ImmunoPrecise Reports Record Revenues and Positive Adjusted EBITDA Fiscal 2020

On August 31, 2020 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSXV: IPA) (OTCQB: IPATF) reported financial results and provided a business update for its fiscal year 2020 (Press release, ImmunoPrecise Antibodies, AUG 31, 2020, View Source [SID1234564203]).

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Recent Highlights:

Characterized a subset of fully human, therapeutic antibodies shown to have potent neutralizing activity and exhibiting enhanced neutralization upon combinatorial (dual antibody) testing
Awarded multiple grants for the development of antibody therapeutics against SARS-CoV-2
Announced TRANSVAC2 funding collaborative COVID-19 vaccine project between ImmunoPrecise Antibodies Europe and LiteVax BV
IPA subsidiary, UPE, joining Genmab and Merus in expansion to new biotech accelerator in the Center of European Science Industry
Collaborating with the NIH and Integrated Biotherapeutics to study the structural details of antibodies with therapeutic potential to treat or prevent COVID-19
Awarded grant by SERC to fund collaboration with the University of Victoria to develop a potential saliva-based COVID-19 antibody test designed to provide real-time results
Added to WHO draft landscape of companies combating COVID-19
Integrated SGI’s automated DNA Printer at Utrecht Site, first in Europe
Financial Results

Revenue. The Company posted record revenue of $14,057,927 compared to revenues of $10,926,268 in the 2019 fiscal year, a 29% increase in revenue for the year. Revenue in Q4 was up 57% over Q4 2019. The Company’s continued focus on identifying and onboarding new clients seeking the breadth and depth of the end-to-end services offered, combined with continued growth to core existing client business, led to increases in both volume and financial value of contracts during the year ended April 30, 2020. Revenue outlook is positive for the first quarter of fiscal 2021.

Gross Margin. Gross profit increased 52% to 8,033,984, compared to 5,294,634 for the for the same period last year an increase of $2,739,350 over year-end April 30, 2019.

Net Loss. The Company reported a net loss of $4,947,426 for year ended April 30, 2020 compared to a net loss of $7,617,467 for the same periods last year, a $2,670.041 improvement over prior year. The decrease in net loss is primarily attributable to the increase in gross profit.

Non-IFRS Measures* Adjusted EBITDA for the year was $52,311 compared to ($2,849,474) for fiscal year ending April 30, 2019. This significant improvement in Adjusted EBITDA is primarily a result of the increase in gross profit compared to the prior year.

"It was a record fiscal year for ImmunoPrecise, a result of our ongoing partnerships with pharma and biotech companies from across the globe, coupled with the continued addition of new clients for research, diagnostic and therapeutic programs," said Jennifer Bath, chief executive officer of ImmunoPrecise. "We work diligently alongside our clients to help them build pipelines and research programs, serving as an innovative extension of their laboratories and building lasting relationships. We are rapidly gaining traction in the market, and I am pleased to report our customer base has grown to include over 400 of the leading pharma and biotech companies worldwide, as well as more than half of the top twenty global pharma companies. We anticipate the continuance of this trend in larger, multi-year agreements to be further bolstered by a robust out-licensing strategy."

"In addition to our strong financial performance, I am pleased to report rapid development of our COVID-19 program. As we have shared previously, current vaccine strategies under development for SARS-CoV-2 are designed to protect uninfected individuals. However, these approaches do not address patients with active disease and will likely not be effective in a number of critical populations including the elderly and immunocompromised. Moreover, given the high potential for continued virus mutation, alternative treatments targeting limited epitopes may not provide long-term efficacy. In contrast, our antibody discovery platforms represent a powerful treatment option for COVID-19 patients generating unparalleled diversity of novel human antibodies, which is being designed to provide maximum clinical benefit for both current and future variants of the virus."

"I am pleased to report that our lead antibodies have produced clear synergistic effects, confirming their activities are enhanced in combination studies and resulting in near complete neutralization of SARS-CoV-2 pseudovirus infection. We are now accelerating pre-clinical testing with plans to submit an IND to the FDA as soon as practical. In the meantime, we are actively pursuing additional collaboration and partnership opportunities. We have also been awarded multiple grants, which further validate our platform, and we will continue to actively explore other non-dilutive funding opportunities."

"Lastly, we are excited to partner with Dr. Alexandre Brolo’s lab at the University of Victoria ("UVic"), to develop a saliva-based antibody-based test for the detection and screening of COVID-19. Unlike current immunoassays that are developed for blood or serum, our goal is to develop a test kit that will provide rapid results, and can be easily administered anywhere, including at home. Overall, we are highly encouraged by the progress of our programs, all leveraging our core antibody expertise, and we look forward to providing further updates."

IPA periodically provides information for investors on its corporate website, ImmunoPrecise.com. This includes press releases and other information on financial performance, reports filed or furnished with the TSX, information on corporate governance and details related to its annual meeting of shareholders. Reports filed or furnished with the TSX can be found at sedar.com.

Vessi Medical Reaps $1.7 Million in Funding for Minimally Invasive Bladder Cancer Treatment

On August 31, 2020 Vessi Medical, a portfolio company of The Trendlines Group Ltd. (SGX: 42T) (OTCQX: TRNLY) reported that it secured $1.7 million in funding for its cryoablation solution for superficial bladder cancer (Press release, Vessi Medical system, AUG 31, 2020, View Source [SID1234564202]). Participating in the financing were Agriline, The Trendlines Group, the Israel Innovation Authority, and ExitValley investors. Vessi’s first-in-human (FIH) study demonstrating safety and efficacy of the Vessi intravesical cryotherapy device is planned for Q1 2021.

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Vessi Medical’s minimally invasive ablation solution for superficial bladder cancer (or non-muscle invasive bladder cancer – "NMIBC") is expected to improve quality of life for many of the two million people globally suffering from NMIBC. NMIBC patients suffer from symptoms including problems with urination, pain, and blood in urine, as well as sexual dysfunction, mental health effects, and a significant decrease in quality of life. The immediate worldwide addressable market of low-grade papillary tumors (70% of NMIBC patients) is estimated at $1.2 billion per year.

Current treatment, Transurethral Resection of Bladder Tumor (TURBT), is a costly, invasive surgical procedure performed under general anesthesia in hospital and is often inadequate (in up to 80% of cases, the cancer returns). Patients often require multiple repeat procedures due to return of the cancer which further reduces quality of life.

Vessi’s minimally invasive NMIBC solution provides a new, first-line outpatient clinic treatment alternative to surgery using bladder-specific cryotherapy technology. The Vessi system consists of a standalone console and a disposable device inserted transurethrally into the bladder.

Vessi Medical, CEO, Eyal Kochavi remarked, "Demonstrating the technology in humans is an important milestone towards making cryo-spray ablation a significant tool for the treatment of superficial bladder cancer. We are currently focused on bladder cancer, but the Vessi technology will address other bladder diseases, such as overactive bladder, benefiting patients, physicians and the healthcare system."

Trendlines Incubators Israel CEO, Barak Singer added: "Vessi Medical has made tremendous progress in their product development. We are very pleased with the company’s ability to complete this financing during the COVID-19 pandemic, which has made fundraising more challenging. The importance of minimally invasive treatment solutions that do not require hospitalization has been highlighted by the pandemic and supports the move to less centralized healthcare options."

Mr. Vincent Tchenguiz, a British entrepreneur and beneficiary of the trust that owns Agriline, commented, "We recognize the strength of Vessi’s platform technology and believe that the company’s product has the potential to offer unique value to patients suffering from bladder cancer. We are keen to work with the company as it matures and look forward to helping it fulfil its mission to significantly improve results for all those involved – the patients, the physicians and the healthcare system as a whole."

ThermoGenesis Holdings to Participate in Investor Conferences in September

On August 31, 2020 ThermoGenesis Holdings, Inc. (Nasdaq: THMO), a market leader in automated cell processing tools and services in the cell and gene therapy field, reported management’s participation in the following investor conferences in September (Press release, Thermogenesis, AUG 31, 2020, View Source [SID1234564201]).

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September 1-4: LD Micro 500. Chris Xu, Ph.D., Chief Executive Officer of ThermoGenesis, will present a company overview at this virtual conference on Wednesday, September 2, at 5:00 pm ET. A live webcast of the presentation will be available on the ThermoGenesis website at: View Source
An archived replay will be available for a period of 90 days after the conference.
September 14-16: H.C. Wainwright 22nd Annual Global Investment Conference. Jeff Cauble, Chief Financial Officer of ThermoGenesis, will present a company overview at this virtual conference on Tuesday, September 15, at 12:00 pm ET. A live webcast of the presentation will be available on the ThermoGenesis website at: View Source
An archive replay will be available for a period of 90 days after the conference.

HealthWell Foundation Launches New Fund to Assist Medicare Patients Living with Prostate Cancer

On August 31, 2020 The HealthWell Foundation, an independent non-profit that provides a financial lifeline for inadequately insured Americans, reported that it has launched a new fund to provide copayment and premium assistance to Medicare patients living with prostate cancer (Press release, HealthWell Foundation, AUG 31, 2020, View Source [SID1234564200]). Through the fund, HealthWell will provide up to $8,000 in financial assistance for a 12-month grant period to eligible patients who have annual household incomes up to 500 percent of the federal poverty level.

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"A prostate cancer diagnosis can be overwhelming, scary, and costly. HealthWell’s new copay assistance program is a welcomed option to help patients better afford their prescribed treatment. Especially during the COVID-19 pandemic, financial barriers are more stressful than ever, and this new fund will provide a critical safety net for patients in need," said Jamie Bearse, CEO of ZERO – The End of Prostate Cancer.

Prostate cancer begins when cells in the prostate gland start to grow out of control. Some prostate cancers grow and spread quickly, but most grow slowly. Almost all prostate cancers are adenocarcinomas, which develop from the gland cells. According to the American Cancer Society (ACS), prostate cancer is the second leading cause of cancer death in American men, behind only lung cancer. In 2020, the ACS estimates approximately 192,000 new prostate cancer cases will be diagnosed and over 33,000 deaths will occur as a result of the disease. Approximately 1 in 9 men will be diagnosed with prostate cancer in their lifetime. Prostate cancer is more likely to develop in older men and in African-American men. About 6 cases in 10 are diagnosed in men who are 65 or older, and it is rare in men under 40. The average age at diagnosis is about 66.

"We are pleased to see that financial resources are now available to this patient community," said Joanna Morales, Esq., Chief Executive Officer at Triage Cancer. "As we continue to see a rise in the cost of cancer treatments, addressing the critical need to relieve the financial burden these patients and their families face is paramount. Recognizing these financial disparities, especially among Medicare patients, and providing resources to enable access to treatments that would otherwise be prohibitive due to cost, will help allay the financial impact of a cancer diagnosis."

"A prostate cancer diagnosis can be devastating to the patient and his family and decisions regarding treatments and the costs of those treatments can pose additional stress and anxiety, especially for patients on Medicare," said Alan Klein, Chief Development Officer at the HealthWell Foundation. "We are particularly proud to add this fund to our growing list of available financial resources for the Medicare community. Thanks to the generosity of our donors, we are now able to provide a financial lifeline to ensure that Medicare patients living with prostate cancer are able to start or continue critical, possibly lifesaving, treatments they otherwise would not be able to afford."

To determine eligibility and apply for financial assistance, visit HealthWell’s Prostate Cancer – Medicare Access Fund page. To learn how you can support this or other HealthWell programs, visit HealthWellFoundation.org.

Transcenta Announces First Patient Dosed in Phase I China Trial of Claudin18.2 Targeting Monoclonal Antibody TST001

On August 31, 2020 Transcenta Holding Limited ("Transcenta"), a global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, reported that the first subject has been dosed successfully on August 28th in China Phase I clinical trial of TST001, a humanized Claudin18.2 (CLDN18.2) monoclonal antibody developed by Transcenta’s subsidiary Mabspace Biosciences (Suzhou) Co., Ltd (Press release, Transcenta, AUG 31, 2020, View Source;301120806.html [SID1234564199]). Transcenta conducts clinical trials of TST001 simultaneously in both China and the US, and the first subject has been dosed in the US on June 29th, 2020.

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NCT04495296 is a Phase I clinical study conducted in China to evaluate the safety, tolerability, Pharmacokinetics, initial clinical activity and recommended dose for Phase 2 study of TST001 in Chinese patients with unresectable or metastatic solid tumors.

"CLDN18.2 is found to be overexpressed in many tumors including gastric cancer, which makes it a promising anti-cancer therapeutic target. Currently, there is no approved anti-CLDN18.2 targeted therapeutics globally," said Professor Lin Shen, the lead investigator from Beijing Cancer Hospital, "We have dosed the first subject in China successfully, and we look forward to having a positive result, and we hope TST001 can be an effective and safe agent to benefit more gastric cancer patients."

"We have made significant progress on TST001 since the beginning of this year. Within the last 6 months, we have obtained IND clearance and dosed first patient in US and in China, and we hope to initiate Phase Ib for TST001 next year," said Dr. Xueming Qian, Transcenta’s Co-Founder and Chief Executive Officer.

About TST001
TST001, developed by Transcenta’s subsidiary Mabspace Biosciences (Suzhou) Co., Ltd., is a high affinity humanized monoclonal antibody targeting CLDN18.2 positive tumors by mechanisms such as complement-dependent cytotoxicity (CDC) and antibody-dependent cellular cytotoxicity (ADCC) through combining CLDN18.2 with high affinity. Through bioprocess engineering, TST001 is produced with reduced fucosylation and results in significant enhancement in its activity against CLDN18.2-expressing tumors. In preclinical pharmacodynamics studies, TST001 shows better anti-cancer activity than similar molecules.