On November 19, 2025 FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics" or the "Company"), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, reported it has entered into a definitive purchase agreement for the issuance and sale to an existing shareholder of 3,540,000 shares of its common stock and pre-funded warrants to purchase 8,570,203 shares of its common stock at a purchase price of $0.3303 per share or pre-funded warrant (less $0.00001 for each pre-funded warrant), in a registered direct offering priced at-the-market under Nasdaq rules. The pre-funded warrants are exercisable at any time at an exercise price of $0.00001 per share and do not expire.

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"We’re grateful for the continued support from one of our major shareholders. Their commitment gives us the flexibility to strengthen our capital structure and stay focused on building the future. This kind of long-term alignment allows us to move faster, innovate more aggressively, and fully pursue the opportunities in our pipeline," said Pete O’Heeron, Founder and Chief Executive Officer.

The purchase price for the shares or prefunded warrants will be paid not in cash but with sovereign-issued .9999 fine gold coins valued at $4,069.18 per oz. based on the spot price of gold at the time of signing of the purchase agreement, delivered to the Company’s depository. The Company intends to liquidate the purchase price into United States dollars in the near term.

In addition, in a concurrent private placement, the Company will issue and sell unregistered warrants to purchase one share of its common stock for each share of common stock or pre-funded warrant purchased in the registered direct offering, for up to 12,110,203 shares of common stock. The unregistered warrants have an exercise price of $0.3303 per share of common stock, will be exercisable beginning on the effective date of, and subject to, approval by our stockholders of the issuance of the shares of common stock upon exercise of the unregistered warrants (the "Stockholder Approval") and will expire five years following the date of the Stockholder Approval. The Company has agreed to file a registration statement with the Securities and Exchange Commission ("SEC") to register the resale of the shares of common stock underlying the unregistered warrants. If at the time of exercise of such warrants there is no effective registration statement registering the shares issuable upon exercise of such warrants, or the prospectus contained therein is not available for the resale of such shares by the warrant holder, then such warrants may also be exercised, in whole or in part, by cashless (net) exercise.

The offering is expected to close on or about November 19, 2025, subject to the satisfaction of customary closing conditions. The gross proceeds to the Company from the offering are expected to be approximately $4.0 million, before deducting offering expenses payable by FibroBiologics. FibroBiologics intends to use the net proceeds from the offering for general corporate purposes, including the satisfaction of debt. In addition, if the holders of the unregistered warrants exercise such warrants in full for cash following the Stockholder Approval, the Company would receive additional gross proceeds of approximately $4.0 million. The Company cannot predict when or if the unregistered warrants will be exercised for cash or exercised at all. It is possible that the unregistered warrants may expire and may never be exercised.

The shares of common stock, pre-funded warrants and shares of common stock issuable upon exercise of the pre-funded warrants offered in the registered direct offering (but not the unregistered warrants issued in the concurrent private placement or the shares issuable upon exercise of such unregistered warrants) are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-284663) previously filed and declared effective by the SEC on February 10, 2025. The offering of the shares of common stock and pre-funded warrants in the registered direct offering is being made only by means of a prospectus supplement that forms a part of the registration statement. The final prospectus supplement relating to the securities offered in the registered direct offering will be filed by FibroBiologics with the SEC. When available, copies of the final prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained from the SEC’s website at www.sec.gov.

The unregistered warrants issued in the concurrent private placement and the shares issuable upon exercise of such warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and/or Regulation D promulgated thereunder, have not been registered under the Act or applicable state securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

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.

(Press release, FibroBiologics, NOV 19, 2025, View Source [SID1234660083])

On November 19, 2025 Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, reported that the Company will participate in a fireside chat at the 8th Annual Evercore Healthcare Conference on Tuesday, December 2nd at 2:10 p.m. ET.

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The presentations will be webcast and may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at View Source

(Press release, Dynavax Technologies, NOV 19, 2025, View Source [SID1234660082])

On November 19, 2025 Amgen (NASDAQ: AMGN) reported that the U.S. Food and Drug Administration (FDA) has granted full approval to IMDELLTRA (tarlatamab-dlle) for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. The decision to convert IMDELLTRA’s prior accelerated approval to a full approval is based on data from the global Phase 3 DeLLphi-304 study. Additionally, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) were recently updated to include tarlatamab as the only Category 1 preferred treatment option for adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy.1*

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The global Phase 3 DeLLphi-304 study met its primary endpoint, demonstrating that IMDELLTRA reduced the risk of death by 40% and significantly extended median overall survival (OS) by more than five months compared to standard of care (SOC) chemotherapy as a treatment for patients with ES-SCLC who progressed on or after one line of platinum-based chemotherapy (median OS: 13.6 vs. 8.3 months; hazard ratio (HR), 0.60; 95% confidence interval (CI): 0.47, 0.77; P < 0.001).2

"The FDA’s decision reinforces IMDELLTRA as a recognized standard of care for people living with extensive stage small cell lung cancer whose disease progressed on or after frontline therapy," said Jay Bradner, M.D., executive vice president, Research and Development, at Amgen. "We are committed to delivering transformative medicines for patients facing challenging cancers, and we are currently focused on rapidly developing IMDELLTRA in earlier stages of disease and earlier lines of therapy for small cell lung cancer patients."

"For far too long, people living with small cell lung cancer had few options once their first treatment stopped working," said Laurie Fenton Ambrose, co-founder, president, and CEO, GO2 for Lung Cancer. "Today’s full approval is an important step forward, reinforcing long-awaited progress for patients facing this devastating disease."

The safety profile for IMDELLTRA in DeLLphi-304 was consistent with its known profile, with fewer Grade 3 or greater adverse events in the IMDELLTRA arm than in the chemotherapy arm (54% vs 80%). The most common Grade 3 or greater treatment-related adverse events (TRAEs) were neutropenia (4%) and lymphopenia (4%) with IMDELLTRA and anemia (28%) and neutropenia (22%) with SOC chemotherapy. Cytokine release syndrome (CRS) with IMDELLTRA primarily occurred after the first two doses and was primarily low grade (42% Grade 1; 13% Grade 2; 1% Grade 3). No Grade 4 or Grade 5 CRS events were reported.2

"Due to its distinctive biology and aggressive nature, small cell lung cancer has long been particularly challenging to treat, with limited progress compared to many other cancers. After years of research efforts, DeLLphi-304 was the first global Phase 3 trial to demonstrate a significant survival benefit over chemotherapy in its setting, leading to NCCN Guidelines Category 1 status for tarlatamab and further demonstrating the validity of this treatment approach in small cell lung cancer," said Charles M. Rudin, M.D., Ph.D., deputy director, Memorial Sloan Kettering Cancer Center, and principal investigator.* "Importantly, data from DeLLphi-304 reflected in today’s approval also equip physicians with a greater understanding of managing treatment with bispecific T-cell engager therapy."

Amgen’s robust IMDELLTRA development program includes the DeLLphi clinical trials, which evaluate IMDELLTRA as a monotherapy and as part of combination regimens, including in both earlier stages of SCLC and earlier lines of treatment.

About the Phase 3 DeLLphi-304 Study
DeLLphi-304 is a global Phase 3, randomized, controlled, open-label clinical trial evaluating the efficacy and safety of IMDELLTRA as a treatment for patients living with SCLC who progressed on or after a single line of platinum-based chemotherapy.3 Five hundred and nine patients were randomized to receive either IMDELLTRA or local SOC chemotherapy (topotecan in all countries except Japan; lurbinectedin in the U.S., Canada, Australia, Singapore, Korea; and amrubicin in Japan).3,4 The primary outcome measure of the trial is OS.3 Key secondary outcome measures include progression-free survival (PFS) and patient-reported outcomes (PROs) including disease-related symptoms, physical function, and quality of life.3 Results from DeLLphi-304 were reviewed as a late-breaking presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in The New England Journal of Medicine.2,5

About Tarlatamab Clinical Trials
Tarlatamab is being investigated in multiple studies including DeLLphi-303, a Phase 1b study investigating tarlatamab in combination with SOC therapies in first-line ES-SCLC; DeLLphi-304, a randomized Phase 3 study comparing tarlatamab monotherapy with SOC chemotherapy in second-line treatment of SCLC; DeLLphi-305, a randomized Phase 3 study comparing tarlatamab in combination with durvalumab vs. durvalumab alone as first-line maintenance treatment in ES-SCLC; DeLLphi-306, a randomized placebo-controlled Phase 3 study of tarlatamab following concurrent chemoradiotherapy in limited-stage SCLC; DeLLphi-308, a Phase 1b study evaluating subcutaneous tarlatamab in second-line or later ES-SCLC; DeLLphi-309, a Phase 2 study evaluating alternative intravenous dosing regimens with tarlatamab in second-line ES-SCLC; DeLLphi-310, a Phase 1b study of tarlatamab in combination with YL201 with or without anti-programmed death ligand 1 (PD-L1) in patients with ES-SCLC; DeLLphi-311, a Phase 1b study of IMDELLTRA in combination with etakafusp alfa (AB248), a novel CD8+ T-cell selective interleukin-2 (IL-2), in patients with ES-SCLC; and DeLLphi-312, a Phase 3 study evaluating tarlatamab as an induction and maintenance therapy in first-line treatment of ES-SCLC in combination with carboplatin, etoposide and durvalumab.6

For more information, please visit www.tarlatamabclinicaltrials.com.

About Small Cell Lung Cancer (SCLC)
SCLC is one of the most aggressive and devastating forms of solid tumor cancers. In the United States, the five-year relative survival rate for SCLC is 5-10% across all stages combined.7 Each year, SCLC accounts for approximately 13-15% of the more than 2.4 million cases of lung cancer diagnosed worldwide, including around 227,000 cases in the United States.8-10 Despite initial high response rates to first-line platinum-based chemotherapy, most patients quickly relapse within months and require subsequent treatment options.9

About IMDELLTRA (tarlatamab-dlle)
IMDELLTRA is a first-in-class targeted immunotherapy engineered by Amgen researchers to bind to both DLL3 on tumor cells and CD3 on T cells, thereby activating T cells to kill DLL3-expressing SCLC cells. This results in the formation of a cytolytic synapse with lysis of the cancer cell.11,12 DLL3 is a protein that is expressed on the surface of SCLC cells in ~85-96% of patients with SCLC, but is minimally expressed on healthy cells, making it an exciting target.13,14

INDICATION
IMDELLTRA (tarlatamab-dlle) is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.

IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME

Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Initiate treatment with IMDELLTRA using the step-up dosing schedule to reduce the incidence and severity of CRS. Withhold IMDELLTRA until CRS resolves or permanently discontinue based on severity.
Neurologic toxicity and immune effector cell-associated neurotoxicity syndrome (ICANS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold IMDELLTRA until ICANS resolves or permanently discontinue based on severity.
WARNINGS AND PRECAUTIONS

Cytokine Release Syndrome (CRS): IMDELLTRA can cause CRS including life-threatening or fatal reactions. In the pooled safety population, CRS occurred in 57% (268/473) of patients who received IMDELLTRA, including 39% Grade 1, 15% Grade 2, 1.7% Grade 3 and 0.2% Grade 4. Recurrent CRS occurred in 24% of IMDELLTRA-treated patients including 20% Grade 1 and 3.4% Grade 2; one patient experienced recurrent Grade 3.

Among the 268 patients who experienced CRS, 73% had CRS after the first dose, 60% had CRS after the second dose, and 15% had CRS following the third or later dose. Following the Cycle 1 Day 1, Day 8, Day 15 infusions, 24%, 8%, and 1% of patients experienced Grade ≥ 2 CRS, respectively. From Cycle 2 onwards, 1.5% of patients experienced Grade ≥ 2 CRS. Of the patients who experienced CRS, 31% received steroids and 10% required tocilizumab. The median time to onset of all grade CRS from most recent dose of IMDELLTRA was 16 hours (range: start of infusion to 15 days). The median time to onset of Grade ≥ 2 CRS from most recent dose of IMDELLTRA was 15 hours (range: start of infusion to 15 days).

Clinical signs and symptoms of CRS included pyrexia, hypotension, fatigue, tachycardia, headache, hypoxia, nausea, and vomiting. Potentially life-threatening complications of CRS may include cardiac dysfunction, acute respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation (DIC).

Administer IMDELLTRA following the recommended step-up dosing and administer concomitant medications before and after Cycle 1 Day 1 and Cycle 1 Day 8 IMDELLTRA infusions as described in Table 3 of the Prescribing Information (PI) to reduce the risk of CRS. Administer IMDELLTRA in an appropriate healthcare facility equipped to monitor and manage CRS. Ensure patients are well hydrated prior to administration of IMDELLTRA.

Closely monitor patients for signs and symptoms of CRS during treatment with IMDELLTRA. At the first sign of CRS, immediately discontinue IMDELLTRA infusion, evaluate the patient for hospitalization and institute supportive care based on severity. Withhold or permanently discontinue IMDELLTRA based on severity. Counsel patients and caregivers to seek medical attention should signs or symptoms of CRS occur.

Neurologic Toxicity, Including ICANS: IMDELLTRA can cause life-threatening or fatal neurologic toxicity, including ICANS. In the pooled safety population, neurologic toxicity occurred in 65% of patients who received IMDELLTRA, with Grade 3 or higher events in 7% of patients including fatal events in 0.2%. The most frequent neurologic toxicities were dysgeusia (34%), headache (17%), peripheral neuropathy (9%), dizziness (9%), and insomnia (8%). The incidence of signs and symptoms consistent with ICANS was 10% in IMDELLTRA-treated patients including events with the preferred terms: ICANS (4.7%), muscular weakness (3.2%), cognitive disorder (0.6%), aphasia (0.6%), depressed level of consciousness (0.4%), seizures (0.4%), encephalopathy (0.4%), and leukoencephalopathy (0.2%). There was one fatal reaction of ICANS. Recurrent ICANS occurred in 1.5% of patients. Of the patients who experienced ICANS, most experienced the event following Cycle 1 Day 1 (2.5%) and Cycle 1 Day 8 (3.6%). Following Day 1, Day 8, and Day 15 infusions, 1.3%, 1.3% and 0.4% of patients experienced Grade ≥ 2 ICANS, respectively. ICANS can occur several weeks following administration of IMDELLTRA. The median time to onset of ICANS from the first dose of IMDELLTRA was 16 days (range: 1 to 862 days). The median time to resolution of ICANS was 4 days (range: 1 to 40 days).

The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Clinical signs and symptoms of ICANS may include but are not limited to confusional state, depressed level of consciousness, disorientation, somnolence, lethargy, and bradyphrenia.

Patients receiving IMDELLTRA are at risk of neurologic adverse reactions and ICANS resulting in depressed level of consciousness. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, until neurologic symptoms resolve.

Closely monitor patients for signs and symptoms of neurologic toxicity and ICANS during treatment with IMDELLTRA. At the first sign of ICANS, immediately discontinue the infusion, evaluate the patient and provide supportive therapy based on severity. Withhold IMDELLTRA or permanently discontinue based on severity.

Cytopenias: IMDELLTRA can cause cytopenias including neutropenia, thrombocytopenia, and anemia. In the pooled safety population, based on laboratory data, decreased neutrophils occurred in 16% of patients, including 9% Grade 3 or 4. The median time to onset for Grade 3 or 4 decreased neutrophil count was 41 days (range: 2 to 306 days). Decreased platelets occurred in 30% including 2.2% Grade 3 or 4. The median time to onset for Grade 3 or 4 decreased platelets was 67 days (range: 3 to 420 days). Decreased hemoglobin occurred in 56% of patients, including 4.7% Grade 3 or 4. Febrile neutropenia was reported as an adverse event in 1.5% of patients treated with IMDELLTRA.

Monitor patients for signs and symptoms of cytopenias. Perform complete blood counts prior to treatment with all doses of IMDELLTRA, up through Cycle 5 Day 15 and then prior to administration on Day 1 of each cycle starting with Cycle 6. Based on the severity of cytopenias, temporarily withhold, or permanently discontinue IMDELLTRA.

Infections: IMDELLTRA can cause serious infections, including life-threatening and fatal infections.

In the pooled safety population, infections, including opportunistic infections, occurred in 43% of patients who received IMDELLTRA, including 14% Grade 3 or 4. The most frequent infections were pneumonia (11%), urinary tract infection (9%), COVID-19 (6%), upper respiratory tract infection (4.7%), respiratory tract infection (4%), candida infection (2.1%), oral candidiasis (2.1%), and nasopharyngitis (2.1%).

Monitor patients for signs and symptoms of infection prior to and during treatment with IMDELLTRA and treat as clinically indicated. Withhold or permanently discontinue IMDELLTRA based on severity.

Hepatotoxicity: IMDELLTRA can cause hepatotoxicity. In the pooled safety population, based on laboratory data, elevated ALT occurred in 39% of patients who received IMDELLTRA, including 2.5% with Grade 3 or 4 ALT. Elevated AST occurred in 43% of patients, including 3.2% Grade 3 or 4. Elevated bilirubin also occurred in 16% of patients, including 1.3% Grade 3 or 4. Liver enzyme elevation can occur with or without concurrent CRS.

Monitor liver enzymes and bilirubin prior to treatment with IMDELLTRA, and as clinically indicated. Withhold IMDELLTRA or permanently discontinue based on severity.

Hypersensitivity: IMDELLTRA can cause severe hypersensitivity reactions. Clinical signs and symptoms of hypersensitivity may include, but are not limited to, rash and bronchospasm. Monitor patients for signs and symptoms of hypersensitivity during treatment with IMDELLTRA and manage as clinically indicated. Withhold or consider permanent discontinuation of IMDELLTRA based on severity.

Embryo-Fetal Toxicity: Based on its mechanism of action, IMDELLTRA may cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with IMDELLTRA and for 2 months after the last dose.
ADVERSE REACTIONS

The pooled safety population reflects exposure to intravenous IMDELLTRA, as a single agent, at the recommended dosage of IMDELLTRA 1 mg on Cycle 1 Day 1 followed by 10 mg on Days 8 and 15, and then every 2 weeks until disease progression or intolerable toxicity in 473 patients with small cell lung cancer enrolled in three clinical trials: DeLLphi-300, DeLLphi-301 and DeLLphi-304. Among 473 patients who received IMDELLTRA, 40% were exposed for 6 months or longer and 19% were exposed for greater than one year.
The most common (≥ 20%) adverse reactions were CRS (57%), fatigue (48%), decreased appetite (38%), dysgeusia (34%), pyrexia (33%), constipation (31%), musculoskeletal pain (31%), and nausea (25%).
The most common (≥ 5%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes (43%), decreased sodium (12%), decreased total neutrophils (9%), and increased uric acid (6%).
DOSAGE AND ADMINISTRATION: Important Dosing Information

Administer IMDELLTRA as an intravenous infusion over 1 hour.
Administer IMDELLTRA according to the step-up dose and schedule in the IMDELLTRA PI (Table 1) to reduce the incidence and severity of CRS.
Evaluate complete blood count, liver enzymes and bilirubin prior to administration of all doses of IMDELLTRA up through Cycle 5 Day 15 and then prior to administration of IMDELLTRA on Day 1 of each cycle starting with Cycle 6. More frequent evaluation may be necessary if clinically indicated.
For Cycle 1, administer recommended concomitant medications before and after Cycle 1 Day 1 and Cycle 1 Day 8 IMDELLTRA infusions to reduce the risk of CRS reactions as described in the PI (Table 3).
IMDELLTRA should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions such as CRS and neurologic toxicity including ICANS.
Due to the risk of CRS and neurologic toxicity, including ICANS, monitor patients from the start of the IMDELLTRA infusion for 22 to 24 hours following Cycle 1 Day 1 and Cycle 1 Day 8 in an appropriate healthcare setting.
Recommend that patients remain within 1 hour of an appropriate healthcare setting for a total of 48 hours from the start of the infusion with IMDELLTRA following Cycle 1 Day 1 and Cycle 1 Day 8 doses, accompanied by a caregiver.
Inform both the patient and the caregiver on the signs and symptoms of CRS and ICANS prior to discharge.
Ensure patients are well hydrated prior to administration of IMDELLTRA.
Please see IMDELLTRA full Prescribing Information, including BOXED WARNINGS.

(Press release, Amgen, NOV 19, 2025, View Source [SID1234660080])

On November 19, 2025 Aptose Biosciences Inc. ("Aptose" or the "Company") (TSX: APS; OTC: APTOF) and Hanmi Pharmaceutical Co. Ltd. ("Hanmi") reported that Aptose, Hanmi and HS North America Ltd., a wholly owned subsidiary of Hanmi ("Hanmi Purchaser" and together with Hanmi, the "Hanmi Purchasers"), have entered into a definitive arrangement agreement (the "Arrangement Agreement") pursuant to which Hanmi Purchaser will acquire all of the issued and outstanding common shares of Aptose ("Common Shares") that are not currently owned or controlled by the Hanmi Purchasers or their respective affiliates.

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Hanmi has participated in multiple financings of Aptose and owns 19.93% of all outstanding Common Shares. During the past 18 months, Hanmi has singularly supported Aptose and the continued development of tuspetinib (TUS) through debt facilities to Aptose totaling more than US$30 million. Under the terms of the Arrangement Agreement, upon the completion of the transactions contemplated under the Arrangement Agreement, Aptose shareholders, other than the Hanmi Purchasers and their respective affiliates that hold any Common Shares, will receive C$2.41 in cash per Common Share, which represents a premium of 28% over Aptose’s 30-day VWAP of C$1.88 on the Toronto Stock Exchange (TSX).

"We are very pleased to have reached an agreement on a transaction with Hanmi," stated William G. Rice, Ph.D., Chairman, President, and Chief Executive Officer of Aptose. "This transaction not only offers a premium value for our minority shareholders but also enables Aptose to continue the development of TUS combined with standard treatment venetoclax plus azacitidine (VEN+AZA) for acute myeloid leukemia (AML) in the TUSCANY Phase 1/2 clinical study. The TUS+VEN+AZA triplet therapy has shown promising response rates and safety in a diverse population of patients newly diagnosed with AML. We are extremely grateful for Hanmi’s ongoing support as we work toward our long-term goal of improving patient outcomes in AML."

"We are very pleased to have reached this agreement with Aptose," said Jae-Hyun Park of Hanmi. "With a growing body of positive data, it is important to support the uninterrupted and expanded development of tuspetinib in the TUSCANY clinical study. This step also marks Hanmi’s first beachhead and direct entry into North America, establishing a strategic foothold for future partnerships and clinical expansion in the region."

Transaction Details

Under the terms of Arrangement Agreement, Aptose will continue from a corporation incorporated under the Canada Business Corporations Act to a corporation continued under the Business Corporations Act (Alberta) (the "Continuance") and, following the completion of the Continuance, Hanmi Purchaser will acquire all of the issued and outstanding Common Shares that are not currently owned or controlled by the Hanmi Purchasers or their respective affiliates by way of a plan of arrangement under the Business Corporations Act (Alberta) (the "Arrangement" and, together with the Continuance, the "Transaction").

Upon the completion of the Transaction, subject to applicable tax withholdings:

each Common Share (other than any Common Share owned or controlled by the Hanmi Purchasers or their respective affiliates or for which dissent rights have been validly exercised) will be transferred to Hanmi Purchaser in exchange for an amount in cash equal to C$2.41 per Common Share;
each Aptose option will cease to represent an option or other right to acquire any Common Share and will be deemed surrendered and exchanged for an amount in cash equal to C$2.41 per Common Share, multiplied by the number of Common Shares subject to the Aptose option, less the aggregate exercise price in respect of such Aptose option;
each Aptose restricted share unit will cease to represent a share unit of Aptose and will be deemed surrendered and exchanged for an amount in cash equal to C$2.41 per Common Share, multiplied by the number of Common Shares subject to the Aptose restricted share unit;
each Aptose warrant held by Armistice Capital Master Fund Ltd. (the "Armistice Warrants") will cease to represent a warrant exercisable for Common Shares and will be deemed surrendered and exchanged for an amount in cash equal to an amount calculated using the "Black Scholes" valuation model in accordance with the terms of the applicable Armistice Warrant; and
each Aptose warrant (other than the Armistice Warrants) will cease to represent a warrant exercisable for Common Shares and will be deemed surrendered and exchanged for an amount in cash equal to C$2.41 per Common Share, multiplied by the number of Common Shares subject to the Aptose warrant, less the aggregate exercise price in respect of such Aptose warrant.
The Arrangement Agreement contains customary non-solicitation provisions prohibiting Aptose from soliciting competing acquisition proposals, as well as "right to match" provisions in favour of Hanmi Purchaser. The Arrangement Agreement provides for a C$300,000 expense fee payable to Hanmi Purchaser if the Arrangement Agreement is terminated in certain circumstances, including in the context of a change in recommendation by the board of directors of Aptose (the "Board") or by the special committee consisting of independent members of the Board formed in connection with the Arrangement (the "Special Committee").

The completion of the Transaction is subject to satisfaction of customary closing conditions, including court approval and approval of Aptose shareholders as further set out below. After completion of the Transaction, Aptose expects to no longer be subject to the reporting requirements of applicable Canadian securities legislation and the Common Shares will be delisted from all stock exchanges where Common Shares are currently listed, including the TSX.

Completion of the Transaction will be subject to the approval of (i) at least two-thirds (66 2/3%) of the votes cast by Aptose shareholders present in person or represented by proxy at a special meeting of Aptose shareholders to be held no later than January 16, 2026 to approve the Transaction (the "Special Meeting"), voting as a single class, and (ii) the majority of the holders of Common Shares present in person or represented by proxy at the Special Meeting, excluding the votes of the Hanmi Purchasers and their respective affiliates, and any other shareholders whose votes are required to be excluded for the purposes of "minority approval" under Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions ("MI 61-101") in the context of a "business combination" (the "Minority Shareholders"). Further details regarding the applicable voting requirements will be contained in a management information circular to be filed and mailed to Aptose shareholders in connection with the Special Meeting to approve the Transaction.

Concurrent with the execution of the Arrangement Agreement, Hanmi Purchaser entered into voting support agreements with each of the directors and officers of Aptose pursuant to which, subject to the terms of the voting support agreements, each Aptose director or officer has agreed to, among other things, vote or cause to be voted all of the Common Shares owned, controlled or directed, directly or indirectly, by them in favour of the Transaction at the Special Meeting.

Further details of the Transaction are set out in the Arrangement Agreement, which will be made available on Aptose’s SEDAR+ profile at www.sedarplus.ca.

Opinion and Formal Valuation

Locust Walk Securities, LLC ("Locust Walk") was retained by the Special Committee to provide financial advice and prepare a formal valuation of the Common Shares, as required under MI 61-101. Locust Walk delivered a valuation that, as of November 18, 2025, and based on Locust Walk’s analysis and subject to the assumptions, limitations and qualifications to be set forth in the formal valuation that will be included in the management information circular that will be sent to Aptose shareholders in connection with the Special Meeting (the "Formal Valuation"), using multiple analyses, including DCF modeling, the fair market value of the Common Shares is in the range of C$1.00 to C$5.23 per Common Share. Locust Walk has also delivered an oral opinion (the "Fairness Opinion") to the Special Committee that, as of November 18, 2025, and subject to the assumptions, limitations and qualifications to be set forth in Locust Walk’s written fairness opinion that will be included in the management information circular, the consideration to be received by the holders of Common Shares (other than the Hanmi Purchasers and their respective affiliates) pursuant to the Arrangement Agreement is fair, from a financial point of view, to such holders of Common Shares. The management information circular will also include factors considered by the Special Committee and the Board and other relevant information.

Unanimous Approval of Aptose Special Committee and Board of Directors

The Special Committee, after consultation with and receiving advice from its financial adviser and outside legal counsel, has unanimously recommended that the Board approve the Arrangement and that Aptose shareholders vote in favour of the Arrangement.

The Board, acting on the unanimous recommendation in favour of the Arrangement by the Special Committee and after receiving advice from its financial adviser and outside legal counsel in evaluating the Arrangement, has unanimously determined that the Arrangement is fair to Aptose shareholders (other than the Hanmi Purchasers and their respective affiliates) and that the Arrangement is in the best interests of Aptose, and resolved to unanimously recommend that Aptose shareholders vote in favour of the Arrangement.

Advisors

Locust Walk is acting as financial advisor and independent valuator to the Special Committee and the Company. McCarthy Tétrault LLP is acting as independent legal advisor to the Special Committee and the Company. Stikeman Elliott LLP is acting as independent legal advisor to Hanmi Purchaser.

About Tuspetinib

Aptose’s lead compound tuspetinib is a convenient once daily oral agent that potently targets SYK, mutated and wild type forms of FLT3, mutated KIT, JAK1/2, and RSK2 kinases, while avoiding many typical toxicity concerns observed with other agents. The ongoing TUSCANY triplet Phase 1/2 study is designed to test various doses and schedules of TUS in combination with standard dosing of azacitidine and venetoclax in newly diagnosed patients with AML who are ineligible to receive induction chemotherapy. Aptose has reported data from the first three dose cohorts that have demonstrated safety, CRs and minimal residual disease (MRD) negativity across patients with diverse mutations. The early data showed that 9 out of 10 patients responded to the TUS triplet therapy, with 100% complete remission (CR/CRh) achieved in the 80mg and 120mg cohorts. Notably, patients with difficult-to-treat mutations in TP53, RAS and FLT3 genes also achieved a 100% CR/CRh rate.

(Press release, Aptose Biosciences, NOV 19, 2025, View Source [SID1234660075])

On November 18, 2025, Aptose Biosciences Inc. (the "Company"), Hanmi Pharmaceuticals Co. Ltd. ("Hanmi") and HS North America Ltd., a wholly owned subsidiary of Hanmi ("Hanmi Purchaser" and together with Hanmi, the "Hanmi Purchasers"), entered into a definitive arrangement agreement (the "Arrangement Agreement") pursuant to which Hanmi Purchaser will acquire all of the issued and outstanding common shares of the Company ("Common Shares") that are not currently owned or controlled by the Hanmi Purchasers or their respective affiliates, subject to satisfaction of certain closing conditions.

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Under the terms of the Arrangement Agreement, the Company’s shareholders, other than the Hanmi Purchasers and their respective affiliates that hold any Common Shares, will receive C$2.41 in cash per Common Share, which represents a premium of 28% over the Company’s 30-day VWAP of C$1.88 on the Toronto Stock Exchange ("TSX").

The Company will continue from a corporation incorporated under the Canada Business Corporations Act to a corporation continued under the Business Corporations Act (Alberta) (the "Continuance") and, following the completion of the Continuance, Hanmi Purchaser will acquire all of the issued and outstanding Common Shares that are not currently owned or controlled by the Hanmi Purchasers or their respective affiliates by way of a plan of arrangement under the Business Corporations Act (Alberta) (the "Arrangement" and, together with the Continuance, the "Transaction").

The completion of the Transaction is subject to satisfaction of customary closing conditions, including court approval and approval of the Company’s shareholders. The Arrangement Agreement contains customary non-solicitation provisions prohibiting the Company from soliciting competing acquisition proposals, as well as "right to match" provisions in favor of Hanmi Purchaser. The Arrangement Agreement provides for a C$300,000 expense fee payable to Hanmi Purchaser if the Arrangement Agreement is terminated in certain circumstances, including in the context of a change in recommendation by the board of directors of the Company (the "Board") or by the special committee consisting of independent members of the Board formed in connection with the Arrangement (the "Special Committee").

The Board, acting on the unanimous recommendation in favor of the Arrangement by the Special Committee and after receiving advice from its financial adviser and outside legal counsel in evaluating the Arrangement, has unanimously determined that the Arrangement is in the best interests of the Company.

The completion of the Transaction is subject to court approval and approval of the Company’s shareholders. After completion of the Transaction, the Company expects to no longer be subject to the reporting requirements of applicable Canadian securities legislation and the Common Shares will be delisted from all stock exchanges where Common Shares are currently listed, including the TSX.

Completion of the Transaction will be subject to the approval of (i) at least two-thirds (66 2/3%) of the votes cast by the Company’s shareholders present in person or represented by proxy at a special meeting of the Company’s shareholders to be held no later than January 16, 2026 to approve the Transaction (the "Special Meeting"), voting as a single class, and (ii) the majority of the holders of Common Shares present in person or represented by proxy at the Special Meeting, excluding the votes of the Hanmi Purchasers and their respective affiliates, and any other shareholders whose votes are required to be excluded for the purposes of "minority approval" under Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions ("MI 61-101") in the context of a "business combination" (the "Minority Shareholders"). Further details regarding the applicable voting requirements will be contained in a management information circular to be filed and mailed to the Company shareholders in connection with the Special Meeting to approve the Transaction.

The representations, warranties and covenants contained in the Arrangement Agreement have been made solely for the benefit of the parties thereto, subject to certain exceptions. In addition, such representations, warranties and covenants (a) have been made only for purposes of the Arrangement Agreement, (b) are subject to materiality qualifications contained in the Arrangement Agreement which may differ from what may be viewed as material by investors, (c) were made only as of the date of the Arrangement Agreement or such other date as is specified in the Arrangement Agreement and (d) have been included in the Arrangement Agreement for the purpose of allocating risk between the contracting parties rather than establishing matters as fact. Investors should not rely on the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or condition of the parties to the Arrangement Agreement or any of their respective subsidiaries or affiliates. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the Arrangement Agreement, which subsequent information may or may not be fully reflected in the Company’s public disclosures.

Concurrent with the execution of the Arrangement Agreement, Hanmi Purchaser entered into voting support agreements with each of the directors and officers of the Company pursuant to which, subject to the terms of the voting support agreements, each director or officer of the Company has agreed to, among other things, vote or cause to be voted all of the Common Shares owned, controlled or directed, directly or indirectly, by them in favor of the Transaction at the Special Meeting.

The foregoing description of the Arrangement Agreement and the Arrangement does not purport to be complete and is subject to and qualified in its entirety by reference to the copy of the Arrangement Agreement attached hereto as Exhibit 2.1 and incorporated herein by reference.

(Press release, Aptose Biosciences, NOV 18, 2025, View Source [SID1234660930])