now Regulus. LEO Pharma will continue our dedication to bringing forward new innovative treatments that are either first or best in class and changing the standards of care within medical dermatology," says Thorsten Thormann, VP Research and Early Development in LEO Pharma.

About eosinophilic esophagitis
Eosinophilic esophagitis (EoE) is a rare chronic disease involving inflammation of the esophageal mucosa; its main symptom is swallowing difficulties. EoE is a relatively new diagnosis that is increasing in incidence. The disease, which has a progressive course, is also known as "allergic esophagitis" and is thought to be triggered by food allergens. Both children and adults can be affected and the diagnosis is most common in children in their teens and in adults aged 30-50. The condition is more common in men.

Chemomab Therapeutics Names David M. Weiner, MD as Interim Chief Medical Officer

On December 3, 2021 Chemomab Therapeutics Ltd. (NASDAQ: CMMB), (Chemomab) a clinical-stage biotech company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, reported that David M. Weiner, MD has been named Interim Chief Medical Officer, effective immediately (Press release, Chemomab, DEC 3, 2021, View Source,-MD-as-Interim-Chief-Medical-Officer [SID1234596432]). This position will be in a part-time capacity. Dr. Weiner is replacing Dr. Arnon Aharon, who has resigned. Dr. Aharon intends to continue at Chemomab for the next 60 days and as a senior medical advisor thereafter to ensure a seamless transition.

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!

Dr. Weiner, who is based in the U.S., has more than 25 years of experience in the discovery and clinical development of novel therapeutics and has held senior executive roles at private and public biotechnology companies.

"We believe that Dr. Weiner is a terrific addition to the Chemomab team, bringing us decades of successful industry experience in managing clinical programs in a variety of therapeutic areas," said Dale Pfost, PhD, Chief Executive Officer of Chemomab. "His keen intellect and broad expertise should serve us well as we advance our current clinical programs for CM-101, establish a growing clinical and business presence in the U.S. and potentially expand our drug development activities to include additional therapeutic indications and assets."

Dr. Pfost continued, "We want to thank Dr. Aharon for his many contributions to Chemomab. He has done an excellent job of creating the foundation for our current clinical development efforts and in progressing three discrete clinical programs to Phase 2 trials in a timely and effective way. We wish him well in his future endeavors."

Dr. Weiner most recently served as Chief Executive Officer of Amathus Therapeutics. Previously he was Chief Medical Officer at Lumos Pharma and at aTyr Pharma and, prior to that, he was the Chief Medical Officer and interim Chief Executive Officer of Proteostasis Therapeutics. Dr. Weiner held key development roles over a five-year period at EMD/Merck Serono and spent almost a decade serving in discovery research and clinical development roles of increasing responsibility at Acadia Pharmaceuticals.

"I have been impressed by the commitment to R&D excellence and substantial scientific accomplishments achieved to date by the Chemomab team," noted Dr. Weiner. "As a small startup they characterized and elucidated a completely novel target with promising potential in fibrotic and inflammatory diseases and then developed CM-101─a neutralizing antibody ‘pipeline in a product’ that is advancing in clinical trials for two rare diseases with high unmet need. I look forward to continuing to assess the potential of CM-101, while also working with the executive team as we seek to broaden our R&D activities to potentially include additional indications and clinical candidates."

Dr. Weiner received a BA degree cum laude with highest honors in research from Brandeis University and an MD degree from the School of Medicine and Biomedical Sciences, State University of New York at Buffalo. He has been a director at a number of biotechnology companies and is currently on the Board of Directors of AxoSim. Dr. Weiner serves as a consultant and scientific and clinical advisory board member to a diverse group of biotechnology companies and foundations.