On August 10, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company developing next-generation products to address the growing needs in oncology, reported that it has signed a supply agreement with 3D Imaging LLC. (3DI), a Contract Development and Manufacturing Organisation (CDMO), covering Clarity’s diagnostic 64Cu SAR-bisPSMA product (Press release, Clarity Pharmaceuticals, AUG 10, 2022, View Source [SID1234618060]).

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The new agreement, effective on August 11th, 2022, enables increased production and will create excess capacity in the supply of Clarity’s differentiated PSMA product in advance of two potential diagnostic Phase III trials in the US, ensuring reliable and seamless supply. 3DI will centrally manufacture and distribute the 64Cu SAR-bisPSMA products from its facility in Little Rock, Arkansas, USA, located close to the Global FedEx hub.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are excited to continue strengthening Clarity’s supply and manufacturing efforts and distinguishing ourselves from the current generation of radiopharmaceuticals that have many logistical limitations due to very short half-lives. In a field with all too many unforeseen product supply limitations and outages, we are building a reliable supply network with excess capacity."

Clarity’s 64Cu-based products can be centrally manufactured on existing cyclotrons and distributed broadly with a widespread geographical reach due to a significantly longer shelf-life of Clarity’s Targeted Copper Theranostics (TCT) products. A single cyclotron can supply 64Cu for the entire Phase III diagnostic clinical program.

"Clarity is overlaying several cyclotrons and manufacturers to enable TCTs’ future expansion into the larger commercial setting. By building a reliable and accessible supply chain that is consistent with that of the "big pharma" oncology model, Clarity aims to create a significant competitive advantage as we continue to pursue our ultimate goal of improving treatment outcomes for children and adults with cancer," said Dr Taylor.

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two prostate-specific membrane antigen (PSMA) binding motifs to Clarity’s proprietary sarcophagene (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide1. The National Cancer Institute estimates in 2022 there will be 268,490 new cases of prostate cancer in the US and around 34,500 deaths from the disease2.

On August 10, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported its financial results for the first half-year of 2022 (Press release, Evotec, AUG 10, 2022, View Source [SID1234618079]).

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HIGHLIGHTSEVOTEC CONTINUES ITS STRONG ORGANIC REVENUE GROWTH IN ALL BUSINESS AREAS

Group revenues increased by 24% to € 336.9 m (H1 2021: € 271.3 m) driven by strong demand for its base business; like-for-like revenue growth (excluding fx-effects) 19%
Continued strong revenue growth momentum: Total EVT Execute revenues (incl. intersegment revenues) up 26% to € 351.0 m (H1 2021: € 279.5 m); EVT Innovate revenues due to a strong growth in Q2 up 36% to € 78.0 m (H1 2021: € 57.3 m)
Reported adjusted Group EBITDA totalled € 33.6 m (H1 2021: € 36.2 m); excellent Group gross margin increasing by 270 bps to 27.3% excluding Just – Evotec Biologics, which is in its build up phase; lower contribution from milestones, upfronts and licenses as well as continued expenses for capacity expansion; higher energy costs, higher costs along the supply chain and costs related to the acquisition of Rigenerand Srl; negative effects partially offset by positive fx-effects
Other non-operating result of € (89.8) m (H1 2021: € 106.1 m) explained by the non-cash fair value adjustments of the equity investment in publicly listed Exscientia plc.

NEW AND EXTENDED ALLIANCES REFLECT SUCCESS OF GROWTH STRATEGY

Significant operational and scientific step-up of targeted protein degradation alliance with Bristol Myers Squibb ("BMS")
Several new integrated drug discovery collaborations signed, including INDiGO, CMC and DMPK agreements
New collaborations signed, based on unique, data-driven platforms with Almirall (dermatology), Boehringer Ingelheim (iPSC), Eli Lilly (E.MPD), Janssen (TargetAlloMod) and Sernova (iPSC)
Just – Evotec Biologics: Just –Evotec Biologics is currently in its initial build up phase. Strategic investments into disruptive technology platform show good progress – foundation laid for accelerated revenue growth; multiple new development and manufacturing agreements, e.g., among others with Alpine Immune Sciences (after period-end)
Co-owned pipeline projects progressing well, e.g. Phase II start of BAY 2395840 (diabetic neuropathic pain), expansion with JingXin for EVT201, submission for approval in China
Successful expansion of the EVOequity portfolio with new strategic equity stakes in several promising companies such as Centauri, IMIDomics, Sernova and Tubulis
Launch of Aurobac Therapeutics, a joint venture with Boehringer Ingelheim and bioMérieux, to create the next generation of antimicrobials along with actionable diagnostics to fight Antimicrobial Resistance ("AMR")

CORPORATE

Effective May 2022, Dr Matthias Evers joins Management Board as Chief Business Officer ("CBO"), responsible for business development, digital technology and strategy
Signing of definitive agreement to acquire the cell technology company Rigenerand Srl, a leader in the field of cGMP manufacturing of cell therapies, which will operate as Evotec (Modena) Srl
Annual General Meeting 2022: Approval of all proposed agenda items; Camilla Macapili Languille elected to the Supervisory Board

BUSINESS OUTLOOK FOR FULL-YEAR 2022 REFINED AND MID-TERM TARGETS 2025 CONFIRMED

Group revenues now expected to be in a range of € 715 – 735 m versus € 700 – 720 m previously (unchanged at € 690 – 710 m at constant exchange rates) (2021: € 618 m)
Adjusted Group EBITDA expected to be unchanged in the range of € 105 – 120 m (new guidance range at constant exchange rates of € 85 – 100 m versus € 95 – 110 m previously) (2021: € 107 m)
Unpartnered research and development expenses expected to be in a range of € 70 – 80 m (2021: € 58 m)
Mid-term goals target revenue growth to more than € 1,000 m, adjusted EBITDA of at least € 300 m and unpartnered research and development expenses of more than € 100 m
The forecast takes in account – as far as possible – the current increased global uncertainties related to e.g. the COVID-19 pandemic and the war in Ukraine, resulting in uncertainty around the global price and supply situation for energy, other raw materials and supplies as well as logistics relevant to the business.

More detailed information and financial tables are available in our half-year report published on the Evotec website under the following link: View Source

Webcast/Conference Call
The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. The conference call will be held in English.

On August 10, 2022 Patrys reported to share promising new preclinical research results (Press release, Patrys, AUG 10, 2022, View Source [SID1234617951]).

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A new animal study has found that PAT-DX1, in combination with radiation therapy, improves survival in an animal model of brain cancer.

The study, which was conducted in the laboratory of Professor Terrance Johns at the Telethon Kids Cancer Centre, showed that combining a therapeutic dose of radiation with PAT-DX1 resulted in significantly prolonged survival in mice, compared to radiation treatment alone.

Additionally, the data also showed that even at a lower dose, PAT-DX1 as a single agent showed significant activity, confirming previous studies in brain cancer models

These results provide strong support for the potential use of PAT-DX1 to improve outcomes for patients with high-grade glioma – an aggressive and clinically challenging form of brain cancer.

Professor Terrance Johns said:

"These impressive results offer the potential for future clinical strategies that allow the reduction of radiation doses and its associated side effects, particularly in children. We are excited to be working with Patrys as we work to optimize strategies for combining standard of care with PAT-DX1 therapies."

On August 10, 2022 Australian biotechnology company Starpharma reported it has signed a new DEP Research Agreement with MSD, the trade name of Merck Sharp & Dohme LLC, Rahway, NJ, USA (Press release, Starpharma, AUG 10, 2022, View Source [SID1234617967]).

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This new DEP program will generate and evaluate additional DEP Antibody Drug Conjugates (ADCs).

This new agreement follows an earlier DEP Antibody Drug Conjugate (ADC) agreement that Starpharma signed with MSD in February 2021 as well as an expanded DEP Research Agreement with another large US biopharmaceutical company in June 2022.

"We are very pleased to add this new DEP ADC program with MSD and to continue building on our partnership with them in such an innovative and valuable area. This new DEP program underlines the potential clinical and commercial value our DEP technology can deliver," said Dr Jackie Fairley, CEO of Starpharma.

"This is the second DEP partnering agreement that Starpharma has signed in the last two months, signifying increased momentum and interest in the DEP platform."

Antibody-drug conjugates (ADCs) have become an increasingly valuable class of therapeutic agents in oncology and hematology. The design of ADCs incorporates the specific cell targeting property of antibodies with the cell killing properties of chemically conjugated drugs, to provide a targeted therapeutic with minimal off target toxicities.

Starpharma’s DEP ADCs have the potential to overcome the limitation of relatively low drug loading that is a feature of first-generation ADCs. The DEP technology allows precise attachment of drug loaded dendrimer(s) to targeting molecules with a high load of covalently link drug (4, 8,16, 32 drug molecules per dendrimer) providing a selective, homogeneous ADC with a significantly higher drug-antibody ratio (DAR) as compared to currently available ADCs.

Starpharma has previously demonstrated the advantages of DEP in ADCs in multiple preclinical studies, including for DEP HER-2 ADC, which showed significant tumour regression and 100% survival, outperforming Herceptin & Kadcyla in a human ovarian cancer model. DEP ADCs are the subject of both internal and partnered DEP programs.

Starpharma has multiple DEP partnerships with leading, international companies, including AstraZeneca, MSD, and Chase Sun, and the company’s DEP technology has already yielded four clinical-stage oncology products.

On August 10, 2022 Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics company with the mission to improve patient outcomes by providing personalized insights that inform critical decisions throughout the patient care journey, reported that financial results for the second quarter 2022, ended June 30, 2022 (Press release, Oncocyte, AUG 10, 2022, View Source [SID1234618045]).

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Second Quarter and Recent Highlights:

Recent rightsizing of organization to match new program priorities is expected to reduce headcount carrying costs by over $4.5 million annually and, in combination with reprioritization cost reduction and anticipated strategic activities, annualized operating costs are expected to be reduced by approximately $12 million in 2023 as compared to 2022.
Reported total revenue of $2.1 million in the second quarter of 2022, compared with $2.0 million in the second quarter of 2021.
Received $1.0 million milestone payment from the final delivery of DetermaRx to Burning Rock, our Chinese partner.
Grew DetermaRx sample volume by 66% compared to second quarter of 2021 and increased onboarded physician base by 82% as compared to the same period in 2021.
Launched our CLIA validated laboratory test for our newly branded VitaGraft Liver Transplant Monitoring, a donor-derived cell-free DNA (dd-cfDNA) test.
Submitted VitaGraft Liver and VitaGraft Kidney for CMS reimbursement.
Clinical Partners presented five abstracts at ASCO (Free ASCO Whitepaper) and AACR (Free AACR Whitepaper) expanding the evidence supporting DetermaIO as clinically relevant to decision making in six different cancer types including:
Independent, prospective randomized clinical trial (RCT) evidence that DetermaIO can identify responders and expand the market for immune checkpoint inhibitor (ICI) therapy in colorectal cancer.
Phase II independent blinded clinical trial evidence that DetermaIO can inform the use of pembrolizumab therapy (Keytruda) in the neoadjuvant treatment of triple negative breast cancer, expanding upon prior reported RCT data with atezolizumab.
Closed an underwritten offering of $32.8 million in net proceeds of common stock and warrants, and a preferred stock offering of $4.9 million in net proceeds, to strengthen the balance sheet and further support our product portfolio.
"Our recent reprioritization efforts have led to a rightsizing of our employee base to better match the resourcing required to deliver DetermaIO, DetermaCNI and VitaGraft to the market. The expected program cost reductions combined with the reduction in headcount and planned monetization of assets through strategic activities are anticipated to result in a decrease of approximately $12 million in annualized operating expenses year over year, extending our cash runway into 2024," said Ron Andrews, Chief Executive Officer of Oncocyte. "We continued to make solid progress in the second quarter, delivering 66% year over year growth in DetermaRx sample volumes and successfully onboarding new physicians and accounts. We also successfully completed our CLIA lab test validation of our VitaGraft product line and submitted both Liver and Kidney for CMS reimbursement."

Continuing, Mr Andrews commented, "Looking ahead, we are excited by the response to the anticipated launch of our VitaGraft Liver test and expect our first samples from a high-profile liver transplant center by the end of August. We also remain on track to submit our dossier for DetermaIO reimbursement this fall. Despite the continued market headwinds, we believe that Oncocyte has an incredibly bright future in front of us as the product development efforts from the past few years are expected to result in new product launches of high value, reimbursed products over the next four to six quarters. I would also like to recognize the promotion of Anish John to CFO and Gisela Paulsen to President and COO. These are well-deserved promotions for two executives that have been instrumental in reshaping our priorities and helping find ways to reduce our burn while still accomplishing our mission. We are now aligned around key areas where our skill sets can best serve Oncocyte’s future. I appreciate the continued support of our shareholders and look forward to updating you as we work to deliver on the key product milestones throughout the second half of 2022."

Second Quarter 2022 Financial Results

Total revenue was $2.1 million for the second quarter of 2022, compared to $1.4 million for the prior quarter. Second quarter revenues associated with DetermaRx were $0.8 million, down $0.2 million sequentially, and up $0.2 million year over year. Operating expenses for the second quarter 2022 were $8.2 million, compared to $13.2 million, a decrease of $5.0 million from the same period in the prior year. Research and Development expense for the second quarter 2022 was $5.6 million, an increase of $3.0 million from the same period a year ago. The increase in R&D expense was due to full integration of the Chronix R&D team, the growth and enrolment of our clinical trials, and added headcount related to the buildout of our IVD product development capabilities. General and Administrative expense for the second quarter of 2022 was $5.5 million, a decrease of $2.4 million for the same period in 2021, primarily due to one-time acquisition related costs related Chronix Biomedical acquisition in the same period in the prior year. Sales and Marketing expense in the quarter was $3.5 million, an increase of $0.8 million year over year, primarily attributable to an increase in headcount and continued ramp in sales and marketing activities related to the transplant business, as well as support the commercialization efforts within oncology.

Net loss was $8.3 million for the second quarter of 2022 and net loss per share was $0.07 on a weighted-average basic and diluted share count of 113.0 million, compared to a net loss of $10.5 million and a net loss per share of $0.12 on a weighted-average basic and diluted share count of 89.8 million in the same period of the prior year.

Cash, cash equivalents, restricted cash and marketable securities were $47.1 million as of June 30, 2022.

Webcast and Conference Call Information
Oncocyte will host a conference call to discuss the second quarter 2022 financial results after market close on Wednesday, August 10, 2022 at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time. The conference call can be accessed live over the phone (877) 407-9716 for U.S. callers or (201) 493-6779 for international callers, using conference ID: 13731553. The live webinar can be accessed at View Source