On May 18, 2020 SQZ Biotechnologies Company (SQZ), a clinical stage cell therapy company developing innovative treatments for multiple therapeutic areas, reported the completion of a $65 million Series D preferred stock financing (Press release, SQZ Biotech, MAY 18, 2020, View Source [SID1234558241]). The round was led by Temasek with participation from another new large, US-based fund as well as additional participation from existing investors, including GV, Illumina Ventures, Invus, JDRF T1D Fund, NanoDimension, and Polaris Partners. The company also announced the expansion of its cellular vaccine platform, currently in trial for oncology, into infectious diseases, and development of a point-of-care system to potentially generate patient product directly at treatment centers.

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!

"Our progress in oncology and recent expansion into the infectious disease space exemplifies the broad potential of the SQZ platforms. Coupled with our rapid central manufacturing and investment in developing a new point-of-care system, we believe SQZ’s differentiated approach to treating disease could provide meaningful benefit to many patients," commented Armon Sharei, PhD, chief executive officer of SQZ Biotech.

The financing will support the advancement of SQZ’s current pipeline of multi-functional cell therapies, designed to direct specific immune responses, and its expansion into infectious diseases. The company is currently progressing its SQZ antigen presenting cell (SQZ APC) platform for oncology, a novel cancer vaccine, in a Phase 1 trial of SQZ-PBMC-HPV for HPV+ tumors. For patients in this trial, SQZ has consistently manufactured autologous doses in under 24 hours. SQZ is developing an additional novel cell therapy platform in oncology, activating antigen carriers (SQZ AACs), as well as continuing to develop its earlier stage platform, tolerizing antigen carriers (SQZ TACs), for autoimmune diseases and tolerance applications.

"We are thrilled to have the support of both our new and long-standing investors who believe in SQZ and our potential to create impactful therapies for patients," said Teri Loxam, chief financial officer of SQZ Biotech. "We remain in a strong position to continue to execute on our goals and achieve milestones across the SQZ portfolio."

SQZ’s announcement included the Company’s expansion of its cellular vaccine capabilities into infectious diseases. Through the generation of pathogen targeting CD8 T cell responses, SQZ’s cell-based vaccines could potentially address numerous chronic infections and novel viruses in both prophylactic and therapeutic patient settings.

To further improve the accessibility of SQZ therapeutics, the company is developing a point-of-care system that could potentially generate patient product at the treatment center. Building upon SQZ’s already rapid manufacturing process, the system has the potential to enable even faster turnaround for patients.

On May 18, 2020 CARsgen Therapeutics Co., Ltd., a clinical-stage biopharmaceutical company, reported that one of its first-in-class drug candidates, CT041 humanized anti-claudin18.2 autologous Chimeric Antigen Receptor (CAR) T Cells (CT041) for the treatment of patients with claudin18.2-positive adenocarcinoma of the stomach, gastroesophageal junction, or pancreas, has received Investigational New Drug (IND) clearance from the United States Food and Drug Administration (FDA) (Press release, Carsgen Therapeutics, MAY 18, 2020, View Source [SID1234558239]). CT041 is the first claudin18.2-targeted CAR-T cell therapy IND cleared for clinical trials in the world. The proof-of-concept preclinical data was published in 2019 [1]. The IND clearance was supported by an ongoing investigator-initiated Phase I trial conducted by Professor Lin Shen at Beijing Cancer Hospital, Peking University in China (NCT03874897). An open label, multicenter, Phase 1b clinical trial to evaluate the safety and efficacy of autologous CT041 cell therapy in patients with advanced gastric or pancreatic adenocarcinoma will be initiated by CARsgen in Q3 2020 in the United States.

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 IND clearance of CT041 by the FDA is of great significance to patients with advanced gastric and pancreatic cancer," said Dr. Zonghai Li, founder, CEO and CSO of CARsgen. "According to the World Health Organization, about 1,030,000 new cases of gastric adenocarcinoma and over 450,000 new cases of pancreatic adenocarcinoma are expected each year[2]. Despite the development of novel therapies, gastric and pancreatic adenocarcinomas remain incurable and new treatment options are needed. Our goal is to continue the development of novel, safe and effective immunotherapies. This is our long-standing commitment to cancer patients worldwide."

References:

[1] Jiang H, Shi Z, Wang P, et al. Claudin18.2 – specific chimeric antigen receptor engineered T cells for the treatment of gastric cancer. J Natl Cancer Inst. 2019;111(4):409-18. doi: 10.1093/jnci/djy134.

[2] Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394-424.

On May 18, 2020 Boston Scientific Corporation (NYSE: BSX) reported that it completed a public offering of $1.7 billion aggregate principal amount of its senior notes (Press release, Boston Scientific, MAY 18, 2020, View Source [SID1234558237]). The public offering consists of $500.0 million of 1.900% notes due 2025 and $1.2 billion of 2.650% notes due 2030.

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 company intends to use the net proceeds from this offering towards (i) refinancing $450.0 million of borrowings under its revolving credit facility and a portion of its pre-payable bank debt, including $750.0 million under its $1.0 billion term loan credit facility maturing in February 2021 and $500.0 million under its $1.25 billion term loan credit facility maturing in April 2021 and (ii) paying related fees, expenses and premiums.

On May 18, 2020 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported financial results for the first quarter ended March 31, 2020 and provided a business update (Press release, Adamis Pharmaceuticals, MAY 18, 2020, View Source [SID1234558236]).

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. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated,

"We are pleased to have resubmitted our ZIMHI New Drug Application to the FDA to get us back on track for regulatory review. We are also very excited to be partnering with US WorldMeds to commercialize both our SYMJEPI and ZIMHI products here in the U.S. Certainly, Adamis has been negatively affected by the COVID-19 outbreak and the various degrees of lockdowns, and it remains to be seen how quickly everyone can get back to a new normal. However, we continue to operate and progress on a number of objectives. We will continue these efforts to mitigate the financial impact of the pandemic."

Product Updates

SYMJEPI (epinephrine) Injection

Earlier this month, the company announced that it had entered into an agreement with Sandoz Inc. providing for the mutually agreed return to Adamis of the marketing, promotion, and distribution rights to the company’s SYMJEPI (epinephrine) Injection 0.3mg, SYMJEPI (epinephrine) Injection 0.15mg products currently marketed and available in the United States, and the termination of the commercialization agreement between Adamis and Sandoz, following a transition period, supported by a transition services agreement that is currently being negotiated. Adamis also simultaneously entered into an exclusive distribution and commercialization agreement with USWM, LLC (USWM) for the United States commercial rights for the SYMJEPI products as well as the Company’s ZIMHI (naloxone HCI Injection, USP) 5mg/0.5mL product candidate.

In addition to the U.S., Adamis continues to seek opportunities to market SYMJEPI into other territories and in October 2019, the company announced it had entered into an exclusive distribution and commercialization agreement with Emerge Health to seek registration and commercialize SYMJEPI in both Australia and New Zealand.

ZIMHI (naloxone) Injection

Adamis has entered into an exclusive distribution and commercialization agreement with USWM for the U.S. commercial rights for ZIMHI (naloxone HCI Injection, USP) 5mg/0.5mL product candidate. Under the terms of the Adamis/USWM agreement, US WorldMeds obtained U.S. rights to commercialize and distribute the SYMJEPI products, upon the termination of Sandoz’s commercial rights, and ZIMHI, if approved by the U.S. Food and Drug Administration, in exchange for an upfront payment and potential regulatory and commercial milestones totaling up to $26 million. Additionally, after deducting the supply price and certain other deductions, including an allocation for US WorldMeds sales and distribution expenses from net sales of the products, Adamis and US WorldMeds will share equally in the net profits, as defined in the agreement.

Earlier today, the company announced the resubmission of the company’s New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for its ZIMHI product candidate. The resubmission follows the company’s meeting with the agency in February and is intended to address the issues raised by the FDA in the agency’s November 2019 Complete Response Letter ("CRL").

Drug Outsourcing Facility

During the first quarter of 2020, sterile and non-sterile revenues from the company’s wholly owned drug outsourcing facility, US Compounding (USC), decreased by approximately 6% in the first quarter compared to the same quarter in the prior year. Revenues from the sale of pharmaceutical formulations by USC were adversely affected by slowing demand due to the novel coronavirus outbreak. The company is seeking to mitigate the impact with the development and launch of products for which there has been a recent increase in demand.

First Quarter Financial Results

Revenues were approximately $4.7 million and $4.9 million for the three months ended March 31, 2020 and 2019, respectively. The decrease of approximately 5.0% in the first quarter of 2020 compared to the comparable period of 2019 was impacted by the effect of the pandemic on demand for USC’s products.

Selling, general and administrative expenses ("SG&A") for the three months ended March 31, 2020 and 2019 were approximately $6.1 million and $8.0 million, respectively. The decrease was primarily attributable to decreases in wages, benefits and other compensation expenses, and to a lesser extent by decreases in operational expenses relating to the ceasing of sales of certain USC products, and decreases in patent, consulting, outside services, professional fees, PDUFA fees, depreciation and other related expenses.

Research and development expenses were approximately $2.0 million and $2.2 million for the three months ended March 31, 2020 and 2019, respectively, a decrease of approximately 7.3%. The decrease was primarily due to a decrease in development costs of our product candidates.

Cash and equivalents at the end of the first quarter was approximately $10.5 million. In February 2020, the company completed a registered direct offering of common stock, and a concurrent private placement of warrants, resulting in estimated net proceeds of approximately $6.2 million.

Targeted Milestones

•Transition SYMJEPI commercial responsibility from Sandoz to US WorldMeds;
•FDA approval and U.S. commercial launch of ZIMHI;
•Develop and launch new USC products to help offset the impact of pandemic; and
•Complete a Phase III ulcer study in horses.

Conference Call

Adamis will host a conference call and live webcast on Monday, May 18, 2020 at 2:00 pm Pacific Time to discuss its financial and operating results for the first quarter of 2020 as well as provide an update on business developments and activities.

US Dial-in (Toll Free): 1-877-423-9813

TOLL/International Dial-in: 1-201-689-8573

Conference ID: 13703885

Webcast: View Source

In addition, a telephone playback of the call will be available after approximately 5:00 pm PT on May 18, 2020. To listen to the replay, call toll free 1-844-512-2921 within the United States or 1-412-317-6671 when calling internationally (toll). Please use the replay PIN number 13703885.

On May 18, 2020 Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that its Board of Directors declared a quarterly cash dividend of $0.56 per share, payable on July 22, 2020 to shareholders of record of Quest Diagnostics common stock on July 8, 2020 (Press release, Quest Diagnostics, MAY 18, 2020, View Source [SID1234558235]).

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!