On August 29, 2019 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSX VENTURE: IPA) (OTC PINK: IPATF) today reports its financial results for the year ended April 30, 2019 (Press release, ImmunoPrecise Antibodies, AUG 29, 2019, View Source [SID1234539109]). The financial statements and related Management’s Discussion and Analysis ("MD&A") can be viewed on SEDAR at www.sedar.com.

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Financial Highlights:

Revenue: ImmunoPrecise achieved record annual revenue of $10,926,268 in fiscal 2019 compared to $5,441,349 in fiscal 2018. This represents a 100% increase in revenue as a result of its completed acquisitions of IPA Europe (formerly ModiQuest Research), and IPA’s ability to grow its core business and expand into higher revenue service offerings in therapeutic discovery.

Gross Margin: ImmunoPrecise increased its gross margin to $5,294,634 from $2,451,026 in 2019. In percentage terms, the Company’s gross margin increased to 48% from 45% in 2018. The higher margin in 2019 was mostly attributable to the Company’s increased focus on larger programs with higher margins at its new B-cell lab, as well as increased efficiencies in operations.

Net Loss: ImmunoPrecise recorded a net loss of $7,617,467 during the year ended April 30, 2019, compared to net loss of $5,171,103 for the year ended April 30, 2018. The net loss increased in 2019, primarily as a result of the acquisitions of U-Protein and IPA Europe, which required higher expenses in all facets of the business in order to manage a global landscape. $1,312,403 of the costs incurred during the year ended April 30, 2019, were one-time costs which are not expected to be incurred again.

Growth Initiatives in Fiscal 2020:

Asset Building: While CRO services remain the mainstay of the Company, ImmunoPrecise has worked continuously on building an intellectual property estate and portfolio of proprietary methods and physical assets through collaborations, joint ventures, acquisitions and in-licensing. The onboarding of existing assets with regard to equipment, technologies, IP and licenses within the Company’s EU operations has been compounded by active research and development at all operational sites this year. This includes the on-going development of new service offerings to be rolled out in the fiscal year 2020, but more notably, internal, discovery programs focused on novel, therapeutic antibodies, primarily in the field of immuno-oncology.

Talem Therapeutics: Recently, the Company formed Talem Therapeutics (Talem), based in Cambridge, Massachusetts, to support its internal, therapeutic, discovery programs. Talem is structured to secure assets during their discovery and development stage and seek out strategic partnerships with clinical-stage pharma and biotech companies, where it will aid in the out-licensing or sale of the therapeutics for clinical trials. The ability for investors to support individual assets or portfolios in Talem generates an asymmetrical opportunity for investments, while avoiding ImmunoPrecise’s shareholders dilution. The depth and speed of IPA’s offerings enables Talem to customize each program and leverages the Company’s expertise and technologies in antibody discovery.

Global Integration and Cost Synergies: ImmunoPrecise integrated IT services, including the global service desk, and decreased cost and risk while removing collaboration barriers, including tools that allow for communicating in different languages. They have also begun to capture synergies after the global integration of sales, marketing, R&D, management, and legal services. IPA has prepared for the integration of fundamental business services such as payroll, financial controls, and an Oracle suite of enterprise software. They will continue to enhance these integrations, as well as create synergies in additional areas such as M&A communications and tax integration.

B cell SelectTM and DeepDisplayTM : IPA Canada and IPA Europe have both been designated as approved CROs for the world’s leading, transgenic animal platform producing human antibodies, and exercised an advantage in optimizing services for various transgenic animal vendors. The Company made strategic investments in R&D activities to develop proprietary technologies enabling the application of their B cell SelectTM and DeepDisplayTM platforms to a broad range of transgenic animal species and strains.

The Market:

CRO Services and Therapeutic Development: In an attempt to streamline, many large pharmaceutical companies are limiting the number of external CRO vendors that can be contracted. This is particularly promising for those CROs that fill multiple niches in the discovery and manufacturing pipeline. The key players serving the monoclonal antibodies market are Pfizer, Inc., GlaxoSmithKline plc, Novartis AG, Merck & Co., Inc, Amgen, Inc., Abbott Laboratories, AstraZeneca, Eli Lilly and Company, Mylan N.V., Daiichi Sankyo Company, Ltd., Bayer AG, Bristol Myers Squibb Co., Johnson & Johnson Services, Inc., Biogen Inc., Thermo Fisher Scientific, Inc., Sanofi Genzyme, F. Hoffmann-La Roche Ltd., and Novo Nordisk A/S2. In 2016 alone, Novartis invested 9 billion USD and Pfizer invested 7.9 billion USD in R&D3. This is of little surprise given the global monoclonal antibody market was valued at USD 85.4 billion in 2015 and is expected to reach a value of USD 138.6 billion by 20241.

1 Healthcare Insights Life Sciences, CRO Sector Fundamentals Remain Hot for M&A Consolidation, July 3, 2019.
2Monoclonal Antibodies (mAbs) Market Size Worth $138.6 Billion By 2024, Nov. 2016
3Monoclonal Antibody Market 2019-2025 Growth, Key Players, Size, Demands and Forecasts, April 2019

"We continue to expand our therapeutic offerings as a global, full-service antibody provider to pharmaceutical and biotech companies internationally, and to accelerate our volume of large-scale, therapeutic programs. Simultaneously, IPA sets itself on a path of Antibody Discovery and IP estate-building through Talem Therapeutics, which will expand our clinical partnerships and continue to build our IP estate" commented Dr. Jennifer Bath, President and CEO of the Company.

On August 29, 2019 SpringWorks Therapeutics, Inc. a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for nirogacestat, an oral, selective, small molecule, gamma-secretase inhibitor, for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis (Press release, SpringWorks Therapeutics, AUG 29, 2019, View Source [SID1234539125]). The Breakthrough Therapy Designation was based on Phase 1 and Phase 2 data evaluating nirogacestat as a monotherapy in patients with desmoid tumors.

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Desmoid tumors are rare and often debilitating and disfiguring soft-tissue tumors that can aggressively invade surrounding healthy tissues and cause significant morbidities, including severe pain, internal bleeding, incapacitating loss of range of motion, and, in rare cases, death.1 It is estimated that 1,000 to 1,500 new desmoid tumor patients are diagnosed each year in the United States.2,3 There are currently no therapies approved by the FDA for the treatment of desmoid tumors.

"We are committed to pursuing the rapid development of nirogacestat given the important need for new therapies for patients with desmoid tumors and are pleased to receive this Breakthrough Therapy Designation," said Saqib Islam, Chief Executive Officer of SpringWorks. "We are currently enrolling adult patients in our Phase 3 DeFi trial and will continue to work closely with the FDA with the goal of bringing nirogacestat to patients as quickly as possible."

The FDA’s Breakthrough Therapy Designation is designed to expedite the development and regulatory review of medicines that are intended to treat a serious condition. To qualify for this designation, preliminary clinical evidence must demonstrate that the medicine may provide substantial improvement over currently available therapy on at least one clinically significant endpoint.4

Previously, the FDA had granted nirogacestat Orphan Drug Designation for the treatment of desmoid tumors (June 2018) and Fast Track Designation for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis (November 2018).

About Desmoid Tumors

Desmoid tumors, also referred to as aggressive fibromatosis or desmoid-type fibromatosis, are rare and often debilitating and disfiguring soft tissue tumors characterized by a growth pattern that can invade surrounding healthy tissues, including joints, muscle and viscera. While they can arise in any part of the body, the most common sites are the upper and lower extremities, abdominal walls, thoracic areas, and the head and neck. The severity of a desmoid tumor can vary based on the location of the tumor and the aggressiveness of its growth pattern. Desmoid tumors can cause significant morbidities, including severe pain, internal bleeding, incapacitating loss of range of motion, and, in rare cases, death.1

Desmoid tumors typically occur in patients between the ages of 15 to 60 years, and are more commonly diagnosed in young adults between 30-40 years of age, with a two-to-three times higher prevalence in females.1,5 It is estimated that there are 1,000 to 1,500 new cases diagnosed per year in the United States.2,3

Historically, desmoid tumors were treated with surgical resection, but this approach has become less favored due to a high recurrence rate after surgery.6 There are currently no FDA-approved therapies for the treatment of desmoid tumors.

About Nirogacestat

Nirogacestat is an oral, selective, small molecule gamma-secretase inhibitor in Phase 3 clinical development for the treatment of desmoid tumors. Gamma secretase cleaves multiple transmembrane protein complexes, including Notch, which is believed to play a role in activating pathways that contribute to desmoid tumor growth.

Nirogacestat has been investigated in 24 patients with desmoid tumors across Phase 1 and Phase 2 clinical trials. In these studies, treatment with nirogacestat demonstrated a 100% disease control rate as measured by RECIST criteria, and median progression free survival was not reached by the time of publication in either trial due to lack of patients progressing on therapy. Nirogacestat was generally well-tolerated in these studies, with many patients remaining on treatment for years and only one desmoid tumor patient in the combined trials discontinuing treatment due to an adverse event. The most common adverse events in the Phase 2 study were diarrhea, skin disorders and hypophosphatemia.

On August 29, 2019 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, reported that Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in two upcoming investor conferences (Press release, Kura Oncology, AUG 29, 2019, View Source [SID1234539110]):

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A panel discussion entitled "Focusing the Laser on Precision Oncology" at Citi’s 14th Annual Biotech Conference in Boston at 9:30 a.m. ET / 6:30 a.m. PT on September 5, 2019; and

An analyst-led discussion at H.C. Wainwright 21st Annual Global Investment Conference in New York at 12:50 p.m. ET / 9:50 a.m. PT on September 10, 2019.
A live audio webcast of both discussions will be available in the Investors section of Kura’s website at www.kuraoncology.com, with an archived replay available immediately following the event.

On August 29, 2019 Johnson & Johnson (NYSE: JNJ) reported that it will participate in the 2019 Morgan Stanley 17th Annual Global Healthcare Conference on Tuesday, September 10th, at The Grand Hyatt Hotel in New York (Press release, Johnson & Johnson, AUG 29, 2019, View Source;johnson-to-participate-in-the-2019-morgan-stanley-17th-annual-global-healthcare-conference-300909436.html [SID1234539127]). Peter F. Lebowitz, M.D., Ph.D. Global Therapeutic Area Head, Oncology and Scott White, Company Group Chairman North America Pharmaceuticals will represent the Company in a session scheduled at 10:00 a.m. (Eastern Time).

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This webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.

A webcast replay will be available approximately two hours after the live webcast.

On August 29, 2019 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, reported that the company will participate in three upcoming investor conferences in September (Press release, Ascendis Pharma, AUG 29, 2019, View Source [SID1234551449]). Company executives will provide a business overview and update on the company’s pipeline programs.

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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

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Details

Event 2019 Wells Fargo Healthcare Conference
Location Boston
Date Wednesday, September 4, 2019
Time 2:25 p.m. Eastern Time

Event Morgan Stanley 17th Annual Global Healthcare Conference
Location New York
Date Tuesday, September 10, 2019
Time 2:55 p.m. Eastern Time

Event Bank of America Merrill Lynch Global Healthcare Conference 2019
Location London
Date Thursday, September 19, 2019
Time 10:40 a.m. British Summer Time
A live webcast of the Wells Fargo and Morgan Stanley conferences will be available in the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A webcast replay will also be available on this website shortly after conclusion of the event for 30 days.