On August 5, 2024 Nuvation Bio Inc. (NYSE: NUVB), a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology, reported financial results for the second quarter ended June 30, 2024, and provided a business update (Press release, Nuvation Bio, AUG 5, 2024, View Source [SID1234645355]).

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"In the second quarter, we were pleased to share data at ASCO (Free ASCO Whitepaper) from TRUST-I, the pivotal study of taletrectinib in China, which although immature due to an early data cutoff, demonstrated taletrectinib’s efficacy, durability, and safety profiles. At WCLC, we will be presenting data from TRUST-II, the global, pivotal Phase 2 study of taletrectinib, while at ESMO (Free ESMO Whitepaper) we will present more mature and comprehensive taletrectinib data, including pooled efficacy and safety data from both pivotal TRUST-I and TRUST-II studies. The ESMO (Free ESMO Whitepaper) data set will be used to support our planned NDA filing in the U.S. and, assuming regulatory approval, will position us to commercialize taletrectinib in 2025," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "We are also progressing the global Phase 2 study of safusidenib and continuing to dose escalate in a Phase 1/2 study of our first clinical-stage drug-drug conjugate, NUV-1511. As we focus on our late-stage pipeline and prepare to potentially bring taletrectinib to patients in the U.S. in 2025, we have decided not to initiate a Phase 2 study of NUV-868 in the solid tumor indications studied to date. This decision comes after careful review of the data generated in the Phase 1 monotherapy study and Phase 1b study of NUV-868 in combination with olaparib or enzalutamide. We are exploring next steps for NUV-868 in new indications and will share updates as available. We are proud of Nuvation Bio’s transformational momentum in the first half of this year and look forward to building upon it as we tackle some of the greatest unmet needs in oncology."

Recent Pipeline Updates:

Taletrectinib, ROS1 inhibitor: Advanced ROS1-positive NSCLC

Latest data from the Phase 2 TRUST-I clinical study evaluating taletrectinib in patients in China with advanced ROS1-positive NSCLC was published in the Journal of Clinical Oncology and presented at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting.
Latest pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies to be presented at the ESMO (Free ESMO Whitepaper) Congress 2024 in September, which will support the Company’s planned NDA in the U.S.
Latest data from the global, pivotal Phase 2 TRUST-II study to be presented at the WCLC in September.
Granted Orphan Drug Designation by the U.S. FDA for the treatment of ROS1-positive NSCLC and other NSCLC indications.
Safusidenib, mIDH1 inhibitor: Diffuse IDH1-mutant glioma

Global phase 2 study of safusidenib for treatment of patients with diffuse IDH1-mutant glioma remains ongoing.
NUV-1511, drug-drug conjugate (DDC): Advanced solid tumors

Phase 1/2 dose escalation study of NUV-1511 for the treatment of patients with various advanced solid tumors remains ongoing.
NUV-868, BD2-selective BET inhibitor: Advanced solid tumors

Concluded the Phase 1b dose escalation study of NUV-868 in combination with olaparib for the treatment of patients with ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer, and other solid tumors, and in combination with enzalutamide for the treatment of patients with mCRPC.
Completed an internal analysis of efficacy and safety data collected from the Phase 1 monotherapy and Phase 1b combination studies of NUV-868. Following this analysis, Nuvation Bio decided not to initiate a Phase 2 study of NUV-868 as a monotherapy or in combination with olaparib or enzalutamide in the advanced solid tumor indications that were part of the Phase 1 and Phase 1b study designs. The Company is evaluating next steps for the NUV-868 program, including further development in combination with approved products for indications in which BD2-selective BET inhibitors may improve outcomes for patients.
Second Quarter 2024 Financial Results

As of June 30, 2024, Nuvation Bio had cash, cash equivalents and marketable securities of $577.2 million.

For the three months ended June 30, 2024, research and development expenses were $29.2 million, compared to $18.6 million for the three months ended June 30, 2023. The increase was primarily due to a $5.9 million increase in personnel-related costs driven by the acquisition of AnHeart Therapeutics, Ltd. (AnHeart), stock-based compensation and other benefits and a $4.7 million increase in third-party costs related to research services and drug manufacturing as a result of clinical study expense for taletrectinib.

On April 9, 2024, as a result of the acquisition of AnHeart, Nuvation Bio recorded a $425.1 million charge representing an acquired in-process research and development asset with no alternative future use in acquired in-process research and development expenses.

For the three months ended June 30, 2024, general and administrative expenses were $16.1 million, compared to $7.5 million for the three months ended June 30, 2023. The increase was due to a $3.9 million increase in personnel-related costs as a result of the acquisition of AnHeart, a $1.1 million increase in professional fees, a $1.2 million increase in marketing expense, a $0.8 million increase in legal fees, a $0.2 million increase in occupancy expense, a $0.2 million increase in foreign currency impact, and a $1.4 million increase in miscellaneous expense offset by a $0.2 million decrease in insurance expense.

For the three months ended June 30, 2024, Nuvation Bio reported a net loss of $462.5 million, or $(1.89) per share. This compares to a net loss of $20.6 million, or $(0.09) per share, for the comparable period in 2023.

About Taletrectinib

Taletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with ROS1-positive non-small cell lung cancer (NSCLC). Taletrectinib is being evaluated for the treatment of patients with advanced ROS1-positive NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study. Taletrectinib has been granted Orphan Drug Designation by the U.S. FDA for the treatment of patients with ROS1-positive NSCLC and Breakthrough Therapy Designations by both the U.S. FDA and China’s National Medical Products Administration (NMPA) for the treatment of patients with advanced or metastatic ROS1-positive NSCLC. Based on results of the TRUST-I clinical study, China’s NMPA has accepted and granted Priority Review Designations to New Drug Applications for taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who either have or have not previously been treated with ROS1 tyrosine kinase inhibitors.

On August 5, 2024 bioAffinity Technologies, Inc. (Nasdaq: BIAF, BIAFW) reported that pursuant to warrant exercise agreements dated Aug. 2, 2024, three existing accredited investors have exercised outstanding warrants to purchase an aggregate of 1,041,667 of the Company’s shares of common stock ("Existing Warrants") at an exercise price that was reduced from $1.64 to $1.25 per share for gross cash proceeds of approximately $1,302,083 (Press release, BioAffinity Technologies, AUG 5, 2024, View Source [SID1234645354]).

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As part of the transaction, the exercising holders received in a private placement new unregistered warrants ("New Warrants") to purchase up to an aggregate of 1,302,083 shares of common stock (equal to 125% of the shares of common stock issued in connection with the exercise of the Existing Warrants). The New Warrants have an exercise price of $1.50 per share and are initially exercisable on the date that stockholder approval of the exercise of the warrants is obtained and will expire five years from the date of such approval. In connection with the exercise of the Existing Warrants, the Company reduced the exercise price of the Existing Warrants from $1.64 to $1.25 per share.

The Company also announced today it has closed the previously announced securities purchase agreement with an institutional investor for the purchase and sale of 360,000 shares of common stock in a registered direct offering and, in a concurrent private placement, common warrants ("Private Warrants") to purchase up to 450,000 shares of common stock (together with the registered direct offering) at a combined purchase price of $1.25. The Private Warrants have an exercise price of $1.50 per share, are initially exercisable on the date that stockholder approval of the exercise of the warrants is obtained and will expire five years from the date of such approval.

The gross proceeds from the offering are expected to be approximately $450,000, excluding any proceeds that may be received upon the exercise of the Private Warrants and before deducting placement agent fees and other offering expenses payable by the Company.

WallachBeth Capital acted as sole placement agent for the registered direct offering and financial advisor for the warrant inducement transaction.

The common stock was issued in a registered direct offering pursuant to an effective shelf registration statement on Form S-3 (File No. 333-275608) previously filed with the U.S. Securities and Exchange Commission ("SEC"), under the Securities Act of 1933, as amended (the "Securities Act"), and declared effective by the SEC on Nov. 27, 2023. The Private Warrants to be issued in the concurrent private placement and the shares issuable upon exercise of such warrants were offered pursuant to an exemption from the registration requirements of the Securities Act under Section 4(a)(2) thereof and Regulation D promulgated thereunder and have not been registered under the Securities Act or applicable state securities laws. A prospectus supplement describing the terms of the proposed registered direct offering will be filed with the SEC and available on the SEC’s website located at View Source Electronic copies of the prospectus supplements may be obtained, when available, from WallachBeth Capital, LLC, via email at [email protected], by calling +1-646-237-8585, or by standard mail at WallachBeth Capital LLC, Attn: Capital Markets, 185 Hudson St., Suite 1410, Jersey City, NJ 07311, USA.

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

About CyPath Lung

CyPath Lung uses advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath Lung incorporates a fluorescent porphyrin, TCPP, that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage cancer can improve outcomes and increase patient survival.

On August 5, 2024 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported a corporate update and provided financial results for the fiscal third quarter ended June 30, 2024 (Press release, ESSA, AUG 5, 2024, View Source [SID1234645353]).

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"With continued focus on execution, we are progressing towards a stream of significant milestones throughout the next nine to twelve months, with the first being the presentation at ESMO (Free ESMO Whitepaper) of more mature durability data from the Phase 1 dose escalation study evaluating masofaniten combined with enzalutamide in patients with metastatic castration-resistant prostate cancer naïve to second-generation antiandrogens," said David Parkinson, MD, President and CEO of ESSA. "We are focused on the enrollment of the Phase 2 dose expansion study evaluating masofaniten in combination with enzalutamide, with 25 sites activated in the US, Canada and Australia and an additional 14 sites being activated in Europe. We look forward to reporting key data across these trials throughout the remainder of this year through 2025."

Third Quarter Fiscal 2024 and Recent Highlights

Masofaniten Combination Studies

Phase 1/2 study is still ongoing evaluating masofaniten in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer ("mCRPC") naïve to second-generation antiandrogens but may have been treated with chemotherapy in the metastatic castration-sensitive setting. The latest reported results, which were presented at the ASCO (Free ASCO Whitepaper)-GU symposium in January 2024, demonstrated that the combination regimen continues to be well tolerated at the dose levels tested in up to 25 cycles of dosing in some patients. Reductions in PSA were observed across evaluable patients for efficacy in all dosing cohorts (n=16). Across all dosing cohorts, 88% of patients achieved PSA50, 81% of patients achieved PSA90, 69% of patients achieved PSA90 in less than 90 days, and 63% of patients achieved PSA <0.2ng/mL. While the data for time to PSA progression were still maturing, the median time to PSA progression was reported as 16.6 months with a median follow up at that time of 11.1 months. ESSA plans to report updated data from the Phase 1 dose escalation study at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2024 congress.
Masofaniten continues to be evaluated in combination with enzalutamide compared to enzalutamide monotherapy in a Phase 2 dose randomized study in patients with mCRPC naïve to second-generation antiandrogens but who may have been treated with chemotherapy in the metastatic castration-sensitive setting. Enrollment in the Phase 2 portion of this Phase 1/2 study is expected to be completed during the first quarter of 2025. The study is currently enrolling at approximately 25 sites in the US, Canada, and Australia. Expansion to European clinical sites is in progress with an additional 14 clinical sites planned to be activated by the third quarter of 2024. ESSA is on track to report preliminary data from the Phase 2 dose expansion portion of the study in mid-2025.
Two additional masofaniten combination arms are continuing enrollment as part of the ongoing Phase 1 masofaniten study. One arm is evaluating masofaniten in combination with abiraterone acetate and prednisone in patients with either metastatic castration-sensitive prostate cancer or mCRPC, while the second arm is evaluating masofaniten in combination with apalutamide in patients with non-metastatic castration-resistant prostate cancer after 12 weeks of masofaniten single agent.
Two additional investigator-sponsored studies testing combinations of masofaniten with darolutamide or enzalutamide in different patient populations are currently enrolling: a) an Australian investigator-sponsored neoadjuvant study evaluating neoadjuvant use of the combination of masofaniten and darolutamide compared to darolutamide monotherapy in high-risk patients undergoing prostatectomy and b) an investigator-sponsored study which is testing masofaniten and enzalutamide in metastatic castration-sensitive prostate cancer patients.
Masofaniten Monotherapy Study

ESSA remains on track to complete the Phase 1b masofaniten monotherapy study evaluating masofaniten in patients with mCRPC resistant to second-generation antiandrogens. The initial results from the monotherapy study were reported at the 2023 ASCO (Free ASCO Whitepaper)-GU Symposium, and demonstrated that masofaniten monotherapy was well-tolerated, achieved clinically significant exposures, and showed preliminary signals of anti-tumor activity in a subset of patients. ESSA plans to present the complete Phase 1b monotherapy results in the second half of 2024 at a medical conference.
Summary Financial results
(Amounts expressed in U.S. dollars)

Net Loss. ESSA recorded a net loss of $7.2 million for the third quarter ended June 30, 2024, compared to $7.3 million for the third quarter ended June 30, 2023.
Research and Development ("R&D") expenditures. R&D expenditures for the third quarter ended June 30, 2024, were $5.5 million compared to $6.3 million for the third quarter ended June 30, 2023, and include non-cash costs related to share-based payments of $851,971 for the third quarter ended 2024 compared to $599,621 for the third quarter ended 2023. The decrease is largely attributable to reductions in preclinical work with the focus on ongoing clinical trials.
General and Administration ("G&A") expenditures. G&A expenditures for the third quarter ended June 30, 2024, were $3.2 million compared to $2.6 million for the third quarter ended June 30, 2023, and include non-cash costs related to share-based payments of $1,748,227 for the third quarter ended 2024 compared to $561,452 for the third quarter ended 2023. The net decrease (net of share-based payments) relates to the timing of corporate projects and lower insurance premiums for the current period.
Liquidity and Outstanding Share Capital

As of June 30, 2024, the Company had available cash reserves and short-term investments of $130.7 million. The Company’s cash position is expected to be sufficient to fund current and planned operations beyond 2025.
As of June 30, 2024, the Company had 44,368,959 common shares issued and outstanding.
In addition, as of June 30, 2024, there were 2,920,000 common shares issuable upon the exercise of prefunded warrants at an exercise price of $0.0001.

On August 5, 2024 Antennova, a clinical-stage biotech company focused on oncology reported that the orally administered CD73 small molecule inhibitor ATN-037 (also known as ATG-037) has been accepted for Mini Oral presentation at the 2024 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (EMSO Congress 2024), taking place from September 13th to September 17th at the Fira Barcelona Gran Via in Barcelona, Spain (Press release, Antennova, AUG 5, 2024, View Source [SID1234645352]).

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Details of the Presentation:

ATN-037 (CD73 Oral Small Molecule Inhibitor)

Title: A First-In-Human Phase I/Ib study of ATG-037 Monotherapy and Combination Therapy with Pembrolizumab in Patients with Advanced Solid Tumours – STAMINA-01

Abstract: 6067

Presentation Number: 997MO

Date: September 16, 2024

Lecture Time:

10:50 AM – 10:55 AM (Central European Summer Time)

4:50 AM – 4:55 AM (US Eastern Time)

On August 5, 2024 Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, reported that shareholders of TenX Keane Acquisition ("TenX") (Nasdaq: TENK), a publicly traded special purpose acquisition company, have voted to approve the previously announced business combination with Citius Pharma’s oncology subsidiary (Press release, Citius Pharmaceuticals, AUG 5, 2024, View Source [SID1234645351]). The newly combined public company will continue to trade on the Nasdaq stock exchange and is to be renamed Citius Oncology, Inc. ("Citius Oncology").

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The transaction has been unanimously approved by the Board of Directors of both companies and Citius Pharma. Subject to certain contractual as well as customary closing conditions, the merger is expected to be completed in the coming weeks.

The transaction is expected to provide Citius Oncology with improved access to the public equity markets, support the commercialization of LYMPHIR, if approved, and position the company to explore additional targeted oncology opportunities.

"We look forward to closing this transaction in the coming weeks and unlocking and growing the value of our oncology asset," stated Leonard Mazur, Chairman and CEO of Citius Pharma.

About the Merger

Pursuant to the proposed agreement, TenX will acquire Citius Pharma’s wholly owned subsidiary via a merger, with the newly combined publicly traded company to be named Citius Oncology, Inc. In the transaction, all shares of Citius Pharma’s wholly owned subsidiary would be converted into the right to receive common stock of Citius Oncology. As a result, upon closing, Citius Pharma would hold approximately 65.6 million shares of common stock of Citius Oncology which would represent approximately 90% of the newly public company. As part of the transaction, Citius Pharma will contribute $10 million in cash to Citius Oncology. An additional 12.75 million existing options will be assumed by Citius Oncology.

At closing, any cash remaining in TenX’s trust account along with the cash provided by Citius Pharma will be contributed to Citius Oncology for working capital and general corporate purposes of Citius Oncology following the transaction. References to available cash from the TenX trust account and retained transaction proceeds are subject to any redemptions by the public stockholders of TenX and payment of transaction fees and expenses.

The description of the transaction contained herein is only a summary and is qualified in its entirety by reference to the merger agreement, a copy of which has been filed by Citius Pharma in a Current Report on Form 8-K, filed with the U.S. Securities and Exchange Commission on October 24, 2023.

Advisors

Maxim Group LLC is acting as exclusive financial advisor to Citius Pharma and Newbridge Securities Corporation is acting as exclusive financial advisor to TenX. Wyrick Robbins Yates & Ponton LLP is acting as legal advisor to Citius Pharma and Citius Oncology. The Crone Law Group P.C. is acting as legal advisor to TenX.