ImmunoPrecise Reports Financial Results and Recent Business Highlights for Full Fiscal Year 2021

On July 28, 2021 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (NASDAQ: IPA) (TSX VENTURE: IPA) a leader in full-service, therapeutic antibody discovery and development, reported financial results for the full fiscal year 2021 ended April 30, 2021 (Press release, ImmunoPrecise Antibodies, JUL 28, 2021, View Source [SID1234585289]).

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Fiscal 2021 Financial Summary*

Earned revenues of $17.9 million, a 27% increase which includes a sale through Talem of an internally generated therapeutic antibody for $1.2 million, core CRO business up 19%
Research and development costs increased to $2.0 million from $446,280 in 2020 due to the extensive research work the Company is undertaking, including COVID-19 related research projects
The Company recorded a net loss of $7.3 million during the year ended April 30, 2021, compared to $5.0 million in 2020
Adjusted EBITDA** of $2.3 million as compared to $52,000 in 2020
As of April 30, 2021, the Company held cash of $41.8 million
*Expressed in Canadian dollars unless otherwise noted.
**For additional information regarding Adjusted EBITDA (a non-IFRS measure) see the Forward Looking Information section below.

Dr. Jennifer Bath, CEO of ImmunoPrecise, stated, "We are pleased with our solid fiscal year end results, with consistently strong and growing recurring revenue. Looking ahead, we will continue to transform IPA, both strategically and operationally. We continue to execute on strategy including ongoing technology innovation and accelerated discovery of internal and partnered novel antibodies. We also continue to work towards becoming a leading CRO of choice and industry consolidator in the antibody discovery and development markets. As it stands, we have partnered with over 500 clients resulting in very strong recurring revenues following client onboarding for services."

"As we begin the new fiscal year, we actively seek expansion of our global footprint and push to broaden our diverse portfolio of technologies, while moving pipeline programs further toward functional and pre-clinical development. While in vitro non-clinical evaluation of four programs is currently ongoing, an additional set of five programs in development by Talem Therapeutics are at the stage of final in vitro (functional) characterization and are anticipated to enter in vivo proof of concept studies later this year. Each of these advanced assets are wholly owned by ImmunoPrecise and we look forward to completing functional and in vivo analyses with the aim of maximizing their value prior to any potential out-licensing events," concluded Dr. Bath.

Recent and Fiscal 2021 Operational Highlights

Successfully demonstrated pre-clinical in vivo results for TATX-03 PolyTope Therapy, a multi-membered monoclonal antibody cocktail designed to retain efficacy against SARS-CoV-2 variants. Results demonstrated strong efficacy for prophylactic and therapeutic use in a well-established SARS-CoV-2 animal model
Pre-released publication in Biorxiv outlining IPA’s approach to the design and development of TATX-03, also demonstrating potent pseudovirus neutralizing activity against the SARS-CoV-2 Delta (B.1.617.2) variant
New co-marketing partnership wherein Eurofins Discovery and ImmunoPrecise co-market non-overlapping service offerings to Eurofins’ global clients, providing greater access to IPA’s end-to-end antibody discovery capabilities
Presented data on TATX-21, investigational antibodies aimed to prevent low density lipid (LDL) uptake with the goal of preventing and treating Atherosclerosis Cardiovascular Disease (ACVD)
Added Dr. Ilse Roodink to the role of Chief Scientific Officer and Dr. Dion Neame to Strategic Advisory Board
Identified a unique antibody with in vivo efficacy in animal model, utilizing an alternative mechanism of action, and which binds all tested SARS-CoV-2 variants of concern
Successfully launched TATX-112 candidate antibody program, for the treatment of cancer and Alzheimer’s disease
Established separate development partnerships with Genmab and LiteVax
Announced the comprehensive screening of twenty-seven proprietary therapeutic antibodies against SARS-CoV-2, identifying antibodies that retained binding to emerging variants of concern including U.K. (B1.1.7 lineage), S. African (B.1.351 lineage) and Brazilian (P.1 lineage) strains
Solidified research partnership with Mila, a world-renowned research institute dedicated to artificial intelligence (AI) development and focused on deep learning optimization for AI and machine language learning
Successfully dual listed to NASDAQ global markets stock exchange
IPA Europe significantly expanded capabilities, releasing its second-generation B cell Select
Entered separate collaborations with Twist Bioscience and Zymeworks
Financial Results

Revenue

The Company achieved revenues of $17.9 million during the year ended April 30, 2021, consisting of an increase in its core CRO business of $2.7 million (19%) and a sale through Talem of an internally generated therapeutic antibody for $1.2 million. This represents a 27% increase over 2020 revenues of $14.1 million. The continued growth trend in CRO revenue is due to increases in both volume and financial values of client contracts due to a continued focus on expanding the breadth and depth of service offerings available in-house, new client onboarding and the sustained growth of its core existing business.

Gross Profit

During the year ended April 30, 2021, gross profit was $11.5 million (64% gross profit margin) compared to gross profit of $8.0 million (57% gross profit margin) in 2020. The increase in gross profit is, in part, a result of the sale of an internally generated asset that was expensed as research and development in prior years. Excluding the internally generated asset sale gross profit margin would have been 62%.

Research & Development

Research and development increased to $2.0 million from $446,280 in 2020, due to the extensive R&D work the Company is undertaking, including COVID-19 related research projects.

Other Income (Expenses)

The Company recorded other income of $1.6 million during the year ended April 30, 2021, compared to other expense of ($739,756) in 2020. The increase is primarily related to 2020 government grant income of $1.9 million and subsidies of $844,417 related to COVID-19, a $553,836 reduction in accretion expense related to its obligations, offset by $1.1 million unrealized foreign exchange losses on cash held in US dollars.

Net Loss

The Company recorded a net loss of $7.3 million during the year ended April 30, 2021, compared to net loss of $5 million for the year ended April 30, 2020. The Company achieved higher gross profits and received grant and subsidy income while investing in research and development, and incurring higher share-based payments, salaries, and Nasdaq uplist related costs.

Non-IFRS Measures*

Adjusted EBITDA for the year ended April 30, 2021, was $2.3 million compared to $52,311 for the same period last year. Adjusted EBITDA is management’s view of operating earnings. The significant improvement in Adjusted EBITDA is primarily the result of increased gross profits and awards of government research grants and subsidies related to COVID-19 partially offset by higher research costs, salaries, and expenses related to the Nasdaq uplist.

Cash Position

As of April 30, 2021, the Company held cash of $41.8 million as compared to $2.7 million as of April 30, 2020 and had working capital of $42.8 million. The increase in cash is primarily due to the public offering of the Company’s stock and proceeds from the exercise of warrants and stock options. The Company’s internal forecast indicates the cash on hand will sustain its existing operations, support its Nasdaq and TSXV on-going listing costs and satisfy its obligations through at least fiscal year ending 2023.

The conference call will be webcast live and available for replay via the same link found on the main page of the Company’s Investors section at: View Source

If you are dialing into the call, please call the conference telephone number five minutes prior to the start time. An operator will register your name and organization.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Toronto Stock Exchange and Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

About IPA’s PolyTope Platform.

IPA’s SARS-CoV-2 PolyTope monoclonal therapies currently in preclinical development are designed to protect against mutagenic escape with an emphasis on efficacy for every patient, variant, and strain of SARS-CoV-2. They are created with the goal of sustainable efficacy in the face of an evolving virus, combining extensively characterized, potently neutralizing, synergistic antibodies exhibiting richly diverse epitope coverage.

Panbela Schedules Conference Call on August 11 to Report 2021 Second Quarter Financial Results

On July 28, 2021 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer reported that it will host a conference call on August 11, 2021, at 4:30 PM Eastern Time to discuss results for its second quarter ended June 30, 2021 (Press release, Panbela Therapeutics, JUL 28, 2021, View Source [SID1234585288]).

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Conference Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

About SBP-101

SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting potential complementary activity with an existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression or peripheral neuropathy, which can be chemotherapy-related adverse events. Recently observed serious visual adverse events are being evaluated and patients with a history of retinopathy or at risk of retinal detachment are excluded from SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial generally provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source .

Perrigo To Release Second Quarter 2021 Financial Results On August 11, 2021

On July 28, 2021 Perrigo Company plc (NYSE; TASE: PRGO) reported that it will release its second quarter 2021 financial results on Wednesday, August 11, 2021 (Press release, Perrigo Company, JUL 28, 2021, View Source,-2021 [SID1234585287]). The Company will also host a conference call beginning at 8:00 A.M. (EDT).

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The conference call will be available live via webcast to interested parties in the investor relations section of the Perrigo website at View Source or by phone at 888-317-6003, International 412-317-6061, and reference ID # 5573644. A taped replay of the call will be available beginning at approximately 12:00 P.M. (EDT) Wednesday, August 11, until midnight Wednesday, August 18, 2021. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code 10158927.

GT Biopharma Announces $16 million in Warrant Exercise Proceeds

On July 28, 2021 GT Biopharma, Inc. (NASDAQ: GTBP), an immuno-oncology company focused on innovative therapies based on the Company’s proprietary NK cell engager (TriKE) technology platform reported the company has raised over $16 million in proceeds from the exercise of warrants (Press release, GT Biopharma, JUL 28, 2021, View Source [SID1234585284]). The warrants were issued as part of the $27 million financing that closed in February 2021.

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The warrant exercise proceeds along with the funds raised when GT Biopharma up listed to the Nasdaq stock exchange puts the company on solid financial ground to accelerate development of GTBP’s drug candidate pipeline. The robust pipeline includes GTB-4550 for lung, lymphoma and other cancers, GTB-5550 for ovarian and prostate cancer, and GTB-6550 for breast and gastric cancer among other drug candidates.

GT Biopharma’s first drug candidate GTB-3550 TriKE monotherapy is currently in FDA Phase 1 Clinical Trial. The Phase 1 trial is focused on evaluating safety, the determination of the Phase 2 dose, dose schedule and the maximum tolerated dose. 12 patients have completed treatment in the Phase 1 trial. The Phase 1 safety part of the study is expected to conclude in August 2021 with data publication currently scheduled for September 2021.

Mr. Anthony Cataldo, the Chairman and Chief Executive Officer of GT Biopharma commented "The confidence shown to us by our investors has put GT Biopharma in the financial position to continue our drug development program for the next two years and beyond. We have approximately $40 million in our treasury and we are ready to execute on our plan to bring real, positive change to cancer patients around the world. Our initial drug candidate GTB-3550 is achieving phenomenal results in its FDA clinical trial and we are looking forward to bringing additional drug candidates into trials very soon."

GSK delivers strong Q2 sales of £8.1 billion, +6% AER, +15% CER Total EPS 27.9p -39% AER, -28% CER; Adjusted EPS 28.1p +46% AER +71% CER

On July 28, 2021 GlaxoSmithKline reported that Sales growth driven by strong commercial execution and favourable prior year comparison (Press release, GlaxoSmithKline, JUL 28, 2021, View Source [SID1234585283])

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Pharmaceuticals £4.2 billion +3% AER, +12% CER with growth in New and Specialty products (+25% CER) including Respiratory +36% CER, Immuno-Inflammation +46% CER, Oncology +69% CER, total HIV +14% CER

Vaccines £1.6 billion +39% AER, +49% CER reflecting strong growth in Meningitis +46% CER, Established Vaccines
+28% CER, Shingrix +1% CER with improved performance notably in the US and £258 million pandemic adjuvant sales. Continue to expect strong growth from Shingrix in H2

Consumer Healthcare £2.3 billion -4% AER, +3% CER (+7% CER excluding divestments/brands under review)

Effective cost control supports delivery of adjusted earnings per share growth
Total Group operating margin 20.7%. Total EPS 27.9p -39% AER, -28% CER
Adjusted Group operating margin 26.7%. Adjusted EPS 28.1p +46% AER, +71% CER (H1 -10% AER, +2% CER). This included a contribution to growth from COVID-19 solutions of approximately +20% AER, +21% CER in Q2 (+7% AER, +7% CER in H1)
Q2 net cash flow from operations £1.3 billion. Free cash flow £316 million

Continued R&D delivery and strengthening of pipeline
FDA rolling review of cabotegravir for prevention of HIV (PrEP) completed
Positive phase III headline results for daprodustat, potential transformative medicine for anaemia due to chronic kidney disease
3 new strategic collaborations announced, iTeos, Alector* and Halozyme strengthen pipeline in next generation immuno-oncology, immuno-neurology and HIV
Emergency use authorisations for sotrovimab; Phase III started for Sanofi-GSK adjuvanted COVID-19 vaccine and EMA rolling review initiated

Investor Update in June outlined new outlooks for growth and plans to maximise shareholder value
GSK expects to deliver step-change in sales, operating profit growth and performance from 2022, driven by high quality Vaccines and Specialty Medicines portfolio and late-stage pipeline
Proposed demerger to create new world-leading Consumer Healthcare company confirmed for mid-2022
Confident in delivering 2021 EPS guidance and reconfirm 2022 outlook
2021 Adjusted EPS to decline by mid-to-high single-digit percentage at CER
2022 meaningful improvements expected in revenues and margins
2021 guidance and 2022 outlook exclude any contribution from COVID-19 solutions
Dividend of 19p/share declared for Q2 2021. Continue to expect 80p/share for 2021

Emma Walmsley, Chief Executive Officer, GSK said:
"GSK delivered an excellent performance in Q2. We expect this positive momentum to continue through the second half of the year driving us towards the better end of our earnings guidance range for 2021, and meaningful performance improvement in 2022. We continue to strengthen our pipeline and are advancing well towards separation. Our clear priority is to focus on execution, unlocking the value of Consumer Healthcare and delivering the step-change in growth and performance we now see for GSK."