On November 4, 2021 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported financial results for the third quarter of 2021. Oncternal management will host a webcast today at 5:00 p.m. ET to provide a business update and discuss its third quarter of 2021 financial results (Press release, Oncternal Therapeutics, NOV 4, 2021, View Source [SID1234594421]).

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"We are excited about the progress of our pipeline during this quarter, especially as we continue to advance towards a registration study for our lead asset, zilovertamab, which we believe can play a key role in the treatment paradigm of patients with mantle cell lymphoma," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "We are also very pleased to introduce ONCT-534, a pre-clinical first-in-class dual-action androgen inhibitor, as part of our pipeline. Tumor-resistance mechanisms related to the expression of splice variants such as AR-V7 represents an important unmet need for prostate cancer patients, and we are committed to developing new treatment options for them. Finally, our cell therapy program targeting ROR1 continues to move forward, with progress on both our lead candidate ONCT-808, an autologous CAR-T, and potential next-generation therapies based on NK cells."

Recent Highlights

Zilovertamab (ROR1 antibody, formerly cirmtuzumab or UC-961):

Interactions with FDA continue on potential registration pathways.
An abstract titled Phase 1b/2 Study of Cirmtuzumab and Ibrutinib in Mantle Cell Lymphoma (MCL) or Chronic Lymphocytic Leukemia (CLL) (Abstract 3534) (NCT0308887) has been accepted for a poster presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Atlanta on December 13, 2021. Abstracts are available on the ASH (Free ASH Whitepaper) website at www.hematology.org.
This abstract reflects early data from June 2021, shortly after our interim data was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting. The results remain encouraging and consistent with previous data releases and will be further updated with additional patients and follow-up at the ASH (Free ASH Whitepaper) meeting.
The investigator-sponsored study of zilovertamab and paclitaxel for metastatic or locally advanced, unresectable breast cancer at UC San Diego (NCT02776917) has completed enrollment and the results are expected to be presented at a scientific conference or in a publication.
The investigator-sponsored study of zilovertamab for treatment of patients with detectable CLL on venetoclax at UC San Diego (NCT04501939) is actively enrolling patients.
ONCT-216 (ETS inhibitor, formerly TK216):

Interim clinical data update for ONCT-216 in patients with relapsed or refractory Ewing sarcoma was accepted for oral presentation at the 2021 Connective Tissue Oncology Society (CTOS) Virtual Annual Meeting on November 13, 2021.
The Phase 2 expansion cohort targeting up to 21 Ewing sarcoma patients is active and enrolling patients, designed to evaluate clinical responses to single agent ONCT-216 using an optimized dosing regimen, treating for 28 days per cycle, to intensify the amount of ONCT-216 administered over time.
ROR1 Cell-Therapy Program:

Selected ONCT-808 as our lead autologous CAR-T targeting ROR1 candidate and made progress on key IND-enabling activities.
Initiated a collaboration with Celularity Inc. to evaluate placental derived T and NK-cell therapies targeting ROR1.
Formed a cell therapy scientific advisory board (SAB) with cross-disciplinary industry and academic experts to support the advancement of our ROR1 cell therapy pipeline.
Joined Karolinska Institutet’s NextGenNK Competence Center for the development of next generation NK cell-based cancer immunotherapies.
Dual-Action Androgen Inhibitor (DAARI) Program:

Selected ONCT-534 (formerly GTx-534) as our lead DAARI preclinical product candidate, based on significant new preclinical data and assessments. We believe ONCT-534 will address unmet medical needs related to tumor resistance to currently approved products for patients with advanced prostate cancer.
Presented preclinical in-vitro and in-vivo data as a virtual poster presentation at the AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in October. The data presented showed that ONCT-534 binds to the AR-AF-1, or N-terminal domain of the androgen receptor (AR) and induces degradation of both AR full length proteins and AR-SV proteins, including the AR-V7 splice variant. ONCT-534 demonstrated potent anti-tumor activity in AR-V7 expressing tumor xenografts in an animal model.
Corporate:

Appointed Steven Hamburger, Ph.D. as Senior Vice President, Regulatory Affairs and Quality Assurance.
Expected Upcoming Milestones

Zilovertamab (ROR1 antibody) program
Clinical data update for patients with MCL and CLL treated with zilovertamab plus ibrutinib in the ongoing Phase 1b/2 study to be presented at the American Society for Hematology (ASH) (Free ASH Whitepaper) 2021 Annual Meeting in Atlanta in December 2021
Ongoing FDA interactions regarding potential registration pathways for zilovertamab in patients with MCL
ONCT-216 (ETS inhibitor) programs
Clinical data update for patients with relapsed or refractory Ewing sarcoma to be shared in an oral presentation at the Connective Tissue Oncology Society (CTOS) 2021 Virtual Annual Meeting in November 2021
ROR1 CAR-T program
IND submission in the first half of 2022
The Company will host an R&D Day on January 25, 2022 to provide a comprehensive update of its pipeline of product candidates and key development priorities, which will include key opinion leaders in the fields of MCL therapies, cellular immunotherapies, and androgen receptor resistance in prostate cancer
Third Quarter 2021 Financial Results

Our grant revenue was $2.1 million for the third quarter ended September 30, 2021. Our grant revenue is derived from a sub-award under a grant from the California Institute for Regenerative Medicine (CIRM) to UC San Diego, which was awarded to advance our Phase 1b/2 clinical trial evaluating zilovertamab in combination with ibrutinib for the treatment of patients with MCL or CLL, and from two grant awards received from the National Institutes of Health, or NIH, during the third quarter ended September 30, 2021 for up to $2.2 million to support pre-clinical and other research activities for our ONCT-216 and ONCT-534 programs, including $0.7 million payable to subawardees.

Our total operating expenses for the third quarter ended September 30, 2021 were $11.8 million, including $1.5 million in non-cash stock-based compensation. Research and development expenses for the quarter totaled $9.0 million, and general and administrative expenses for the quarter totaled $2.8 million. Net loss for the third quarter was $9.6 million, or a loss of $0.19 per share, basic and diluted.

As of September 30, 2021, we had $97.4 million in cash and cash equivalents. We believe these funds will be sufficient to fund our operations into 2023. As of September 30, 2021, we had approximately 49.4 million shares of common stock outstanding.

Management Webcast

As previously announced, Oncternal will host a webcast today, November 4, 2021, at 5:00 p.m. ET (2:00 p.m. PT). The live webcast will be available online at investor.oncternal.com. A replay of the webcast will be available beginning approximately one hour after the conclusion of the call and will remain available for at least 30 days thereafter.

On November 4, 2021 NantHealth, Inc. (NASDAQ-GS: NH), a leading provider of enterprise solutions that help businesses transform complex data into actionable insights, reported financial results for its third quarter ended September 30, 2021 (Press release, NantHealth, NOV 4, 2021, View Source [SID1234594438]).

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"Expansion of our Eviti Connect decision support solution to additional diseases states (beyond oncology) has been a major focus for us this year," said Ron Louks, Chief Operating Officer, NantHealth. "With that in mind, I am pleased to report that, during the third quarter, we signed and are preparing to launch the very first Eviti Connect autoimmune disease program with a key customer and interest in this new offering is strong. This was a significant accomplishment and, when coupled with investments we are making in our network monitoring and management service suite (OpenNMS) and data capabilities (Quadris), we believe these advancements lay the foundation for substantial new growth opportunities for our business.

"On the financial front, net revenue for the 2021 third quarter was lower than the previous quarter, primarily due to timing differences between the expiration of certain contracts and the initiation of others. For the 2021 fourth quarter, we expect net revenue to return closer to our average run rate for this year.

"Also, as announced today in a dedicated press release, we added three senior executives to head our sales, strategy and human resource functions. All are accomplished and experienced leaders, and we look forward to the benefit of their insights as we begin the next stage of our growth."

Software and Services Highlights:

Clinical Decision Support (Eviti):
Continued expansion of services provided through a key Eviti channel partner, with the addition of two new health plans and expect further growth in the fourth quarter with the addition of a large, multi-state customer-owned health insurer
Signed agreement with Care Continuity, Inc., a leader in network integrity and care navigation, to partner on product offerings that improve care logistics management for complex, high risk and chronic diseases, with an initial focus on extending care pathways for Eviti Connect customers and their members (with NaviNet care pathway opportunities to follow)
Dr. Tiffany Avery, NantHealth Chief Medical Officer, was selected to present continuing education session on advancing equity in cancer care at the Oncology Clinical Pathways Congress. The virtual session took place October 1
Launched Eviti Connect 8.6, which includes more robust savings and ROI visualizations for payer customers via expanded reporting that is enabled by our Quadris data analytics capabilities
Payer Engagement (NaviNet and Population Health Management):
In October, signed a multi-year agreement with a new third party administrator that will use NaviNet Open to enhance the services it provides to self-insured health plan customers
Signed three-year renewal with a long-term partner and leading provider of drug authorizations, enabling electronic submission of prior authorization for any drug under any plan, including Medicare and Medicaid
Established a collaboration with Intraprise Systems to bring HIPAA One compliance management solutions to the NaviNet provider network, helping providers meet HIPAA compliance requirements and protect patient data
Launched the new NantHealth Help Center, an innovative platform that provides users with easy access to help and training content, online channels to contact support, and tools to view in progress and resolved support requests
Introduced new Authorization Submission APIs that allow providers to automate and streamline prior authorization requests to connected NaviNet payer customers
Network Monitoring and Management (The OpenNMS Group, Inc.):
Renewed agreements with 12 key customers and expanded services with one of the nation’s largest telecom providers (an existing account), reaffirming the value OpenNMS provides its customers
Continued development and preparation for fourth quarter launch of zero-touch appliances, simplifying the deployment of distributed monitoring capabilities at scale
Business and Financial Highlights

For the 2021 third quarter:

Total net revenue was $14.4 million compared with $18.8 million in Q3 of 2020.
Gross profit was $7.5 million, or 52% of total net revenue, compared with $11.2 million, or 60% of total net revenue, for the prior-year period.
Selling, general and administrative (SG&A) expenses increased to $13.0 million from $12.4 million in the 2020 third quarter.
Research and development (R&D) expenses decreased to $4.6 million from $4.7 million.
Net loss from continuing operations, net of tax, was $10.8 million, or $0.09 per share, compared with $11.0 million, or $0.10 per share, in the 2020 third quarter.
Non-GAAP net loss from continuing operations was $11.5 million, or $0.10 per share, compared with $7.2 million, or $0.07 per share, for the third quarter of 2020.
At September 30, 2021, cash and cash equivalents totaled $45.5 million.
Conference Call Information and Forward-Looking Statements

Later today, the Company will host a conference call at 1:30 p.m. PT (4:30 p.m. ET) to review its results of operations for the third quarter ended September 30, 2021. The conference call will be available to interested parties by dialing 800-584-1507 from the U.S. or Canada, or 212-231-2902 from international locations. The call will be broadcast via the Internet at www.nanthealth.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.

Discussion during the conference call may include forward-looking statements regarding topics such as the Company’s financial status and performance, regulatory and operational developments, and other comments the Company may make about its future plans or prospects in response to questions from participants on the conference call.

On November 4, 2021 Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease with three ongoing Phase 1 clinical trials, reported it will host a live webcast presentation highlighting the clinical data being presented at the 2021 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) on Friday, November 12, 2021 at 8:00 a.m. ET (Press release, Shattuck Labs, NOV 4, 2021, https://ir.shattucklabs.com/news-releases/news-release-details/shattuck-labs-host-conference-call-and-webcast-highlighting-data [SID1234594454]).

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The event will be led by Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck, and will include presentations by Lini Pandite, MBChB, M.B.A., Chief Medical Officer of Shattuck and Andrew Neill, M.B.A., Chief Financial Officer of Shattuck. During the event, the company will highlight dose-escalation data for SL-172154 (SIRPα-Fc-CD40L), its lead bi-functional fusion protein designed to simultaneously inhibit the CD47/SIRPα checkpoint interaction and activate the CD40 costimulatory receptor, in platinum-resistant ovarian cancer patients, and dose-escalation data for SL-279252 (PD1-Fc-OX40L), which is designed to simultaneously inhibit the PD-1/PD-L1 interaction and activate the OX40 receptor, in patients with advanced solid tumors or lymphoma. Members of Shattuck leadership will be available to answer questions at the end of the event.

The live call may be accessed by dialing (833) 614-1555 (domestic) or (516) 575-8754 (international) and entering the conference code: 4068596. The live and archived webcast will be available on the Events & Presentations section of the Company’s website. A replay of the webcast will be archived for up to 90 days following the presentation date.

On November 4, 2021 XOMA Corporation (Nasdaq: XOMA) reported NIS793, an anti-TGFβ monoclonal antibody licensed from the Company, has advanced to the Phase 3 development stage, triggering a $35 million milestone payment from Novartis (Press release, Xoma, NOV 4, 2021, View Source [SID1234594490]). The Phase 3 trial (NCT04935359) is designed to assess the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo, in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). In July, Novartis announced the U.S. Food and Drug Administration has granted Orphan Drug Designation to NIS793 in combination with standard of care chemotherapy for the treatment of pancreatic cancer.

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"Pancreatic cancer claims far too many lives every year, and we appreciate that Novartis chose to pursue it as the first indication for late-stage development with NIS793. We are grateful to the patients and their families who are participating in all of the NIS793 clinical studies," stated Jim Neal, Chief Executive Officer of XOMA. "NIS793 represents one of several important assets in our partner-funded portfolio. This $35 million milestone gives us additional capital to acquire the rights to potential future milestone and royalty economics from biotech companies who can then use the capital to pursue their goal of curing a disease or condition by advancing their clinical development activities."

More information about the NIS793 Phase 3 clinical study, NCT04935359, titled "Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)" can be found at ClinicalTrials.gov.

Under the terms of the 2015 anti-TGFβ development and commercialization agreement with Novartis, XOMA has the potential to earn up to $410 million in additional milestone payments. Should Novartis receive regulatory approval to commercialize NIS793, XOMA will receive tiered royalties on net product sales that range from mid-single digit to low double digits.

NIS793 is an investigational compound. Efficacy and safety have not been established. There is no guarantee that NIS793 will become commercially available.

On November 4, 2021 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company"), a leader in the development of targeted radiotherapies for patients with unmet needs, reported that the Phase 1 trial studying Actimab-A with the salvage chemotherapy CLAG-M in patients with relapsed or refractory acute myeloid leukemia (r/r AML) who are fit for intensive therapy has completed the planned dose escalation and patient enrollment. Patients in the fourth and final dose escalation cohort received 1.0 μCi/kg of Actimab-A with the standard CLAG-M dose regimen (Press release, Actinium Pharmaceuticals, NOV 4, 2021, View Source [SID1234594506]). This novel combination trial is being conducted at the Medical College of Wisconsin. Updated Phase 1 data is expected will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December and Actinium expects to provide an update on the future clinical development of this combination by year end.

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Actimab-A CLAG-M combination data was presented at ASH (Free ASH Whitepaper) 2020 from the first three dose cohorts, which highlighted:

100% remission rate (CR/CRi) in patients receiving 0.75 μCi/kg of Actimab-A with CLAG-M
83% remission rate in patients who received 3 or fewer lines of prior treatment
70% of patients achieving a remission were MRD negative
67% of patients in the study achieved a remission including patients receiving 0.25 and 0.50 μCi/kg of Actimab-A, which has shown to be subtherapeutic as a single agent in prior studies
All patients had intermediate (N=5, 33%) or adverse (N=10, 67%) cytogenetics
Patients had a median of 2 prior therapies (range:1- 5) including prior Venetoclax/HMA (N=7,47%) or bone marrow transplant (N=8, 53%)
These results compare favorably to outcomes with CLAG-M as a single agent, which was shown in a separate study to have a 55% overall response rate and a 39% MRD negativity rate.

Dr. Avinash Desai, Actinium’s Chief Medical Officer, said, "This novel combination has produced promising data with high rates of remission and MRD negativity with an acceptable safety profile thus far. Despite multiple new drug approvals for patients with AML, including several targeted agents, outcomes for patients with relapsed or refractory AML remain poor, especially those with adverse molecular or cytogenetic features. Actimab-A enables the treatment of AML with radiation at a cellular level, which is a novel mechanism not achievable with traditional external beam radiation given the diffuse nature of blood cancers like AML. Given the sensitivity of AML and other blood cancers to radiation, we are optimistic in its potential to improve patient outcomes. We hypothesized that the combination of Actimab-A with CLAG-M would be tolerable given the non-overlapping mechanisms of action and lead to higher and deeper remissions. We have been very pleased with the data from the trial to date and look forward to advancing this novel combination once we have reviewed the data from all dose cohorts, including the data to be presented at ASH (Free ASH Whitepaper) in December."