On October 23, 2020 Invitae Corporation (NYSE: NVTA), a leading medical genetics company, reported that it will report its third quarter 2020 financial results on Thursday, November 5, 2020 and will host a conference call and webcast that day at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss its financial results and recent highlights (Press release, Invitae, OCT 23, 2020, View Source [SID1234568916]).

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

To register for the conference call and webcast, please use one of the methods below. Upon registering, each participant will be provided with call details and a registrant ID. Reminders will also be sent to registered participants via email.

Online registration: View Source

Phone registration: (888) 869-1189 or (706) 643-5902

The live webcast of the call and slide deck may be accessed here or by visiting the investors section of the company’s website at ir.invitae.com. A replay of the webcast and conference call will be available shortly after the conclusion of the call and will be archived on the company’s website.

Following prepared remarks, management will respond to questions from analysts, subject to time limitations. We encourage our shareholders and those representing them to send in questions to ir.invitae.com.

On October 23, 2020 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported that AstraZeneca (LSE/STO/Nasdaq: AZN) has dosed the first patient in its Phase 3 clinical trial, INTERLINK-1, evaluating monalizumab in combination with cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors ("IO-pretreated") (Press release, Innate Pharma, OCT 23, 2020, View Source [SID1234568899]). Monalizumab, Innate’s lead partnered asset, is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.

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Dosing of the first patient in this trial has triggered a $50 million milestone payment from AstraZeneca to Innate.

"We are very pleased that our key late-stage asset, monalizumab, has progressed into Phase 3 with our partner, AstraZeneca. The launch of INTERLINK-1 represents an important financial milestone for Innate, as it triggers a $50 million milestone payment that fortifies our cash position through the end of 2022," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "The steady and rapid progress of this program is a testament to our strong collaboration with AstraZeneca, and we are hopeful that together we will bring a novel treatment option to this patient population with high unmet medical need."

"Patients with head and neck cancer previously treated with a checkpoint inhibitor are a newly-defined patient population that is currently underserved. We look forward to evaluating the novel combination of monalizumab and cetuximab in the Phase 3 INTERLINK-1 study," said Cristian Massacesi, Senior Vice President, Head of Late Development Oncology R&D, AstraZeneca.

Presented at the ESMO (Free ESMO Whitepaper) 2019 Congress, the combination of monalizumab and cetuximab demonstrated a manageable safety profile and a response rate of 27.5% (36% and 17% in IO-naïve, n=22, and IO-pretreated patients, n=18, respectively). Based on these Phase 1b/2 results and the unmet need in the IO-pretreated population, AstraZeneca and Innate elected to advance this program directly to a Phase 3 study.

During the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program, Innate presented preliminary data from its Phase 2 expansion cohort evaluating monalizumab and cetuximab in IO-pretreated patients (cohort 2), which confirmed an overall response rate (ORR) of 20% across 40 patients enrolled. Overall, the combination therapy data to date supports the expedited development of monalizumab and cetuximab in this indication. Innate intends to provide an update on this data at an upcoming scientific meeting.

About INTERLINK-1:
INTERLINK-1 is a global, multi-center, randomized, double-blind Phase 3 study of monalizumab and cetuximab vs. placebo and cetuximab that will enroll approximately 600 patients with recurrent or metastatic head and neck squamous cell carcinoma of the head and neck (R/M SCCHN) who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors ("IO-pretreated").

The primary endpoint is overall survival (OS) with secondary endpoints including progression-free survival (PFS), ORR, duration of response (DoR), safety and quality of life. Additional details on the INTERLINK-1 clinical trial can be found here.

About the Innate-AstraZeneca monalizumab agreement:
On April 24, 2015, the Company signed a co development and commercialization agreement with AstraZeneca to accelerate and broaden the development of monalizumab.

The financial terms of the agreement include potential cash payments up to $1.275 billion to Innate Pharma. Including the $50 million payment triggered by dosing the first patient in the Phase 3 INTERLINK-1 clinical trial, Innate Pharma has received $400 million to date.

AstraZeneca will book all sales revenue and will pay Innate low double-digit to mid-teen percentage royalties on net sales worldwide except in Europe where Innate Pharma will receive 50% share of the profits and losses in the territory. Innate will co-fund 30% of the costs of the Phase 3 development program of monalizumab with a pre-agreed limitation of Innate’s financial commitment.

On October 22, 2020 Araris Biotech AG, a company pioneering antibody-drug conjugate (ADC)-linker technology, reported it has received an additional CHF 12.7 million in seed financing, bringing the total amount raised to CHF 15.2 million (Press release, Araris Biotech, OCT 22, 2020, View Source [SID1234651278]).

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The investment round was led by Pureos Bioventures with participation from new investors 4BIO Capital, btov Partners and existing investors Redalpine, VI Partners and Schroder Adveq. The proceeds will be used to nominate a clinical candidate and advance Araris’ lead program into preclinical and clinical development. The new funds will also support the development of a broad proprietary pipeline of ADC compounds.

Philipp Spycher, Ph.D., CEO and co-founder of Araris, said, "We see this funding as strong validation of our company, lead programs and the Araris ADC-linker platform. We’re focused on using our unique linker technology, that allows development of ADCs without engineering the native antibody, to design better medicines for cancer. This capital will allow us to advance our lead program to the next stage of development and progress our preclinical pipeline towards the clinic. We are also pleased to further strengthen our investor base with such a distinguished group of investors, all of whom have a proven track record of supporting successful emerging companies."

Dragan Grabulovski, Ph.D. co-founder and founding chairman of Araris added, "The quality of the investors reflectsthe quality of the science, the product candidates and the entire team at Araris Biotech. I would like to welcome Dominik Escher, Dmitry Kuzmin, Michael Sidler and Arnd Kaltofen to the board of directors. Their experience and knowledge of the sector will be key to ensuring Araris’ continued success."

Dominik Escher, Ph.D., managing partner at Pureos, commented, "With this significant seed round, Araris is in an excellent position to advance its antibody-drug conjugates towards the clinic. Today, there are nine antibody-drug conjugates approved by the FDA but many of them cannot be dosed high enough to elicit efficacy due to systemic toxicity often caused by linker instability or heterogenous distributions of the payload. The Araris technology addresses these limitations and offers a novel and innovative approach to bring better therapies to patients in need."

Dmitry Kuzmin, Ph.D., managing partner at 4BIO Capital, said, "We are excited to be investing at this early stage of what we expect to be an extraordinary future for Araris. Its pioneering technology, enabling fast and precise production of ADCs, is highly innovative and we believe has huge potential to bring enhanced therapies to patients across the globe."

On October 22, 2020 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it will release third quarter 2020 financial results on Thursday, November 5, 2020, before the market opens, and host a conference call and live audio webcast 8:00am Eastern Time to discuss financial results and provide a business update (Press release, Athenex, OCT 22, 2020, View Source [SID1234573870]).

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To participate in the call, dial 877-407-0784 (domestic) or 201-689-8560 (international) fifteen minutes before the conference call begins and reference the conference passcode 13711719. The live conference call and replay can also be accessed via audio webcast at the Investor Relations section of the Company’s website, located at View Source

On October 22, 2020 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), reported financial results for the third quarter ended September 30, 2020, and provided an overview of recent business highlights (Press release, PLUS THERAPEUTICS, OCT 22, 2020, View Source [SID1234572294]).

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"Our lead investigational drug, RNL for recurrent glioblastoma, continues to progress toward its first major data readout," said Dr. Marc Hedrick, President and Chief Executive Officer of Plus Therapeutics. "In the third quarter, we advanced RNL successfully to the sixth dosing cohort and we are now administering over 1,000% more radiation to patients in a single treatment than can be delivered with traditional external beam radiation therapy."

Third Quarter 2020 and Recent Clinical Highlights

Plus Therapeutics has three clinical stage, nanoscale injectable oncology drugs, each designed to provide enhanced benefits versus existing therapies. The Company’s lead investigational drug is Rhenium NanoLiposome (RNL), a radiotherapy being developed for several cancer targets. RNL is being evaluated in the U.S. NIH/NCI-supported, multi-center ReSPECT Phase 1 dose-finding trial and for the treatment of recurrent glioblastoma. RNL is designed to safely, effectively, and conveniently deliver a targeted and very high dose of radiation directly to brain tumors. In addition:

The U.S. Food and Drug Administration (FDA) granted the Company Orphan Drug and Fast Track Designations for RNL for the treatment of glioblastoma patients.
The Company established a Clinical Advisory Board of five leading experts in the fields of neurological surgery and neuro-oncology that will advise the Company as it advances its nanoscale therapeutics to treat rare brain and neurological cancers.
The independent Data and Safety Monitoring Board (DSMB) of the ReSPECT Phase 1 trial in recurrent glioblastoma approved the Company to commence enrollment in the sixth cohort of patients.
Expected Upcoming Milestones and Events

The first nine months of 2020 marked the successful implementation of the Company’s expanded development focus, pipeline expansion and optimized costs and operational structure. In upcoming quarters, the Company intends to focus on a number of additional business objectives and potential milestones:

Report preliminary RNL data from the ReSPECT Phase 1 dose-finding trial in recurrent glioblastoma at the Society of Neuro-Oncology Annual Meeting being held virtually November 19-22, 2020.
Finalize plans for the next stage of clinical development for RNL in recurrent glioblastoma.
Continue evaluations of additional external and internal drug development candidates.
Initiate IND-enabling RNL studies for additional indications.
Explore partnership opportunities for RNL, DocePLUS and DoxoPLUS assets.
Third Quarter 20 20 Financial Results

As of September 30, 2020, the Company had cash of approximately $7.6 million, compared to cash of approximately $17.6 million as of December 31, 2019. During the third quarter of 2020, 317,521 series U warrants were exercised, raising $0.7 million. Net cash used in operating activities was $5.2 million for the nine months ended September 30, 2020, compared to net cash used of $6.9 million during the same period in 2019. During the second quarter of 2020, $5 million of the Oxford debt principal was paid down.
On September 30, 2020, the Company entered into a purchase agreement and registration rights agreement with Lincoln Park Capital Fund, LLC (LPC) pursuant to which and following the filing and effectiveness of a registration statement, the Company will have the right at its sole discretion, but not the obligation, to sell to LPC up to $25 million worth of shares over the 36-month term of the agreement, subject to various terms and conditions.
On October 9, 2020 the Company filed a shelf registration on Form S-3 allowing for the sale of securities "at the market" of up to $10 million.
Loss from continuing operations for the third quarter 2020 was $1.7 million, or $(0.39) per share, compared to operating income of $0.5 million, or $(0.03) per share (on a fully diluted basis including preferred stock), for the same period in 2019.
Net loss in the third quarter of 2020 was $1.7 million, or $(0.39) per share, compared to net income of $0.5 million, or $(0.03) per share (on a fully diluted basis including preferred stock), for the third quarter of 2019.
Clinical expenses relating to the ReSPECT Phase 1 dose-finding trial in recurrent glioblastoma continue to be funded under a $3 million grant with the U.S. NIH/NCI.
Conference Call

The Company will hold a conference call and live audio webcast at 5:00 p.m. Eastern Time today to discuss its financial results and provide a general business update.

Event: Plus Therapeutics Third Quarter 2020 Financial Results Conference Call and Webcast
Date: Thursday, October 22, 2020
Time: 5:00 p.m. Eastern Time.
Live Call: 877-402-3914; 631-865-5294 (Intl.); Conference ID: 2108916
The webcast can be accessed live via the investor section of the Plus Therapeutics website at ir.plustherapeutics.com/events and will be available for replay beginning two hours after the conclusion of the conference call.