On February 5, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported the closing of its previously announced best-efforts public offering of 762,500 common shares at a public offering price of $4.00 per share (Press release, BriaCell Therapeutics, FEB 5, 2025, View Source [SID1234650080]). The Company received gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, of $3.05 million. The Company relied upon the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as Nasdaq.

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The Company intends to use the net proceeds from the offering for working capital requirements, general corporate purposes, and the advancement of business objectives.

ThinkEquity acted as sole placement agent for the offering.

The securities were offered and sold pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333-276650), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on January 22, 2024 and declared effective on January 31, 2024. The offering was made by means of a prospectus supplement and prospectus which have been filed with the SEC and are available on the SEC’s website at www.sec.gov . You should read the applicable prospectus supplement and prospectus for more complete information about the Company and the offering. You may obtain these documents free of charge by visiting the SEC website at www.sec.gov . Alternatively, you may obtain copies by contacting ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.

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

On February 5, 2025 Cytokinetics, Incorporated (Nasdaq: CYTK) reported that Robert I. Blum, President and Chief Executive Officer, reported to participate in a virtual fireside chat at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on Wednesday, February 12, 2025 at 4:40 PM Eastern Time (Press release, Cytokinetics, FEB 5, 2025, View Source [SID1234650062]).

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Interested parties may access the live webcast of the fireside chat by visiting the Investors & Media section of the Cytokinetics website at View Source The webcast replay will be archived on the Cytokinetics website for 90 days following the conclusion of the event.

On February 5, 2025 Bio-Techne Corporation (NASDAQ: TECH) reported its financial results for the second quarter ending December 31, 2024 (Press release, Bio-Techne, FEB 5, 2025, View Source [SID1234650063]).

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Second Quarter FY2025 Highlights

Second quarter organic revenue increased by 9% (9% reported) to $297.0 million.
GAAP earnings per share (EPS) was $0.22 versus $0.17 one year ago. Delivered adjusted EPS of $0.42 compared to $0.40 one year ago.
Improving biopharma end-market conditions combined with continued momentum of our cell and gene therapy workflow solutions, led to 8% organic growth in our Protein Sciences Segment (7% reported).
Strong commercial execution in Diagnostics & Spatial Biology led to 12% organic growth (12% reported) in the segment.
The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States (GAAP). Adjusted diluted EPS, adjusted net earnings, adjusted gross margin, adjusted operating income, adjusted tax rate, organic revenue, adjusted operating margin, earnings before interest, taxes, depreciation, and amortization (EBITDA), and adjusted EBITDA are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of non-GAAP Adjusted Financial Measures." A reconciliation of GAAP to non-GAAP financial measures is included in this press release.

"The Bio-Techne team once again executed at a high level and delivered strong second quarter results," said Kim Kelderman, President and Chief Executive Officer of Bio-Techne. "It is encouraging to see early signs of improvement in the biopharma end-market, which was evident in our cell and gene therapy and protein analysis instrumentation businesses. We delivered this top-line result with a continued focus on profitability, which resulted in a 30.1% adjusted operating margin, an increase of 110 basis points sequentially."

Kelderman added, "The Bio-Techne growth vectors empower the discovery of novel biological insights, the development and manufacturing of advanced therapeutics and, enable precision diagnostics. Our portfolio plays a key role in the healthy aging of global populations. The combination of this unique portfolio with the talented Bio-Techne team positions the Company for continued differentiated financial performance."

Bio-Techne will host an earnings conference call today, February 5, 2025, at 8:00 a.m. CST. To listen, please dial 1-877-407-9208 or 1-201-493-6784 (for international callers), and reference conference ID 13751305. The earnings call can also be accessed via webcast through the following link View Source

A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-844-512- 2921 or 1-412-317-6671 (for international callers) and referencing Conference ID 13751305. The replay will be available from 11:00 a.m. CST on Wednesday, February 5, 2025, until 11:00 p.m. CST on Wednesday, March 5, 2025.

Second Quarter Fiscal 2025

Revenue

Net sales for the second quarter increased 9% to $297.0 million. Organic revenue increased 9% compared to the prior year. Foreign currency exchange and a business held-for-sale did not have a material impact.

GAAP Earnings Results

GAAP EPS was $0.22 per diluted share, versus $0.17 in the same quarter last year. GAAP operating income for the second quarter of fiscal 2025 increased 25% to $47.4 million, compared to $38.0 million in the second quarter of fiscal 2024. GAAP operating margin was 16.0%, compared to 13.9% in the second quarter of fiscal 2024. Current year GAAP operating margin was favorably impacted by volume leverage and a non-recurring prior year impairment of a business held-for-sale.

Non-GAAP Earnings Results

Adjusted EPS increased to $0.42 per diluted share compared to $0.40 in the same quarter last year. Adjusted operating income for the second quarter of fiscal 2025 increased 8% to $88.7 million, compared to $81.9 million in the second quarter of fiscal 2024. Adjusted operating margin remained flat at 30.1% for the second quarter of fiscal 2025 compared to the second quarter of fiscal 2024. Adjusted operating margin was impacted by favorable volume leverage offset by re-instatement of incentive compensation accruals.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the Company’s business segments, as highlighted below.

Protein Sciences Segment

The Company’s Protein Sciences segment is one of the world’s leading suppliers of specialized proteins such as cytokines and growth factors, immunoassays, antibodies and reagents, to the biopharma and academic research communities. Additionally, the segment provides an array of platforms useful in various areas of protein analysis. Protein Sciences segment’s second quarter fiscal 2025 net sales were $211.6 million, an increase of 7% from $197.7 million for the second quarter of fiscal 2024. As of December 31, 2023, a business within the Protein Sciences Segment met the criteria as held-for-sale; this held-for-sale business has been excluded from the segment’s second quarter fiscal 2025 operating results. The exclusion of fiscal 2025 sales related to this held-for-sale business reduced sales by 1%. Organic revenue growth was 8% for the second quarter of fiscal 2025, with foreign currency exchange not having a material impact. The Protein Sciences segment’s operating margin increased to 41.2% in the second quarter of fiscal 2025 compared to 40.3% in the second quarter of fiscal 2024. The segment’s operating margin increased primarily due to volume leverage offset by re-instatement of incentive compensation accruals.

Diagnostics and Spatial Biology Segment

The Company’s Diagnostics and Spatial Biology segment develops and provides spatial biology products, carrier screening and oncology kits, as well as exosome-based diagnostics for various pathologies, including prostate cancer. The Diagnostics and Spatial Biology segment also provides blood chemistry and blood gas quality controls, hematology instrument controls, immunoassays and other bulk and custom reagents for the in vitro diagnostic market. The Diagnostics and Spatial Biology segment’s second quarter fiscal 2025 net sales were $84.1 million, an increase of 12% from $75.4 million for the second quarter of fiscal 2024. Organic revenue growth was 12% for the second quarter of fiscal 2025, with foreign exchange not having a material impact. The Diagnostics and Spatial Biology segment’s operating margin was 3.9% in the second quarter of fiscal 2025 compared to 6.0% in the second quarter of fiscal 2024. The segment’s operating margin decreased primarily due to re-instatement of incentive compensation accruals, partially offset by favorable volume leverage.

On February 5, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported Safety Committee approval to proceed with the Phase 2 portion of the Phase 1b/2 clinical trial involving AIM’s Ampligen (rintatolimod) and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of late-stage pancreatic cancer ("DURIPANC") (Press release, AIM ImmunoTech, FEB 5, 2025, View Source [SID1234650048]).

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DURIPANC is an investigator-initiated, exploratory, open-label, single-center study in the Netherlands at the Erasmus Medical Center ("Erasmus MC"). The approval to proceed to Phase 2 was granted following the Safety Committee’s review of the complete Phase 1 safety data, which found the combination therapy to be generally well-tolerated with no treatment-related severe adverse events or dose-limiting toxicities.

AIM CEO Thomas K. Equels stated: "Patients with late-stage pancreatic cancer have very few options. This is a lethal malignancy that kills approximately 50,000 Americans every year and there is no effective therapy. It is one of the highest unmet needs in oncology, and we are excited to see this clinical study at Erasmus Medical Center in the Netherlands move to Phase 2. Ampligen is believed to reprogram the immune system to enhance the cellular response, and this combination study with Imfinzi is part of our broader strategy to explore these effects in combination with synergistic anti-cancer agents, including checkpoint inhibitors."

Prof. Casper H.J. van Eijck, MD, PhD, Pancreato-biliary Surgeon at Erasmus MC and Coordinating Investigator for the DURIPANC study, commented: "We have observed improvements in quality of life and we saw no toxicity at all – with ‘quality of life’ recognized as an indicator of stable disease. As a comparison, approximately 80% of patients at Erasmus MC with similar disease, but who did not receive the treatment, showed disease progression after only three months. While this new data is extremely preliminary, it is also encouraging since some patients with metastatic pancreatic cancer still have stable disease for 15 or more months after starting FOLFIRINOX, including six or seven months of maintenance therapy. By analyzing blood samples and tumor biopsies taken at different time points before and after the start of immunotherapy, we will obtain crucial insights into several aspects of treatment response, immune dynamics and tumor evolution."

Up to 25 patients are expected to be enrolled in the Phase 2 portion of DURIPANC. Six patients from Phase 1 will be included in Phase 2, as per the protocol and based on their Phase 1 participation. Continued enrollment is expected to begin soon.

Read more at about DURIPANC at ClinicalTrials.gov NCT05927142 – "Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy efficacy (DURIPANC)"

On February 5, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported the completion of patient enrollment in the global Phase III clinical trial (HARMONi-6/AK112-306) evaluating ivonescimab, its independently developed PD-1/VEGF bispecific antibody (Press release, Akeso Biopharma, FEB 5, 2025, View Source [SID1234650064]). This clinical study, conducted in China, compares ivonescimab in combination with platinum-based chemotherapy to tislelizumab (a PD-1 inhibitor) combined with platinum-based chemotherapy as a first-line treatment for squamous non-small cell lung cancer (sq-NSCLC).

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In addition, several international Phase III clinical trials of ivonescimab are underway. These clinical studies include the HARMONi-3 clinical trial, which compares ivonescimab plus chemotherapy to pembrolizumab plus chemotherapy for the first-line treatment of both sq-NSCLC and non-squamous NSCLC (nsq-NSCLC). This trial is being efficiently led by Summit Therapeutics, Akeso’s global partner for ivonescimab.

The HARMONi-6/AK112-306 trial is one of six registrational/Phase III studies worldwide for ivonescimab for lung cancer. It is also one of six studies where PD-1/L1 inhibitors are used as comparators. This initiative is a critical step in advancing cancer immunotherapy, establishing superior global treatment standards, and exploring the full clinical and commercial potential of ivonescimab within Akeso’s portfolio.

Ivonescimab, in combination with chemotherapy, has already been approved in China for the treatment of EGFR-TKI-resistant, non-squamous NSCLC. The New Drug Application (sNDA) for ivonescimab monotherapy as a first-line treatment for PD-L1-positive NSCLC (in comparison to pembrolizumab) is currently under review and has been granted priority status in China.

As a next-generation, highly efficacious cancer immunotherapy, ivonescimab is also in multiple Phase III studies beyond lung cancer. These studies include ongoing Phase III trials for PD-L1-positive head and neck squamous carcinoma (vs. pembrolizumab), first-line treatment of biliary tract cancer (with chemotherapy vs. durvalumab + chemotherapy), and the first-line treatment of pancreatic cancer. Clinical trials of ivonescimab for the first-line treatment of triple-negative breast cancer, colorectal cancer, hepatocellular carcinoma, ovarian cancer and gastric cancer, are also in progress.

As these studies progress, ivonescimab has the potential to redefine the standard of care in immuno-oncology around the world, with its clinical and commercial potential realized on a global scale.

Data indicates that the annual incidence of advanced, driver gene-negative sq-NSCLC exceeds 520,000 cases, with many patients ineligible for anti-angiogenesis treatments like bevacizumab. While PD-1/L1 inhibitors combined with chemotherapy have become the global standard of care, including in the U.S. and China, the prognosis for these patients remains poor, highlighting a critical unmet need. Phase III studies show that ivonescimab, targeting both PD-1 and VEGF, offers a synergistic anti-tumor effect with a favorable safety profile. This makes ivonescimab a promising alternative for sq-NSCLC patients who cannot receive bevacizumab due to bleeding risks. Ivonescimab is poised to transform first-line treatment for locally advanced or metastatic sq-NSCLC, providing a safer and more effective immunotherapy option that exceeds current treatment standards.