Entry into a Material Definitive Agreement

As previously disclosed in the Aptose Biosciences Inc.’s (the "Company") current report on Form 8-K filed August 30, 2024, the Company and Hanmi Pharmaceutical Co., Ltd. ("Hanmi") reported to have entered into a facility agreement on August 27, 2024 (the "Facility Agreement") whereby Hanmi agreed to loan certain amounts to the Company (the amounts loaned are referred to herein as the "Indebtedness Amount") (Filing, 8-K, Aptose Biosciences, MAR 24, 2025, View Source [SID1234651362]). On March 18, 2025, the Company entered into a debt conversion and interest payment agreement ("Debt Conversion Agreement") with Hanmi pursuant to which the Company and Hanmi agreed to convert $1,513,533.10 of the Indebtedness Amount, into 409,063 common shares (the "Conversion Shares") at $3.70 per share which is the average closing price of the Company’s common shares on Nasdaq for the five trading days immediately prior to entering into the Debt Conversion Agreement which such price being equal to Nasdaq’s "Minimum Price" as defined in Nasdaq’s Listing Rule 5635(d). The Company and Hanmi agreed that without prejudice with respect to interest payments owed to Hanmi as set forth in the Facility Agreement for the period commencing on December 21, 2024 and ending on March 31, 2025 (the "Interest Payments") that the Interest Payments may be made on before the final closing date of the Capital Raise (as defined in the Debt Conversion Agreement) and shall not be considered an event of default under the Facility Agreement is such interest payments are made no later than June 27, 2025. The Debt Conversion Agreement reiterated that failure to pay the Interest Payments would constitute an event of default under the Facility Agreement.

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The Debt Conversion Agreement also provides that additional conversions of Indebtedness Amount will be available in Hanmi’s discretion after the completion of the Capital Raise subject to certain additional conditions, including, but not limited to, Hanmi’s ownership threshold not exceeding 19.99%.

Investor’s Rights Agreement

In connection with the Debt Conversion Agreement, the Company and Hanmi entered into a Second Amended and Restated Investor’s Rights Agreement (the "Investor Rights Agreement"), which amends and restates the Amended and Restated Investor’s Rights Agreement entered by the parties on January 25, 2024. The Investor Rights Agreement provides, among other things, that Hanmi shall benefit from Rule 144 of the U.S. Securities Act of 1933, as amended ("Rule 144"), such as receiving from the Company a written statement that it has complied with the requirements of Rule 144 and other such information that may be reasonably requested by Hanmi so that it may sell its securities pursuant to Rule 144 without registration. So long as Hanmi owns at least 10% of the Company’s issued and outstanding common shares, Hanmi will have the right to designate for employment one or more individuals that are legally able to work in the United States or Canada (each, an "Hanmi Nominee") to a position or positions within the Company in applicable areas based on each Hanmi Nominee’s skills, education and experience. The parties agreed that the Hanmi Nominee shall be subject to the Company’s usual employment rules, practices, policies, evaluation procedures, as amended from time to time and the Company shall retain the right, in its sole discretion, to terminate such Hanmi Nominee’s appointment with the Company for violations of the Company’s employment rules, practices, policies and procedures. The parties also agreed that the Hanmi Nominee shall be entitled to salary, bonus, vacation, incentive payments and bonuses, expenses, allowances and any applicable benefits in amounts and to the extent consistent with employees of the Company serving or having recently served in a similar capacity with the Company with such amounts to be reimbursed to the Company by Hanmi. In the event that a visa or other permit is required to be obtained to permit the Hanmi Nominee to work in the United States or Canada the parties agreed that the Company would use its commercially reasonable efforts to assist the Hanmi Nominee with obtaining such visa or permit. The parties agreed that upon the nomination of the Hanmi Nominee that the parties would enter into a separate service agreement to outline the specific terms and conditions of the Hanmi Nominee’s appointment.

The Investor Rights Agreement also provides for customary demand and piggyback registration rights to Hanmi. Among other things, Hanmi is entitled to four (4) demand registrations where Hanmi can require the Company to register on a registration statement the common shares it has received in prior issuances, including pursuant to the Debt Conversion Agreement, and common shares issuable upon the exercise of the warrants under which Hanmi is entitled to purchase up to an additional 77,972 common shares. Hanmi was also granted piggyback registration rights where if the Company proposes to file a registration statement, Hanmi, at the Company’s own cost and expense can have such common shares included on that registration statement on the same term and conditions as any similar securities of the Company. Further, upon Hanmi’s request, the Company must provide inspection rights for Hanmi to access the Company’s books and records, and to the Company’s management to the extent that such access to management does not materially interfere with the operations of the Company.

The foregoing is only a summary of the Debt Conversion Agreement and Investor’s Rights Agreement, and does not purport to be complete descriptions. The summaries of the Debt Conversion Agreement and Investor’s Rights Agreement are qualified in their entirety by reference to the Debt Conversion Agreement and Investor’s Rights Agreement, which are attached hereto as Exhibit 10.1 and Exhibit 10.2 respectively, and are incorporated herein by reference.

Entry into a Material Definitive Agreement

On March 18, 2025, HCW Biologics Inc. (the "Company") and WY Biotech Co., Ltd. ("WY Biotech") reported to have agreed to amend their License, Research and Co-Development Agreement ("Agreement") dated November 17, 2024, due to a delay in WY Biotech coming to a definitive agreement with their designated contract development and manufacturing organization ("CDMO") (Filing, 8-K, HCW Biologics, MAR 18, 2025, View Source [SID1234651256]). Specifically, in order to accommodate that delay, the parties agreed to restructure the payment schedule for the $7.0 million upfront license fees, including delaying the initial $4.0 million portion thereof that was originally due on or about March 17, 2025, to reduce the performance milestones that the Company must complete in order to earn the full $7.0 million nonrefundable upfront payments in June 2025, and to provide that either party may terminate the Agreement if WY Biotech is not able to definitively engage its CDMO by June 2025. There were no other material changes to the Agreement, which involves the grant to WY Biotech of an exclusive, world-wide license to use and apply HCW11-006 for in vivo applications. In particular, the Company will retain the Opt-In Right thereunder, which gives the Company the option to assume all control and responsibility for the development, manufacture and commercialization of HCW11-006 for in vivo applications in the North America, South America, and Central America. The foregoing summary of certain terms of the Agreement and the referenced amendment does not purport to be complete.

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Sofinnova Partners and Gustave Roussy launch first biotech company through Strategic Partnership

On March 18, 2025 Sofinnova Partners, a leading European life sciences venture capital firm, in collaboration with Gustave Roussy, Europe’s leading cancer center, reported the creation of their first pioneering biotech company (Press release, Institut Gustave Roussy, MAR 18, 2025, View Source [SID1234651246]).

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Signadori Bio, developed with scientific founders Dr. Jean-Luc Perfettini and Professor Nathalie Chaput, is a breakthrough cell therapy platform focused on transforming cancer treatment. This milestone marks a significant achievement in their strategic partnership, aimed at accelerating biotech innovation through rigorous evaluation and development of scientific research.

Since the partnership’s inception in 2023, it has rigorously evaluated 50 promising projects. This has culminated in the creation of a groundbreaking biotech venture in the cell and gene space that is set to advance innovative approaches in oncology. More information will be released as the company comes out of stealth later this year. Additionally, several other promising projects are in the pipeline, showcasing the immense potential for future breakthroughs in cancer therapeutics.

"With cancer on the rise, particularly among younger populations, it’s critical that we fast-track the most promising scientific breakthroughs into tomorrow’s treatments. This partnership is a powerful example of how academia and investors can work together to drive innovation through new companies," said Professor Fabrice Barlesi, General Director of Gustave Roussy. "Gustave Roussy is at the forefront of cancer discovery. With Sofinnova’s expertise in company creation, we are now able to quickly translate these innovations into real-world therapies to benefit patients worldwide."

Matthieu Coutet, Partner at Sofinnova Partners and CEO of Signadori Bio, added: "Turning cutting-edge research into biotech success stories requires more than financing or scientific excellence—it demands the right ecosystem. By combining Gustave Roussy’s research power with Sofinnova’s proven ability to build and scale biotech ventures, we’re creating a direct path from lab to the clinic."

As these ventures progress, Sofinnova Partners and its academic collaborators remain committed to fostering the next generation of biotech companies and driving innovation in cancer therapeutics. This groundbreaking initiative, supported by Sofinnova’s Biovelocita II—a €165M biotech acceleration fund dedicated to identifying and developing cutting-edge scientific advancements from top institutes like Gustave Roussy. This effort is undertaken in close collaboration with the institute’s technology transfer office, Gustave Roussy Transfert.

NeoGenomics Appoints Warren Stone as President & Chief Operating Officer

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.

Aadi Bioscience Relaunches as Whitehawk Therapeutics Marking Evolution into ADC Company

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.