On May 4, 2022 Charles River Laboratories International, Inc. (NYSE: CRL) reported its results for the first quarter of 2022 (Press release, Charles River Laboratories, MAY 4, 2022, View Source [SID1234613478]). For the quarter, revenue was $913.9 million, an increase of 10.8% from $824.6 million in the first quarter of 2021.

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Acquisitions contributed 4.7% to consolidated first-quarter revenue growth. The divestiture of the Research Models and Services operations in Japan (RMS Japan) in October 2021 reduced reported revenue growth by 1.6%. The impact of foreign currency translation reduced reported revenue growth by 1.7%. Excluding the effect of these items, organic revenue growth of 9.4% was driven by contributions from all three business segments.

On a GAAP basis, first-quarter net income attributable to common shareholders was $93.0 million, an increase of 51.2% from net income of $61.5 million for the same period in 2021. First-quarter diluted earnings per share on a GAAP basis were $1.81, an increase of 50.8% from $1.20 for the first quarter of 2021. The increases in the GAAP net income and earnings per share were driven primarily by higher revenue and operating income, as well as lower costs associated with the Company’s debt refinancing activities in the first quarter of 2021.

On a non-GAAP basis, net income from continuing operations was $141.1 million for the first quarter of 2022, an increase of 9.3% from $129.2 million for the same period in 2021. First‑quarter diluted earnings per share on a non-GAAP basis were $2.75, an increase of 8.7% from $2.53 per share for the first quarter of 2021. The non-GAAP net income and earnings per share increases were driven primarily by higher revenue and operating margin improvement, partially offset by a higher tax rate and increased interest expense.

James C. Foster, Chairman, President and Chief Executive Officer, said, "We are pleased with our solid, first-quarter financial results that were in line with our expectations, and believe we are continuing to distinguish ourselves from the competition in the current business environment. We continue to benefit from strong, sustained business trends, including record booking activity and robust backlog growth in the Discovery and Safety Assessment segment, that is affording us exceptional visibility into future demand as studies are booked well into 2023. We believe these trends, coupled with the continued strength of biopharmaceutical client spending, support our expectation that the revenue growth rate will accelerate from the first-quarter level, positioning us to achieve our financial guidance for the year."

First-Quarter Segment Results

Research Models and Services (RMS)

Revenue for the RMS segment was $176.5 million in the first quarter of 2022, essentially unchanged from $176.9 million in the first quarter of 2021. Reported revenue growth was reduced by 7.7% due to the divestiture of RMS Japan, and by 1.2% due to the impact of foreign currency translation. Organic revenue growth of 8.7% was driven by broad-based growth for research models, particularly in North America, and research model services, particularly in the Insourcing Solutions (IS) business.

In the first quarter of 2022, the RMS segment’s GAAP operating margin increased to 27.1% from 25.4% in the first quarter of 2021. On a non-GAAP basis, the operating margin increased to 29.9% from 28.7% in the first quarter of 2021. The GAAP and non-GAAP operating margin increases were driven primarily by operating leverage from higher sales of research models.

Discovery and Safety Assessment (DSA)

Revenue for the DSA segment was $544.3 million in the first quarter of 2022, an increase of 8.6% from $501.2 million in the first quarter of 2021. The impact of foreign currency translation reduced revenue by 1.6%, while acquisitions contributed 0.7% to DSA revenue growth. Organic revenue growth of 9.5% was primarily driven by the Safety Assessment business.

In the first quarter of 2022, the DSA segment’s GAAP operating margin increased to 19.3% from 18.1% in the first quarter of 2021. The GAAP operating margin increase was driven by lower acquisition-related adjustments associated with contingent consideration. On a non-GAAP basis, the operating margin decreased to 22.9% from 23.8% in the first quarter of 2021, primarily reflecting higher staffing costs.

Manufacturing Solutions (Manufacturing)

Revenue for the Manufacturing segment was $193.1 million in the first quarter of 2022, an increase of 31.8% from $146.5 million in the first quarter of 2021. The acquisitions of the Cognate BioServices (Cognate) and Vigene Biosciences (Vigene) CDMO businesses contributed 24.4% to Manufacturing revenue growth, while the impact of foreign currency translation reduced revenue by 2.7%. Organic revenue growth of 10.1% was driven by strong demand for Biologics Testing Solutions services, with Microbial Solutions revenue also increasing.

In the first quarter of 2022, the Manufacturing segment’s GAAP operating margin decreased to 24.0% from 33.8% in the first quarter of 2021. On a non-GAAP basis, the operating margin decreased to 33.1% from 35.5% in the first quarter of 2021. The GAAP and non-GAAP operating margin decreases were driven primarily by the additions of Cognate and Vigene. Higher amortization and other integration costs associated with these acquisitions also contributed to the GAAP operating margin decline.

Updates 2022 Guidance

The Company is updating its 2022 financial guidance, which was previously provided on February 16, 2022. Reported revenue growth guidance is being increased by 50 basis points to 13.5% to 15.5% to reflect the Explora BioLabs acquisition, which was completed on April 5, 2022, partially offset by unfavorable movements in foreign currency translation. Organic revenue growth guidance remains unchanged for 2022.

The Company is maintaining its non-GAAP earnings per share guidance as a result of its first-quarter financial performance that was in line with prior expectations and an outlook of accelerating revenue growth during the remainder of the year. The 2022 non-GAAP earnings per share outlook includes a higher-than-expected tax rate, due principally to a lower excess tax benefit associated with stock-based compensation in the first quarter, as well as increased interest expense due to higher rate assumptions for the year. GAAP earnings per share guidance is being lowered to reflect amortization and other acquisition-related costs associated with Explora BioLabs, as well as the first-quarter loss from venture capital and other strategic investments.

Footnotes to Guidance Table:

(1) The contribution from acquisitions/divestitures (net) reflects only those transactions that have been completed.

(2) Organic revenue growth is defined as reported revenue growth adjusted for acquisitions, divestitures, the 53rd week in 2022, and foreign currency translation.

(3) Acquisition-related amortization includes an estimate of $0.05-$0.15 for the impact of the Explora BioLabs acquisition because the preliminary purchase price allocation has not been completed.

(4) These adjustments are related to the evaluation and integration of acquisitions and divestitures, and primarily include transaction, advisory, and certain third-party integration costs, as well as adjustments related to contingent consideration and certain costs associated with acquisition-related efficiency initiatives.

(5) Venture capital and other strategic investment performance only includes recognized gains or losses. The Company does not forecast the future performance of these investments.

(6) These items primarily relate to charges associated with U.S. and international tax legislation that necessitated changes to the Company’s international financing structure; environmental litigation costs related to the Microbial Solutions business; and severance and other costs related to the Company’s efficiency initiatives.

Webcast

Charles River has scheduled a live webcast on Wednesday, May 4th, at 9:30 a.m. ET to discuss matters relating to this press release. To participate, please go to ir.criver.com and select the webcast link. You can also find the associated slide presentation and reconciliations of GAAP financial measures to non-GAAP financial measures on the website.

Bank of America Healthcare Conference Presentation

Charles River will present at the Bank of America 2022 Healthcare Conference in Las Vegas, Nevada, on Wednesday, May 11th, at 1:20 p.m. PT (4:20pm ET). Management will provide an overview of Charles River’s strategic focus and business developments.

A live webcast of the presentation will be available through a link that will be posted on ir.criver.com. A webcast replay will be accessible through the same website shortly after the presentation and will remain available for approximately two weeks.

Non-GAAP Reconciliations

The Company reports non-GAAP results in this press release, which exclude often-one-time charges and other items that are outside of normal operations. A reconciliation of GAAP to non-GAAP results is provided in the schedules at the end of this press release.

On May 4, 2022 Catalyst Clinical Research, a market-leading provider of clinical research services, reported a strategic acquisition of Aptus Clinical to expand the geographic reach of the two companies, and to enhance patient access to advanced, life-changing therapies (Press release, Catalyst Clinical Research, MAY 4, 2022, View Source [SID1234613510]). Together, the two entities will become one multi-region clinical research organization with an accelerated growth trajectory in both the U.S. and Europe.

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Catalyst’s offerings will now encompass extensive and expanded clinical consulting services, as it inherits Aptus’ strong and established relationship with the Experimental Cancer Medicine Centre (ECMC) network to support trial set-up and clinical design input. Positioned at the forefront of novel cancer treatment trends, Catalyst’s active portfolio serves more than 5,300 cancer patients in need and will grow by nearly 600 patients concurrent to this acquisition.

"We are thrilled to be working with Aptus Clinical to expand our reach in the European market, serving clients around the globe to help develop innovative new therapies, improve patient outcomes and enhance our company’s long-term impact," said Catalyst Clinical Research CEO, Nick Dyer. "Our complementary service offerings and therapeutic area alignment will improve outcomes for all our clients."

"Catalyst continues to prove its capabilities as a leader in oncology clinical development and as a preferred strategic acquirer for growing businesses," said Vern Davenport, Partner at NovaQuest Capital Management and Catalyst Board Chairman. "Aptus provides Catalyst with a highly capable team of experts in Europe to accelerate its global ambitions, of which we are incredibly supportive." Catalyst Clinical Research is a portfolio company of global platform NovaQuest Capital Management, LLC.

Formed in 2014 by three former AstraZeneca clinical development experts, Aptus Clinical has rapidly established itself as a specialist CRO offering flexible clinical research solutions in oncology, cell and gene therapies and rare diseases. Together the companies, operating as Catalyst Oncology, will continue to deliver on a portfolio of more than 100 active oncology studies via a network of 500 keenly involved investigator sites. Additional studies outside the Oncology therapeutic area will be delivered under the Catalyst Flex solution and operating models.

"We are proud to partner with Catalyst to strengthen our shared commitment to delivering cutting edge science to patient populations who are in desperate need of new therapies", said Aptus Clinical CEO, Dr. Steve McConchie. "We firmly believe Aptus Clinical and Catalyst are better together and look forward to combining our decades of experience in developing and delivering high quality clinical trials to support our combined organisation to become a significant global provider of innovative clinical research solutions."

Combined headcount for the unified company will now exceed 800 staff members. Catalyst will also work to leverage Aptus’ strategic site relationships integrating them into its own site network spanning North America and Europe. The clinical research organization joined forces with Triangle Biostatistics in 2019, and then with Ce3 in 2020. Although this is Catalyst’s third M&A transaction, it is its first international union that will accelerate and expand the companies’ geographic reach greatly.

On May 4, 2022 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, reported financial results for the quarter ended March 31, 2022 (Press release, DiaMedica, MAY 4, 2022, View Source [SID1234613526]). DiaMedica will host a conference call on Thursday, May 5, 2022, at 8:00AM Eastern Time / 7:00AM Central Time, to discuss its business update and first quarter financial results.

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Clinical Developments

DM199 for the Treatment of Acute Ischemic Stroke

DiaMedica reported that it has increased the number of activated clinical trial sites to 9, more than doubling the number of active sites reported in March 2022 and is currently on track with its site activation goals for its ReMEDy2 trial, which is an adaptive design, randomized, double-blind, placebo-controlled trial studying the use of the Company’s product candidate, DM199, to treat acute ischemic stroke (AIS). DiaMedica believes that it has experienced slower than expected site activations and enrollment in the ReMEDy2 trial due primarily to staffing shortages and overall resourcing at study sites due to the COVID-19 pandemic and challenges of the study sites managing logistics and compliance for patients discharged from the hospital to an intermediate care facility. The Company is putting resources and processes in place to address both of these issues and expects continued improvement in site activations and patient enrollment over the course of 2022, subject to new pandemic related challenges which may arise for study sites.

DM199 for the Treatment of Chronic Kidney Disease

As previously reported, patient enrollment is completed in DiaMedica’s Phase 2 REDUX trial, which is a multi-center, open-label, investigation to assess the safety and efficacy of multiple doses of DM199, administered over 90 days, in participants with chronic kidney disease (CKD) (Stage 2 or 3).

In total, 79 patients were enrolled and initiated treatment, including 21 African American patients in Cohort 1, 25 patients with IgAN in Cohort 2 and 33 patients with Type 2 diabetes in Cohort 3. The last patient visit was completed in March 2022 and DiaMedica is working to complete the study close-out and the final data analysis while evaluating next steps for the CKD program.

Balance Sheet and Cash Flow

DiaMedica reported total cash and investments of $41.0 million, consisting of cash and cash equivalents of $3.0 million and marketable securities of $38.0 million, current liabilities of $1.4 million and working capital of $40.7 million as of March 31, 2022, compared to total cash and investments of $45.1 million, $1.5 million in current liabilities and $43.9 million in working capital as of December 31, 2021. The decreases in cash and investments and in working capital were due primarily to cash used to fund operating activities during the quarter ended March 31, 2022.

Net cash used in operating activities for the three months ended March 31, 2022, was $3.9 million compared to $4.3 million for the three months ended March 31, 2021. This decrease relates primarily to reduced effects of changes in operating assets and liabilities on the net cash used in operating activities in the current year period.

Financial Results

Research and development (R&D) expenses were $2.0 million for the three months ended March 31, 2022, compared with $2.4 million for the three months ended March 31, 2021, a decrease of $0.4 million. This decrease was driven mainly by a reduction in costs related to the REDUX CKD trial and a lower level of DM199 manufacturing process development work in the current year quarter as compared to the prior year quarter. These decreases were partially offset by increased costs incurred in the ReMEDy2 AIS trial and higher personnel costs related to the expansion of the clinical team in the current year period.

General and administrative (G&A) expenses were $1.6 million for the three months ended March 31, 2022, up from $1.2 million for the three months ended March 31, 2021. This $0.4 million increase resulted from a combination of increased professional services costs, directors’ and officers’ liability insurance and personnel costs incurred in support of expanding the operations and clinical programs.

Conference Call and Webcast Information

DiaMedica Management will host a conference call and webcast to discuss its business update and first quarter 2022 financial results on Thursday, May 5, 2022, at 8:00 AM Eastern Time / 7:00 AM Central Time:

Interested parties may access the conference call by dialing in or listening to the simultaneous webcast. Listeners should log on to the website or dial in 15 minutes prior to the call. The webcast will remain available for play back on DiaMedica’s website, under investor relations – events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until May 12, 2022, by dialing (800) 770-2030 (US Toll Free) and entering the replay passcode: 4814247.

About ReMEDy2 Trial

The ReMEDy2 trial is an adaptive design, randomized, double-blind, placebo-controlled trial studying the use of the Company’s product candidate, DM199, to treat AIS patients. The trial is intended to enroll approximately 350 patients at 75 sites in the United States. Patients enrolled in the trial will be treated for three weeks with either DM199 or placebo beginning within 24 hours of the onset of AIS symptoms, with the final follow-up at 90 days. The trial excludes patients treated with tissue plasminogen activator (tPA) and/or mechanical thrombectomy. The study population is representative of the approximately 80% of AIS patients who do not have treatment options today, primarily due to the limitations on treatment with tPA or mechanical thrombectomy. DiaMedica believes that the proposed trial has the potential to serve as a pivotal registration study of DM199 in this patient population.

The ReMEDy2 trial has two separate, independent, primary endpoints based upon both the results observed in the first ReMEDy1 phase 2 trial and published results from the urine-derived form of KLK1 used to successfully treat AIS in China. ReMEDy2 is powered for success with either endpoint: 1) physical recovery from stroke as measured by the well-established modified Rankin Scale (mRS) at day 90, and 2) the rate of ischemic stroke recurrence through day 90. Recurrent strokes represent 25% of all ischemic strokes, often occurring in the first few weeks after an initial stroke and are typically more disabling, costly, and fatal than initial strokes.

About DM199

DM199 is a recombinant (synthetic) form of human tissue kallikrein-1 (KLK1). KLK1 is a serine protease (protein) that plays an important role in the regulation of diverse physiological processes including blood flow, inflammation, fibrosis, oxidative stress and neurogenesis via a molecular mechanism that increases production of nitric oxide and prostaglandin. KLK1 deficiency may play a role in multiple vascular and fibrotic diseases such as stroke, chronic kidney disease, retinopathy, vascular dementia, and resistant hypertension where current treatment options are limited or ineffective. DiaMedica is the first company to have developed a recombinant form of the KLK1 protein. The KLK1 protein, produced from porcine pancreas and human urine, has been used to treat patients in Japan, China and South Korea for decades. DM199 is currently being studied in patients with acute ischemic stroke and patients with chronic kidney disease. In September 2021, the U.S. Food and Drug Administration granted Fast Track Designation to DM199 for the treatment of acute ischemic stroke.

On May 4, 2022 Medigene AG (Medigene, FSE: MDG1, Prime Standard), an immuno-oncology company focusing on the development of T-cell-based cancer therapies, reported an update on the first quarter of 2022 and confirms its financial guidance for the full year (Press release, MediGene, MAY 4, 2022, View Source [SID1234613544]). The full version of the Quarterly Statement Q1 2022 can be downloaded here: View Source

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Prof. Dolores Schendel, Chief Executive Officer (CEO) and Chief Scientific Officer (CSO) at Medigene: "Medigene continues to develop technology to power the activity and safety of T cell receptor-modified T cell (TCR-T) immunotherapies in solid cancers. Our extensive partnership signed with BioNTech SE (BioNTech) in February not only validated our leading position in the field but also provided a sound financial basis at an important phase in the Company’s evolution. Also in February, we reported that our blood cancer program MDG1011 was successfully produced, safe, well tolerated, with signals of both biological and/or clinical activity.

The Company is strategically positioned to increase value through partnerships and internal discovery, seeking novel T cell receptors (TCRs) and developing the necessary vital tools that will make TCR-T therapies safer, more efficacious and cost effective."

Business review since beginning of 2022 and outlook

Validating, comprehensive TCR-T and technology partnership with BioNTech SE (BioNTech)

BioNTech recently acquired Medigene’s PRAME-specific TCR-4 from the MDG10XX program and has an exclusive option to acquire additional existing TCRs in Medigene’s discovery pipeline. Medigene will develop a number of new TCRs under a development partnership agreement with BioNTech lasting initially for three years and has granted BioNTech licenses to its PD1-41BB switch receptor and precision pairing library. These are technologies that could make TCR-T therapies safer and more effictive.

Under the agreement, Medigene received an upfront payment of EUR 26 million and will be reimbursed for research and development costs incurred during the period of the collaboration. Medigene will be eligible for development, regulatory and commercial milestone payments up to a triple-digit million Euro amount per program. In addition, the Company will be eligible for tiered deferred option payments on global net sales for products based on TCRs arising from the collaboration and royalties on products utilizing at least one of the licensed technologies.

MDG1011 – clinically validated TCR-T therapy in blood cancers

In June 2021, the last patient was enrolled in the third dose cohort of the Phase-I part of the Phase I/II trial of MDG1011 in blood cancer. Medigene reported on safety, tolerability and feasibility in December 2021. In February 2022, first efficacy and immune monitoring data were published. MDG1011 was successfully produced for 12 of the 13 heavily pretreated patients (92.3%) and proved to be safe and well tolerated. MDG1011 showed signs of both biological and clinical activity. One patient is currently still under observation, over nine months after treatment. In line with Medigene’s focus on solid cancers, the Company has decided that, contingent on the final results from the Phase I part, the Phase II part of the trial would only be conducted with or by a partner.

Tools to empower TCR-T therapies

Medigene develops several tools to make TCR-T therapies even safer, more specific and more effective, especially for use in solid cancers. In March 2022, preclinical data on Medigene’s PD1-41BB switch receptor were published in the peer-reviewed scientific publication "T-Cells Expressing a Highly Potent PRAME-Specific T-Cell Receptor in Combination with a Chimeric PD1-41BB Co-Stimulatory Receptor Show a Favorable Preclinical Safety Profile and Strong Anti-Tumor Reactivity" in the scientific journal Cancers.

Development partnerships

Medigene continues its successful collaboration with 2seventy bio, Inc. (formerly: bluebird bio, Inc.) and has initiated operations under the new partnership with BioNTech. Cytovant Sciences HK Limited, a biopharmaceutical company founded by Roivant Sciences, has reported that its development activities would be delayed due to the COVID-19 pandemic, and separately has temporarily suspended Medigene’s activities within the second TCR-T development project since April 2022.

To maximize the Company’s value, Medigene continues to evaluate new partnering opportunities related to its suite of technologies and portfolio of product candidates.

Financial development and financial forecast

As of 31 March 2022, cash and cash equivalents amounted to EUR47.8 m (31 December 2021: EUR22.4 m). In Q1 2022, Medigene generated revenues of EUR23.0 m (Q1 2021: EUR2.1 m) and had research and development expenses of EUR2.0 (Q1 2021: EUR4.0 m). As a result, the earnings before interest, taxes, depreciation, and amortization (EBITDA) amounted to EUR16.8 m (Q1 2021: EUR‑3.1 m).

Currently, Medigene does not expect any material impact on revenues, research and development expenses and EBITDA due to COVID-19 or the Ukraine crisis. Thus, Medigene confirms its financial forecast for 2022 published in the Group Management’s Discussion and Analysis 2021 and continues to expect revenues of EUR23 – 28 m, research and development expenses of EUR11 – 15 m and a positive EBITDA in the amount of EUR3 – 5 m in 2022. Based on its current planning, the Company has sufficient financial resources to fund business operations into Q4 2024.

Conference Call

Medigene will not hold a telephone conference regarding the Quarterly Statement Q1 2022, but we remain available in the usual way for all enquiries.

On May 4, 2022 Amphera B.V. reported positive REACtiVe Phase 2 study safety and efficacy data from the first cohort of 10 patients receiving Amphera’s MesoPher dendritic cell therapy. Patients, with resected pancreatic cancer who had completed standard-of-care chemotherapy, received 3 bi-weekly injections of MesoPher and booster injections at 4 and 7 months (Press release, Amphera, MAY 4, 2022, View Source [SID1234613563]). The results from this first cohort have been published in the European Journal of Cancer1.

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The latest REACtiVe data showed an average Overall Survival after surgery of approximately 36 months, with 8 of 10 patients alive, which is far beyond expected survival. No disease recurrence or any tumour progression is seen in 7 of 10 patients. Remarkably, the 3 patients with disease recurrence did not demonstrate rapid tumour growth. Furthermore, the safety profile of the treatment was favourable, with only transient grade 1 and 2 adverse events.

Prof. Casper van Eijck, principal investigator on the study and author on the paper said: "These latest data should be interpreted with care, as they are from a small cohort of patients, without a control arm. Nevertheless, these are very promising results that are exceeding disease progression and survival expectations for this group of patients. We hope to confirm these observations in the expansion cohort, with first results anticipated in the fourth quarter of this year."

Ilona Enninga PhD, COO of Amphera said: "Pancreatic cancer is notoriously challenging to treat, as the historical medical literature illustrates. In this paper, the investigators consistently identified activated T-cells against autologous tumour. We believe this mechanism of action of MesoPher, the ability to activate T-cells, is central to the efficacy signal we are observing."

Rob Meijer, CEO of Amphera said: "We are very excited by this new data showing impressive survival in this challenging disease setting. It is worth noting that MesoPher has also demonstrated encouraging safety and efficacy Phase I/II data in mesothelioma, providing strong proof of concept for the application of MesoPher in multiple cancer indications. In the fourth quarter of this year, we will also see results from our pivotal Phase II/III DENIM study with MesoPher in mesothelioma next to the expansion cohort of the REACtiVe Phase 2 study."