On September 16, 2024 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (NASDAQ: IPA), an artificial intelligence-driven biotherapeutic research and technology company, reported financial results for the first quarter of its 2025 fiscal year ("FY25"), which ended July 31, 2024. All numbers are expressed in Canadian dollars, unless otherwise noted (Press release, ImmunoPrecise Antibodies, SEP 16, 2024, View Source [SID1234646683]).

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"Our commitment to end-to-end in silico engineering of antibodies for challenging targets has delivered exceptional results. By harnessing our advanced computational capabilities, we’ve not only accelerated our R&D process, but also significantly reduced costs compared to traditional technologies," stated Dr. Jennifer Bath, President and CEO. "Notably, two of our three wet lab locations reported impressive double-digit revenue growth this quarter, underscoring the effectiveness of our strategy. Our third site focused efforts on rebuilding its off-the-shelf inventory, a move designed to support future sales of higher-margin products. This balanced approach of driving immediate growth while strategically positioning for future profitability demonstrates our commitment to long-term value creation. Our innovative antibody development techniques, combined with astute operational decisions, reinforce our competitive edge in this dynamic market. We’re confident that this multifaceted strategy will continue to drive sustainable growth and enhance shareholder value in the quarters to come."

Business Highlights and Corporate Update

ImmunoPrecise continues to execute its growth strategy, focusing on scaling its AI-driven antibody drug discovery platforms, expanding its global client base, and optimizing operational efficiencies. The Company’s comprehensive approach to antibody discovery and development is consistently yielding tangible outcomes. In the quarter ending July 31, 2024, ImmunoPrecise recorded revenue of $5.3 million, with two of its three sites delivering impressive double-digit growth rates year-over-year. While IPA’s protein manufacturing site experienced a year-over-year decline this quarter, this was primarily due to an exceptionally strong performance in the previous year and rebuilding off-the-shelf inventory of higher-margin products. ImmunoPrecise’s balanced approach of driving immediate growth while strategically positioning for the future underscores its commitment to long-term value creation and reinforces its competitive edge in the dynamic antibody market.

BioStrand is driving revenue growth through its LENSai platform, offering fee-for-service solutions while developing commercial products tailored to IPA’s extensive client base of over 600 companies. Recently, BioStrand achieved a significant breakthrough by developing and optimizing antibodies entirely through computer simulations, targeting a protein within the Tumor Microenvironment (TME). This achievement is particularly noteworthy given the TME’s intricate nature and the lack of prior structural data on the target. Despite these formidable challenges, our team successfully navigated the complexities of end-to-end in silico antibody development in this demanding context. Building on this AI-driven success, BioStrand is now accelerating the rollout of advanced in silico antibody engineering solutions, positioning the company at the forefront of computational drug discovery and potentially opening new revenue streams in this high-growth market segment.

BioStrand is also making progress in developing applications for the AWS Marketplace. For context, the AWS Marketplace is a global platform that enables partners to leverage Amazon Web Services’ technologies, programs, and expertise to build and deliver cutting-edge solutions. This marketplace provides BioStrand with enhanced visibility to a broader customer base, opening new opportunities for growth and collaboration while ensuring the delivery of high-quality, AI-driven SaaS solutions.

Talem Therapeutics and BioStrand have partnered to enhance Talem’s lead therapeutic assets using BioStrand’s LENSai software suite, which includes over 80 in silico applications. This collaboration aims to increase the data quality and value of these assets. By leveraging LENSai to refine existing lead candidates, the Company expects to improve their market readiness and commercial potential. The Company plans to soon release more details on these enhanced assets, demonstrating LENSai’s utility in antibody engineering and its impact on asset value.

First Quarter FY25 Financial Results

Revenue: Total revenue was $5.3 million, compared to revenue of $5.7 million in fiscal year 2024 ("FY24") Q1. Project revenue generated $4.9 million, including projects using IPA’s proprietary B Cell Select platform and IPA’s proprietary LENSai platform, compared to $5.2 million in FY24 Q1. Product sales and cryostorage revenue were $0.4 million, compared to $0.5 million in FY24 Q1.
Research & Development (R&D) Expenses: R&D expenses were $1.6 million, compared to $0.9 million in FY24 Q1, with the increase reflecting increased expenditures related to the build of the Company’s LENSai platform.
Sales & Marketing (S&M) Expenses: S&M expenses were $0.7 million, compared to $1.1 million in FY24 Q1. The reduction in sales and marketing expenses reflect lower share-based expense and cost savings from our synergistic sales efforts across our comprehensive AI-enhanced antibody discovery and development services.
General & Administrative (G&A) Expenses: G&A expenses were $4.2 million, compared to $4.0 million in FY24 Q1.
Net Loss: Net loss of $4.0 million, or $(0.15) per share on a basic and diluted basis, compared to a net loss of $3.4 million or $(0.14) on a basic and diluted basis in FY24 Q1.
Liquidity: Cash totaled $4.0 million as of July 31, 2024, compared to $6.8 million as of July 31, 2023.
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 Monday, September 16, 2024, 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 – Toronto (647) 932-3411
Canada – Toll-Free (800) 715-9871

On September 16, 2024 Cellworks Group Inc., a leader in Personalized Therapy Decision Support and Precision Drug Development, reported results from a study using the Cellworks Platform to predict homologous recombination deficiency (HRD) and the effectiveness of PARP inhibitors (PARPi) in real-world cohorts of patients with ovarian, pancreatic, prostate, and triple-negative breast cancers (TNBC) (Press release, Cellworks, SEP 16, 2024, View Source [SID1234646682]). This research highlights the potential of the Cellworks mechanistic biosimulation model to go beyond BRCA mutation status and provide more comprehensive predictions of patient response to PARPi therapies.

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Results from the study were showcased in a poster presentation titled, Use of Biosimulation to Predict Homologous Recombination Deficiency and PARPi Benefit in Patients with Ovarian, Pancreatic, Prostate and Triple Negative Breast Cancers, as part of the ESMO (Free ESMO Whitepaper) Congress 2024 held in Barcelona, Spain from September 13-17, 2024.

"PARP inhibitors have become a standard treatment for cancers characterized by homologous recombination deficiency," said Professor Daniel Palmer, Molecular and Clinical Cancer Medicine, University of Liverpool, and Principal Investigator of the study. "However, current HRD tests do not capture all patients who might benefit from PARPi, often focusing primarily on BRCA status. By using Cellworks personalized therapy biosimulation in this study, we produced an HRD classifier that was predictive of PARPi benefit in patients with wild-type BRCA. This is an important step towards using biosimulation to identify wild-type BRCA patients who may benefit from PARPi therapy."

"Biosimulation incorporates multiple levels of genomic, transcriptomic, and protein regulation, capturing the molecular interactions of key homologous recombination components," said Dr. Michael Castro, Cellworks Chief Medical Officer. "This study utilized Cellworks mechanistic biology model along with a patient’s tumor-based genomic profile to identify dysregulations in HR signaling pathways and predict differential responses to PARPi. Through this approach, we can capture patients with HRD but lacking BRCA1 or BRCA2 mutations who can benefit from PARPi therapy, leading to more personalized and effective treatment strategies."

Study Design

Cellworks computational biosimulation was performed on four real-world retrospective cohorts from The Cancer Genome Atlas (TCGA), including ovarian, pancreatic, prostate, and triple-negative breast cancer patients. The model output, representing key HR pathways, was used to develop a classifier that distinguishes HRD by comparing BRCA wild-type (WT) ovarian cancer patients (n=32) to BRCA-mutated patients (n=187). This locked classifier was then prospectively validated in independent sets of ovarian, pancreatic, and prostate cancer patients (n=336, 428, 189 respectively). Efficacy scores, based on biosimulated composite cell growth in response to the PARP inhibitor Olaparib, were evaluated in relation to the predicted HRD status in BRCA wild-type patients.

Study Results

The HRD classifier produced through Cellworks biosimulation was significantly associated with BRCA status across all four validation sets, demonstrating strong predictiveness for BRCA status in ovarian (AUC = 0.863, p < 0.001), pancreatic (AUC = 0.759, p = 0.002), prostate (AUC = 0.717, p < 0.001), and TNBC (AUC = 0.88, p < 0.001) cancers. Additionally, in all four cancer types, predicted PARPi efficacy was significantly higher in BRCA wild-type patients identified as HRD (ovarian p = 0.026, prostate p < 0.001, pancreatic p < 0.001, TNBC p < 0.001).

The Cellworks Platform

The Cellworks Platform performs computational biosimulation of protein-protein interactions, enabling in silico modeling of tumor behavior using comprehensive genomic data. This allows for the evaluation of how personalized treatment strategies interact with the patient’s unique tumor network. Multi-omic data from an individual patient or cohort is used as input to the in silico Cellworks Computational Biology Model (CBM) to generate a personalized or cohort-specific disease model. The CBM is a highly curated mechanistic network of 6,000+ human genes, 30,000 molecular species and 600,000 molecular interactions. This model along with associated drug models are used to biosimulate the impact of specific compounds or combinations of drugs on the patient or cohort and produce therapy response predictions. The Cellworks CBM has been tested and applied against various clinical datasets with results provided in over 125 presentations and publications with global collaborators.

On September 16, 2024 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage allogeneic cell therapy and genetic medicines company advancing differentiated non-viral treatments for patients with cancer and rare diseases, reported that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to P-BCMA-ALLO1, an investigational stem cell memory T cell (TSCM)-based allogeneic CAR-T cell therapy in Phase 1/1b clinical development for the treatment of patients with relapsed/refractory multiple myeloma (Press release, Poseida Therapeutics, SEP 16, 2024, View Source [SID1234646681]).

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RMAT designation includes all the benefits of the Fast Track and Breakthrough Therapy designation programs, including early interactions with the FDA. Poseida’s RMAT application was evaluated based on encouraging early data from its ongoing Phase 1 study of P-BCMA-ALLO1, which demonstrated P-BCMA-ALLO1’s potential to offer promising efficacy, safety profile and rapid ‘off-the-shelf’ patient access.

"The RMAT designation for P-BCMA-ALLO1, our lead program, is based on impressive early clinical data from our ongoing Phase 1 study and further validates its potential to address the unmet needs of patients with relapsed/refractory multiple myeloma," said Kristin Yarema, Ph.D., president and chief executive officer of Poseida Therapeutics. "Importantly, our data has shown clinical responses in very sick, refractory patients, including those that have received prior BCMA-targeted therapies. With both RMAT and Orphan Drug designations for P-BCMA-ALLO1, we look forward to working closely with the FDA as we continue to advance this next-generation, off-the shelf allogeneic CAR-T therapy, including the recently initiated Phase 1b portion of the trial."

The Company will report new clinical data from the P-BCMA-ALLO1 Phase 1 study in an oral session at the 21st International Myeloma Society Annual Meeting, which is being held in Rio de Janeiro from September 25-28, 2024. Additional clinical updates are planned for the second half of 2024, subject to coordination with Roche, which has a strategic collaboration with Poseida covering multiple investigational allogeneic CAR-T therapies targeting blood cancers, including P-BCMA-ALLO1.

The RMAT designation is a program under the 21st Century Cures Act that is intended to expedite the development and review of regenerative medicine therapies for serious or life-threatening diseases or conditions. A regenerative medicine therapy is eligible for RMAT designation if it is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the regenerative medicine therapy has the potential to address unmet medical needs for such disease or condition.

RMAT designation includes all Breakthrough Therapy designation features, including early interactions to discuss any potential surrogate or intermediate endpoints. RMATs may be eligible for accelerated approval based on previously agreed-upon surrogate or intermediate endpoints that are reasonably likely to predict long-term clinical benefit, or reliance upon data obtained from a meaningful number of sites, including through expansion to additional sites, as appropriate.

About P-BCMA-ALLO1
P-BCMA-ALLO1 is an allogeneic CAR-T product candidate licensed to Roche targeting B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma. This allogeneic program includes a VH-based binder that targets BCMA and clinical data presented at ASH (Free ASH Whitepaper) in December 2023 support the Company’s belief that T stem cell (TSCM)-rich allogeneic CAR-Ts have the potential to offer effective, safe, and reliable treatment addressing unmet needs in multiple myeloma. The FDA has granted P-BCMA-ALLO1 Regenerative Medicine Advanced Therapy (RMAT) designation for adult patients with relapsed/refractory multiple myeloma after three or more prior lines of therapies including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and anti-CD38 antibody in addition to Orphan Drug designation for multiple myeloma. Additional information about the Phase 1/1b study is available at www.clinicaltrials.gov using identifier: NCT04960579.

On September 16, 2024 Johnson & Johnson (NYSE: JNJ) reported interim data from the ongoing Phase 2 SunRISe-4 study showing neoadjuvant treatment with investigational TAR-200 plus cetrelimab (CET) achieved nearly double the pathological complete response (pCR) rate compared to CET alone in patients with muscle-invasive bladder cancer (MIBC) who are ineligible or refuse neoadjuvant platinum-based chemotherapy and scheduled for radical cystectomy (RC) (Press release, Johnson & Johnson, SEP 16, 2024, View Source [SID1234646680]). These data were featured as a late-breaking oral presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2024 Congress (Abstract #LBA84).

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"These findings from the SunRISe-4 study show for the first time that an intravesical treatment with TAR-200, combined with a systemic PD-1 inhibitor, could potentially result in a complete pathological response in a high proportion of patients, as well as allowing a tolerable approach," said Andrea Necchi, M.D., of Italy’s Vita-Salute San Raffaele University and the IRCCS San Raffaele Hospital and Scientific Institute and a presenting author of the study. "These preliminary findings show a potential for a future change in the local treatment of muscle-invasive bladder carcinoma using TAR-200."

In the interim analysis of the SunRISe-4 study, neoadjuvant TAR-200 plus CET (n=53) showed overall efficacy with a centrally confirmed pathologic complete response (pCR, [T0]) rate of 42 percent compared to 23 percent (95 percent CI, 28-56; 10-41, respectively) with CET alone (n=31) in patients with histologically proven, non-metastatic MIBC. The pathological overall response (pOR) rate (defined as the proportion of patients ≤ pT1) was 60 percent compared to 36 percent, respectively (CI 95 percent, 46-74; 19-55).1

In a subgroup analysis of patients with organ-confined disease (cT2), those treated with TAR-200 plus CET (n=40) showed a 48 percent pCR rate compared to 23 percent pCR with CET alone (n=26, 95 percent CI, 32-64; 9-44, respectively) and 68 percent were downstaged (≤ pT1) at the time of radical cystectomy, potentially improving surgical outcomes and reducing risk of recurrence.1

"With these promising results, TAR-200 plus cetrelimab as a neoadjuvant therapy before radical cystectomy could potentially alter how bladder cancer is treated," said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Innovative Medicine, Johnson & Johnson. "This investigational innovative approach may offer a possible alternative for many patients who are not eligible for the current standard of pre-operative treatments."

Treatment-related adverse events (TRAEs) occurred in 72 percent of patients treated with TAR-200 combined with CET and 44 percent of patients treated with CET alone, with the majority being Grade 1-2. Nine percent of patients discontinued treatment with TAR-200 and eight percent discontinued treatment with CET in the combined treatment cohort due to TRAEs; no patients discontinued treatment due to TRAEs when treated with CET alone.1

Bladder cancer is the ninth most common cancer in the world.2 Although BCG immunotherapy has been accepted as the standard of care for nearly five decades, 30-40 percent of patients do not respond to BCG and experience disease recurrence or progression.3 In such scenarios, radical cystectomy (removal of the bladder and neighboring structures and organs) emerges as the primary treatment option. This major abdominal procedure requires a urinary diversion to be created to collect and store urine.4

TAR-200 is an investigational targeted releasing system designed to provide extended local release of gemcitabine into the bladder. It is installed in a physician’s office setting during a 2-3 minute procedure with no anesthesia. In December 2023, the FDA granted TAR-200 Breakthrough Therapy Designation (BTD) for the potential future treatment of patients with BCG-unresponsive HR-NMIBC, who are ineligible for or elected not to undergo radical cystectomy (surgical removal of the bladder).

About SunRISe-4
SunRISe-4 (NCT04919512) is an open-label, multicenter, randomized Phase 2 study assessing the efficacy and safety of neoadjuvant TAR-200 + cetrelimab (CET) (anti-programmed death-1 antibody) or neoadjuvant CET alone in patients with MIBC scheduled for RC who are ineligible for or refuse neoadjuvant platinum-based chemotherapy.

About TAR-200
TAR-200 is an investigational targeted releasing system, enabling extended release of gemcitabine into the bladder, increasing the amount of time the drug delivery system spends in the bladder and sustaining local drug exposure. The safety and efficacy of TAR-200 are being evaluated in Phase 2 and Phase 3 studies in patients with MIBC in SunRISe-2 and SunRISe-4, and NMIBC in SunRISe-1, SunRISe-3 and SunRISe-5.

About Cetrelimab
Cetrelimab is an investigational programmed cell death receptor-1 (PD-1) monoclonal antibody being studied for the treatment of bladder cancer, prostate cancer, melanoma, and multiple myeloma as part of a combination treatment. Cetrelimab is also being evaluated in multiple other combination regimens.

About Muscle-Invasive Bladder Cancer
Muscle-invasive bladder cancer (MIBC) is a severe form of bladder cancer where the tumor penetrates the muscular layer of the bladder wall, significantly increasing the risk of metastasis.5 Approximately 25 percent of bladder cancer cases are diagnosed as MIBC at the time of initial presentation.6 Early detection and timely intervention are crucial for managing MIBC, as delayed treatment can lead to poor prognosis.

On September 16, 2024 Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported positive, mature data from its ongoing phase 1b / 2a study of fostroxacitabine bralpamide (fostrox) + Lenvima in advanced liver cancer (hepatocellular carcinoma/HCC) at the ESMO (Free ESMO Whitepaper) (European Society of Medical Oncology) Congress in Barcelona, Spain (Press release, Medivir, SEP 16, 2024, View Source;lenvima-confirm-promise-of-improved-outcomes-in-advanced-liver-cancer-detailed-and-mature-data-presented-at-esmo-302248817.html [SID1234646679]).

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Today’s ESMO (Free ESMO Whitepaper) update, poster number 986P, presented by Dr Hong Jae Chon on Monday September 16, shows promising duration of benefit with 19% of patients continuing treatment for more than a year and the longest running patient remaining on treatment for over 2 years, with sustained partial response. The patients in the study had disease control on fostrox + Lenvima independent if they benefitted from previous line of therapy, showing potential for all second-line patients to benefit from the combination. The safety and tolerability profile continues to be encouraging with no unexpected adverse events. While hematological adverse events were common, they were temporary in nature. Decreases in neutrophil & platelet counts showed a cyclic pattern with recovery before next cycle of treatment, enabling patients to remain on treatment long-term. Importantly, no patient experienced febrile neutropenia or low platelet count with bleeding and there were no fostrox-related serious adverse events.

Results come despite very poor prognosis for most second-line HCC patients today, with just 5–10% responding to current standard of care treatment, and a typical TTP of only 3–4 months.

Dr. Pia Baumann, Chief Medical Officer at Medivir, said:
– "With three patients still remaining on study treatment, all of whom treated for more than a year, this data-set is now quite mature. At a median follow-up of 10.5 months, fostrox + Lenvima have clearly shown promise of improved outcomes beyond current alternatives for second-line liver cancer patients. Fostrox is designed to only target tumor cells locally in the liver, without harming healthy cells. It is therefore reassuring to see the tolerability profile of fostrox enabling the combination of two highly potent treatments, fostrox + Lenvima, without compromising patient safety. Patients were able to stay on treatment long-term, which evidently contributes to the extended duration of benefit and a median time to progression of 10.9 months, substantially longer than previously seen in second-line liver cancer. It is with reinforced confidence we continue our preparations for the initiation of the planned phase 2b study comparing fostrox + Lenvima with Lenvima alone in a randomized setting to confirm the benefit of the combination."

Dr Hong Jae Chon, Professor at CHA Bundang Hospital in Korea, and investigator in the fostrox + Lenvima study, commented:
"Treatment outcomes have improved in first-line with the use of immunotherapy combinations, resulting in more patients fit enough to receive second-line treatment. But with no treatments approved in second-line after immunotherapy, there is a significant unmet medical need for new treatments options for these patients. The phase 1b/2a data for fostrox + Lenvima show highly encouraging clinical benefits for patients, indicating that when adding fostrox to Lenvima, efficacy is better than expected from Lenvima alone. It is especially encouraging that in addition to patients experiencing benefit for an extended period of time, patients also responded to the treatment independent of outcome in previous line of therapy. I look forward to evaluating the efficacy of fostrox plus Lenvima in a randomized, controlled trial."

The data are from Medivir’s ongoing phase 1b/2a open-label, multi-center, dose-escalation and dose-expansion study, evaluating the safety and efficacy of fostrox in combination with Lenvima in patients for whom current first- or second-line treatment has proven ineffective or is not tolerable.

HCC is the most common type of liver cancer, accounting for more than 80% of cases worldwide.2 There are approximately 660,000 patients diagnosed with HCC per year globally and current five-year survival is less than 20 percent3.

Medivir will host a webcast where Dr Chon and Dr Pia Baumann will present the data and answer questions. The webcast will take place Today, September 16, at 13.45 CET, and will be streamed via a link on the website: www.medivir.com/investors/presentations.

The poster and the presentation from the webcast will also be available on Medivir’s website after the presentation.