On August 4, 2025 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported its financial results for the second quarter and six months ended June 30, 2025 (Press release, Castle Biosciences, AUG 4, 2025, View Source [SID1234654725]).

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"Following a strong first quarter, our team closed out a very successful second quarter that we believe continued to reflect the clinical value our tests provide to clinicians and their patients," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We saw very solid total year-over-year test volume growth in our core revenue drivers, with both DecisionDx-Melanoma and TissueCypher exceeding our volume expectations for the quarter, driving our top-line performance.

"In alignment with our capital allocation priorities and M&A strategy, we closed the Previse tuck-in acquisition and announced an exciting collaboration and license agreement with SciBase, both of which we believe will support our mid- to long-term value creation goals. At the same time, we remain deeply focused on execution across our current test portfolio, which we believe positions us well for continued near-term success. Our ability to invest in the future while advancing our core franchises reflects the strength of our growth initiatives and commitment to delivering sustainable value to our stakeholders."

Second Quarter Ended June 30, 2025, Financial and Operational Highlights
•Revenues were $86.2 million, compared to $87.0 million in the second quarter of 2024. Affecting second quarter 2025 revenue was the Novitas local coverage determination (LCD), Genetic Testing in Oncology: Specific Tests, that included DecisionDx-SCC as noncovered, which became effective April 24, 2025, as well as discontinuation of IDgenetix in May 2025.
•Adjusted Revenues, which exclude the effects of revenue adjustments related to tests delivered in prior periods, were $86.2 million, compared to $86.6 million for the same period in 2024.
•Delivered 26,574 total test reports in the second quarter of 2025, an increase of 6% compared to 25,102 in the same period of 2024. Affecting second quarter 2025 test report volume was the Novitas LCD, Genetic Testing in Oncology: Specific Tests, that included DecisionDx-SCC as noncovered, which became effective April 24, 2025, as well as discontinuation of IDgenetix in May 2025:
◦DecisionDx-Melanoma test reports delivered in the quarter were 9,981, compared to 9,585 in the second quarter of 2024.
◦TissueCypher Barrett’s Esophagus test reports delivered in the quarter were 9,170, compared to 4,782 in the second quarter of 2024.
◦DecisionDx-SCC test reports delivered in the quarter were 4,762, compared to 4,277 in the second quarter of 2024. Affecting second quarter test report volume was the

Novitas LCD, Genetic Testing in Oncology: Specific Tests, that included DecisionDx-SCC as noncovered, which became effective April 24, 2025.
◦MyPath Melanoma test reports delivered in the quarter were 1,166, compared to 1,099 in the second quarter of 2024.
◦IDgenetix test reports delivered in the quarter were 1,027, compared to 4,903 in the second quarter of 2024. The Company discontinued its IDgenetix test offering effective May 2025.
◦DecisionDx-UM test reports delivered in the quarter were 468, compared to 456 in the second quarter of 2024.
•Gross margin was 77%, and Adjusted Gross Margin was 80%, compared to 81% and 83%, respectively, for the same periods in 2024.
•Net cash provided by operations was $20.8 million, compared to net cash provided by operations of $24.0 million for the same period in 2024.
•Net income, which includes non-cash stock-based compensation expense of $11.2 million, was $4.5 million, compared to net income of $8.9 million for the same period in 2024.
•Net income per share and Adjusted Net Income per Share, Basic and Diluted, was $0.16 and $0.15, respectively, compared to $0.32 and $0.31, respectively, for the same period in 2024.
•Adjusted EBITDA was $10.4 million, compared to $21.5 million for the same period in 2024.

Six Months Ended June 30, 2025, Financial and Operational Highlights

•Revenues were $174.2 million, a 9% increase compared to $160.0 million during the same period in 2024. Affecting six months ended June 30, 2025 revenue was the Novitas LCD, Genetic Testing in Oncology: Specific Tests, that included DecisionDx-SCC as noncovered, which became effective April 24, 2025, as well as discontinuation of IDgenetix in May 2025.

•Adjusted Revenues, which exclude the effects of revenue adjustments related to tests delivered in prior periods, were $176.2 million, an 11% increase compared to $159.0 million for the same period in 2024.
•Delivered 50,976 total test reports in the six months ended June 30, 2025, an increase of 11% compared to 45,990 in the same period of 2024. Affecting six months ended June 30, 2025 test report volume was the Novitas LCD, Genetic Testing in Oncology: Specific Tests, that included DecisionDx-SCC as noncovered, which became effective April 24, 2025, as well as discontinuation of IDgenetix in May 2025:
◦DecisionDx-Melanoma test reports delivered in the six months ended June 30, 2025, were 18,602, compared to 17,969 for the same period in 2024.
◦TissueCypher Barrett’s Esophagus test reports delivered in the six months ended June 30, 2025, were 16,602, compared to 8,211 for the same period in 2024.
◦DecisionDx-SCC test reports delivered in the six months ended June 30, 2025, were 9,137, compared to 7,854 for the same period in 2024. Affecting six months ended June 30, 2025 volume was the Novitas LCD, Genetic Testing in Oncology: Specific Tests, that included DecisionDx-SCC as noncovered, which became effective April 24, 2025.
◦MyPath Melanoma test reports delivered in the six months ended June 30, 2025, were 2,092, compared to 2,097 for the same period in 2024.
◦IDgenetix test reports delivered in the six months ended June 30, 2025, were 3,605, compared to 8,981 for the same period in 2024. The Company discontinued its IDgenetix test offering effective May 2025.
◦DecisionDx-UM test reports delivered in the six months ended June 30, 2025, were 938, compared to 878 for the same period in 2024.
•Gross margin for the six months ended June 30, 2025, was 63%, and Adjusted Gross Margin was 81%.
•Net cash provided by operations was $14.8 million, compared to $17.2 million net cash provided by operations for the same period in 2024.
•Net loss, which includes non-cash stock-based compensation expense of $22.4 million, was $21.3 million, compared to net income of $6.4 million for the same period in 2024.
•Net loss per share, Basic and Diluted, was $0.74 and Adjusted Net Loss per Share, Basic and Diluted, was $0.04, compared to Net income per share and Adjusted Net Income per Share, Basic and Diluted, of $0.23 and $0.22, respectively, for the same period in 2024.
•Adjusted EBITDA was $23.4 million, compared to $32.1 million for the same period in 2024.
Cash, Cash Equivalents and Marketable Investment Securities
As of June 30, 2025, the Company’s cash, cash equivalents and marketable investment securities totaled $275.9 million.
2025 Outlook
Castle Biosciences is raising its guidance for anticipated total revenue in 2025. The Company now anticipates generating between $310-320 million in total revenue in 2025, compared to the previously provided guidance of between $287-297 million.

Second Quarter and Recent Accomplishments and Highlights

Dermatology
•DecisionDx-Melanoma: DecisionDx-Melanoma test has been granted Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). The FDA grants Breakthrough Device designation to select qualifying devices that may offer improved treatment or diagnosis of life-threatening or irreversibly debilitating diseases when compared to currently available alternatives. The Breakthrough Devices Program is intended to provide patients and healthcare providers with timely access to medical devices by speeding up development, assessment and review. See the Company’s news release from July 23, 2025, for more information.
•DecisionDx-Melanoma: Prior studies have shown that clinicians use DecisionDx-Melanoma to inform both avoiding sentinel lymph node biopsy procedures in low-risk patients and initiation of surveillance imaging and referrals to medical oncology in high-risk patients, which enables early detection of recurrences and initiation of therapy. Early detection has been shown to improve outcomes to a greater extent when therapy is initiated with smaller metastatic burden, which can improve net health outcomes. The Company presented novel research as part of Castle’s ongoing collaboration with the NCI’s SEER Program Registries at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The study presented an updated matching of patients who received DecisionDx-Melanoma as part of their clinical care to those who did not. In this large, real-world cohort of 13,560 patients with CM – the largest real-world study of gene expression profile testing to date – the DecisionDx-Melanoma was associated with a 32% reduction in mortality risk compared to untested patients, providing further evidence of the test’s association with improved patient survival. Additionally, test performance on independent risk stratification was re-confirmed. See the Company’s news release from May 29, 2025, for more information.
•DecisionDx-SCC: The Company submitted a DecisionDx-SCC reconsideration request for the Novitas LCD and received notification confirming acceptance of the reconsideration submission.
•DecisionDx-SCC: Two new studies were published in SKIN The Journal of Cutaneous Medicine supporting the clinical utility of DecisionDx-SCC in patients with high-risk cutaneous squamous cell carcinoma (SCC). The first study represents a new validation milestone, establishing DecisionDx-SCC as a significant predictor of local recurrence (LR) in patients classified as high-risk by National Comprehensive Cancer Network (NCCN) guidelines, thereby adding a third utility to the test’s existing capabilities. The test has now been validated to predict individual risk of metastasis, benefit from adjuvant radiation therapy (ART) and risk of LR, providing comprehensive results to support tailored post-surgical management and treatment pathway recommendations for patients with SCC. The second study shares results from a clinician survey, affirming the impact of the test’s results in guiding these recommendations, specifically the use of ART and surveillance imaging, by providing actionable decision points based on individual patient risk.
Gastroenterology
•The Company closed its acquisition of Capsulomics, Inc., d/b/a Previse. This acquisition has the potential to increase Castle’s GI offerings. There is the potential to create a multiomics approach for improved patient care in Barrett’s esophagus, as well as a nonendoscopic sample collection device for pipeline opportunities to potentially expand screening and diagnostic support for patients with Barrett’s esophagus and other GI diseases. See the Company’s news release from May 5, 2025, for more information.
Uveal Melanoma
•The Company announced new data from the first independent validation of the recently published Collaborative Ocular Oncology Group Study No. 2 (COOG2.) by Harbour et al. The data, from a real-world cohort of 1,297 patients with uveal melanoma (UM), was presented at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting in Salt Lake City. The findings provided further support for adding Preferentially Expressed Antigen in Melanoma (PRAME) gene expression information to the DecisionDx-UM test result to further refine metastatic risk prediction for patients with UM, which is a rare but aggressive eye cancer. See the Company’s news release from May 9, 2025, for more information.
Pipeline Initiatives
•The Company announced that it entered into a collaboration and license agreement with SciBase Holding AB ("SciBase") utilizing SciBase’s Electrical Impedance Spectroscopy technology, which includes both desktop and point-of-care instruments. The initial goal of the collaboration is to advance the development of a diagnostic test that predicts flares in patients diagnosed with atopic dermatitis (AD), a U.S., market with an estimated up to 24 million patients.1, 2 See the Company’s news release from June 16, 2025, for more information.
Corporate
•The Company announced that its founder, president and chief executive officer Derek Maetzold was awarded a distinguished Lifetime Achievement Award in the Management: Business Products Industries category in the 23rd Annual American Business Awards. The American Business Awards recognizes outstanding business performances in the United States, with more than 3,600 nominations from organizations of all sizes submitted this year for consideration in a wide range of categories. See the Company’s news release from June 4, 2025, for more information.
•The Company announced that it earned multiple awards through the 2025 Top Workplaces program: a third consecutive national Healthcare Industry Top Workplaces award, with Castle ranking third among other recognized companies in its size bracket; a fourth consecutive regional Arizona Top Workplaces award from AZ Central; and consecutive national Top Workplaces Culture Excellence awards for Innovation, Work-Life Flexibility, Compensation & Benefits, Leadership and Purpose & Values. Top Workplaces award designations are garnered solely through anonymous employee feedback gathered through a third-party survey administered by Energage. The confidential survey measures the workplace experience and various culture themes that are indicative of successful organizations. See the Company’s news release from July 17, 2025, for more information.
•The Company announced that Maetzold was also named a 2025 Most Admired CEO by the Houston Business Journal. This prestigious honor celebrates leaders who have demonstrated outstanding financial stewardship, fostered inclusive and thriving workplace cultures, and made meaningful contributions to the greater Houston community. See the Company’s news release from July 25, 2025, for more information.

Conference Call and Webcast Details
Castle Biosciences will hold a conference call on Monday, August 4, 2025, at 4:30 p.m. Eastern time to discuss its second quarter 2025 results and provide a corporate update.

A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website, View Source Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until August 25, 2025.

To access the live conference call via phone, please dial 833 470 1428 from the United States, or +1 404 975 4839 internationally, at least 10 minutes prior to the start of the call, using the conference ID 638217.

There will be a brief Question & Answer session following management commentary.

On August 4, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that its global, multicenter, randomized Phase II registrational trial (COMPASSION-36/AK104-225) has been approved to initiate by both China’s National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) (Press release, Akeso Biopharma, AUG 4, 2025, View Source [SID1234654739]). The trial will evaluate cadonilimab, Akeso’s first-in-class PD-1/CTLA-4 bispecific antibody, in combination with lenvatinib versus lenvatinib alone for the treatment of advanced hepatocellular carcinoma (HCC) in patients previously treated with atezolizumab (a PD-L1 inhibitor) and bevacizumab. Akeso is now moving forward with the initiation of the study.

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The COMPASSION-36/AK104-225 study is a key part of cadonilimab’s global development for hepatocellular carcinoma, continuing Akeso’s mission to advance cancer immunotherapy standards and to address the current limited survival benefits of single-target therapies. This international, multicenter Phase II trial is designed to tackle the common issue of limited treatment options following resistance to immune checkpoint inhibitors (IO) in cancer therapy.

Currently, immune checkpoint inhibitor (IO) combination therapies have become the standard first-line treatment for various advanced malignancies. However, for patients worldwide whose disease progresses after IO combination therapy, there is a lack of effective second-line treatment options. The very limited second-line treatment options for advanced malignancies drives the critical need to explore new therapeutic strategies. Cadonilimab-based combination therapies have shown substantial potential in overcoming IO resistance across multiple tumor types.

Hepatocellular carcinoma (HCC) is one of the most prevalent malignancies worldwide, with approximately 865,000 new cases of liver cancer reported globally in 2022. The combination of atezolizumab and bevacizumab (A+T regimen) is the standard first-line therapy for advanced HCC, as recommended by the NCCN guidelines. However, for patients whose disease progresses after first-line A+T treatment, there is currently no FDA-approved second-line therapy available in the U.S., and also no approved treatment options from the NMPA in China. This creates a significant unmet need in the clinical management of these patients.

Cadonilimab is the first bispecific antibody for cancer immunotherapy to be approved globally and also the first bispecific antibody to be approved in China. The potential of cadonilimab for the treatment of HCC has been validated in multiple studies：

At the 2023 European Society for Medical Oncology Asia Congress (ESMO Asia), a study was presented demonstrating that cadonilimab, combined with FOLFOX-HAIC as neoadjuvant therapy, achieved a 100% disease control rate (DCR) in patients with resectable multinodular HCC, with an acceptable safety profile.
Additionally, data presented at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress revealed that the combination of cadonilimab and lenvatinib as first-line treatment for advanced HCC shows superior antitumor activity compared to currently approved therapies for advanced HCC.
Akeso’s exploration of combination therapies with cadonilimab in the treatment of HCC offers a broad and effective approach to disease management. These combinations address both early and advanced stages of HCC and provide promising therapeutic options for a wide range of patients:

In addition to the international multicenter Phase II registrational study COMPASSION-36, patient enrollment for the Phase III clinical trial of cadonilimab as adjuvant therapy for high-risk recurrence following curative surgery for HCC has been completed.
Furthermore, a Phase III registrational study of cadonilimab combined with lenvatinib and transarterial chemoembolization (TACE) for the treatment of intermediate to advanced unresectable HCC is currently ongoing.
Additionally, multiple Phase II studies investigating cadonilimab in combination with pulocimab (VEGFR-2), ivonescimab (PD-1/VEGF), and other therapies are currently underway for PD-1/L1 inhibitor-resistant non-small cell lung cancer (NSCLC), HCC, and other malignancies. These studies demonstrate cadonilimab’s potential in treating IO-resistant tumors.
Dr. Yu Xia, Founder, Chairwoman, President, and CEO of Akeso, remarked, "We are excited to initiate cadonilimab’s first international multicenter registrational trial, a pivotal step in addressing the global challenge of cancer immunotherapy resistance. This study represents a key milestone in Akeso’s global strategy to address the substantial clinical unmet needs in oncology. Akeso is advancing the clinical development of its innovative pipeline, including ivonescimab, cadonilimab, ligufalimab (CD47), and AK146D1 (Trop2/Nectin4 bispecific ADC) through both in-house initiatives and strategic global collaborations. Our goal is to provide accessible and impactful survival benefits to patients worldwide, and to position Akeso at the forefront of oncology innovation."

On August 1, 2025 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported that it has selected standard fludarabine and cyclophosphamide (FC) as the lymphodepletion regimen to be used in its ALPHA3 study evaluating cemacabtagene ansegedleucel (cema-cel) in first-line consolidation for large B-cell lymphoma (LBCL) (Press release, Allogene, AUG 1, 2025, View Source [SID1234654703]). This lymphodepletion regimen selection was made in conjunction with the ALPHA3 Data and Safety Monitoring Board (DSMB) and Steering Committee and following consultation with the U.S. Food and Drug Administration (FDA).

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The arm testing FC plus ALLO-647, an anti-CD52 mAb (FCA), is now closed to further enrollment. This decision, made ahead of the scheduled futility analysis, was prompted by a Grade 5 adverse event in the FC plus ALLO-647 arm that has been attributed to the use of ALLO-647. The event occurred on Day 54 post-infusion from hepatic failure, believed to have resulted from disseminated adenovirus infection in the setting of immune suppression. This event was deemed unrelated to cema-cel. Severe viral infections have been rare across Allogene’s clinical trials. However, when present, they have been attributed to immunosuppression due in part to ALLO-647. There have been no cases of adenoviral infection or hepatic failure in any participant treated with FC lymphodepletion across Allogene’s trials.

"The loss of a patient is always deeply saddening, and we extend our heartfelt condolences to the patient’s family," said David Chang, M.D., Ph.D., President, Chief Executive Officer, and Co-Founder of Allogene. "This event, which prompted an early review of the trial data, compelled us to make a decisive choice – one that may ultimately help bring this potentially life-saving therapy to patients more quickly. The ability to administer cema-cel following standard FC lymphodepletion in an outpatient setting will simplify study treatment and has the potential to accelerate trial enrollment and streamline regulatory review, ultimately transforming care for patients."

The adoption of standard FC in the ALPHA3 trial marks a key shift in Allogene’s clinical strategy. As a result, no trials open to enrollment or pipeline programs include ALLO-647. Instead, the Company is advancing its next-generation AlloCAR T product candidates using the proprietary Dagger Platform Technology, which is designed to minimize or potentially eliminate the need for standard lymphodepletion. This approach is showcased in the ALLO-316 TRAVERSE trial for advanced renal cell carcinoma and the ALLO-329 RESOLUTION trial for autoimmune diseases, both of which leverage the Dagger Technology to reduce reliance on traditional lymphodepletion strategies.

The amended ALPHA3 trial now proceeds as a randomized study with two arms, comparing cema-cel after standard FC lymphodepletion to observation, the current standard of care. Statistical design of the trial and the prespecified study conduct remain the same. The next milestone will be the futility analysis comparing MRD conversion and is expected to occur 1H 2026. To date, over 50 clinical sites are activated across the United States and Canada, including community cancer centers and major academic institutions.

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 8:00 a.m. PT / 11:00 a.m. ET to discuss this recent update. If you would like the option to ask a question on the conference call, please use this link to register. Upon registering for the conference call, you will receive a personal PIN to access the call, which will identify you as the participant and allow you the option to ask a question. The listen-only webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

About Cemacabtagene Ansegedleucel (cema-cel)
Cemacabtagene ansegedleucel, or cema-cel, is a next generation anti-CD19 AlloCAR T investigational product for the treatment of large B cell lymphoma (LBCL). The ALPHA3 pivotal Phase 2 trial in first line (1L) consolidation for the treatment of LBCL launched in June 2024. Allogene has oncology rights to cema-cel in the US, EU and UK with options for rights in China and Japan.

About the ALPHA3 Trial
Over 60,000 patients are expected to be treated for LBCL annually in the US, the EU and the UK. While first line (1L) R-CHOP or other chemoimmunotherapy is effective for most patients, approximately 30% who initially respond will relapse and require subsequent treatment. The current standard of care after 1L treatment has been simply to "watch and wait" to see if the disease relapses. The pivotal Phase 2 ALPHA3 study takes advantage of cema-cel as a one-time, "off-the-shelf" treatment that can be administered immediately upon discovery of MRD following six cycles of R-CHOP or other chemoimmunotherapy, positioning it to become the standard "7th cycle" of frontline treatment available to all eligible patients with MRD.

On August 1, 2025 I-Mab (NASDAQ: IMAB) (the Company), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, reported the pricing of an underwritten offering in the United States of 33,333,334 American Depositary Shares (ADSs) representing 76,666,668 ordinary shares at an offering price of $1.95 per ADS, for total gross proceeds of approximately $65 million (Press release, I-Mab Biopharma, AUG 1, 2025, View Source [SID1234654726]). All of the ADSs to be sold in the offering will be offered by I-Mab. The offering is expected to close on August 5, 2025, subject to customary closing conditions.

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The offering included participation from new and existing investors including Everest Medicines, Janus Henderson Investors, Adage Capital Partners LP and Exome Asset Management.

Leerink Partners is acting as the lead bookrunning manager. BTIG is acting as a bookrunning manager. Lucid Capital Markets is acting as lead manager.

The Company intends to use the net proceeds from the offering, together with its existing cash and cash equivalents, to fund ongoing clinical development of its pipeline product candidates, including a randomized Phase 2 trial of givastomig, a bispecific Claudin 18.2 x 4-1BB antibody, intended to have sufficient power and size to generate clinically meaningful progression-free survival (PFS) data by end of 2027, and for working capital and other general corporate purposes.

The ADSs are being offered pursuant to an effective F-3 shelf registration statement that was previously filed with the Securities and Exchange Commission (the SEC). A prospectus supplement will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. Copies of the prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, for free from Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected].

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

On August 1, 2025 Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, reported that it has entered into a securities purchase agreement with certain established institutional investors for a private placement of equity securities (PIPE) (Press release, Kazia Therapeutics, AUG 1, 2025, View Source [SID1234654704]). Pursuant to the securities purchase agreement, the Company agreed to offer and sell to an aggregate of approximately $2.0 million of ordinary shares and prefunded warrants. The securities being sold in the PIPE are priced at a 5% premium to the closing price of Kazia’s ADSs on July 31, 2025. The PIPE is structured as a straightforward equity investment with no common warrant coverage. The transaction is expected to close on Monday, August 4, 2025, subject to customary closing conditions.

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The Company estimates that the net proceeds to the Company from the PIPE will be approximately $2 million, after deducting estimated offering expenses. The Company intends to use the net proceeds from this offering to support the continued clinical development of its lead programs, including paxalisib, a brain-penetrant dual PI3K/mTOR inhibitor currently in clinical trials for both brain cancer and advanced breast cancer, and EVT801, a selective VEGFR3 inhibitor, and for general corporate purposes.

"This transaction provides Kazia with additional capital to advance our clinical-stage assets through key near-term catalysts most notably additional data from our ongoing advanced breast cancer trial," said Dr. John Friend, CEO of Kazia Therapeutics. "We are grateful for the continued support of our investors and look forward to delivering updates on upcoming milestones."

The securities sold in this PIPE are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws, and may not be offered or sold in the United States absent an effective registration statement or an applicable exemption from registration requirements. Pursuant to the securities purchase agreement, the Company has agreed to file a shelf registration statement with the U.S. Securities and Exchange Commission (SEC) within 60 days of the closing to register the resale of ADSs representing the ordinary shares and those underlying the pre-funded warrants.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. Any offering of the securities described above under the resale registration statement will only be by means of a prospectus.