On July 29, 2025 AbbVie (NYSE: ABBV) reported the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the fixed-duration, all-oral combination regimen of VENCLEXTA (venetoclax) and acalabrutinib in previously untreated patients with CLL, offering CLL patients another VENCLEXTA combination regimen with the potential for time-limited treatment (Press release, AbbVie, JUL 29, 2025, View Source [SID1234654613]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The submission is based on the positive results from the Phase 3 AMPLIFY trial.1 The combination regimen of VENCLEXTA and acalabrutinib improved progression-free survival (PFS) compared to standard chemoimmunotherapy in previously untreated patients with CLL.2

"This FDA submission marks a milestone for CLL treatment with the potential approval for the first oral combination regimen of VENCLEXTA and acalabrutinib for previously untreated patients with chronic blood cancer. This new fixed-treatment duration approach could allow patients the opportunity for time off treatment, if approved, and be potentially practice-changing in frontline CLL care," said Svetlana Kobina, vice president, global medical affairs, oncology, AbbVie.

About the AMPLIFY Study
AMPLIFY is an AstraZeneca-sponsored, global, multi-center Phase 3 trial evaluating VENCLEXTA plus acalabrutinib alone or combined with obinutuzumab versus chemoimmunotherapy in patients with previously untreated CLL without del(17p) or TP53 mutation.1

Data presented at the 2024 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting showed that the fixed-duration combination regimen of VENCLEXTA and acalabrutinib reduced the risk of disease progression or death by 35% vs chemoimmunotherapy (HR 0.65; 95% CI: 0.49-0.87; p=0.004). The safety profile of the VENCLEXTA and acalabrutinib combination regimen is consistent with the known safety profile of each individual therapy alone. The most common adverse events in any grade were neutropenia, hemorrhage, and COVID-19 in patients administered VENCLEXTA plus acalabrutinib. The most frequent Grade 3 or higher adverse event was neutropenia seen in 26.8% of patients. Among events of clinical interest, low rates of tumor lysis syndrome were observed with events of any grade seen in 0.3% of patients treated with VENCLEXTA plus acalabrutinib compared to 3.1% for patients treated with chemoimmunotherapy. No new safety signals were observed in the AMPLIFY study.2

About VENCLEXTA (venetoclax)
VENCLEXTA (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLEXTA targets the BCL-2 protein and works to help restore the process of apoptosis.

VENCLEXTA is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood and other cancers. Venetoclax is approved in more than 80 countries, including the U.S.

VENCLEXTA (venetoclax) U.S. Uses and Important Safety Information3

Uses
VENCLEXTA is a prescription medicine used:

to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly diagnosed acute myeloid leukemia (AML) who:
‒ are 75 years of age or older, or
‒ have other medical conditions that prevent the use of standard chemotherapy.
It is not known if VENCLEXTA is safe and effective in children.

Important Safety Information

What is the most important information I should know about VENCLEXTA?

VENCLEXTA can cause serious side effects, including:

Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your healthcare provider will do tests to check your risk of getting TLS before you start taking VENCLEXTA. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Your healthcare provider will do blood tests to check for TLS when you first start treatment and during treatment with VENCLEXTA. It is important to keep your appointments for blood tests. Tell your healthcare provider right away if you have any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain.

Drink plenty of water during treatment with VENCLEXTA to help reduce your risk of getting TLS. Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased.

Your healthcare provider may delay, decrease your dose, or stop treatment with VENCLEXTA if you have side effects. When restarting VENCLEXTA after stopping for 1 week or longer, your healthcare provider may again check for your risk of TLS and change your dose.

Who should not take VENCLEXTA?

Certain medicines must not be taken when you first start taking VENCLEXTA and while your dose is being slowly increased because of the risk of increased TLS.

Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements. VENCLEXTA and other medicines may affect each other causing serious side effects.
Do not start new medicines during treatment with VENCLEXTA without first talking with your healthcare provider.
Before taking VENCLEXTA, tell your healthcare provider about all of your medical conditions, including if you:

have kidney or liver problems.
have problems with your body salts or electrolytes, such as potassium, phosphorus, or calcium.
have a history of high uric acid levels in your blood or gout.
are scheduled to receive a vaccine. You should not receive a "live vaccine" before, during, or after treatment with VENCLEXTA, until your healthcare provider tells you it is okay. If you are not sure about the type of immunization or vaccine, ask your healthcare provider. These vaccines may not be safe or may not work as well during treatment with VENCLEXTA.
are pregnant or plan to become pregnant. VENCLEXTA may harm your unborn baby. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with VENCLEXTA, and you should use effective birth control during treatment and for 30 days after the last dose of VENCLEXTA. If you become pregnant or think you are pregnant, tell your healthcare provider right away.
are breastfeeding or plan to breastfeed. It is not known if VENCLEXTA passes into your breast milk. Do not breastfeed during treatment with VENCLEXTA and for 1 week after the last dose.
What should I avoid while taking VENCLEXTA?

You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood.

What are the possible side effects of VENCLEXTA?

VENCLEXTA can cause serious side effects, including:

Low white blood cell counts (neutropenia). Low white blood cell counts are common with VENCLEXTA, but can also be severe. Your healthcare provider will do blood tests to check your blood counts during treatment with VENCLEXTA and may pause dosing.
Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with VENCLEXTA. Your healthcare provider will closely monitor and treat you right away if you have a fever or any signs of infection during treatment with VENCLEXTA.
Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment with VENCLEXTA.

The most common side effects of VENCLEXTA when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell counts; low platelet counts; low red blood cell counts; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of your arms, legs, hands, and feet.

The most common side effects of VENCLEXTA in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include nausea; diarrhea; low platelet count; constipation; low white blood cell count; fever with low white blood cell count; tiredness; vomiting; swelling of arms, legs, hands, or feet; fever; infection in lungs; shortness of breath; bleeding; low red blood cell count; rash; stomach (abdominal) pain; infection in your blood; muscle and joint pain; dizziness; cough; sore throat; and low blood pressure.

VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of VENCLEXTA. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

The full U.S. prescribing information, including Medication Guide, for VENCLEXTA can be found here. Globally, prescribing information varies; refer to the individual country product label for complete information.

On July 29, 2025 Ikena Oncology presented its corporate presentation (Presentation, Ikena Oncology, JUL 29, 2025, View Source [SID1234654597]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On July 29, 2025 Atossa Therapeutics, Inc. (NASDAQ: ATOS), a clinical-stage biopharmaceutical company developing innovative medicines in oncology, reported positive written feedback from the U.S. Food and Drug Administration (FDA) regarding the company’s proposed dose optimization trial of (Z)-endoxifen for the treatment of estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer (Press release, Atossa Therapeutics, JUL 29, 2025, View Source;metastatic-breast-cancer-302516013.html [SID1234654614]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The FDA has provided highly constructive responses ahead of the scheduled pre-Investigational New Drug (IND) meeting, affirming key elements of Atossa’s clinical development plan, negating the need for a virtual meeting, and paving the way for a potential IND submission targeted for the fourth quarter of 2025.

"These FDA responses mark a significant milestone for the Company and are supportive of our comprehensive approach to developing (Z)-endoxifen for metastatic breast cancer," stated Dr. Steven Quay, Atossa’s Chief Executive Officer and Chairman of the Board. "The detailed feedback received significantly advances our goal of submitting an IND by year-end. Importantly, the FDA’s support of our dose optimization strategy and general agreement with our nonclinical data package leave us confident in our scientific rationale and overall regulatory approach."

Key Highlights:

Dose Optimization Strategy Affirmed: FDA agreed that existing clinical and nonclinical data are sufficient to initiate Part A (monotherapy) of the proposed dose optimization study and provided clear guidance on randomization cohort sizes and study design enhancements.

Combination Study Support: The Agency agreed with the scientific rationale for combining (Z)-endoxifen with approved breast cancer standard-of-care therapies, such as some CDK4/6 inhibitors, PI3K inhibitors, mTOR inhibitors, and capecitabine. While not all combinations will be investigated in this study, FDA guidance on the matter is helpful in narrowing the strategic approach for the potential IND.

Nonclinical Data Package Deemed Adequate: FDA indicated the existing nonclinical safety data package is adequate to proceed without additional general toxicity or neurotoxicity studies.

Agreement on Cardiac Safety Assessments for Monotherapy: FDA confirmed Atossa’s cardiac safety assessment plan, including serial electrocardiograms (ECGs) and QT interval monitoring, is sufficient for the monotherapy portion of the trial.

Next steps: In the coming weeks, Atossa will announce plans for the target patient population, combination backbone, and overall trial design for the upcoming dose-ranging study. The Agency acknowledged the Company’s plan to file an IND in 2025 and encouraged Atossa to incorporate specific safety and eligibility refinements in the final protocol, which the Company has accepted.
Dr. Quay continued, "With the FDA’s feedback now in hand, Atossa is energized and moving quickly. We believe the company is well positioned to maintain strategic momentum and meet regulatory milestones, bringing us closer to delivering (Z)-endoxifen to patients in need and driving shareholder value. Further updates will be provided as the trial design is finalized, and next steps are implemented."

Atossa’s progress reflects the strong strategic momentum promised in the March 11, 2025 announcement of a metastatic focus; momentum that aligns well with FDA expectations and regulatory standards, including fulfilling Project Optimus requirements, a crucial next step in advancing (Z)-endoxifen toward potential approval.

The FDA’s Project Optimus initiative emphasizes data-driven dose exploration to maximize benefit and minimize toxicity. In line with this guidance, Atossa will explore multiple dose levels in its upcoming clinical study to define the optimal dose for combination therapy, while seeking to maintain a balance between efficacy and patient safety.

About (Z)-Endoxifen

(Z)-endoxifen is a highly potent Selective Estrogen Receptor Modulator (SERM) with demonstrated ability to inhibit—and potentially degrade—estrogen receptors. It has shown activity even in tumors that have developed resistance to other endocrine therapies. Beyond its anti-estrogenic properties, (Z)-endoxifen also targets protein kinase C beta 1 (PKCβ1), an oncogenic signaling protein, at clinically achievable blood levels. Importantly, (Z)-endoxifen seems to deliver comparable or superior bone-protective effects relative to tamoxifen.

Atossa is developing a proprietary oral formulation of (Z)-endoxifen that is enteric-coated to bypass stomach acid, which would otherwise convert the active (Z)-isomer to its inactive (E)-form. This innovation ensures optimal bioavailability and therapeutic integrity. Clinical studies have shown Atossa’s (Z)-endoxifen to be well tolerated in both healthy women and those with breast cancer. In over 700 subjects (healthy volunteers and breast cancer patients), doses up to 360 mg/day have been administered with no maximum tolerated dose (MTD) identified, supporting continued dose-ranging exploration.

Atossa is prioritizing the development of (Z)-endoxifen for the treatment of metastatic breast cancer, where novel therapeutic options are urgently needed. The compound is currently being evaluated in three Phase 2 trials: one in women with ductal carcinoma in situ (DCIS) and two in women with ER+/HER2- breast cancer. Atossa’s (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including three recently issued U.S. patents and numerous pending applications worldwide.

On July 29, 2025 Alphamab Oncology (stock code: 9966.HK) reported that anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer and gastroesophageal junction cancer (GC/GEJ).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

GC/GEJ is the fifth most common cancer and the fifth leading cause of cancer death worldwide. According to the 2022 Global Cancer Statistics report released by the International Agency for Research on Cancer (IARC), a subsidiary of the World Health Organization, there are approximately 960,000 new cases diagnosed and 660,000 deaths worldwide annually. In the U.S., the SEER database model predicts that there will be 26,890 new cases and 10,880 new deaths of GC/GEJ in 2024, with a five-year overall survival rate of less than 40%. Fluoropyrimidine and platinum-based regimens are commonly used as first-line treatments. Available second-line or later-line treatment options include paclitaxel plus ramucirumab, paclitaxel, docetaxel or irinotecan monotherapy, and best supportive care, with objective response rates of approximately 15-25%. The median overall survival is approximately 8-9 months for second-line treatment and 4-6 months for later lines.

JSKN003 is an anti-HER2 biparatopic ADC developed inhouse with Alphamab’s proprietary glycan-specific conjugation platform. The antibody molecule KN026 is site-specifically modified via enzyme catalytic reaction and click chemistry to achieve a drug-to-antibody ratio (DAR) of approximately 4. It can bind HER2 on the surface of tumor cells, and release topoisomerase I inhibitors (TOPIi) through cellular endocytosis, thereby exert anti-tumor effects. Compared with its ADC counterparts, JSKN003 demonstrated better serum stability and stronger bystander effect, which effectively expands the therapeutic window. Research results from the Phase I clinical study JSKN003-101 (NCT05494918) conducted in Australia and the Phase I/II clinical study JSKN003-102 (NCT05744427) in China have demonstrated favorable tolerability and safety profile, with promising efficacy of JSKN003 in heavily pretreated patients with advanced solid tumors, especially in patients with high HER2-expressing gastrointestinal tumors. Detailed data were presented at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress for the first time and subsequently updated at the 2025 Annual Meeting of American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in June 2025.

The "Orphan Drug Designation", originated from the Orphan Drug Act (ODA), is a U.S. FDA initiative aimed at encouraging the development of innovative drugs for the treatment of diseases affecting fewer than 200,000 people in the U.S. The designation of JSKN003 will be beneficial to obtain relevant policy supports for subsequent research and development, registration, and commercialization in the U.S., including funding for research and development costs, tax credits for clinical trial expenditures, waiver of prescription drug user fee, accelerated review and approval processes, and, upon approval, the potential for seven years of market exclusivity in the U.S.

About JSKN003

JSKN003 is a bispecific ADC developed based on KN026 using Alphamab’s proprietary glycan-specific conjugation platform. JSKN003 can bind HER2 on the surface of tumor cells and release topoisomerase I inhibitors (TOPIi) through cellular endocytosis, thereby exerting anti-tumor effects. Compared with its ADC counterparts, JSKN003 demonstrated better serum stability and stronger bystander effect, which effectively expands the therapeutic window.

Results of multiple clinical studies at various stages of JSKN003 in China and Australia have demonstrated favorable safety profile, with promising efficacy of JSKN003 in heavily pretreated patients with advanced solid tumors, especially in patients with platinum-resistant ovarian cancer (PROC), HER2-expressing breast cancer (BC), or high HER2-expressing solid tumors. JSKN003 was granted breakthrough therapy designation by CDE. The designation is for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. Three Phase III clinical studies of JSKN003 for the treatment of HER2-low expressing BC, PROC, and HER2-positive BC as well as multiple exploratory Phase II clinical studies are currently undergoing smoothly.

In September 2024, the Company entered a licensing agreement with JMT-Bio Technology Co., Ltd. ("JMT-Bio"), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (stock code: 1093.HK), pursuant to which, JMT-Bio was granted the exclusive license and sublicense rights to develop, sell, offer for sale and commercialize JSKN003, for the treatment of tumor-related indications (the "Field") in mainland China (excluding Hong Kong, Macau or Taiwan) (the "Territory") and become the sole marketing authorization holder for JSKN003 for the Field in the Territory. Alphamab retains the sole right to supply JSKN003.

(Press release, Alphamab, JUL 29, 2025, View Source [SID1234657001])

On July 29, 2025 ImmunoPrecise Antibodies Ltd. ("IPA", "Company", "we" or "us") (NASDAQ: IPA), a bio-native AI company operating at the intersection of TechBio and next-generation drug discovery, reported its financial results for the fiscal year ended April 30, 2025. All numbers are expressed in Canadian dollars unless otherwise noted (Press release, ImmunoPrecise Antibodies, JUL 29, 2025, View Source [SID1234654598]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Financial Highlights:

•
Achieved record revenue for Fiscal Year 2025 of $24.5 million
•
Delivered highest-ever fourth quarter revenue of $7.0 million
•
Reported record fourth quarter Adjusted EBITDA of ($0.3) million, reflecting improved operating efficiency
•
Achieved fourth quarter gross margin of 64%, representing strongest margin performance since Q3 of Fiscal Year 2021
•
BioStrand segment grew over 180% in Fiscal year 2025 and had gross margins approaching 90%
•
BioStrand currently represents over 5% of total annual revenue this year, up from less than 2% in Fiscal Year 2024
Recent Corporate Highlights:

•
The Company’s LENSai platform demonstrated that its in silico epitope mapping achieves results on previously unseen antibody–antigen complexes with results that are on par with gold-standard X-ray crystallography—delivering structural insights in hours instead of weeks.
•
An important breakthrough using the Company’s HYFT-powered LENSai platform, as it identified a highly conserved epitope across all four dengue virus serotypes, a key milestone toward developing a potential universal dengue vaccine. Subsequently announced in silico data supporting the vaccine candidate’s safety and its ability to activate a balanced immune response.
•
IPA’s AI-designed GLP-1 peptides outperformed or matched semaglutide in independent receptor activation studies, further validating the Company’s HYFT-driven LENSai platform.
•
Entered into a strategic USD $8M – 10M partnership with a biotechnology company focusing on advancing the discovery and development of Antibody-Drug Conjugates and bispecific antibodies for the cancer treatment.
•
Realigned internal R&D strategy to focus on launching an AI-powered therapeutic pipeline, reinforcing IPA’s shift toward a bio-native AI drug discovery model.
•
ImmunoPrecise subsidiary signed material transfer agreement with Biotheus (now BioNTech), who is evaluating the antibody asset for bispecific tumor-targeting.

•
Successfully engineered antibodies in silico to a challenging tumor target using LENS, advancing IPA’s vision for accessible, next-gen therapeutics.
•
Appointed industry veteran Jon Lieber to its Board of Directors, bringing over 30 years of strategic leadership across biotech, capital markets, and public company governance, further strengthening IPA’s financial oversight and commercial execution.
•
Named Jeff Fried, a recognized healthcare data visionary, to its Advisory Board. Fried has played a key role in advancing IPA’s AI platform capabilities, particularly the integration of vector search to support large-scale, AI-driven discovery within LENSai ecosystem.
•
Regained compliance with Nasdaq minimum bid price requirement, reflecting strengthened investor confidence and continued alignment with strategic listing standards.
"Fiscal 2025 was a record-setting year for IPA across multiple dimensions," said Dr. Jennifer Bath, ImmunoPrecise Antibodies CEO. "We delivered our highest-ever annual and fourth quarter revenues, significantly improved gross margins, and achieved one of our strongest adjusted EBITDA performances in recent years, with a loss of only $316,000. This reflects our continued progress toward profitability while accelerating innovation through our HYFT-powered LENSai platform. Our BioStrand segment alone grew by more than 180% in Fiscal 2025, highlighting the strength of our AI-driven pipeline. These results underscore the growing commercial validation of our technology, our strategic collaborations, and our ability to deliver real-world impact through next-generation antibody discovery and therapeutic design."

"As we look ahead to the next fiscal year, we are well-positioned to build on our momentum. We are poised to refocus our business on our AI-based product development utilizing our LENSai platform, powered by our HYFT technology. We anticipate the near-term completion of the previously announced divestiture of our Dutch subsidiary, as part of our continued focus on streamlining operations and aligning resources with strategic priorities. Together, these strategic steps will sharpen our focus, strengthen our core capabilities, and set the stage for an even brighter future for IPA," concluded Dr. Bath.

Fourth Quarter 2025 Financial Results

Revenue for the three months ended April 30, 2025, was $7.0 million, representing an 8% increase compared to $6.5 million for the same period in 2024. This growth was primarily driven by a $0.6 million increase in project revenues.

Gross profit for the three months ended April 30, 2025, was $4.5 million, up from $3.1 million in the same period last year. Gross margin rose sharply to 64%, compared to 48% in the same period in 2024. This improvement was driven, in part, by a greater contribution from high-margin BioStrand revenues.

Research and development ("R&D") expenses totaled $1.1 million, down from $1.3 million in the prior-year quarter, due to reallocating project-related R&D efforts to cost of sales.

Sales and marketing expenses increased to $1.0 million, compared to $0.9 million in the same period last year, due to an increase in digital campaign expenses.

General and administrative expenses declined to $3.7 million from $4.1 million, driven by ongoing cost control efforts.

Operating loss, excluding amortization and non-recurring charges, improved significantly to $1.4 million, compared to $3.2 million in the fourth quarter of Fiscal Year 2024.

Net loss narrowed to $2.2 million, a marked improvement from a net loss of $17.6 million in the same quarter last year, which included a $15 million non-cash impairment charge related to BioStrand’s goodwill and intangible assets.

Adjusted EBITDA loss improved to $0.3 million, compared to a loss of $1.7 million in the fourth quarter of Fiscal Year 2024, reflecting improved gross profits and enhanced operating efficiency.

Full Year 2025 Financial Results

Revenue for Fiscal Year 2025, was $24.5 million, up slightly versus $24.5 million in Fiscal Year 2024.

Gross Profit for Fiscal Year 2025 was $13.5 million, a 12.4% increase compared to $12.1 million in Fiscal Year 2024. Gross margin expanded by 600 basis points to 55%, up from 49% in the prior year. This margin improvement was driven by a greater revenue contribution from the high-margin BioStrand segment, coupled with an increased focus on cost efficiencies.

Research and development expenses were $4.9 million in Fiscal Year 2025, up from $4.0 million in Fiscal Year 2024, reflecting increased investment in R&D activities within the BioStrand segment.

Sales and marketing expenses were $4.3 million in Fiscal Year 2025, compared to $3.5 million in Fiscal Year 2024, reflecting increased spending on advertising related to digital campaign expenses.

General and administrative expenses totaled $14.7 million in Fiscal Year 2025, down from $15.6 million in Fiscal Year 2024, reflecting the Company’s continued focus on operational efficiency and cost discipline.

Operating loss in Fiscal Year 2025, excluding amortization and non-recurring charges, improved to $10.4 million, compared to $11.1 million in Fiscal Year 2024.

Net loss in Fiscal Year 2025 was $30.2 million, or $(0.91) per share on a basic and diluted basis, compared to a net loss of $26.1 million or $(1.02) on a basic and diluted basis in Fiscal Year 2024.

Total cash, cash equivalents, and marketable securities, including restricted cash, were $10.8 million as of April 30, 2025.

The reconciliation of Net Loss to Adjusted EBITDA is presented in the table below:

Three Months Ended
April 30,

Year Ended
April 30,

(in thousands)

2025
$

2024
$

2025
$

2024
$

Net loss

(2,161

)

(17,610

)

(30,234

)

(26,115

)

Income taxes

261

(1,214

)

(4,033

)

(2,588

)

Amortization and depreciation

913

1,579

5,119

5,735

Accretion

2

4

10

19

Asset impairment charge

—

15,031

21,184

15,031

Foreign exchange realized gain (loss)

(33

)

18

(5

)

142

Interest expense

209

323

948

849

Interest and other income

(3

)

3

283

(23

)

Unrealized foreign exchange loss (gain)

443

(65

)

594

(86

)

Share-based expense

53

237

445

1,535

Adjusted EBITDA

(316

)

(1,694

)

(5,689

)

(5,501

)

*All financial figures are in Canadian Dollars (CAD) unless otherwise stated.

Conference Call and Webcast Details

The Company will host a live conference call and webcast to discuss these results and provide a corporate update on Friday, July 29, 2025, at 10:30AM ET.

The conference call will be webcast live and available for replay via a link provided in the Events section of the Company’s IR pages at View Source

***Participant Dial-In Details***

Participants call one of the allocated dial-in numbers (below) and advise the Operator of either the Conference ID 3224490 or Conference Name.

USA / International Toll +1 (646) 307-1963
USA – Toll-Free (800) 715-9871
Canada – Toll-Free (800) 715-9871

***Webcast Details***

Attendee URL:
View Source

Please call the conference telephone number five minutes prior to the start time. An operator will register your name and organization.

Anyone listening to the call is encouraged to read the company’s periodic reports available on the company’s profile at www.sedarplus.com and www.sec.gov, including the discussion of risk factors and historical results of operations and financial condition in those reports.