On July 29, 2024 Haystack Oncology, a Quest Diagnostics (NYSE: DGX) company, reported a research collaboration with Dr. Simon Turcotte, hepatopancreatobiliary surgeon and scientist at Université de Montréal’s affiliated hospital research centre, the CRCHUM, to utilize Haystack Oncology’s personalized MRD technology (Haystack MRD) to evaluate treatment effectiveness in patients with metastatic colorectal cancer (mCRC) with metastases confined to the liver (Press release, Quest Diagnostics, JUL 29, 2024, View Source,-the-CRCHUM,-to-Deploy-Haystack-MRD-TM-Technology-in-Research-Study-for-Metastatic-Colorectal-Cancer [SID1234645136]).

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This prospective, observational study, Early Detection of Treatment Failure in Metastatic Colorectal Cancer Patients (eDetect), will use Haystack MRD to assess circulating tumor DNA (ctDNA) as an early biological marker of treatment response and disease recurrence in patients with mCRC undergoing systemic treatment and liver surgery with curative intent. Haystack MRD is a blood-based liquid biopsy test that measures ctDNA shed into circulation by solid tumors in order to identify residual, recurrent, or resistant cancer, at the earliest possible stage.

"Our collaboration with the CRCHUM presents a valuable opportunity to leverage the performance of our Haystack MRD technology in a population of mCRC patients for whom cure is possible," said Dan Edelstein, Vice President and General Manager of Haystack Oncology. "Designed for detecting ctDNA with exceptional sensitivity, Haystack MRD is well-suited to measure treatment response in oligometastatic CRC patients to better understand how ctDNA can guide the sequence and intensity of therapy in the future."

Université de Montréal’s affiliated hospital research centre, the CRCHUM, is one of North America’s leading hospital research centres. Located in the heart of Montreal, the CRCHUM is a major centre for creation, knowledge generation and training.

"mCRC is a challenging disease in need of improved biomarkers to guide optimal patient care," said Dr. Simon Turcotte, hepatopancreatobiliary surgeon and scientist at the CRCHUM, also principal investigator of the eDetect study. "By teaming up with Haystack, we will be able to understand the best use of the MRD technology to inform treatment decisions. This will guide the design of future interventional trials to assess impact on patient survival."

Colorectal cancer is the second leading cause of cancer death in Canada and the United States, representing approximately 62,310 related deaths in 2023.1,2 While early-stage CRC can frequently be cured by surgery (with or without adjuvant chemotherapy), mCRC is often treatment-resistant and can be more difficult to address.3

Metastases are the primary cause of colorectal cancer-related mortality, with the liver being the most frequent site for metastasis, followed by the lung. Patients presenting with metastases confined to the liver represent a unique clinical opportunity to pursue surgery with intent to cure. However, even after surgery with no evidence of residual tumor by medical imaging, 80% of patients relapse. A more sensitive diagnostic tool, such as ctDNA, is needed to detect whether residual microscopic cancer cells remain after surgery, to detect relapse earlier than medical imaging so as to treat before the disease burden is too high, and to know as early as possible whether chemotherapy is effective to limit unnecessary use and side effects.

On July 29, 2024 Novartis reported that Scemblix (asciminib) has been granted Priority Review status by the US Food and Drug Administration (FDA) for treatment of newly diagnosed adult patients with Philadelphia chromosome-positive CML in chronic phase (Ph+ CML-CP) (Press release, Novartis, JUL 29, 2024, View Source [SID1234645135]).

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The FDA grants Priority Review to medicines that address serious or life-threatening diseases or conditions and, if approved, would provide significant improvements in treatment safety or efficacy5. Scemblix previously received Breakthrough Therapy designation for the treatment of newly diagnosed adult patients and is currently being reviewed under the FDA’s Real-Time Oncology Review (RTOR) program. Scemblix received Priority Review and Breakthrough Therapy designations at the time of the original new drug application for the treatment of adult patients with Ph+ CML-CP who have previously been treated with two or more TKIs2-4,6,7.

"We welcome the FDA’s decision to grant Priority Review and Breakthrough Therapy designations to Scemblix for newly diagnosed CML patients, which underscores the substantial need for additional effective, safe and tolerable treatment options," said Rodney Gillespie, Senior Vice President, Therapeutic Area Head, US Oncology, Novartis. "The ASC4FIRST data indicate that Scemblix, if approved, has the potential to address a critical gap in CML by offering a highly effective treatment along with a favorable safety and tolerability profile."

Priority Review designation is based on results from ASC4FIRST, a Phase III study that evaluated the efficacy, tolerability and safety of once daily Scemblix against investigator-selected (IS) tyrosine kinase inhibitors (TKIs) (imatinib, nilotinib, dasatinib, and bosutinib) representing the current standard of care (SoC) in newly diagnosed adult patients with Ph+ CML-CP1. Scemblix demonstrated superior major molecular response (MMR) rates in both primary endpoints at week 48 vs. IS SoC TKIs (68% vs. 49.0%) and imatinib alone (69% vs. 40%)1. Additionally, Scemblix is the first CML treatment to show superior efficacy along with a favorable safety and tolerability profile vs. imatinib and 2G TKIs, with fewer grade ≥3 AEs (38% vs. 44% and 55%), dose adjustments (30% vs. 39% and 53%) and half the rate of AEs leading to treatment discontinuation (5% vs. 11% and 10%)1. In newly diagnosed patients, the safety profile was consistent with previous registration studies, with no new safety concerns observed1.

Earlier this year, ASC4FIRST data were presented as a late-breaking abstract at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, as a plenary at the European Hematology Association (EHA) (Free EHA Whitepaper) 2024 Congress and published in The New England Journal of Medicine1.

Scemblix is currently approved by the FDA, European Medicines Agency and other regulatory authorities for adult patients with Ph+ CML-CP who have been treated previously with two or more TKIs2,4,6.

About ASC4FIRST Phase III Clinical Trial
ASC4FIRST (NCT04971226) is a Phase III, head-to-head, multi-center, open-label, randomized study of oral Scemblix 80 mg QD vs. investigator-selected first- or second-generation TKIs (imatinib, nilotinib, dasatinib or bosutinib) in 405 adult patients with newly diagnosed Ph+ CML-CP6. The two primary endpoints of the study are to compare efficacy of asciminib vs. investigator-selected SoC TKIs and to compare efficacy vs. that of TKI within the stratum of participants with imatinib as pre-randomization selected TKI, based on proportion of patients that achieve MMR at week 486.

The study remains ongoing with key secondary endpoints of proportion of patients that achieve MMR at week 96 and a safety endpoint of discontinuation of study treatment due to an AE (TTDAE) by week 966. The study also assesses additional secondary safety and efficacy endpoints, including MMR, MR4, MR4.5, complete hematological response (CHR) and BCR::ABL1 ≤1% at and by all scheduled data collection time points; duration of and time to first MMR, MR4 and MR4.5; time to treatment failure; event-free survival, failure-free survival, progression-free survival and overall survival6.

About Scemblix (asciminib)
Scemblix is the first CML treatment that works by Specifically Targeting the ABL Myristoyl Pocket (referred to as a STAMP inhibitor in scientific literature)8-10. The current approved CML treatments are TKIs that target the ATP-binding site (ATP-competitive)10.

Scemblix is approved in more than 70 countries, including the US, the EU and JP, to treat adults with Ph+ CML-CP who have previously been treated with two or more TKIs2,3,7. In some countries, including the US, Scemblix is also approved in patients with Ph+ CML-CP with the T315I mutation2-4.

Scemblix is an important treatment option for patients who experience resistance and/or intolerance after two prior TKI therapies11-26, and it is being studied across multiple treatment lines for Ph+ CML-CP, both as a monotherapy and in combination6,8,9,19,27-39.

About Novartis Commitment to CML
Novartis has a long-standing scientific commitment to patients living with CML. For more than two decades, our bold science has helped transform CML from a life-limiting to a chronic condition for many patients. Despite these advancements, there’s still work to be done. We continue to research ways to target the disease more selectively and to address the challenges of not reaching treatment efficacy goals, experiencing treatment resistance and/or intolerance that many patients face. Our legacy inspires our future innovation – we continue to lead the way in developing novel medicines to address serious unmet needs in CML. Our commitment also goes beyond science. Our 20+ year collaboration with the Max Foundation has provided access to Gleevec (imatinib), Tasigna (nilotinib) and now Scemblix and is delivering tremendous patient impact in low- and middle-income countries, with over 100,000 patients supported to date.

Indication
SCEMBLIX (asciminib) tablets is a prescription medicine used to treat adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with 2 or more tyrosine kinase inhibitor (TKI) medicines.
SCEMBLIX is also approved for use in adults with Ph+ CML in CP with the T315I mutation.

It is not known if SCEMBLIX is safe and effective in children.

Important Safety Information
SCEMBLIX (asciminib) tablets may cause low platelet counts (thrombocytopenia), low white blood cell counts (neutropenia), and low red blood cell counts (anemia). Patients should tell their doctor right away if they have unexpected bleeding or easy bruising; blood in their urine or stools; fever; or any signs of an infection. SCEMBLIX may increase enzymes in the patient’s blood called amylase and lipase, which may be a sign of inflammation of the pancreas (pancreatitis). Patients should tell their doctor right away if they have sudden stomach-area pain or discomfort, nausea, or vomiting. During treatment with SCEMBLIX, doctors may check their patients’ blood pressure and treat any high blood pressure as needed. Patients should tell their doctor if they develop elevated blood pressure or symptoms of high blood pressure including confusion, headaches, dizziness, chest pain, or shortness of breath.

If a patient has an allergic reaction while on SCEMBLIX, they should stop taking SCEMBLIX and get medical help right away. Signs or symptoms of an allergic reaction include trouble breathing or swallowing; feeling dizzy or faint; swelling of the face, lips, or tongue; fever; skin rash or flushing; or a fast heartbeat. SCEMBLIX may cause heart and blood vessel problems, including heart attack; stroke; blood clots or blockage of patient’s arteries; heart failure; and abnormal heartbeat which can be serious and may sometimes lead to death. These heart and blood vessel problems can happen in people with risk factors or a history of these problems and/or previously treated with multiple TKI medicines. Patients should tell their doctor right away if they get shortness of breath; chest pain or pressure; a feeling like their heart is beating too fast or they feel abnormal heartbeats; swelling in their ankles or feet; dizziness; weight gain; numbness or weakness on one side of their body; decreased vision or loss of vision; trouble talking; pain in their arms, legs, back, neck, or jaw; headache; or severe stomach-area pain.

Before taking SCEMBLIX, patients should tell their doctor about all of their medical conditions, including if they have a history of pancreatitis; a history of heart problems; or blood clots in their arteries and veins (types of blood vessels). SCEMBLIX can harm an unborn baby. Women should tell their doctor right away if they become pregnant or think they may be pregnant during treatment with SCEMBLIX. Women who are able to become pregnant should have a pregnancy test before they start SCEMBLIX and should use effective birth control during treatment and for 1 week after the last dose of SCEMBLIX. Women should not breastfeed during treatment and for 1 week after their last dose of SCEMBLIX.

Patients should tell their doctor about all the medicines they take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. SCEMBLIX and other medicines may affect each other, causing side effects. The most common side effects of SCEMBLIX include nose, throat, or sinus (upper respiratory tract) infections; muscle, bone, or joint pain; rash; tiredness; nausea; and diarrhea. The most common blood test abnormalities include decreased blood counts of platelets, white blood cells, and red blood cells; and increased blood levels of triglycerides, creatine kinase, liver enzymes, or pancreas enzymes (amylase and lipase).

Please see full Prescribing Information for SCEMBLIX, available at View Source

On July 29, 2024 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported financial results for the second quarter ending June 30, 2024.

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Second Quarter 2024 Highlights
•Second quarter revenues of $418.2 million increased 9.7% on a reported basis and 2.3% on an organic basis compared to the prior year. Revenue increased 0.3% on an organic basis excluding Boston.

•Second quarter GAAP earnings per diluted share of $(0.16), compared to $0.05 in the prior year; adjusted earnings per diluted share of $0.63, compared to $0.71 in the prior year.

•Early integration success with the Acclarent ENT acquisition.

•Announced plans to focus relaunch of SurgiMend and PriMatrix at new state-of-the-art manufacturing facility in Braintree, Massachusetts, with operational readiness expected in the first-half of 2026.

•Received PMA approvable notification pending GMP certification for SurgiMend.

•Implementing compliance master plan to address quality system and GMP compliance learnings. As a result, the company has initiated temporary shipping holds on certain products that will primarily impact the third quarter.

•Updating full-year 2024 revenue guidance to a range of $1.609 billion to $1.629 billion and adjusted EPS guidance to a range of $2.41 to $2.57 per share reflecting the temporary shipping holds and significant second half investments in quality system and GMP compliance improvements.

"Our second quarter financial performance continues to reflect the persistent market demand for our diversified portfolio and the commitment of our teams," said Jan De Witte, Integra LifeSciences’ president and chief executive officer. "Using the learnings from our Boston facility, we are continuing a thorough analysis of our operations and are committed to enhancing the quality, reliability and resilience of our manufacturing operations and supply chain. The reduction in our full-year guidance reflects an updated view of our operational challenges and critical investments in our compliance improvement program that will allow our supply to meet our strong commercial demand strength over time."

Second Quarter 2024 Consolidated Performance

Total reported revenues of $418.2 million increased 9.7% on a reported basis and 2.3% on an organic basis compared to the prior year. Organic growth excluding Boston was 0.3%.
The Company reported GAAP gross margin of 54.0%, compared to 54.3% in the second quarter of 2023. Adjusted gross margin was 65.2%, compared to 67.6% in the prior year.
Adjusted EBITDA for the second quarter of 2024 was $83.8 million, or 20.0% of revenue, compared to $88.8 million, or 23.3% of revenue, in the prior year.

The Company reported a GAAP net loss of $(12.4) million, or $(0.16) per diluted share, in the second quarter of 2024, compared to GAAP net income of $4.2 million, or $0.05 per diluted share, in the prior year.
Adjusted net income for the second quarter of 2024 was $49.0 million, or $0.63 per diluted share, compared to $57.4 million or $0.71 per diluted share, in the prior year.

Second Quarter 2024 Segment Performance
Codman Specialty Surgical (~70% of Revenues)
Total revenues were $301.8 million, representing reported growth of 11.3% and organic growth of 0.9% compared to the second quarter of 2023.

•Sales in Neurosurgery grew 1.2% on an organic basis. Key drivers for the quarter include:
•Dural access and repair grew high-single-digits driven by DuraGen and Mayfield
•Advanced energy grew low-single digits driven by Aurora
•CSF management decreased low-double digits due to supply backorders
•Neuro monitoring was down low-single digits driven by double-digit growth in CereLink monitors and micro sensors offset by supply challenges
•Sales in international markets grew low-single digits
•Sales in Instruments declined 3.1% on an organic basis
•ENT grew low-double digits reflecting MicroFrance ENT instruments

Tissue Technologies (~30% of Revenues)

Total revenues were $116.4 million, representing reported growth of 5.6% and organic growth of 5.7% compared to the second quarter of 2023. Tissue Technologies sales were down 1% excluding Boston. Key drivers for the quarter include:

•High double-digit growth for DuraSorb
•Mid-double-digit growth in Gentrix
•Low double-digit growth in MicroMatrix, Cytal and amniotics
•Low double-digit decline in Integra Skin
•Sales in private label increased 1.5% on an organic basis excluding Boston

Advancing our Strategy

•Broad demand for Integra’s diverse portfolio of leading brands
•Continued successful market uptake of CereLink monitors and microsensors
•Expanded international commercial footprint and portfolio for CUSA, DuraGen and Mayfield
•Growth in DuraSorb above expectations
•Early integration success with the Acclarent ENT acquisition
•Positive early clinical response to MicroMatrix Flex launch
•Finalized plans to restart the manufacture of PriMatrix and SurgiMend at our new manufacturing facility in Braintree, Massachusetts with operational readiness expected in the first half of 2026
•Received PMA approvable notification pending GMP certification from the FDA for SurgiMend
•Significantly stepping up investments in quality, reliability and capacity

Balance Sheet, Cash Flow and Capital Allocation
The Company generated cash flow from operations of $40.4 million in the quarter. Total balance sheet debt and net debt at the end of the quarter were $1.83 billion and $1.54 billion, respectively, and the consolidated total leverage ratio was 3.8x.

As of quarter end, the Company had total liquidity of approximately $1.18 billion, including $297 million in cash plus short-term investments and the remainder available under its revolving credit facility.

2024 Outlook
For the full year 2024, the Company is updating its revenue and adjusted EPS expectations to $1.609 to $1.629 billion and $2.41 to $2.57, respectively. The revenue range represents reported growth of 4.4% to 5.7%, with organic growth of –1.0% to 0.3%, reflecting third quarter quality and labeling compliance shipping holds and significant second half investments in quality and compliance improvement.

For the third quarter 2024, the Company expects reported revenues in the range of $372 million to $382 million, representing reported growth of -2.6% to 0.0% and organic growth of -9.4% to –6.7%. The Company expects adjusted EPS in a range of $0.36 to $0.44.

The Company’s organic sales growth guidance for the third quarter and the full-year excludes acquisitions and divestitures, as well as the effects of foreign currency.

Conference Call and Presentation Available Online
Integra has scheduled a conference call for 8:30 a.m. ET on Monday July 29, 2024, to discuss second quarter 2024 financial results and forward-looking financial guidance. The conference call will be hosted by Integra’s senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question-and-answer session following the call. Integra’s management team will reference a presentation during the conference call, which can be found on the Investor section of the website at investor.integralife.com.

A live webcast will be available on the Investors section of the Company’s website at investor.integralife.com. For those planning to participate on the call, register here to receive dial-in details and an individual pin. While not required, it is recommended to join 10 minutes prior to the event’s start. A webcast replay of the conference call will be available on the Investors section of the Company’s website following the call.

On July 29, 2024 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, reported that it will release topline results from the Phase 2 OVATION 2 Study with IMNN-001 in patients with advanced ovarian cancer tomorrow, July 30, at approximately 8:00 a.m. Eastern time, and will host an investment community conference call to discuss the results and answer questions at 8:30 a.m. Eastern time (Press release, IMUNON, JUL 29, 2024, View Source [SID1234645133]). IMNN-001 is the Company’s interleukin-12 (IL-12) immunotherapy based on its TheraPlas technology.

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To participate in the conference call, please dial 833-816-1132 (Toll-Free/North America) or 412-317-0711 (International/Toll) and ask for the IMUNON call. A live webcast of the call will be available here.

Participants are encouraged to preregister for the call here.

The call will be archived for replay through August 13, 2024. The replay can be accessed at 877-344-7529 (U.S. Toll-Free), 855-669-9658 (Canada Toll-Free) or 412-317-0088 (International Toll), using the replay access code 7783601. A webcast of the call will be available here for 90 days.

On July 29, 2024 ImmunoPrecise Antibodies Ltd. ("IPA", "Company", "we" or "us") (NASDAQ: IPA), an artificial intelligence (AI)-driven biotherapeutic research and technology company, reported its financial results for the fiscal year ended April 30, 2024 (Press release, ImmunoPrecise Antibodies, JUL 29, 2024, View Source [SID1234645132]). All numbers are expressed in Canadian dollars unless otherwise noted.

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"IPA has achieved significant milestones this fiscal year," said Dr. Jennifer Bath, CEO and President of IPA. "We are proud to report our fifth consecutive quarter of record revenues as well as record annual revenues, which reflect strong demand for our comprehensive antibody discovery and development services. This impressive growth is driven by our B Cell Select platforms and the enhanced capacity of our manufacturing facilities. We are excited to share that our strategic investments in AI technologies are starting to pay off, as demonstrated by the progress of BioStrand in meeting significant milestones with the rollout of their LENSai software both internally and to the public. This progress highlights our commitment to innovation and positions us at well amongst AI-driven drug discovery and development."

Business Highlights and Corporate Update

ImmunoPrecise Antibodies Ltd. (IPA) has reported a record-breaking fiscal year for the Company, achieving revenues of $24.5 million, a 19% increase from $20.7 million the previous year. This growth underscores IPA’s capability to meet the rising demand for its end-to-end antibody services, including comprehensive wet lab and in silico discovery and development technologies. The Company’s financial prudence and operational efficiency are further highlighted by a notable reduction in cash burn.

Technological advancements have been pivotal in IPA’s success. We believe that BioStrand’s patented HYFT Technology has significantly enhanced the Company’s ability to solve complex biological problems, leading to major advancements in developing novel potential therapeutics against challenging targets for our clients and partners. Strategic collaborations, including with InterSystems and PGxAI, have expanded IPA’s capabilities in healthcare data processing and pharmacogenomics, respectively. Our commitment to innovation was recently recognized with the 2024 Impact Award for BioStrand’s LENSai technology and the launch of the LENSai API, offering commercial access across multiple sectors.

FY24 Enhancements to Functionality of LENSai

•
HYFT Technology Advancement: Unveiled a new approach to biological sequence retrieval, combining Natural Language Processing (NLP) and database research for improved accuracy and efficiency.
•
Advanced AI Model Introduction: Introduced an advanced Foundation AI Model in January, combining Large Language Models (LLMs) with HYFT Technology, advancing AI-driven drug discovery.
•
Healthcare Data Processing Partnership: Partnered with InterSystems Corporation in February to integrate vector search with LENSai for AI-driven drug discovery and healthcare applications, enhancing data processing and expanding market reach.
•
Electronic Health Record (EHR) Data Integration: Developed an advanced LLM for EHRs in March, improving retrieval and analysis to optimize collaboration outputs with InterSystems.

Commercialization of LENSai

•
Internal Rollout of LENSai: Successfully rolled out LENSai internally, including to IPA’s sites in Utrecht and Oss, the Netherlands, showcasing the platform’s security and utility.
•
Commercial Projects: Successfully executed end-to-end programs entirely in silico using LENSai, solving challenging therapeutic antibody programs for partners and clients, providing feedback on LENSai’s performance and resilience in solving complex biological challenges.
•
Public Commercial Launch of LENSai API: BioStrand announced the commercial launch of its LENSai API software, and is working to offer the platform, in conjunction its partner, AWS, on the AWS Marketplace, a sales channel that enables Independent Software Vendors (ISVs) and consulting partners to sell their solutions to AWS customers.
•
LENSai Rollout Success: BioStrand has initiated the public rollout of LENSai with selected pharmaceutical partners ahead of schedule. Based on client positive experience and outcomes from LENSai applications, one of our large pharmaceutical company clients has chosen to expand from initial services to a broader integration with our Software-as-a-Service (SaaS) and API solutions. This successful pilot demonstrates the platform’s capability to generate significant revenue streams through these commercially available solutions, which may support recurring revenue for BioStrand.
•
2024 Impact Award for LENSai Technology: BioStrand was awarded the prestigious 2024 Impact Award in April for their LENSai technology, recognizing the potential of our HYFT-powered platform with EHR analysis capabilities.

•
Collaboration with PGxAI: This commercial collaboration represents a strategic move in the growing trend of AI-to-AI collaborations, a burgeoning strategy within the industry. By fostering enhanced interactions between AI systems, this approach is driving significant advancements, particularly in precision medicine. Following the launch of the LENSai API, IPA signed a collaboration with PGxAI to develop an AI model for pharmacogenomics, further solidifying its position at the forefront of AI-driven healthcare solutions.

Growth of Discovery and Development Service Offerings

•
Expansion of Oss Laboratory Facilities: The Company expanded its laboratory facilities at its Oss, the Netherlands, site in February 2024. This increased lab space has enabled enhanced service offerings and additional equipment, such as the Carterra LSA, to support the high throughput needs from the downstream outputs of LENSai. These new services are already in high demand.
IPA’s ongoing efforts to expand its technological and service capabilities, including the acquisition of additional laboratory space and equipment, forecast continued robust growth. The expansion of its B Cell Select platforms and advancements in VHH antibody discovery technologies further bolster its position as a leader in biotherapeutic research and development. Overall, these strategic initiatives have improved IPA’s financial performance and technological prowess.

Fourth Quarter 2024 Financial Results

Revenue was $6.5 million for the three months ended April 30, 2024, compared to $5.6 million for the three months ended April 30, 2023.

Research and development (R&D) expenses were $1.3 million for the three months ended April 30, 2024, compared to $0.9 million for the three months ended April 30, 2023. This increase was primarily driven by increased R&D activities at BioStrand.

Selling and marketing expenses were $0.9 million for the three months ended April 30, 2024, compared to $0.9 million for the three months ended April 30, 2023.

General and administrative expenses were $4.8 million for the three months ended April 30, 2024, compared to $5.0 million for the three months ended April 30, 2023.

Net loss was $18.0 million for the three months ended April 30, 2024, including a $15 million impairment expense related to BioStrand’s goodwill and intangible assets. This compares to the net loss of $5.1 million for the three months ended April 30, 2023, including a $2.5 million impairment expense related to BioStrand.

Full Year 2024 Financial Results

Revenue was $24.5 million for the fiscal year 2024, marking an increase from $20.7 million in the previous year fiscal 2023. We attribute this growth to the successful implementation of our strategic initiatives, including the expansion of our B Cell Select platforms and the ongoing development of our VHH antibody discovery technologies.

Research and development expenses were $4.0 million, down from $14.1 million in fiscal 2023, reflecting the transition of Talem assets from R&D build to the focus of revenue generation.

Sales and marketing expenses were $3.5 million, compared to $3.6 million in fiscal 2023, down slightly year over year as we managed our expenses, even with achieving record revenue growth.

General and administrative expenses were $15.6 million, compared to $15.4 million in fiscal 2023, flat year over year as the company grew.  

The Company recorded an impairment charge of $15 million related to BioStrand’s goodwill and intangible assets. This adjustment reflects a rise in the discount rate and delays in expected cash flows. Despite this change in accounting valuation, IPA remains committed to its strategic investments and long-term growth plans. The Company recorded an impairment charge of $2.5 million related to BioStrand in fiscal 2023.

Net loss for the fiscal year was $27.2 million, or $(1.07) per share on a basic and diluted basis, compared to a net loss of $26.6 million or $(1.06) on a basic and diluted basis in fiscal 2023, for an increase of $0.6 million. However, the impairment recognized in fiscal 2024 was $12.5 million higher than fiscal 2023.

Total cash, cash equivalents, and marketable securities, including restricted cash, were $3.5 million as of April 30, 2024, reflecting the focus on managing operational costs while investing in R&D and capital equipment. The Company used cash in operating activities of $4.2 million in fiscal 2024, compared to $19.8 million in 2023. Equipment purchases were $1.4 million in fiscal 2024 and $1.5 million in fiscal 2023. To offset these uses of cash, net funds of $2.4 million were raised in fiscal 2024 versus $0.7 million in fiscal 2023.

Subsequently, on July 16, 2024, the Company agreed to sell and issue to A II PN, Ltd., an investment fund managed by Yorkville Advisors Global, LP ("Yorkville"), U.S.$3.0 million of convertible debentures in two tranches and at a purchase price of 95% of the aggregate principal amount.

(in thousands, CAD$)

Q4 FY24

Q4 FY23

FY24

FY23

Revenue

$6,459

$5,620

$24,518

$20,665

Gross Profit

3,108

3,341

12,053

11,563

Research & Development Expense

1,260

912

4,043

14,101

Sales & Marketing Expense

910

933

3,543

3,608

General & Administrative Expense

4,821

4,963

15,592

15,383

Impairment Expense

15,031

2,460

15,031

2,460

Net Loss

(18,045)

(5,129)

(27,177)

(26,560)

Conference Call and Webcast

IPA will host a live conference call and webcast to discuss these results and provide a corporate update on July 29, 2024, at 10:30 AM 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 IPA Events and Presentations.

Conference Call

Event Title: ImmunoPrecise Reports Financial Results and Recent Business Highlights for Full Fiscal Year 2024

Event Date: July 29th, 2024

Time: 10:30 AM (GMT-04:00) Eastern Time (US and Canada)

Participant Dial-In Details

Participants call one of the allocated dial-in numbers (below) and advise the Operator of either the Conference ID 9236374 or Conference Name.

North America Toll-Free: (888) 550-5658

North America Toll: (646) 960-0289

International Toll: +1(646) 960-0289

Webcast Details

Attendee URL:

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