On March 30, 2021 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications, reported financial results for the fiscal year ended December 31, 2020 and provided an update on the Company’s recent and anticipated future developments (Press release, Pieris Pharmaceuticals, MAR 30, 2021, View Source [SID1234577332]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We are pleased to announce the achievement of our second clinical milestone for PRS-060/AZD1402, triggered by the initiation of phase 2a by our partner, AstraZeneca, who further demonstrated their commitment to our respiratory-focused alliance with an equity investment," said Stephen S. Yoder, President and Chief Executive Officer of Pieris. "Within our immuno-oncology franchise, we look forward to presenting additional data for two of our 4-1BB-based bispecific programs at AACR (Free AACR Whitepaper), cinrebafusp alfa (PRS-343) and PRS-344, reinforcing our commitment to and leadership in the 4-1BB space. Following the generation of synergistic in vitro data for the combination of cinrebafusp alfa with TUKYSA (tucatinib), we plan to pursue this combination in lower HER2-expressing gastric cancer patients with Seagen. Seagen has also recently made an equity investment in Pieris, further strengthening the alliance we signed in 2018. Partnerships are an important part of our corporate strategy, and our recent announcements reinforce the value our current alliances continue to bring."

PRS-060 & AstraZeneca Collaboration: Pieris will receive a $13 million milestone payment from AstraZeneca for the initiation of patient enrollment in the phase 2a study of PRS-060/AZD1402, an inhaled IL-4 receptor alpha inhibitor the companies are developing for the treatment of moderate-to-severe asthma. The global phase 2a study of PRS-060/AZD1402 is a two-part, multi-center, placebo-controlled clinical study that will evaluate the drug candidate at up to three dose levels using a dry powder formulation administered twice daily on top of standard of care. Additionally, the companies amended their existing agreement to restructure certain commercial economics for PRS-060/AZD1402 by adjusting various milestones and royalty provisions, while fundamentally maintaining the overall value split between AstraZeneca and Pieris. In connection with the amendment, AstraZeneca will make a $10 million equity investment in Pieris through the purchase of 3,584,230 newly-issued shares of Pieris common stock at a price of $2.79 per share.
Cinrebafusp Alfa (PRS-343): Pieris will present an updated dataset for cinrebafusp alfa (PRS-343), a 4-1BB/HER2 bispecific for the treatment of HER2-expressing solid tumors, in an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021 (AACR) (Free AACR Whitepaper) on April 10, 2021. The presentation will include additional clinical benefit and safety data from cohort 13b (18 mg/kg, administered Q2W), as well as biomarker data across all active dose cohorts. The Company is preparing for the phase 2 study of cinrebafusp alfa, expected to begin in the summer of 2021. The phase 2 study will evaluate cinrebafusp alfa in combination with ramucirumab and paclitaxel in high HER2-expressing gastric cancer and in combination with tucatinib in low HER2-expressing gastric cancer. Collaboration partners Lilly and Seagen will supply ramucirumab and tucatinib, respectively, for these study arms.
Seagen Collaboration Expansion: Seagen made a $13 million equity investment in Pieris as part of an ongoing collaboration between the companies. Additionally, the companies have entered into a clinical trial and supply agreement to evaluate the safety and efficacy of combining Pieris’ cinrebafusp alfa with Seagen’s TUKYSA (tucatinib), a small-molecule tyrosine kinase HER2 inhibitor, for the treatment of gastric cancer patients expressing lower HER2 levels (IHC2+/ISH- & IHC1+) as part of the upcoming phase 2 study to be conducted by Pieris. The companies have also amended their existing immuno-oncology collaboration whereby Pieris’ option to co-develop and co-commercialize the second of three programs in the collaboration has been converted to a co-promotion option in the United States.
PRS-344 & Servier Collaboration: Pieris and Servier will present preclinical data for PRS-344/S095012, a 4-1BB/PD-L1 bispecific, as part of a poster session at the AACR (Free AACR Whitepaper) Annual Meeting 2021. The presentation will showcase synergistic data, including in vitro data evaluating potential effects of combining 4-1BB with PD-L1 and the effects of PRS-344 on CD8+ T cells, as well as dose-dependent anti-tumor response in in vivo preclinical models. PRS-344 is expected to enter phase 1 studies this year. Pieris holds exclusive commercialization rights for PRS-344 in the United States and will receive royalties on ex-U.S. sales by Servier for this program. Additionally, Pieris completed non-GLP preclinical work for PRS-352, a preclinical-stage program addressing undisclosed targets for immuno-oncology, last quarter; Servier is fully responsible for further development of that program.
Preclinical Respiratory Pipeline: Pieris and AstraZeneca continue to advance each of the four programs in the collaboration beyond PRS-060/AZD1402. Pieris also continues to advance several proprietary discovery-stage respiratory programs and expects to share data and rationale for advancement of one of its proprietary programs this year.
AACR Details:

Cinrebafusp Alfa Oral Presentation:

Title: Clinical and biomarker activity of PRS-343, a bispecific fusion protein targeting 4-1BB and HER2, from a Phase 1 study in patients with advanced solid tumors
Abstract: CT017
Session: CTMS01 – Early Clinical Trials with New Anticancer Agents
Date/Time: The presentation will take place at 2:05 PM EDT on Saturday, April 10, 2021 on Channel 08.

PRS-344 Poster:

Title: Simultaneous costimulatory T-cell engagement and checkpoint inhibition by PRS-344/S095012, a PD-L1 / 4-1BB bispecific compound for tumor localized activation of the immune system
Abstract: LB135
Session: PO.ET01.08 – Targeting the Tumor Microenvironment in Drug Development
Date/Time: This poster will be available beginning at 8:30AM EDT on Saturday, April 10, 2021.

Fiscal Year Financial Update:

Cash Position – Cash and cash equivalents totaled $70.4 million for the year ended December 31, 2020, compared to a cash, cash equivalents, and investments balance of $104.2 million for the year ended December 31, 2019. The decrease was primarily due to funding operating and capital expenses in 2020, partially offset by ATM proceeds and milestone achievements during the year. The December 31, 2020 ending cash position excludes the $13 million received from Seagen in March 2021 and the $23 million to be received from AstraZeneca in connection with the phase 2a study initiation and equity investment.

R&D Expense – R&D expenses were $46.5 million for the year ended December 31, 2020, compared to $55.0 million for the year ended December 31, 2019. The decrease in R&D expenses was primarily due to lower clinical and manufacturing costs on our immuno-oncology programs, in part due to the partial clinical hold on cinrebafusp alfa, lower manufacturing spending on PRS-060 (which is fully reimbursed by AstraZeneca), and lower travel-related expenditures due to COVID-19 restrictions. The overall decrease was partially offset by an increase in allocated IT and facility costs due to the move to a new R&D facility in Hallbergmoos, Germany in early 2020.

G&A Expense – G&A expenses were $16.7 million for the year ended December 31, 2020, compared to $18.4 million for the year ended December 31, 2019. The decrease in G&A expenses was primarily due to lower personnel costs, lower audit and professional fees related to Sarbanes-Oxley readiness, and lower travel-related expenditures due to COVID-19 restrictions. These decreases were partially offset by higher allocated IT and facility costs due to the move to the new R&D facility.

Net Loss – Net loss attributable to common stockholders was $37.2 million or $(0.68) per share for the year ended December 31, 2020, compared to a net loss of $28.3 million or $(0.56) per share for the year ended December 31, 2019.

Conference Call:

Pieris management will host a conference call beginning at 8:00 AM EDT on Tuesday, March 30, 2021, to discuss the full-year financial results and provide a corporate update. Individuals can join the call by dialing +1-877-407-8920 (US & Canada) or +1-412-902-1010 (International). An archived replay of the call will be available by dialing +1-877-660-6853 (US & Canada) or +1-201-612-7415 (International) and providing the Conference ID #: 13661472.

On March 30, 2021 Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported financial results for the fourth quarter and full year 2020 and provided an operational update (Press release, Bellicum Pharmaceuticals, MAR 30, 2021, View Source [SID1234577358]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"In 2020, we refined our focus on our next generation CAR-T cell therapies," said Rick Fair, President and Chief Executive Officer. "We are excited to have resumed our trial of BPX-601 with a focus on prostate cancer and initiated the BPX-603 trial in HER2+ solid tumors, and we look forward to providing updates on both programs as the year progresses."

Program Highlights and Current Updates

BPX-601 GoCAR-T
•In January, Bellicum announced the U.S. Food and Drug Administration (FDA) had lifted the clinical hold on patient enrollment and dosing in an ongoing Phase 1/2 dose-escalation clinical trial evaluating BPX-601 and rimiducid in patients with previously treated metastatic pancreatic or prostate cancer. Bellicum has worked with clinical investigators to resume screening for patient enrollment without modification to the current study protocol.

•Bellicum plans to present a Phase 1 data update on BPX-601 and rimiducid in patients with metastatic castration-resistant prostate cancer in the first quarter of 2022.

BPX-603 GoCAR-T
•In December, Bellicum announced the enrollment and apheresis of the first patient in the Phase 1/2 clinical trial for BPX-603 in patients with solid tumors that express human epidermal growth factor 2 (HER2), including breast, endometrial, ovarian, gastric, and colorectal cancers. BPX-603 is the company’s first dual-switch GoCAR-T product candidate, which incorporates Bellicum’s iMC activation and CaspaCIDe safety switch technologies. The company expects to provide initial Phase 1 data from this trial in the second half of 2021.

CaspaCIDe
•In February, Bellicum announced the first reported use of the CaspaCIDe safety switch to mitigate CAR-T cell toxicity. The report, published as an ahead-of-print publication in the digital edition of Blood, a journal published by The American Society of Hematology (ASH) (Free ASH Whitepaper), was a case from an investigator-sponsored trial (IST) at the University of North Carolina Lineberger Comprehensive Cancer Center of autologous CAR-T cells expressing CD19 and CaspaCIDe. In this patient, grade 3-4 immune effector cell-associated neurotoxicity syndrome (ICANS) refractory to standard therapies was treated with rimiducid to activate CaspaCIDe. Within twelve hours of rimiducid administration, ICANS grade improved from 3 to 1 and was fully resolved after four days.

1

Exhibit 99.1

Corporate Updates

•In November, Bellicum completed an underwritten offering of 1,040,000 shares of common stock, pre-funded warrants to purchase 3,109,378 shares of common stock and accompanying warrants to purchase 4,149,378 shares of common stock. Gross proceeds to Bellicum were approximately $25.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by Bellicum and excluding any proceeds that may be received upon exercise of the warrants.

•In October, Bellicum implemented a restructuring program to focus on the clinical development of BPX-601 and BPX-603, reduce headcount, pause the BCMA GoCAR-NK program, and discontinue discovery research and new product development.

•In October, Bellicum repaid in full all outstanding indebtedness and terminated all commitments and obligations under its loan agreement with Oxford Finance, for a payment of $27.4 million.

Fourth Quarter 2020 Financial Results

R&D Expenses: Research and development expenses were $8.7 million and $39.1 million for the fourth quarter and year ended December 31, 2020, respectively, compared to $13.3 million and $64.5 million during the comparable periods in 2019. The reduction in expenses in the fourth quarter resulted primarily from reduced expenses related to reduced rivo-cel related activities, reduced expenses resulting from Bellicum’s sale of its manufacturing facility and the corporate restructuring implemented during the fourth quarter of 2020, partially offset by an increase in expenses related to the GoCAR programs.

G&A Expenses: General and administrative expenses were $3.4 million and $15.5 million for the fourth quarter and year ended December 31, 2020, respectively, compared to $5.7 million and $30.0 million during the comparable periods in 2019. The reduction in expenses during the fourth quarter relative to the comparable period in 2019 was primarily due to the reduction in rivo-cel related commercialization activities as well as the effects of the corporate restructuring that reduced employee-related charges.

Loss from Operations: Bellicum reported a loss from operations of $13.0 million and $51.7 million for the fourth quarter and year ended December 31, 2020, respectively, compared to a loss from operations of $13.9 million and $87.4 million for the comparable periods in 2019.

Net Income/Loss: Bellicum reported net income of $18.8 million and a net loss $7.7 million for the fourth quarter and year ended December 31, 2020, respectively, compared to a net loss of $29.0 million and $112.5 million for the comparable periods in 2019. The results included a non-cash gain of $31.9 million and $46.1 million related to the change in fair value of the warrant and private placement option liability for the fourth quarter and year ended December 31, 2020, respectively.

Shares Outstanding: As of March 22, 2021, Bellicum had 8,318,273 shares of common stock and 452,000 shares of preferred stock outstanding. Each share of preferred stock can be converted into 10 shares of common stock. In the November 2020 financing, the company issued 1,040,000 shares of common stock and pre-funded warrants to purchase 3,109,378 shares of common stock.

Cash Position and Guidance: Bellicum reported cash and cash equivalents and restricted cash totaling $37.0 million as of December 31, 2020, compared to $93.8 million as of December 31, 2019. Based on current operating plans, Bellicum expects that current cash resources will be sufficient to meet operating requirements into the second quarter of 2022.

Conference Call and Webcast
Bellicum’s management will host a webcast and conference call today at 5 p.m. ET / 2 p.m. PT, March 30, 2021, to discuss the financial results for the fourth quarter 2020 and provide a corporate update. The live call may be accessed by dialing (877) 407-3103 for domestic callers and (201) 493-6791 for international
2

Exhibit 99.1

callers. A live webcast of the call will be available from the Investors and Media section of the company’s website at www.bellicum.com and a replay will be available shortly after the live event.

On March 30, 2021 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported financial results for the third quarter of fiscal year 2021, which ended February 28, 2021 (Press release, AngioDynamics, MAR 30, 2021, View Source [SID1234577374]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"I am pleased with our strong third quarter performance, driven by continued strength in our AngioVac and Auryon platforms. Our revenue grew 2% year over year despite continued COVID-19 headwinds, particularly in January and the first half of February. Further, we are encouraged by the recent improvements in our end markets and increasing availability of vaccines," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "We continue to execute on our strategy to drive revenue growth through our key technology platforms: Auryon, AngioVac, and NanoKnife. In addition, our balanced approach to cash and expense management continues to yield profitability on an adjusted basis while allowing us to invest in the development and progression of these key platforms. I am excited about the planned launch of our new mechanical thrombectomy device later in calendar 2021, as well as a number of other planned product improvements and clinical and regulatory pathway expansions that will open up opportunities for us in larger, higher-growth markets."

Third Quarter 2021 Financial Results

Net sales for the third quarter of fiscal 2021 were $71.2 million, an increase of 2.0% compared to the prior-year quarter. Net sales in the third quarter continued to be impacted by the disruption to procedure volumes resulting from the COVID-19 global pandemic. Foreign currency translation did not have a significant impact on the Company’s sales in the quarter.

Vascular Interventions and Therapies ("VIT") net sales were $33.3 million, an increase of 8.8%, compared to $30.6 million a year ago. Growth was driven primarily by increased sales of the Company’s Auryon and AngioVac platforms compared to the previous year. This growth was partially offset by a decline in sales of Venous products resulting from a decline in elective procedure volumes due to the ongoing COVID-19 global pandemic. Auryon sales during the quarter were $3.3 million.
Oncology net sales were $13.1 million, a decrease of 10.1% from $14.6 million in the prior-year period. The year-over-year decline was primarily attributable to lower capital sales and ongoing procedure impacts of COVID-19, particularly in international markets, partially offset by continued growth in sales of NanoKnife disposables in the United States.
Vascular Access net sales were $24.8 million, compared to $24.6 million a year ago.
U.S. net sales in the third quarter of fiscal 2021 were $58.7 million, an increase of 6.9% from $54.9 million a year ago. International net sales were $12.5 million in the third quarter of fiscal 2021 compared to $14.9 million a year ago.

Gross margin for the third quarter of fiscal 2021 was 54.1%, a decline of 370 basis points compared to the third quarter of fiscal 2020. Consistent with the first half of the year, the year-over-year decline in gross margin was primarily due to Auryon start-up costs and the Company’s previously discussed COVID-related operating plan, including under-absorption of the Company’s manufacturing facilities attributable to additional operating protocols designed to secure the supply-chain and prioritize employee safety. In addition, gross margin was negatively impacted by staffing challenges in the Company’s upstate New York manufacturing facility. During the third quarter, inventory was reduced by $0.6 million when compared to inventory levels on November 30, 2020. During the fiscal year, inventory levels have been reduced by $10.9 million.

The Company recorded a net loss of $3.5 million, or loss per share of $0.09, in the third quarter of fiscal 2021. This compares to a net loss of $5.7 million, or loss per share of $0.15, a year ago.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income for the third quarter of fiscal 2021 was $0.7 million, and adjusted earnings per share was $0.02, compared to adjusted net income in the prior-year period of $0.4 million and adjusted earnings per share of $0.01. Adjusted net income and adjusted earnings per share in the third quarter of fiscal 2021 includes a $1.9 million, and $0.04 per share benefit, respectively, related to the reimbursement of certain expenses under the CARES Act.

Adjusted EBITDA in the third quarter of fiscal 2021, excluding the items shown in the reconciliation table below, was $5.4 million, compared to $3.8 million in the third quarter of fiscal 2020.

In the third quarter of fiscal 2021, the Company generated $5.9 million in operating cash and had capital expenditures of $1.4 million. As of February 28, 2021, the Company had $54.5 million in cash and cash equivalents compared to $58.0 million in cash and cash equivalents on November 30, 2020. The Company reduced its debt outstanding under its revolving credit facility at February 28, 2021, to $30.0 million compared to $40.0 million at November 30, 2020. Subsequent to the end of the third fiscal quarter, the Company further reduced debt outstanding under the revolving credit facility to $20 million. Management remains focused on cash preservation and expense management amid the current environment.

Nine Months Financial Results

For the nine months ended February 28, 2021:

Net sales were $214.2 million, an increase of 4.1%, compared to $205.8 million for the same period a year ago.
The Company’s net loss was $12.1 million, or a loss of $0.32 per share, compared to a net loss of $9.7 million, or a loss of $0.26 per share, a year ago.
Gross margin decreased 490 basis points to 53.4% from 58.3% a year ago due to the Company’s COVID-related operating plan and Auryon start-up costs.
Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income was $1.9 million, with adjusted earnings per share of $0.05, compared to adjusted net income and adjusted earnings per share of $5.7 million, and $0.15, respectively, a year ago.
Adjusted EBITDA, excluding the items shown in the reconciliation table below, was $15.0 million, compared to $17.5 million for the same period a year ago.
Fiscal Year 2021 Financial Guidance

The Company is increasing its guidance for fiscal year 2021. Management now projects net sales between $285 and $288 million and fiscal year 2021 adjusted earnings per share between $0.04 and $0.06, compared to previous projections of net sales between $278 and $284 million and adjusted earnings per share between $0.00 and $0.05.

Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its fiscal 2021 third quarter results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13717367.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Tuesday, March 30, 2021, until 11:59 p.m. ET on Tuesday, April 6, 2021. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13717367.

Use of Non-GAAP Measures

Management uses non-GAAP measures to establish operational goals and believes that non-GAAP measures may assist investors in analyzing the underlying trends in AngioDynamics’ business over time. Investors should consider these non-GAAP measures in addition to, not as a substitute for or as superior to, financial reporting measures prepared in accordance with GAAP. In this news release, AngioDynamics has reported adjusted EBITDA, adjusted net income, adjusted earnings per share, and free cash flow. Management uses these measures in its internal analysis and review of operational performance. Management believes that these measures provide investors with useful information in comparing AngioDynamics’ performance over different periods. By using these non-GAAP measures, management believes that investors get a better picture of the performance of AngioDynamics’ underlying business. Management encourages investors to review AngioDynamics’ financial results prepared in accordance with GAAP to understand AngioDynamics’ performance taking into account all relevant factors, including those that may only occur from time to time but have a material impact on AngioDynamics’ financial results. Please see the tables that follow for a reconciliation of non-GAAP measures to measures prepared in accordance with GAAP.

On March 30, 2021 Applied BioMath (www.appliedbiomath.com), the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, reported a collaboration with Asher Biotherapeutics for systems pharmacology modeling in solid tumors (Press release, Applied BioMath, MAR 30, 2021, View Source [SID1234577390]). "We have experience that development of a biotherapeutic has the best chance of success when the R&D process is supported by mathematical modeling," said Lioudmila Tchistiakova, Entrepreneur in Residence at Third Rock Ventures. "We have chosen to collaborate with Applied BioMath given their proven track record in this space," said Ivana Djuretic, PhD, Chief Scientific Officer of Asher Biotherapeutics. "This collaboration will enable us to confidently predict pharmacokinetics, receptor occupancy, and pharmacodynamics of our lead molecule."

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Applied BioMath employs a rigorous fit-for-purpose model development process which quantitatively integrates knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms. Their approach employs proprietary algorithms and software that were designed specifically for systems pharmacology model development, simulation, and analysis. "Systems pharmacology modeling’s impact is extremely effective when leveraged early on in the R&D process," said Dr. John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath. "Incorporating modeling early on helps the project team gain thorough understanding of their lead molecule which in turn helps increase the likelihood of success in the clinic."

On March 30, 2021 Immunovia reported improved performance of its blood based IMMray PanCan-d biomarker signature together with CA 19-9, in a clinical retrospective study (Press release, Immunovia, MAR 30, 2021, View Source [SID1234577294]). The study was designed to evaluate detection of early stage pancreatic cancer in high risk patients with non-specific but concerning symptoms. The study data demonstrate that Immunovia’s test now detects pancreatic cancers (all stages) with 92% specificity and 81% sensitivity for this cohort, which is equivalent to results presented in the previous Commercial Test Model Study (link to PR). Importantly, early stage PDAC I/II were detected with specificity of 92% and sensitivity of 80%. The improved test performance was demonstrated in a combined samples cohort of newly collected samples and samples from the Clinical Verification study. In total 433 samples of which 202 were PDACs whereof 89 PDAC stage I/II and 231 symptomatic controls were analyzed. These samples have been freshly collected from 7 sites in the US and Europe: Beth Israel Deaconess Medical Center, University of Pittsburgh Medical Center, Pancreatic Cancer Center at NYU Langone’s Perlmutter Cancer Center in the US; University College London in the UK; Sahlgrenska University Hospital in Sweden; and University Hospital Erlangen in Germany; and Ramón y Cajal University Hospital, IRYCIS, CIBERONC in Spain.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Linda Mellby, PhD, VP R&D Immunovia commented: "Detecting pancreatic cancer as early as possible in high risk symptomatic patients is a challenging but extremely important achievement that will support clinicians in providing accelerated and correct diagnosis to the patients. We are very excited to report 92% specificity and 80 % sensitivity for detecting early stage pancreatic cancer in this risk group of patients."

Patrik Dahlen, CEO, Immunovia added: " These results demonstrate great performance for detection of early stage pancreatic cancer in symptomatic cohorts, and they further confirm the commercialization strategy for this important risk group of patients. The market size for the symptomatic risk group is 1-2 million patients in USA and Europe. Our test is designed to help clinicians find the cancer at a treatable stage and thus help the patients live longer."

Webcasted teleconference

These results will be presented Tuesday March 30, 2021, in a webcasted teleconference at 16.30 (CET).

Presenters: Thomas King, MD, PhD, Linda Mellby, PhD, Patrik Dahlen CEO, Immunovia

The presentations will be followed by a Q&A session. The webcasted teleconference will be held in English.