On July 16, 2024 Tempus AI, Inc. (NASDAQ: TEM), a leader in artificial intelligence and precision medicine, reported that its multimodal immune profile score (IPS) algorithmic test is now available for research use only (RUO) (Press release, Tempus, JUL 16, 2024, View Source [SID1234644904]). IPS is the first offering of a larger immunotherapy-based portfolio being developed at Tempus to bring next-generation algorithmic diagnostics to the immuno-oncology space. Additionally, Tempus is collaborating with other partners, like Cleveland Clinic, to bring additional immunotherapy-focused algorithmic tests to this growing portfolio, leveraging clinical, laboratory, genomic, and transcriptomic data to identify patients that may respond to immunotherapy.

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Tempus’ IPS is a pan-cancer, laboratory developed test (LDT) that assesses a combination of immunotherapy-related biomarkers from prior DNA and RNA test results to calculate an IPS from 0-100 and a classification of either IPS-Low or IPS-High. IPS results can support patient stratification across pan-cancer cohorts to help inform who may or may not respond to immunotherapy. The IPS test is available today to life sciences partners for research use only, and is intended to be available as an add-on option for clinicians ordering Tempus’ xT and xR at the end of the year. Tempus is performing a retrospective, real-world study to evaluate the prognostic and the predictive utility of IPS in advanced pan-cancer patients treated with immune checkpoint inhibitors (ICI) and will be releasing data later this year.

In addition to developing and launching IPS, Tempus has licensed a machine-learning-based algorithmic test developed by Timothy A. Chan, MD, PhD, Cleveland Clinic. As described in Nature Biotechnology, the test demonstrates an ability to predict the efficacy of immune checkpoint blockade based on patient-specific biological, laboratory, genomic, and clinical factors, and adds to our expanding immunotherapy specific biomarker portfolio.

"Immune checkpoint inhibitors continue to have an incredible impact on patient outcomes, and we are excited to continue building a portfolio of AI-enabled diagnostics and tools to better equip clinicians in understanding which patients may benefit from these kinds of therapies," said Halla Nimeiri, MD, Chief Development Officer at Tempus. "The IPS test is our first multimodal algorithm to be introduced in the immunotherapy space, and we are excited to advance this field by providing critical insights that inform patient care."

"It’s a great pleasure to collaborate with Tempus on developing artificial intelligence powered models for better identification of patients who may respond to cancer immunotherapies," said Timothy A. Chan, MD, PhD, Department Chair of Immunotherapy and Precision Oncology and Professor of Medicine at Cleveland Clinic. "We look forward to working together with Tempus to bring multimodal immunotherapy response prediction assays to patients."

Tempus’ AI-enabled platform generates the type of rich multimodal data required to develop a novel class of predictive algorithms that can be introduced in the clinic to support personalized patient treatment selection. The IPS and Cleveland Clinic immune response tests joins a growing suite of algorithmic tests offered by Tempus, including Homologous Recombination Deficiency (HRD), Tumor Origin (TO), dihydropyrimidine dehydrogenase (DPYD), and PurISTSM. Each of these tests is designed to predict specific biological signals or clinical endpoints, ultimately supporting clinicians and life science partners as they seek to make more informed decisions for patients.

For more information on IPS, reach out to Tempus at tempus.com/contact-us.

On July 15, 2024 Enveric Biosciences (NASDAQ: ENVB) ("Enveric"), a biotechnology company dedicated to the development of novel neuroplastogens for the treatment of neuropsychiatric disorders, and Aries Science & Technology ("Aries"), a developer of encapsulation technologies, reported a licensing agreement for the clinical development of Enveric’s patented radiation dermatitis topical product (Press release, Enveric Biosciences, JUL 15, 2024, View Source [SID1234644868]).

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Radiation dermatitis is a side effect of radiation treatment that impacts roughly two million cancer patients per year and has a market opportunity estimated at $400 million annually. The formulation licensed to Aries is protected by an allowed US patent application, as well as a pending PCT application.

"This product offers the potential to provide much needed relief to cancer patients suffering from the painful side effects of radiation therapy," said Ram Lalgudi, Ph.D., CEO of Aries. "We are excited by the opportunity to advance this promising molecule to clinical trials."

Dr. Lalgudi announced: "Aries has nominated Hari Harikumar, Ph.D., as Chairman-elect of an Aries subsidiary being formed to advance this opportunity. Dr. Harikumar is a techno-commercial entrepreneur having experience with multiple companies, including his current role as VP for Performance Additives in CHASM Advanced Materials and earlier roles as CEO of QM Power, and VP, Innovation, Sustainability and Technology for Ingersoll Rand/TRANE, and President & CTO for USHA, a leading consumer brand in India. We look forward to great success under his leadership."

Joseph Tucker, Ph.D., CEO of Enveric, stated: "With its proven expertise in encapsulation solutions and strong management team, we believe Aries is the ideal partner to continue the development of this cancer support care product while Enveric sharpens its focus on neuropsychiatric indications."

Under the terms of the agreement, executed through Enveric’s subsidiary, Akos Biosciences, Inc., Enveric will be eligible to receive aggregate milestone payments of up to $61 million, as well as tiered royalties ranging from 2.5% to 10% on future sales, if all conditions are met.

On July 15, 2024 IPA (IMMUNOPRECISE ANTIBODIES LTD.) (the "Company" or "IPA") (NASDAQ: IPA), an AI-driven biotherapeutic research and technology company, reported its full year fiscal 2024 financial results and business highlights on Thursday, July 25, 2024, and will hold an earnings call at 10:30 am Eastern Time the same day (Press release, ImmunoPrecise Antibodies, JUL 15, 2024, View Source [SID1234644869]).

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A live audio webcast of the earnings conference may be accessed through a link that will be posted on IPA’s Investor Relations website at ir.ipatherapeutics.com. A replay will be archived and available for replay following the conference call.

Conference Call:

Event Title: ImmunoPrecise Reports Financial Results and Recent Business Highlights for Full Fiscal Year 2024
Event Date: July 25th, 2024
Time: 10:30 AM (GMT-04:00) Eastern Time (US and Canada)

***Participant Dial-In Details***
Participants call one of the allocated dial-in numbers (below) and advise the Operator of either the Conference ID 9236374 or Conference Name.

North America Toll-Free: (888) 550-5658
North America Toll: (646) 960-0289
International Toll: +1(646) 960-0289

***Webcast Details ***
Attendee URL:
View Source

On July 15, 2024 Onconetix, Inc. ("Onconetix" or the "Company") (Nasdaq: ONCO), reported the closing of the previously announced exercise of certain existing warrants to purchase 7,458,642 shares of its common stock having exercise prices ranging from $1.09 to $2.546 per share, at a reduced exercise price of $0.15 per share (Press release, Onconetix, JUL 15, 2024, View Source [SID1234644870]). The aggregate gross proceeds from the exercise of the existing warrants were approximately $1.11 million, before deducting placement agent fees and other offering expenses payable by the Company.

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H.C. Wainwright acted as the exclusive placement agent for this transaction.

The Company expects to use the net proceeds from the transaction for working capital and general corporate purposes.

The shares of common stock issued upon exercise of the existing warrants are registered pursuant to an existing registration statement on a Form S-1 (File No. 333-277066), declared effective by the Securities and Exchange Commission (the "SEC") on July 1, 2024.

In consideration for the immediate exercise of the existing warrants for cash, the Company issued new unregistered warrants to purchase up to an aggregate of 22,375,926 shares of common stock in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the "1933 Act"). The shares of common stock issuable upon exercise of the new warrants are subject to stockholder approval and the new warrants will become exercisable on the effective date of the stockholder approval. The new warrants have an exercise price of $0.15 per share. One-third of the new warrants have a term of exercise equal to five years from the date of stockholder approval, and the remaining two-thirds have a term of exercise equal to twenty-four months from the date of stockholder approval.

The new warrants offered in the private placement have not been registered under the 1933 Act, or applicable under state

securities laws. Accordingly, the new warrants and shares of common stock issuable upon the exercise of the new warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the 1933 Act and such applicable state securities laws. As part of the offering, the Company has agreed to file a resale registration statement on Form S-3 with the SEC as soon as practicable to register the resale of the shares of common stock issuable upon the exercise of the new warrants issued in the private placement.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On July 15, 2024 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that enrollment has been completed and dosing initiated for the sixth dose cohort of its Phase 1/2 study of ONCT-534 for the treatment of patients with metastatic castration-resistant prostate cancer who are relapsed or refractory to approved androgen receptor pathway inhibitors (ARPI) (Press release, Oncternal Therapeutics, JUL 15, 2024, https://investor.oncternal.com/news-releases/news-release-details/oncternal-announces-enrollment-completed-and-dosing-initiated-0 [SID1234644871]). Patients in the sixth cohort are receiving ONCT-534, the company’s dual-action androgen receptor inhibitor (DAARI), at a dose of 1200 mg taken orally once each day. The decision to proceed to this higher dose level was made by the study’s Safety Review Committee (SRC) after reviewing data from the fifth dose level of 600 mg ONCT-534 daily. An initial update on ONCT-534 safety and efficacy based on prostate–specific antigen (PSA) levels from this study is expected in the third quarter of 2024 and will include data from this 1200 mg dose cohort.

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"We are encouraged by the rapid enrollment in the dose escalation portion of our Phase 1/2 study with ONCT-534. The drug has been well tolerated, with no dose limiting toxicities observed to date. Patient demand continues to be strong," said Salim Yazji M.D., Chief Medical Officer at Oncternal Therapeutics. "We are looking forward to sharing initial safety and efficacy data soon, which will include a larger, more robust set of clinical and biomarker results, as well as longer follow-up from the earlier dosing cohorts."

About Study ONCT-534-101
Study ONCT-534-101 is a Phase 1/2, single-arm, open-label, multi-center study to evaluate the safety and tolerability, pharmacokinetics, and preliminary anti-tumor activity of ONCT-534 in patients with mCRPC who have relapsed or are refractory to approved ARPIs including enzalutamide, abiraterone, apalutamide, and darolutamide. After the safety and tolerability and preliminary antitumor activity of ONCT-534 have been assessed in Phase 1, Phase 2 will commence to further evaluate the safety and antitumor activity of ONCT-534 to support selecting an optimal dose.