On July 7, 2023 IPA (IMMUNOPRECISE ANTIBODIES LTD.) (the "Company" or "IPA") (NASDAQ: IPA), an AI-driven biotherapeutic research and technology company, reported financial results for the full fiscal year 2023 ended April 30, 2023 (Press release, ImmunoPrecise Antibodies, JUL 7, 2023, View Source [SID1234633110]).

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"As we usher in Fiscal Year 2024, we carry with us a strong momentum from the impressive strides we made in the previous year. In the fiscal year ended April 30, 2023, we achieved a revenue of $20.7 million, marking a notable 6.7% (or 9% when adjusting for the effects of currency translation) increase compared to the year ended April 30, 2022. We also recorded our highest quarterly revenue total of $5.6 million in the last quarter ending April 30, 2023. These milestones serve as a testament to the soundness of our strategies and the dedication of our team.

As we look ahead to Fiscal Year 2024, we see immense potential for our in silico suite of services and data management capabilities to further bolster our growth. We expect these innovative offerings to significantly contribute to our financial performance this year and set the stage for long-term success.

Our unwavering commitment to excellence, coupled with our robust pipeline and agile execution, position us to deliver continued strong performance this year and beyond. This is a thrilling period for our company, and we are eager to embark on the new fiscal year, further driving innovation and growth." Stated Dr. Jennifer Bath, CEO of IPA.

Recent and Fiscal 2023 Operational Highlights

Talem entered into exclusive research collaboration and license option agreement with Astellas targeting an undisclosed protein in the tumor microenvironment (TME)
Talem presented its latest data on the development of bispecific T-cell engagers targeting TrkB at the annual AACR (Free AACR Whitepaper) meeting in Orlando, Florida, in April 2023.
Talem entered into a multi-target license agreement with OmniAb, Inc to further the development and commercialization of immuno-oncology antibody panels.
BioStrand entered into a research collaboration and license agreement with BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT)
IPA’s subsidiary, BioStrand, secured second €460,000 VLAIO research grant.
BioStrand has successfully solved the Information Integration Dilemma (IID)
BioStrand publicly unveiled use case showing solution of the Information Integration Dilemma (IID)
BioStrand completed the full integration of 20 million Structural HYFTs with DeepMind’s AlphaFold and META’s ESM-2 Fold platforms.
EPO granted BioKey’s patent application covering the company’s HYFT Technology used to organize and analyze biological sequence information.
IPA achieved a record global CRO revenue of $5.6 million in Q4 FY23, representing a 7.3% increase from the previous year, reflecting strong demand and stability.
IPA secured $4.65M sales orders for future fee-for-service work in Q4, demonstrating market confidence and high demand for services.
IPA Europe’s human phage display and humanization offerings experienced financial growth and improved capabilities with newly generated phage libraries and modernized workflows.
IPA expanded its single B cell screening capabilities to include species from the camelid family, leading to increased requests for VHH-based discovery programs and new revenue opportunities.
Talem, a subsidiary of IPA, elevated three key programs with significant value potential, generating interest from prospective partners and focusing on partnering discussions with larger corporations.
IPA’s revenue streams consist of non-cannibalistic in silico technologies, in silico de novo antibody discovery and development partnerships, and a Data Organization and Management Platform, all demonstrating robust growth.
IPA’s commitment to innovation is reflected in its unique platform that integrates biological data dimensions using AI and HYFT technology to unlock valuable insights and connections.
The ongoing advancements in software development, including LENSai software, have enabled IPA to solve real-life biological problems and overcome the challenges of omics data integration and analysis.
IPA has strategically positioned itself to capture opportunities in multiple revenue streams, including in silico technologies, de novo antibody discovery, and data organization and management.
The investor call will dive deeper into IPA’s achievements, discuss exciting prospects, and invite participants to join in driving innovation in AI-driven antibody discovery.
Financial Results

Revenue

The Company achieved record revenue of $20.7 million during the year ended April 30, 2023, a 6.7% increase from the year ended April 30, 2022. Revenue growth from the prior year was 9.0% when adjusting for the effect of currency translations. The increase in revenue was primarily driven by growth in the Company’s B cell Select platform and protein manufacturing services.

Research and development

During the year ended April 30, 2023, research and development expenses increased to $12.3 million from $7.7 million during the year ended April 30, 2022. Expenditures on research activities totaled $10.8 million during the year ended April 30, 2023 (2022 – $6.7 million), including $8.3 million on Talem’s PolyTope antibody combination therapy. Additional expenditures include compensation expense of $1.2 million (2022 – $0.7 million), and depreciation of $0.2 million (2022 – $0.2 million).

Sales and marketing

Sales and marketing expenses totaled $3.6 million during the year ended April 30, 2023, compared to $2.7 million during the year ended April 30, 2022. Expenditures during the year ended April 30, 2023, include $2.5 million in compensation expense (2022 – $2.1 million), $0.7 million in advertising costs (2022 – $0.5 million), and $0.2 million in travel costs (2022 – $0.03 million).

General and administrative

During the year ended April 30, 2023, general and administrative expenses totaled $19.8 million, an increase of $4.4 million compared to the year ended April 30, 2022. Salaries and benefits increased $2.1 million due primarily to the addition of staff at BioStrand and routine pay increases. The Company recorded an impairment charge of $2.5 million related to the BioStrand cash-generating unit. Professional fees decreased $0.2 million, driven primarily by a decrease in legal costs. Management fees increased $1.3 million due to contracted general managers at the BioStrand site. Share-based payment expenses decreased by $1.0 million.

Other Income / Expense

The Company recorded other income of $0.8 during the year ended April 30, 2023, compared to other income of $0.9 million during the year ended April 30, 2022. The most noteworthy variance is the decrease in unrealized foreign exchange gain of $0.4 million compared to the year ended April 30, 2022, a result of currency revaluations at the current quarter-end exchange rate. Grant income increased $0.3 million compared to the year prior, as the Company recorded the first round of grant funding from VLAIO (Flanders Innovation & Entrepreneurship), the research fund of the Flemish regional government in Belgium.

Net Loss

The Company recorded a net loss of $26.6 million during the year ended April 30, 2023, compared to a net loss of $16.7 million during the year ended April 30, 2022. The increased net loss is the result of an increase in gross profit of $0.6 million, offset by an increase in research and development expenses of $4.6 million, an increase in sales and marketing expenses of $0.9 million, an increase in general and administrative expenses of $4.4 million.

Liquidity and Capital Resources

As of April 30, 2023, the Company had cash on hand of $8.4 million compared to $30.0 million as of April 30, 2022, and had working capital of $11.1 million (April 30, 2022 – $28.2 million). During the year ended April 30, 2023, the cash used in operating activities was $19.8 million. As part of investing activities, the Company made equipment purchases of $1.5 million, and paid deferred acquisition payments of $0.6 million. As part of financing activities, the Company received $0.7 million from issuing common shares, and incurred lease repayments of $1.3 million.

Conference Call:

Event Date: July 07, 2023
Event Time: 10:30 ET

Participant Details:

Conference ID: 9236374
Participant Toll-Free Dial-In Number: 1 (888) 550-5658
Participant Toll Dial-In Number: 1 (646) 960-0289
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On July 7, 2023 Ichnos Sciences Inc., a global clinical-stage biotechnology company developing innovative multispecific immune cell engager antibodies in oncology, reported that it has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for its first-in-class T-cell engaging trispecific antibody, ISB 2001, for the treatment of multiple myeloma (Press release, Ichnos Sciences, JUL 7, 2023, View Source [SID1234633109]).

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ISB 2001, Ichnos’ third clinical-stage asset to receive ODD for the treatment of multiple myeloma, is the company’s first BCMA x CD38 x CD3 TREATTM1 trispecific antibody based on the company’s proprietary BEAT platform2, which enables the development of immune cell engagers. This designation closely follows that of Ichnos’ first-in-class CD38 x CD47 biparatopic bispecific antibody innate cell modulator, ISB 1442, which was granted ODD by the FDA in March 2023.

"The FDA’s decision to grant orphan drug designation to ISB 2001 – our third clinical-stage asset to receive that designation in five years – underscores the importance of the work our team is doing to develop potentially curative therapies for the treatment of multiple myeloma," said Cyril Konto, M.D., President and Chief Executive Officer of Ichnos Sciences. "As new multiple myeloma diagnoses continue to climb, our charge of providing patients more innovative, novel therapies that can overcome the limitations of options available to them today becomes that much more urgent."

This milestone is achieved as Ichnos prepares to initiate a Phase 1 first-in-human dose-escalation dose-expansion study of ISB 2001 later this summer, after securing approval from the Human Research Ethics Committee (HREC) in Australia and IND clearance from the FDA.

"The entire team at Ichnos – across every role and function – comes to work focused on realizing our vision of a world free of multiple myeloma. This decision by the FDA reinforces that we are on the right path," said Lida Pacaud, M.D., Chief Medical Officer of Ichnos Sciences. "Securing orphan drug designation for ISB 2001 is a critical milestone as we advance the clinical development of this promising asset, and it comes at a pivotal moment as we prepare to initiate a Phase 1 clinical trial."

ISB 2001 combines three proprietary Fab arms binding to CD3 on T cells, as well asBCMA and CD38 on multiple myeloma cells. Through targeting two tumor-associated antigens, ISB 2001 has increased binding specificity to multiple myeloma cells due to enhanced avidity-based binding, and it has demonstrated increased killing of tumor cells in vitro across variable levels of expression of both BCMA and CD38 compared to teclistamab, alnuctamab and EM-801. Additionally, ISB 2001 exhibits higher potency in vitro when compared to the combination of daratumumab and teclistamab currently under clinical investigation, as demonstrated by data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2023.

The FDA grants ODD to therapies that show promise in the treatment, prevention, or diagnosis of rare disease or conditions that affect fewer than 200,000 people in the United States, such as multiple myeloma, which is a rare cancer of plasma cells. According to the National Cancer Institute, in 2019, there were an estimated 159,787 people living with myeloma in the United States with approximately 34,470 new cases estimated in 20223. While there has been headway in the treatment of multiple myeloma, there remains a significant unmet need for therapies that can overcome developed resistance and decreased effectiveness over time.

On July 7, 2023 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, reported that the Company will host an investor Research and Development Day in New York City and via webcast on July 18, 2023 (Press release, BeiGene, JUL 7, 2023, View Source [SID1234633108]). John V. Oyler, BeiGene’s Co-Founder, Chairman and CEO, along with the Company’s leadership team, will provide an update on BeiGene’s deep and broad global innovation pipeline and platforms, and share insights on the Company’s vision, differentiated capabilities, and value creation drivers.

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Live webcast of this event can be accessed from the investors section of BeiGene’s website at View Source , View Source or View Source Archived replays will be available for 90 days following the event.

On July 7, 2023 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported the grant of 116,550 restricted stock units of Atara’s common stock to five newly hired employee (Press release, Atara Biotherapeutics, JUL 7, 2023, View Source [SID1234633107]). These awards were approved by the Compensation Committee of Atara’s Board of Directors and granted under the Atara Biotherapeutics, Inc. 2018 Inducement Plan, with a grant date of July 3, 2023, as an inducement material to the new employee entering into employment with Atara, in accordance with Nasdaq Listing Rule 5635(c)(4).

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The restricted stock units vest over four years, with 25 percent vesting on the first quarterly vesting date after the first anniversary of the vesting commencement date and the remainder vesting in 12 approximately equal quarterly installments over the following three years, subject to the employee being continuously employed by Atara as of such vesting dates.

Atara is providing this information in accordance with Nasdaq Listing Rule 5635(c)(4).

On July 7, 2023 Asgard Therapeutics ("Asgard"), a private biotech company pioneering in-vivo direct reprogramming approaches for cancer immunotherapy, reported the publication in Science Immunology demonstrating reprogramming of over 60 mouse and human tumors cells across a broad spectrum of tumor types into functional antigen-presenting cells (Press release, Asgard Therapeutics, JUL 7, 2023, View Source [SID1234633106]). This study[1] represents a significant milestone for Asgard’s reprogramming technologies, providing the foundation for the ongoing development of its in-vivo engineering programs.

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To access the publication: DOI: 10.1126/sciimmunol.add4817

Fabio Rosa, PhD, Co-Founder and Head of Research at Asgard Therapeutics, said: "This study represents a major output of our long-lasting collaboration with the Pereira Lab at Lund University focusing on the unique anti-tumor properties of conventional type 1 dendritic cells (cDC1s). We showed for the first time that reprogrammed cDC1s kick start in-vivo anti-tumor immunity, leading to complete regression of tumors! In addition, reprogramming induced loss of tumorigenic properties in cancer cells, supporting the feasibility of moving towards an in-vivo engineering approach. At Asgard, we have recently selected our lead candidate AT-108, an off-the-shelf gene delivery vector encoding our proprietary combination of reprogramming factors. AT-108 is delivered directly in-vivo to recreate cDC1s’ functional properties in tumor cells and kick-start personalized anti-tumor immunity, bypassing limitations of ex-vivo cell therapies and complex tumor neoantigen identification. AT-108 is now moving into advanced pre-clinical development with IND planned for 2026."

Filipe Pereira, PhD, Co-founder and Head of Innovation at Asgard Therapeutics, Professor and Group leader at Lund University said: "Cancer cells downregulate antigen presentation to evade immune surveillance. Reversal of this mechanism has been attempted with definite mediators and downstream pathways, but we wanted to take it a step forward. By applying our knowledge of cell fate reprogramming, we have now demonstrated that the minimal transcription factor network of cDC1s[2] can be applied to engineer cancer cells’ identity. We observed that a common cDC1 and antigen presenting signature (of more than 600 genes) was commonly upregulated across mouse and human cancer cells, including patient-derived samples from 7 indications, broadly activating downstream pathways critical for efficient anti-tumor immunity (i.e. class I and II MHC molecules, co-stimulatory signaling, IL-12, CXCL10, among others). Our findings support the platform potential of our reprogramming approach which armed cancer cells with the ability to present their own endogenous tumor antigens and activate in-vivo cytotoxic CD8+ T cell responses, leading to increased survival of tumor-bearing mice".

The study was led by Filipe Pereira in a collaborative effort between his team in the Cell Reprogramming in Hematopoiesis and Immunity Group at Lund University Stem Cell Center (LSCC), Asgard Therapeutics, a member of SmiLe Incubator, and its collaborators, Inge Marie Svane from the National Center of Cancer Immune Therapy in Denmark, Lennart Greiff and Malin Lindstedt from Lund University, among many others. The research at Asgard has been carried out with support from the Eurostars-2 Joint Program with co-funding from the European Union’s Horizon 2020 research and innovation program, and Sweden’s Innovation Agency, E!115376 REPRINT Grant 2021-03371, and the Strategic innovation programs Swelife and Medtech4Health, a joint venture by Vinnova, Formas and the Swedish Energy Agency, Grant 2020-04744.

The illustration depicts a novel Trojan horse approach to cancer immunotherapy by reprogramming cancer cells to become traitors to their kind. Using the minimal regulatory network of type 1 conventional dendritic cells (connections and cells inside the horse), Zimmermannova & Ferreira et al. reprogrammed human and mouse cancer cells into dendritic cells. This strategy bypassed tumor evasion mechanisms and endowed tumor cells with professional antigen presentation leading to activation of specific CD8+ T cells (soldiers), and anti-tumor immunity in vivo. This study paves the way for a new class of cancer immunotherapies based on cell fate reprogramming.