On March 18, 2025 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported financial and operating results for the fourth quarter and full year ended December 31, 2024 (Press release, Olema Oncology, MAR 18, 2025, View Source [SID1234651228]).

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"2024 was a productive year for Olema and we closed the year with significant positive momentum. We announced a new clinical trial collaboration and supply agreement with Novartis, raised approximately $250 million through an equity private placement with high-quality, long-term investors, presented compelling data supporting palazestrant in combination with ribociclib at SABCS, received clearance from the FDA for our IND application for OP-3136, and moved quickly to begin enrolling patients in the OP-3136 Phase 1 study before the end of the year," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Bolstered by a strong balance sheet, we are focused on exemplary execution throughout 2025. We plan to advance patient enrollment in the pivotal Phase 3 OPERA-01 trial in second- and third-line ER+/HER2- metastatic breast cancer, initiate our second pivotal Phase 3 trial, called OPERA-02, in frontline metastatic breast cancer, continue enrolling patients in the Phase 1 trial of OP-3136, present mature data from the Phase 1b/2 trial of palazestrant in combination with ribociclib, and further expand our capabilities through drug discovery and partnerships – all to help patients living with cancer feel better, longer."

Recent Progress

Presented new preclinical data demonstrating anti-tumor activity for palazestrant in combination with capivasertib and everolimus as well as new preclinical data for OP-3136 as a single agent and in combination with palazestrant and other targeted agents at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics in October.
Announced a new clinical trial collaboration and supply agreement with Novartis in frontline metastatic breast cancer.
Successfully completed a $250 million equity private placement with new and existing institutional and accredited investors.
Announced intention to proceed with OPERA-02, the Company’s second pivotal Phase 3 trial, of palazestrant in combination with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor ribociclib in frontline metastatic breast cancer.
Presented updated clinical results from the ongoing Phase 1b/2 study of palazestrant in combination with ribociclib in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer at the San Antonio Breast Cancer Symposium (SABCS) in December. Presented updated median progression-free survival (mPFS) from this trial at the TD Cowen 45th Annual Health Care Conference in March 2025.
Received clearance from the U.S. Food and Drug Administration (FDA) for the Investigational New Drug (IND) application for OP-3136.
Initiated the Phase 1 clinical trial for OP-3136 and began enrolling patients before year-end.
Anticipated Upcoming Events

Advance patient accrual in the pivotal Phase 3 OPERA-01 clinical trial of palazestrant as a monotherapy in second- and third-line (2/3L) metastatic breast cancer; top-line data are anticipated in 2026.
Initiate the pivotal Phase 3 OPERA-02 clinical trial of palazestrant in combination with ribociclib in frontline metastatic breast cancer.
Present new preclinical data for OP-3136.
Present mature data from the Phase 1b/2 clinical trial of palazestrant in combination with ribociclib at a medical meeting.
Fourth Quarter and Full Year 2024 Financial Results
Cash, cash equivalents, and marketable securities as of December 31, 2024, were $434.1 million.

Net loss for the quarter and year ended December 31, 2024 was $33.6 million and $129.5 million, respectively, as compared to $26.8 million and $96.7 million for the quarter and year ended December 31, 2023, respectively. The increase in net loss for the fourth quarter was primarily related to increased spending on clinical development and research activities as a result of late-stage clinical trials for palazestrant, the advancement of OP-3136, and lower interest income earned from marketable securities.

GAAP research and development (R&D) expenses were $32.3 million and $124.5 million for the quarter and year ended December 31, 2024, respectively, as compared to $25.9 million and $86.1 million for the quarterand year ended December 31, 2023. The increase in R&D expenses was primarily related to increased spending on clinical operations and development-related activities as the Company continues to advance palazestrant through late-stage clinical trials, research-related activities associated with the advancement of OP-3136, and personnel related costs, including an increase in non-cash stock-based compensation expense.

Non-GAAP R&D expenses were $27.7 million and $108.0 million for the quarter and year ended December 31, 2024, respectively, excluding $4.6 million and $16.5 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $23.0 million and $74.4 million for the quarter and year ended December 31, 2023, respectively, excluding $2.9 million and $11.8 million non-cash stock-based compensation expense, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

GAAP G&A expenses were $4.5 million and $17.7 million for the quarter and year ended December 31, 2024, respectively, as compared to $4.5 million and $18.8 million for the quarter and year ended December 31, 2023. The decrease in G&A expenses was primarily due to decreased spending on corporate-related costs, offset by an increase in non-cash stock-based compensation expense.

Non-GAAP G&A expenses were $2.8 million and $11.7 million for the quarter and year ended December 31, 2024, respectively, excluding $1.7 million and $6.0 million non-cash stock-based compensation expense, respectively. Non-GAAP G&A expenses were $3.1 million and $13.3 million for the quarter and year ended December 31, 2023, excluding $1.4 million and $5.5 million non-cash stock-based compensation expense, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

On March 18, 2025 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), formerly known as Aadi Bioscience, Inc., an oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved cancer treatments, reported it changed its name to Whitehawk Therapeutics, reflecting the Company’s evolution and focus on accelerating its portfolio of antibody drug conjugates (ADCs) with speed, agility and precision (Press release, Aadi Bioscience, MAR 18, 2025, View Source [SID1234651244]). The Company’s common stock will begin trading under the ticker "WHWK" effective March 19, 2025.

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The three assets in the portfolio are in-licensed from WuXi Biologics and utilize HANGZHOU DAC’s advanced ADC technology platform, which consists of a highly stable yet cleavable linker that delivers a Topoisomerase I (TOPO1) inhibitor payload. The platform is coupled with clinically validated tumor targets that are upregulated in high-potential cancer indications, including lung and ovarian. These assets are engineered to produce minimal off-target toxicity, with a higher therapeutic index and greater stability than first-generation predecessors.

"Today marks a transformative moment as we reintroduce ourselves as Whitehawk Therapeutics – a focused oncology company combining science, strategy and execution to swiftly advance our portfolio of promising ADC assets," said David Lennon, President and CEO, Whitehawk Therapeutics. "By leveraging the foundation of well-established tumor biology and integrating cutting-edge technologies, our strategy is designed to address the challenges of treating the most difficult cancers efficiently and effectively. Our goal is to bring all three assets to IND in the next 15 months. Importantly, we believe our robust balance sheet will enable us to see these three assets through early clinical inflections. We are invigorated by the opportunity we have to overcome the limitations of first-generation ADCs to make a meaningful impact for patients."

Recent Operational Highlights:

All proposals were approved at the Company’s Special Meeting of Stockholders on February 28, 2025. Subsequently, the $100 million PIPE financing closed. The closing of the divestiture of Aadi Subsidiary, Inc. ("Aadi Sub") to Kaken Pharmaceuticals ("Kaken") is pending.

Aadi Bioscience divided into two organizations. Upon the divestiture of Aadi Sub to Kaken, Kaken will assume ownership of Aadi Sub, including the Aadi name, trademark and the FYARRO business. As of March 18, 2025, the Aadi parent company has become Whitehawk Therapeutics, with a focus on its portfolio of ADC assets.
Fourth Quarter and Full-year 2024 Financial Results:

Cash, cash equivalents and short-term investments as of December 31, 2024, were $47.2 million as compared to $108.8 million as of December 31, 2023.

Following closing of the strategic transactions, we expect to have cash and cash equivalents in the range of $170 million to $180 million, including the payment of the upfront and early milestones under the Wuxi ADC agreement.

Total revenue for the quarter ended December 31, 2024, was $7.2 million, and $26.0 million for the full-year ended December 31, 2024, resulting from sales of FYARRO.

Net loss for the three months ended December 31, 2024, was $18.3 million as compared to $16.3 million for the three months ended December 31, 2023. Net loss for the full-year ended December 31, 2024, was $63.7 million, as compared to $65.8 million for the same period in 2023.
About the ADC Portfolio

HWK-007 represents a differentiated opportunity to potentially be among the first next-wave ADCs in clinical development for high PTK7 expressing cancers. HWK-007 is being evaluated in IND-enabling studies. The Phase 1 trial is planned in non-small cell lung cancer and platinum resistant ovarian cancer, with potential to expand into novel indications (e.g. gastrointestinal, gynecological).

HWK-016 is the first ADC that targets the membrane-bound portion of MUC16, a glycoprotein often overexpressed in cancers of female origin. HWK-016 is currently being evaluated in IND-enabling studies. The Phase 1 trial is planned in ovarian cancer, with potential to expand into additional indications (e.g. endometrial, cervical).

HWK-206 is designed to address the neuronal target, SEZ6, which is often overexpressed in cancers of neuroendocrine origin. HWK-206 utilizes a dual epitope binding, or biparatopic, approach which can potentially improve internalization and effectiveness of the ADC. HWK-206 is currently in candidate selection. The Phase 1 trial is planned in small-cell lung cancer and neuroendocrine neoplasms, where there are limited treatment options.
Conference Call Information

The Whitehawk management team is hosting a conference call and webcast tomorrow at 8:30 am ET (5:30 am PT) to provide a corporate update and discuss results for the fourth quarter and full-year 2024.

Participants may access a live webcast of the call and the associated slide presentation on the "Investors & News" page of the Whitehawk Therapeutics website at whitehawktx.com. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

On March 18, 2025 Purple biotech presented its corporate presentation (Presentation, Purple Biotech, MAR 18, 2025, View Source [SID1234651229]).

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On March 18, 2025 NeoGenomics, Inc. ("NeoGenomics" or the "Company") (NASDAQ:NEO), a leading provider of oncology diagnostic solutions that enable precision medicine, reported that it has promoted Warren Stone, the Company’s current Chief Commercial Officer (CCO), to President & Chief Operating Officer, effective April 1, 2025 (Press release, NeoGenomics Laboratories, MAR 18, 2025, View Source [SID1234651245]).

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Mr. Stone has over 25 years of general management and cross-functional commercial experience. In his expanded role, he will be responsible for driving the Company’s lab operations, data solutions division and enterprise operations functions, while maintaining his overall existing commercial responsibilities – including clinical, pharma, marketing and product management functions, and customer service initiatives. Melody Harris, the Company’s current Chief Operations Officer, will depart NeoGenomics at the end of May.

"Since joining NeoGenomics in November 2022, Warren has played an integral role in shaping the Company’s long-term growth strategy by instilling rigor and accountability throughout our commercial organization and advanced our critical business initiatives. This has resulted in eight consecutive quarters of double-digit revenue growth for the Clinical division and affirmed a leadership position in the cancer marketplace," said Chris Smith, CEO of NeoGenomics. "We are grateful to Melody for her many contributions to NeoGenomics and wish her the very best in her next endeavor."

"I am excited to continue working closely with Warren in his new role. The alignment of our commercial and operations teams increases agility and enables us to further leverage our portfolio and the selling channel, as we focus on driving innovation through research & development and business development opportunities," said Tony Zook, incoming CEO. "We have a strong leadership team in place with diverse and complementary skills and experience. Together, we look forward to accelerating our strategy to drive growth and profitability in line with our long-range plan while focusing on delivering an exceptional experience for patients and providers."

Beth Eastland, NeoGenomics’ Senior Vice President, Enterprise Sales, will support Mr. Stone in his new role and assume day-to-day responsibility for all enterprise sales functions. Prior to joining NeoGenomics in 2024, Ms. Eastland was employed by a leading oncology diagnostics provider and has over 35 years of commercial experience in healthcare.

On March 18, 2025 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, reported financial results for the year and quarter ended December 31, 2024, and provided a business update (Press release, Pyxis Oncology, MAR 18, 2025, View Source [SID1234651230]).

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"We are committed to the development of a novel therapy for patients with recurrent or metastatic head and neck squamous cell carcinoma who will progress following platinum-based therapies and prior PD-(L)1 therapy, and those that progress after current and emerging EGFRi therapies," said Lara S. Sullivan, M.D., President and Chief Executive Officer. "We look forward to expanding upon the encouraging safety and efficacy results observed from our Phase 1 trial evaluating micvotabart pelidotin, and we believe targeting Extradomain-B Fibronectin (EDB+FN) will offer a novel approach to addressing the limitations of existing therapies."

"Given the positive micvotabart pelidotin data, it is critical that we ensure the flawless execution of our clinical programs on the fastest possible timeline," said Dr. Sullivan. "To support this goal, we have streamlined our organization to allocate resources in a way that gives us the greatest opportunity to deliver on our mission and bring meaningful therapies to patients who need them most. I am confident that our focused approach will drive value for both patients and shareholders," concluded Dr. Sullivan.

Pipeline Updates

In 2024 the Company established that its lead therapeutic candidate, micvotabart pelidotin (MICVO, formerly referred to as PYX-201), has profound monotherapy effect on multiple tumor types with significant tumor regression demonstrated during the Phase 1 dose escalation study. MICVO is a first-in-concept antibody-drug conjugate antibody-drug conjugate (ADC) that targets EDB+FN, a non-cellular structural component of the tumor extra-cellular matrix.

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Recently reported positive preliminary data from the ongoing Phase 1 dose-escalation trial of micvotabart pelidotin evaluating its safety and efficacy in multiple solid tumor types. In six heavily pretreated HPV-positive and HPV-negative efficacy evaluable patients who had received a median of four prior lines of therapy with R/M HNSCC, micvotabart pelidotin achieved a confirmed 50% objective response rate (ORR) based on RECIST 1.1 criteria, including one complete response and a disease control rate (DCR) of 100%.

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Initiated Part 2 monotherapy expansion cohorts of the ongoing Phase 1 clinical trial to evaluate micvotabart pelidotin in 2L and 3L R/M HNSCC patients who have received prior platinum and PD-1 inhibitor therapy, and 2L and 3L R/M HNSCC patients who have received prior EGFRi and PD-1 inhibitor therapy. Preliminary data from patients who have received prior platinum and PD-1 inhibitor therapy are expected in the second half of 2025 and preliminary data from patients who have received prior EGFRi and PD-1 inhibitor therapy are expected in the first half of 2026. R/M HNSCC continues to be an area of high medical need despite improvements in treatment options.

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Initiated Phase 1/2 combination study of micvotabart pelidotin and Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with R/M HNSCC and other advanced solid tumors. We aim to select a dose of micvotabart pelidotin in combination with pembrolizumab by mid-year 2025 and share preliminary data from the trial in the second half of 2025.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

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Received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for micvotabart pelidotin for the treatment of adult patients with R/M HNSCC whose disease has progressed following treatment with platinum-based chemotherapy and an anti-PD-(L)1 therapy.
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In December 2024, suspended further development of PYX-106 — a fully human IgG1 monoclonal antibody targeting Siglec-15 to allocate resources toward advancing micvotabart pelidotin.
Business Updates

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Pyxis Oncology recently announced a portfolio prioritization, focusing resources on advancing its lead clinical program, micvotabart pelidotin. In connection with the portfolio prioritization, the Company reported it has reduced its workforce by approximately 20%, with a majority of the headcount reductions from the Company’s G&A and preclinical group. In addition, Ken Kobayashi, M.D., F.A.C.P, is stepping down as Chief Medical Officer and Lara S. Sullivan, M.D., President and Chief Executive Officer will assume the role of Chief Medical Officer along with her current role as President and Chief Executive Officer.

Full Year 2024 Financial Results

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As of December 31, 2024, Pyxis Oncology had cash and cash equivalents, including restricted cash, and short-term investments, of $128.4 million. The Company believes that its current cash, cash equivalents, and short-term investments will be sufficient to fund its operations into the second half of 2026.

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Research and development expenses were $58.7 million for the year ended December 31, 2024, compared to $49.6 million for the year ended December 31, 2023. The increase was primarily due to increased clinical trial-related expenses, including manufacturing of drug product and drug substance for Phase 1 clinical trials of micvotabart pelidotin and the recently attrited PYX-106 asset.

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General and administrative expenses were $25.4 million for the year ended December 31, 2024, compared to $32.6 million for the year ended December 31, 2023. The decrease was primarily due to lower employee costs including stock-based compensation and decrease in legal, professional and consulting fees.

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During the fourth quarter of 2024, Pyxis Oncology recorded a non-cash impairment loss of $21.0 million for in-process research and development (IPR&D) intangible asset related to PYX-107, which was acquired by the Company in August 2023 as part of the acquisition of Apexigen. The impairment loss was mainly due to de-prioritization of clinical development of PYX-107. Despite the impairment loss, acquisition of Apexigen remains a net accretive transaction for the Company wherein we received $9.5 million of cash since acquisition from the sale of royalty rights and royalty payments.

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Net loss was $77.3 million, or ($1.32) per common share, for the year ended December 31, 2024, compared to $73.8 million, or ($1.85) per common share, for the year ended December 31, 2023. Excluding non-cash stock-based compensation expense and impairment loss, the net loss for the year ended December 31, 2024, was $43.4 million, compared to net loss of $56.8 million for the year ended December 31, 2023.

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As of March 17, 2025, the outstanding number of shares of Common Stock of Pyxis Oncology was 61,590,415.