Oncopeptides AB: Interim Report Q2 2020

On August 26, 2020 Oncopeptides AB reported that Interim Report Q2 2020 (Press release, Oncopeptides, AUG 26, 2020, View Source [SID1234564078])

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Financial overview April 1 – June 30, 2020

Net sales amounted to SEK 0.0 M (0.0)
Loss for the period was SEK 401.0 M (loss: 171.9)
Loss per share, before and after dilution, was SEK 6.79 (loss: 3.52)
On June 30 cash and cash equivalents amounted to SEK 937.8 M (626.8)
Significant events during the period April 1 – June 30, 2020

Marty J Duvall was appointed CEO from July 1, and Jakob Lindberg assumed the role as
Chief Scientific Officer
NDA for accelerated approval of melflufen in the U.S was submitted
A laboratory for preclinical development was taken over to strengthen the technology platform and build the company’s pipeline
A directed share issue of SEK 1,414 M (USD 144 M) (before issue costs) to well-known life science investors, out of which SEK 716.4 M (before issue costs) was paid in after the end of the reporting period was completed
Enrollment in the OCEAN phase 3 study continues after the initial recruitment goal of 450 patients was reached in May
Final data from the pivotal HORIZON study were presented at EHA (Free EHA Whitepaper)
Patient enrollment to the company’s exploratory clinical studies was resumed in May after a temporary pause due to the COVID-19 pandemic
Significant events after the reporting period

The first patient was enrolled in the phase 1/2 AL-Amyloidosis study. This is the first study with melflufen in an indication outside multiple myeloma
Oncopeptides started a phase 2 study called PORT to evaluate an alternative administration of melflufen
Financial overview of the group

Conference call for investors, analysts and the media
The Interim Report Q2 2020 and an operational update will be presented by CEO Marty J Duvall and members of Oncopeptides management team, Wednesday August 26, 2020 at 14:00 (CET). The conference call will also be streamed via a link on the website: www. oncopeptides.com.

This information is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 08:00 CET on August 26, 2020.

Concord Medical Reports Financial Results for the First Half of 2020

On August 26, 2020 Concord Medical Services Holdings Limited ("Concord Medical" or the "Company") (NYSE: CCM), a healthcare provider specializing in cancer care, research and prevention by operating a network of medically advanced comprehensive cancer hospitals and standalone radiotherapy and diagnostic imaging centers in China, reported its unaudited consolidated financial results for the six months ended June 30, 2020[1] (Press release, Concord Medical Services Holdings, AUG 26, 2020, View Source [SID1234564077]).

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2020 First Half Highlights

Total net revenues were RMB83.0 million ($11.7 million) in the first half of 2020, representing a 16.6% decrease from total net revenues of RMB99.5 million in the same period last year. Total net revenues included the net revenues from the network business of RMB37.7 million ($5.3 million) and the net revenues from hospital business of RMB45.3 million ($6.4 million).
Gross loss was RMB3.5 million ($0.5 million) in the first half of 2020, compared to the gross profit of RMB3.1 million in the first half of 2019. The gross loss margin was 4.2% for the first half of 2020, compared to the gross profit margin of 3.1% for the same period last year.
Net loss attributable to ordinary shareholders in the first half of 2020 was RMB128.8 million ($18.2 million), compared to RMB140.1 million in the same period last year.
Basic and diluted loss per share for Class A and Class B ordinary shares[2] in the first half of 2020 were both RMB2.23 ($0.32), compared to RMB2.03, respectively, in the same period last year.
Non-GAAP net loss in the first half of 2020 was RMB155.0 million ($21.9 million), compared to non-GAAP net loss of RMB149.3 million in the same period last year. Non-GAAP basic and diluted loss per share for Class A and Class B ordinary shares in the first half of 2020 were both RMB2.15 ($0.30), compared to RMB1.95 in the same period last year.
Adjusted EBITDA[3] (non-GAAP) was negative RMB113.1 million ($16.0 million) in the first half of 2020, compared to negative RMB108.3 million in the same period last year.
Dr. Jianyu Yang, Chairman and Chief Executive Officer of Concord Medical, commented, "In the first half of 2020, the Company’s business was affected by the coronavirus disease (COVID-19) epidemic. As the epidemic situation is under control in China, the Company’s business has returned to normal. In particular, compared with the same period in 2019, our Shanghai Meizhong Jiahe Cancer Center nearly doubled its revenue."

"The Company’s Shanghai Meizhong Jiahe Medical Imaging Diagnostic Center (the "Imaging Diagnosis Center") has been officially opened in April 2020, which will expand the Company’s business income."

"The proton equipment of Guangzhou Concord Cancer Center (the "Cancer Center") has arrived and is expected to be hoisted in the recent months. Besides, the construction of the Cancer Center (exclude the proton part) is nearly competed, and the Company is starting the preparation for the opening of the Cancer Center. With the gradual operation of the Cancer Center to the mature stage, the Company’s revenue will also be greatly improved in the next few years."

2020 First Half Financial Results

Network Business

Net revenues from the network business were RMB37.7 million ($5.3 million), representing a 44.6% decrease from net revenues of RMB68.0 million in the first half of 2019, primarily attributable to the effect of the COVID-19 epidemic and the closure of certain centers in our network of centers. With four centers closed in the first half of 2020, the Company operated a network of 27 centers in 20 cities in China as of June 30, 2020.

Cost of revenues of the network business was RMB14.6 million ($2.1 million), representing a 58.0% decrease from RMB34.8 million in the first half of 2019.

Gross profit from the network business was RMB23.1 million ($3.3 million), representing a 30.4% decrease from RMB33.2 million in the first half of 2019. The gross profit margin of the network business for the first half of 2020 was 61.3%, compared to the gross profit margin of 48.8% for the same period last year.

Selling expenses of the network business were RMB19.4 million ($2.7 million), representing a 108.6% increase from RMB9.3 million in the first half of 2019. Selling expenses as a percentage of net revenues from the network business was 51.5% in the first half of 2020, compared to 13.7% in the first half of 2019. The increase in selling expenses of the network business was mainly due to the increase in advertisement and promotion expenses.

General and administrative expenses of the network business were RMB56.9 million ($8.1 million), representing a 30.1% decrease from RMB81.4 million in the first half of 2019. General and administrative expenses as a percentage of net revenues from the network business were 150.9% in the first half of 2020, compared to 119.7% in the same period last year. The decrease was mainly because Zhongrong Fund management fees have been fully settled in the second half of 2019.

Comparing to RMB24.8 million in the same period last year, capital expenditures decreased to RMB3.9 million ($0.6 million) in the first half of 2020, primarily for procuring equipment for network centers.

Accounts receivable were RMB61.1 million ($8.6 million) as of June 30, 2020, compared to RMB67.1 million as of December 31, 2019. The average period of sales outstanding for accounts receivable (also known as "Days Sales Outstanding") was 298 days in the first half of 2020.

During the first half of 2020, the Company handled 3,837 patient treatment cases and 40,444 patient diagnostic cases, representing a 28.1% decrease and a 45.9% decrease from the same period last year, respectively. The decreases in patient treatment and diagnostic cases were mainly due to the influence of the COVID-19 epidemic.

Hospital Business

Net revenues from the hospital business were RMB45.3 million ($6.4 million) in the first half of 2020, representing a 43.8% increase from net revenues of RMB31.5 million in the first half of 2019, mainly because the operation of Shanghai Meizhong Jiahe Cancer Center Co., Ltd. has gradually matured and the Imaging Diagnostic Center opened in this April.

Cost of revenues of the hospital business in the first half of 2020 was RMB71.8 million ($10.2 million), representing a 16.6% increase from cost of revenues of RMB61.6 million in the first half of 2019, mainly because of the preparation and operation of the Imaging Diagnostic Center.

Gross loss from the hospital business was RMB26.5 million ($3.8 million) in the first half of 2020, compared to RMB30.1 million in same period last year. The gross loss margin of the hospital business for the first half of 2020 was 58.5%, compared to the gross loss margin of 95.8% for the same period last year.

Selling expenses of the hospital business were RMB2.7 million ($0.4 million) in the first half of 2020, representing an 80.0% increase from selling expenses of RMB1.5 million in the first half of 2019. Selling expenses as a percentage of net revenues from the hospital business was 6.0% in the first half of 2020, compared to 4.8% in the first half of 2019. The increase was mainly because the market research cost increase for the Imaging Diagnosis Center and the Cancer Center.

General and administrative expenses of the hospital business were RMB77.5 million ($11.0 million) in the first half of 2020, of which employee benefit expenses were RMB31.7 million ($4.5 million). In the same period of last year, general and administrative expenses of the hospital business were RMB58.1 million. The increase was mainly due to the increase in salary and rental fees for hospitals. General and administrative expenses as a percentage of net revenues from the hospital business was 171.1% in the first half of 2020, compared to 184.4% in the first half of 2019.

Comparing to RMB410.5 million in the first half of 2019, capital expenditures of the hospital were RMB364.9 million ($51.6 million) in the first half of 2020. The decrease was mainly related to the decrease in construction fees and medical equipment payment for Beijing Proton Medical Center, Shanghai Concord Cancer Center and the Cancer Center.

As of June 30, 2020, accounts receivable from hospital business were RMB11.2 million ($1.6 million), representing an 18.2% decrease from accounts receivable of RMB13.7 million as of December 31, 2019. The number of Days Sales Outstanding was 50 days in the first half of 2020.

As of June 30, 2020, the Company had bank loans and other borrowings totaling RMB2.0 billion ($288.6 million).

Recent Developments

The Imaging Diagnosis Center commenced operation in April 2020. The Imaging Diagnosis Center is located on the second floor of the Medical Technology Center of Shanghai Xinhongqiao International Medical Park (the "Park"), which is the center of the Park. The Imaging Diagnosis Center provides high-quality diagnostic imaging services, such as radiology, ultrasound and nuclear medicine, diagnosis and remote consultation, education and training, to all the medical institutions, premium clinics and medical institutions around the Park. Advanced imaging diagnostic equipment, such as CT, magnetic resonance, PET-CT and PET-MRI, have been installed in the Imaging Diagnosis Center.

Phosplatin Therapeutics Completes $18.4 Million Private Financing Round

On August 26, 2020 Phosplatin Therapeutics LLC, a clinical stage pharmaceutical company focused on oncology therapeutics, reported the completion of an oversubscribed $18.4 million private financing round (Press release, Phosplatin, AUG 26, 2020, View Source [SID1234564076]). Participation included new and existing investors, inclusive of family offices from the US, Europe and Asia-Pacific, and high net worth individuals .

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Robert Fallon, President and Chief Executive Officer of Phosplatin Therapeutics, commented, "The success of the financing underscores the breadth of our data from three different Phase I trials and the broad potential of our lead compound, PT-112, which is advancing through clinical development as a monotherapy, including in mCRPC and multiple myeloma, and in combination with PD-L1 immune checkpoint inhibition. We plan to utilize the proceeds of this capital raise to complete Phase 2 development of PT-112, and our continued planning prior to launching intended pivotal trials."

Phosplatin Therapeutics has raised $56 million in equity capital since inception, and receives milestone fees from its sub-licensee for Greater China.

About PT-112

PT-112 is the first small molecule conjugate of pyrophosphate developed in oncology therapeutics. PT-112 promotes immunogenic cell death (ICD), or the release of damage associated molecular patterns (DAMPs) that lead to downstream immune effector cell recruitment in the tumor microenvironment. PT-112 represents a potential best-in-class small molecule inducer of this immunological form of cancer cell death, and is under Phase 2 development. The first-in-human study of PT-112 demonstrated an attractive safety profile and evidence of long-lasting responses among heavily pre-treated patients, and won "Best Poster" at the ESMO (Free ESMO Whitepaper) 2018 Annual Congress within the Developmental Therapeutics category. The novelty of its pyrophosphate moiety also results in osteotropism, or the propensity of the drug to reach the mineralized bone. This property is of interest in cancer types that originate in bone, or frequently lead to metastatic bone involvement, such as metastatic castrate-resistant prostate cancer (mCRPC). The first human clinical results in mCRPC were presented at the 2020 Genitourinary Cancers Symposium.

RareCyte announces first commercially available ARv7/Synaptophysin CTC assay for blood-based characterization of treatment resistant prostate cancer

On August 26, 2020 RareCyte reported a new dual biomarker liquid biopsy assay for androgen receptor splice variant 7 (ARv7) and the neuroendocrine marker, synaptophysin (SYP), enabling customers to evaluate both ARv7 and SYP expression on circulating tumor cells (CTCs) with industry leading accuracy and precision in patients with prostate cancer (Press release, RareCyte, AUG 26, 2020, https://www.prnewswire.com/news-releases/rarecyte-announces-first-commercially-available-arv7synaptophysin-ctc-assay-for-blood-based-characterization-of-treatment-resistant-prostate-cancer-301118268.html [SID1234564074]). The ARv7/Synaptophysin Panel Kit was validated based on rigorous requirements set to clinical standards and enables blood-based investigation of two prominent mechanisms by which tumors become resistant to second-line endocrine therapies.

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"Resistance to second-line anti-androgen therapies has emerged as an important clinical challenge," explained Eric Kaldjian, MD, Chief Medical Officer of RareCyte. "New therapies are in development to target the resistance mechanisms. Identification of ARv7 and synaptophysin on CTCs via a non-invasive blood sample will allow investigational monitoring for tumor transformation, as well as confirmation of clinically suspected resistance in multi-center clinical trials."

The assay comprises processing blood to slides with the AccuCyte Sample Preparation System followed by staining with the RarePlex 0919-LB ARv7/Synaptophysin CTC Panel Kit and imaging on a CyteFinder Instrument. Machine learning enabled analysis and scoring maximizes reviewer concordance. In addition, the RareCyte platform enables cell-free DNA analysis on the same sample, providing a comprehensive liquid biopsy assessment of tumor status.

"In prostate cancer, ARv7 has been associated with resistance to certain therapies, and SYP is a commonly used histologic marker for the neuroendocrine phenotype," said Amir Goldkorn, MD, an oncologist at University of Southern California (USC) Norris Cancer Center and associate professor of medicine at Keck School of Medicine of USC. Goldkorn and his collaborators at USC Norris Cancer Center collaborated with RareCyte to validate the assay. "Using the ARv7/SYP assay, it will be exciting to test whether CTCs bearing these markers are associated with unique biological phenotypes or clinical outcomes in men with prostate cancer."

The ARv7/Synaptophysin CTC Panel Kit is now available for purchase; more information on the kit and the RareCyte platform is available at View Source

Debiopharm’s New Generation Radionuclide Therapy Advances Into Clinical Research In The Fight Against Lung Cancer

On August 26, 2020 Debiopharm (www.debiopharm.com), a Swiss-based, global biopharmaceutical company, reported the first patient dosed in the multicenter, single-arm, open-label Phase 1 study assessing the safety, distribution, and dosing of Debio 1124 in patients with advanced, unresectable pulmonary and extrapulmonary small cell carcinoma. This targeted, investigational radiotherapy belongs to the emerging class of Peptide Receptor Radionuclide Therapies (PRRT), having been designed to selectively deliver molecular radiotherapy to tumor cells expressing the cholecystokinin 2 receptor (CCK2R) (Press release, Debiopharm, AUG 26, 2020, View Source [SID1234564073]). Research will leverage a theranostic approach, combining both diagnostic and therapeutic capacities of the compound. This will allow the pre-identification of patients who have the CCK2R receptors necessary to respond to the targeted radiotherapy using an imaging dose of Debio 1124 followed by a therapeutic dose of the same compound for qualifying patients only.

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The advancement of the Debio 1124 program is part of Debiopharm’s expanding radio-oncology pipeline including other radio-pharmaceutical and chemoradiotherapy enhancing compounds. Initially discovered by the Swiss based Paul Scherrer Institute (PSI), before being licensed by Debiopharm, Debio 1124 has shown anti-tumor activity in pre-clinical cancer models. The advancement of Debio 1124 into this clinical study may reveal improved therapeutic results for suffering from pulmonary and extrapulmonary small cell carcinoma.

"We’re very excited to bring the potential benefit of molecular radiotherapy to patients with small cell lung cancer showing expression of CCK2R. PRRT has the potential to impact the tumor while minimizing the off-target effects," explained Carlos Chanquia, Medical Director of Oncology at Debiopharm.

SCLC is a highly aggressive cancer associated with patients over 65 years old with a history of smoking. Without treatment, extensive stage small cell lung cancer (ES-SCLC), representing approximately two-thirds of all cases, is rapidly and invariably fatal.1 Combination chemotherapy induce dramatic but short-lived responses, with median overall survival in the third line setting <6 months. Ongoing research will evaluate if SCLC could potentially benefit from this specifically targeted radiotherapy.

About Debio 1124
Debio 1124 is a new-generation peptide analogue of minigastrin, coupled to the isotope Lutetium 177 (177Lu) designed to selectively deliver molecular radiotherapy to tumor cells expressing the Cholecystokinin B Receptor (CCK2R). The compound can be used as both a diagnostic tool during initial imaging step and subsequently as an intravenous radio-pharmaceutical for treatment. This targeted, theragnostic compound is being researched in various cancer types including advanced Medullary Thyroid Cancer (MTC) and SCLC.

Debiopharm’s commitment to cancer patients
Debiopharm aims to develop innovative therapies that target high unmet medical needs in oncology. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.