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February 16, 2021

Cend Therapeutics and Qilu Pharmaceutical Announce Partnership

SAN DIEGO and JINAN, China, Feb. 16, 2021 — Cend Therapeutics, Inc., a clinical-stage biotech company, and Qilu Pharmaceutical, a major Chinese pharmaceutical company, announced today that the companies have entered a Collaboration and License Agreement to develop and commercialize Cend’s investigational drug, CEND-1, in Greater China.

Cend presented favorable clinical results at the European Society for Molecular Oncology (ESMO) meeting September 2020 and is advancing into Phase 2 clinical trials in pancreatic cancer with CEND-1 in combination with gemcitabine and nab-paclitaxel. The Company is planning registration clinical trials in pancreatic cancer and will explore combinations with additional therapies, including immunotherapies, as well as expansion of its programs into additional solid tumor cancers.

“This partnership with Qilu will help us bring our treatment to patients with pancreatic and other solid tumor cancers in China. This collaboration will also speed global development to bring the treatment to market expeditiously. Qilu’s excellent development team and market position will position CEND-1 for success in China,” commented David Slack, CEO of Cend.

“CEND-1 has generated encouraging clinical results in combination with standard of care chemotherapy for the treatment of pancreatic cancer, which remains a significant health issue in China. We are pleased to work with Cend to advance this program and explore broader potential applications for CEND-1,” commented Oliver Kong, MD, Chief Medical Officer and Corporate Vice President of Qilu.

About the Qilu-Cend Partnership

In the Collaboration and License Agreement, Qilu will gain exclusive rights to CEND-1 in Greater China, including Taiwan, Hong Kong and Macau. Qilu will take on development as well as commercialization responsibilities within Greater China. Cend will continue to retain all rights outside of Greater China. Qilu will pay Cend an up-front license fee of US$10 million. Cend will be eligible to receive up to $225 million in milestones as well as tiered double digit royalties on product sales in the region.

About CEND-1

CEND-1 is an investigational drug that modifies the tumor microenvironment. It is targeted to tumors by its affinity for alpha-v integrins, which are selectively expressed in tumors but not normally expressed in healthy tissues. CEND-1 is a cyclic peptide that, once bound to these integrins, is cleaved by protease expressed in tumors to release a peptide fragment, called a CendR fragment, which binds to a second receptor, called neuropilin, to activate a novel uptake pathway that causes anticancer drugs to more selectively penetrate solid tumors. CEND-1 has also been shown to further modify the tumor microenvironment by selectively depleting tumor-infiltrating immunosuppressive cells, including T regulatory cells, and to increase the number of cancer-fighting immune cells within the tumor, potentially enabling patients’ immune systems or immunotherapies to more effectively fight cancer.

About Qilu Pharmaceutical

Qilu Pharmaceutical is one of the leading vertically integrated pharmaceutical companies in China focusing on the development, manufacturing and marketing of innovative medicines, active pharmaceutical ingredients (APIs) & finished formulations. Qilu currently has 12 subsidiaries, 10 manufacturing sites and over 23,000 employees worldwide. Qilu ranks among the top Chinese pharmaceutical companies by sales revenue in 2019. Dedicated to offering more affordable medicines to the world and improving people’s well-being, Qilu has exported its products to over 80 countries. Qilu has always maintained an innovative development strategy based on unmet medical needs and is achieving its organic growth strategy utilizing a strong pool of 2000+ scientists spread across 5 R&D platforms based in the US (Seattle WA, Boston MA, San Francisco CA) and China (Shanghai, and Jinan). To date, Qilu has launched 200+ products with 30+ products “First to launch” in China and 3 products “D181 launch” in US. The company also has a robust pipeline, including 200+ generic products, 20+ biosimilar products and 50+ innovative products. Qilu’s finished formulations and APIs have been approved by US FDA, European Medicines Agency(EMA), Therapeutic Goods Administration (TGA) of Australia, Medicines and Healthcare products Regulatory Agency (MHRA) of UK, PMDA of Japan and other national regulatory authorities.

About Cend Therapeutics

Cend is a clinical-stage biotech company focused on a novel approach to enable more effective treatments for solid tumor cancers. Poor penetration of drugs into tumors is a major issue in cancer therapy as it limits access and therefore efficacy of current therapies. The CendR Platform provides a targeted tissue penetration capability to specifically enhance drug delivery to tumors. The presence of immunosuppressive cell types, such as T regulatory cells, in the tumor microenvironment can limit the ability of patients’ immune systems to fight their cancer and render some tumors refractory to immunotherapies. Cend is applying its technology to deplete such immunosuppressive cells from the tumor microenvironment to enable patients’ immune system and immunotherapies to more effectively fight cancer.

November 20, 2020

World Pancreatic Cancer Day 2020

To honor the Pancreatic Cancer Awareness Day (today) and Pancreatic Cancer Awareness Month (November) we are raising awareness about the symptoms and risks of this devastating disease and the urgent need for earlier detection.

The results of our first clinical trial testing CEND-1 in pancreatic cancer patients were published at the annual European cancer meeting ESMO 2020 and Annals of Oncology. We are now preparing to test CEND-1 in multi-center randomized clinical trials in pancreatic cancer patients and expand into additional indications in our effort to help patients with hard-to-treat solid tumors.

September 25, 2020

Cend Therapeutics Announces Acquisition of Impilo Therapeutics

San Diego, September 21, 2020 – Cend Therapeutics, Inc., a clinical-stage biotech company, announced today that it has acquired Impilo Therapeutics, Inc. The combination expands Cend’s drug delivery capabilities to create a unique platform for targeted tissue penetrating delivery of nucleic acid-based medicines to solid tumor cancers.

While antisense and siRNA medicines have reached market for a range of metabolic, neurological and neuro-muscular conditions, none have reached market for anticancer applications. “By combining Impilo with Cend our objective is to address delivery issues that have limited the ability of nucleic acid-based medicines to benefit cancer patients,” commented David Slack, CEO of Cend.

“Cend’s lead asset, CEND-1, has generated encouraging clinical data showing the ability to enhance delivery of standard-of-care chemotherapy for pancreatic cancer patients, and the Company has generated similarly encouraging preclinical results for a variety of therapeutic modalities,” commented Sangeeta Bhatia, MD, PhD, scientific co-founder of Impilo and Director of MIT’s Center for Cancer Nanomedicine.

“With the combination of Cend and Impilo technologies, we have demonstrated unique abilities to deliver antisense, siRNA, microRNA, and immunostimulatory oligonucleotides selectively to solid tumor cancers and certain immune cells,” commented Frank Slack, PhD, scientific cofounder of Impilo and Director of Harvard’s Initiative for RNA Medicine.

“The scientific founders of Cend and Impilo have collaborated for many years and generated significant publications” commented Cend Executive Chairman, Erkki Ruoslahti. “Cend will continue to work closely with Impilo’s founders as part of our extended team.”

Via acquisition of Impilo’s assets, the CendR PlatformÔ combines Cend’s clinical-stage targeted tumor penetrating peptide, CEND-1, with additional targeting capabilities. It also brings nanoparticle technologies, including fusogenic nanoparticles that can deliver high payloads of nucleic acid-based drugs directly into the cytosol compartment of cells.

Financial details of the transaction have not been disclosed. Accompanying the acquisition, Sangeeta Bhatia and Frank Slack will join Erkki Ruoslahti, MD, PhD; Tambet Teesalu, PhD; and Kazuki Sugahara, MD on Cend’s Scientific Advisory Board. Impilo scientific co-founder and Distinguished Professor at UC San Diego, Michael Sailor, PhD will join Cend’s Board of Directors. About Cend Therapeutics

September 15, 2020

Cend Therapeutics Announces Presentation and Abstract Publication at 2020 European Society for Medical Oncology (ESMO) Meeting

San Diego, September 15, 2020 – Cend Therapeutics, Inc., a clinical-stage biotech company, announced the publication of its abstract on the website of the annual meeting of the European Society for Medical Oncology. The poster that includes the detailed results will be presented at the virtual meeting on September 17, 2020.

The poster presenter and the Principal Investigator, Andrew Dean, MD of the St. John of God Hospital , Subiaco, Australia. Dr. Dean commented: “This first-in-human clinical study with CEND-1 provides encouraging results and highlights potential to enhance delivery of standard-of-care therapy for patients with metastatic pancreatic ductal adenocarcinoma (PDAC).”

“Inability to target delivery of drugs to primary tumor and metastases represents a significant factor limiting successful treatment of pancreatic cancer patients, who represent a high-need patient population. Our aim with CEND-1 is to provide a new tumor-targeted penetration capability to improve outcomes for pancreatic cancer patients,” commented Harri Jarvelainen, Chief Operating Officer at Cend Therapeutics.

The details of the poster are as follows:
Title: Phase I trial of the first-in-class agent CEND-1 in combination with gemcitabine and nab-paclitaxel in patients with metastatic pancreatic cancer
Presentation Number: 1528P
Speaker: Andrew Dean (Subiaco, WA, Australia)
Date: 17.09.2020

About Cend Therapeutics
Cend is a clinical-stage biotech company focused on a novel approach to enhance and more selectively deliver treatments for solid tumor cancers. Poor penetration of drugs into tumors is a major issue in cancer therapy as it limits access and therefore efficacy of current therapies. The CendR Platform™ provides a targeted tissue penetration capability to specifically enhance drug delivery to tumors.

July 8, 2020

CEND Therapeutics Announces Board Member David Slack Will Succeed Erkki Ruoslahti as President & CEO

LA JOLLA, Calif., July 08, 2020 — Cend Therapeutics, Inc. (formerly DrugCendR, Inc.), a clinical-stage biotech company, announced today changes in the senior management of the company. David Slack, MBA will take over as President and CEO. Erkki Ruoslahti, MD, PhD, co-founding CEO will remain Chairman and serve as a senior advisor for the Company.

Mr. Slack has over 25 years of experience in the biotech and pharmaceutical industry having served in senior positions in several companies with focus on advancing innovative treatments for cancer patients. He has served as a member of the Cend Therapeutics board of directors since 2019. Most recently, Mr. Slack served as Chief Business Officer of Viracta Therapeutics. Prior to Viracta, he has served as co-founding CEO at Kinagen, Inc.; Vice President for Business Development at Ionis Pharmaceuticals; and in senior roles at Aventis Pharma, Rhone-Poulenc Rorer Pharmaceuticals and RPR Gencell.

Dr. Ruoslahti said: “I am very pleased to announce David’s appointment as CEO. He brings extensive senior management, financing and business development expertise to the Company. Cend has come a long way in the past 5 years; we have nearly completed a Phase 1 clinical trial with our lead investigational drug, CEND-1, in combination with standard-of-care chemotherapy for the treatment of metastatic pancreatic cancer, and we have an extensive preclinical-stage opportunities to apply our CendR drug delivery platform. David is the right leader to take the company through the next stage in its development.”

Mr. Slack said: “I am honored to take on this role with Cend. In addition to the encouraging results in the clinic, Erkki and the Cend team have laid the groundwork for broad applications of the Company’s technology, which opens up additional funding, product and partnering opportunities.”

May 5, 2020

Cend Therapeutics to Participate in BIO Digital Conference June 8-12, 2020

LA JOLLA, CA, May 5, 2020 — Cend Therapeutics Inc. a clinical stage oncology biotech, today announced that the company will attend the BIO Digital Conference on June 8-12, 2020.

Harri Jarvelainen, Chief Operating Officer will host virtual one-on-one meetings throughout the conference. Please contact us to arrange a meeting.

March 18, 2020

Cend Therapeutics Selected as a Buzz of BIO 2020 Finalist

Cend Therapeutics Inc, a clinical-stage oncology company developing innovative therapies to overcome drug delivery barriers in solid tumors, today announced that it was selected as one of the finalists of Buzz of BIO International Convention.

The Buzz of BIO contest provides great visibility and an excellent opportunity for companies looking to make the connections needed to take their product to the next phase. The contest helps to identify companies based in the U.S. with groundbreaking technologies that have the overall potential to improve lives in difficult-to-treat conditions.

To vote, visit https://www.bio.org/events/bio-international-convention/buzz-bio-voting and select Cend Therapeutics in the “Pipelines of Promise” category (companies are listed alphabetically). Harri Jarvelainen, COO of Cend Therapeutics, is available for meetings during the conference.

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Publications

More than 200 scientific papers from laboratories all over the world provide non-clinical validation for Cend’s technology and show enhanced antitumor activity of a variety of therapeutics in a range of solid tumor types, documenting the broad applicability of Cend’s technology.

August 10, 2018

Cancer Research: Nanoparticles That Reshape the Tumor Milieu Create a Therapeutic Window for Effective T-cell Therapy in Solid Malignancies

August 10, 2018

Molecular Cancer Therapeutics: iRGD-guided Tumor-penetrating Nanocomplexes for Therapeutic siRNA Delivery to Pancreatic Cancer:

August 24, 2017

Nature Communications: In vivo cation exchange in quantum dots for tumor-specific imaging

April 17, 2017

The Journal of Clinical Investigation: Tumor-penetrating peptide enhances transcytosis of silicasome-based chemotherapy for pancreatic cancer

April 1, 2016

Advanced Drug Delivery Reviews: Tumor penetrating peptides for improved drug delivery

August 1, 2015

Cancer Research: Improving Drug Penetrability with iRGD Leverages the Therapeutic Response to Sorafenib and Doxorubicin in Hepatocellular Carcinoma

March 18, 2014

British Journal of Cancer: Anticancer effects of gemcitabine are enhanced by co-administered iRGD peptide in murine pancreatic cancer models that overexpressed neuropilin-1

May 21, 2010

Science: Coadministration of a Tumor-Penetrating Peptide Enhances the Efficacy of Cancer Drugs

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