On November 7, 2022 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported that results for the third quarter of 2022 and first nine months of 2022, and increased the outlook for full-year 2022 (Press release, Qiagen, NOV 7, 2022, View Source [SID1234623273]).

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Net sales for Q3 2022 declined 7% (0% at constant exchange rates, CER) to $500 million from Q3 2021. Sales at CER were $533 million, ahead of the outlook for at least $510 million CER and driven by 18% CER growth in the non-COVID-19 portfolio to $417 million. COVID-19 product group sales fell 43% CER to $83 million amid reduced demand. Adjusted diluted earnings per share (EPS) were $0.53 ($0.55 CER) compared to $0.58 in Q3 2021, and ahead of the outlook for at least $0.48 CER.

QIAGEN raised its full-year 2022 outlook based on the strong results in the first nine months of the year and also to reflect the strong outlook for the fourth quarter. Net sales are now expected to be about $2.25 billion CER (prior outlook for at least $2.2 billion CER) and adjusted diluted EPS are expected to be about $2.40 CER (prior outlook for at least $2.30 CER). This update includes a reaffirmation for double-digit CER sales growth from the non-COVID product groups, which grew 14% CER in the first nine months of 2022, but for a decline in COVID-19 sales amid volatile pandemic trends. It also reflects an updated assessment of current macro-economic trends.

"QIAGEN delivered another solid performance in the third quarter of 2022, led by ongoing double-digit sales growth in our non-COVID product portfolio, a high level of profitability and strong cash flow," said Thierry Bernard, Chief Executive Officer of QIAGEN N.V. "We continue to see broad-based demand for QIAGEN’s solutions in both molecular research and clinical testing markets around the world. Our results demonstrate our focus on delivering against the targets we have set, in particular achieving another quarter of double-digit sales growth in our non-COVID portfolio. As we proactively address various macro trends, we are executing on our strategy focused on advancing our Five Pillars of Growth. QIAGEN is clearly set to finish the year with strong results in 2022, and anchored by our commitment to create value for our shareholders and other stakeholders."

Roland Sackers, Chief Financial Officer of QIAGEN N.V., said: "Our results for the third quarter exceeded the outlook for sales and adjusted EPS, and enabled QIAGEN to again raise the full-year 2022 outlook. We have been proactively addressing macro trends, such as energy sourcing and supply chain constraints to ensure QIAGEN can continue to serve the needs of customers worldwide. With our strong cash flow and healthy balance sheet, we continue to make targeted investments into key areas and review opportunities to strengthen our business portfolio while also increasing returns through our disciplined capital deployment strategy that has proven its value."

Please find a PDF of the full press release incl. tables here.

Investor presentation and conference call

A conference call is planned for Tuesday, November 8 at 15:00 Frankfurt Time / 14:00 London Time / 9:00 New York Time. A live audio webcast will be made available in the investor relations section of the QIAGEN website, and a replay will also be made available after the event. A presentation is planned to be available before the conference call at View Source

Use of adjusted results

QIAGEN reports adjusted results, as well as results on a constant exchange rate (CER) basis, and other non-U.S. GAAP figures (generally accepted accounting principles), to provide additional insight into its performance. These results include adjusted net sales, adjusted gross income, adjusted gross profit, adjusted operating income, adjusted operating expenses, adjusted operating income margin, adjusted net income, adjusted net income before taxes, adjusted diluted EPS, adjusted EBITDA, adjusted EPS, adjusted income taxes, adjusted tax rate, and free cash flow. Free cash flow is calculated by deducting capital expenditures for Property, Plant & Equipment from cash flow from operating activities. Adjusted results are non-GAAP financial measures that QIAGEN believes should be considered in addition to reported results prepared in accordance with GAAP but should not be considered as a substitute. QIAGEN believes certain items should be excluded from adjusted results when they are outside of ongoing core operations, vary significantly from period to period, or affect the comparability of results with competitors and its own prior periods. Furthermore, QIAGEN uses non-GAAP and constant currency financial measures internally in planning, forecasting and reporting, as well as to measure and compensate employees. QIAGEN also uses adjusted results when comparing current performance to historical operating results, which have consistently been presented on an adjusted basis.

On November 7, 2022 Promontory Therapeutics Inc., a clinical stage pharmaceutical company advancing small molecule immunotherapies in oncology, reported that it will present data on lead therapeutic candidate, PT-112, and its immunological effects on cancer cell mitochondria (Press release, Promontory Therapeutics, NOV 7, 2022, View Source [SID1234623272]). The presentation will take place at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). SITC (Free SITC Whitepaper) 2022 will take place virtually and in Boston on November 8-12.

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About PT-112
PT-112 is the first small-molecule conjugate of pyrophosphate in oncology, and possesses a unique pleiotropic mechanism of action that promotes immunogenic cell death (ICD), through the release of damage associated molecular patterns (DAMPs) that bind to dendritic cells and lead to downstream immune effector cell recruitment in the tumor microenvironment. PT-112 represents a highly potent inducer of this immunological form of cancer cell death. Further, PT-112 harbors a property known as osteotropism, or the propensity of the drug to reach its highest concentrations in certain areas of the bone, making it a candidate for treatment of patients with cancers that originate in, or metastasize to, the bone. The first in-human study of PT-112 demonstrated an attractive safety profile and evidence of long-lasting responses among heavily pre-treated patients and won "Best Poster" within the Developmental Therapeutics category at the ESMO (Free ESMO Whitepaper) 2018 Annual Congress. The combination Phase 1b dose escalation study of PT-112 with PD-L1 checkpoint inhibitor avelumab in solid tumors was reported in an oral presentation at the ESMO (Free ESMO Whitepaper) 2020 Virtual Congress. The Phase 1 study in patients with relapsed or refractory multiple myeloma presented at ASH (Free ASH Whitepaper) is the third completed Phase 1 study of PT-112. Monotherapy Phase 2 development is ongoing in mCRPC, and now includes the Phase 2 proof of concept study in thymic epithelial tumors under the company’s formal collaboration with the NCI. The PD-L1 combination Phase 2a study is ongoing in a dose confirmation cohort of non-small cell lung cancer (NSCLC) patients.

On November 7, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, reported upcoming poster presentations of clinical data from two Phase 2 clinical trials of PDS0101 at the 37th Annual Meeting for the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2022) being held November 8-12, 2022 in Boston (Press release, PDS Biotechnology, NOV 7, 2022, View Source [SID1234623270]). PDS0101 is PDS Biotech’s lead candidate being developed as a potential treatment for HPV-positive cancers.

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The first abstract accepted for presentation, titled, "IMMUNOCERV, an ongoing Phase II trial combining PDS0101, an HPV-specific T cell immunotherapy, with chemotherapy and radiation for treatment of locally advanced cervical cancers," highlights data from The University of Texas MD Anderson Cancer Center-led IMMUNOCERV Phase 2 clinical trial (NCT04580771). The study is investigating PDS0101 in combination with standard-of-care chemoradiotherapy (CRT) for the potential treatment of cervical cancer in patients with large tumors over 5cm in size and/or cancer that has spread to the lymph nodes (lymph node metastasis). Highlights from the study being presented at SITC (Free SITC Whitepaper) 2022 include:

17 patients have been enrolled in the trial.

8 of the 17 patients had completed a Day 170 post-treatment Positron Emission Tomography, Computed Tomography (PET CT) scan to assess the status of the cancer.

87.5% (7/8) of patients treated with the combination of PDS0101 and CRT demonstrated a complete response (CR) on Day 170 by PET CT. One patient who received 3 of the 5 scheduled doses of PDS0101 showed signs of residual disease.

In comparison, 74.1% (40/54) of locally advanced patients who received CRT alone and were monitored at The University of Texas MD Anderson Cancer Center on a prospective protocol independent of IMMUNOCERV had a CR on PET CT at Day 170.

The 1-year overall survival is 100% (8/8) in patients treated with the combination of PDS0101 and CRT.

The observed 1-year disease-free survival rate for IMMUNOCERV patients is 87.5% (7/8).

Patients treated with the combination of PDS0101 and CRT had a 71% increase in multi-cytokine-inducing (polyfunctional) killer (CD8+) T cells within the tumors from baseline to end of treatment (38% to 65%). This increase in activated T cells was not seen in patients receiving standard-of-care CRT.

Toxicity of PDS0101 was limited to low-grade local injection site reactions.

The second abstract, titled "Immune Correlates Associated with Clinical Benefit in Patients with Checkpoint Refractory HPV-Associated Malignancies Treated with Triple Combination Immunotherapy," reports data from the Phase 2 triple combination trial (NCT04287868), which is being led by the Center for Cancer Research at the National Cancer Institute (NCI), part of the National Institutes of Health. The study is investigating PDS0101 in combination with two investigational immune-modulating agents: M9241, a tumor-targeting IL-12 (immunocytokine), and bintrafusp alfa, a bifunctional checkpoint inhibitor (PD-L1/ TGF-β). The triple combination is being studied in checkpoint inhibitor (CPI)-naïve and -refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers who have failed prior therapy. For most patients who are CPI refractory, there is no effective therapy. The immune correlates before and after treatment in the CPI refractory patient population were studied. Highlights from the study being presented at SITC (Free SITC Whitepaper) 2022 include:

A more than two-fold increase in HPV16-specific T cells in the blood of 79% (11/14 tested) of the evaluated patients.

Immune responses were associated with increases in natural killer cells, soluble granzyme B (associated with active killer T cells), IFN-γ, TNF-α, etc., two weeks after the first treatment cycle thus signaling a pro-inflammatory response.

These immunogenicity findings highlight the potential role of the combination in altering immune suppressive forces, and support previously announced results documenting promising clinical outcomes in the CPI-refractory population receiving the triple combination.

"We are very pleased that research describing PDS0101’s therapeutic potential will be highlighted in two poster presentations at SITC (Free SITC Whitepaper) 2022, including encouraging preliminary efficacy results from the ongoing IMMUNOCERV Phase 2 clinical trial," said Dr. Frank Bedu-Addo, CEO of PDS Biotech. "Taken together, the data being presented at SITC (Free SITC Whitepaper) 2022 demonstrate the potential ability of PDS0101 to elicit in patients the right type and quality of therapeutic immune response. This seems to allow PDS0101 to work in combination with a variety of therapeutic agents to generate clinical responses that appear to exceed current standards of care and allow for improved outcomes in patients with HPV-positive cancers. We look forward to continued progression of our Phase 2 clinical trials evaluating the efficacy, safety and tolerability of PDS0101 in combination with other therapies."

Details of the posters being presented at SITC (Free SITC Whitepaper) 2022 are as follows:

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune and Infectimune T cell-activating technology platforms. We believe our targeted Versamune based candidates have the potential to overcome the limitations of current immunotherapy by inducing large quantities of high-quality, potent polyfunctional tumor specific CD4+ helper and CD8+ killer T cells. To date, our lead Versamune clinical candidate, PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-expressing cancers in multiple Phase 2 clinical trials. Our Infectimune based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About PDS0101
PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune platform with targeted antigens in HPV-expressing cancers. In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer, and also in second line treatment of recurrent or metastatic head and neck cancer in patients who have failed prior checkpoint inhibitor therapy. A National Cancer Institute-supported Phase 2 clinical study of PDS0101 in a triple combination therapy is also being conducted in checkpoint inhibitor refractory patients with multiple advanced HPV-associated cancers. A third Phase 2 clinical trial in first line treatment of locally advanced cervical cancer is being led by The University of Texas MD Anderson Cancer Center. A final Phase 2 clinical trial of PDS0101 monotherapy in first line treatment of newly diagnosed patients HPV16+ head and neck cancer patients is being conducted at the Mayo Clinic.

KEYTRUDA is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

On November 7, 2022 Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, reported financial results for the third quarter ended September 30, 2022 and provided a clinical update on its Phase 3 clinical program of simufilam in Alzheimer’s disease (Press release, Pain Therapeutics, NOV 7, 2022, View Source [SID1234623269]). Simufilam is Cassava Sciences’ lead drug candidate for the proposed treatment of Alzheimer’s disease.

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"The clinical development of oral simufilam for Alzheimer’s disease continues to make headway," said Remi Barbier, President & CEO. "We now have over 650 patients enrolled in our on-going Phase 3 studies of simufilam in Alzheimer’s disease, up from 150 patients approximately six months ago. We also look forward to presenting new clinical data for simufilam from two other ongoing studies in Alzheimer’s disease."

Net loss for third quarter 2022 was $20.3 million, or $0.51 per share, compared to a net loss of $9.6 million, or $0.24 per share, for the same period in 2021. Net cash used in operations was $56.2 million during the first nine months of 2022. Net cash use for operations for full-year 2022 is expected to be approximately $80 to $90 million, consistent with previous guidance. Cash and cash equivalents were $174.7 million as of September 30, 2022, with no debt.

Financial Results for Third Quarter 2022

At September 30, 2022, cash and cash equivalents were $174.7 million, with no debt.
Net loss was $20.3 million, or $0.51 per share. This compares to a net loss of $9.6 million, or $0.24 per share, for the same period in 2021. Net loss increased compared to the prior period due primarily to a significant increase in our R&D activities for a Phase 3 program of simufilam in Alzheimer’s disease.
Net cash used in operations was $56.2 million during the first nine months of 2022.
Net cash use in operations for full year 2022 is expected to be approximately $80 to $90 million, consistent with previous guidance.
Research and development (R&D) expenses were $18.5 million. This compared to $8.0 million for the same period in 2021. R&D expenses increased compared to the prior period due primarily to increased activities and expenses related to clinical and pre-clinical studies and support functions.
General and administrative (G&A) expenses were $2.8 million. This compared to $1.7 million for the same period in 2021. G&A expenses increased compared to the prior period due primarily to increased activities and expenses related to legal services as well as depreciation and amortization.
Overview of On-going Phase 3 Clinical Program
Cassava Sciences’ Phase 3 program consists of two randomized controlled trials of oral simufilam in patients with mild-to-moderate Alzheimer’s disease. The two studies are named RETHINK-ALZ and REFOCUS-ALZ. In 2021, both studies received Special Protocol Assessments (SPA) from the U.S. Food and Drug Administration.

Over 650 patients are now enrolled in our Phase 3 studies. Studies are being conducted in over 100 clinical trial sites across the U.S., Canada, Puerto Rico, South Korea and Australia.

Cassava Sciences’ RETHINK-ALZ Phase 3 study is designed to evaluate the safety and efficacy of oral simufilam 100 mg in enhancing cognition and slowing functional decline over 52 weeks. This randomized, double-blind, placebo-controlled study plans to enroll approximately 750 patients with mild-to-moderate Alzheimer’s disease. Patients are randomized (1:1) to simufilam 100 mg or matching placebo twice daily.

Cassava Sciences’ REFOCUS-ALZ Phase 3 study is designed to evaluate the safety and efficacy of oral simufilam 100 mg and 50 mg over 76 weeks. This randomized, double-blind, placebo-controlled study plans to enroll approximately 1,000 patients with mild-to-moderate Alzheimer’s disease. Patients are randomized (1:1:1) to simufilam 100 mg, 50 mg, or matching placebo twice daily.

Both of Cassava Sciences’ Phase 3 studies have the same co-primary efficacy endpoints: ADAS-Cog12 (a cognitive scale) and ADCS-ADL (a functional scale). A secondary efficacy endpoint is iADRS, a clinical tool that combines cognitive and functional scores from ADAS-Cog & ADCS-ADL.

Open-label Study – closed enrollment
In March 2020, we initiated a long-term, open-label study to evaluate simufilam, our lead drug candidate, in patients with mild-to-moderate Alzheimer’s disease. The study is intended to monitor the long-term safety and tolerability of simufilam 100 mg twice daily for 12 or more months. The open-label study has reached its final target enrollment of approximately 200 patients with Alzheimer’s disease. We expect to announce open-label study results approximately yearend 2022, consistent with our prior guidance.

Cognition Maintenance Study (CMS) – on-going
In May 2021, we initiated a Cognition Maintenance Study (CMS). This is a randomized, double-blind, placebo-controlled study of oral simufilam in patients with mild-to-moderate Alzheimer’s disease. Patients are randomized (1:1) to simufilam 100 mg or matching placebo twice daily for six months. To enroll in the CMS, patients must have previously completed 12 months or more of open-label treatment with simufilam. The CMS is designed to evaluate simufilam’s effects on in Alzheimer’s patients who continue with drug treatment versus patients who discontinue drug treatment. Over 100 patients are now enrolled in the CMS and over 65 patients have completed this study. We expect to announce CMS study results approximately Q3 2023, consistent with our prior guidance.

SavaDx – on-going
This earlier-stage program refers to the detection of Alzheimer’s disease with a simple blood test. SavaDx was initially designed as an antibody-based detection system for altered filamin A (FLNA). We are currently evaluating a new approach—based on mass spectrometry—to detect FLNA in plasma without the use of antibodies. Mass spectrometry is an analytical tool that measures the mass-to-charge ratio (m/z) of a molecule present in a sample.

About Simufilam
Simufilam (sim-uh-FILL-am) is Cassava Sciences’ proprietary, small molecule (oral) drug that restores the normal shape and function of altered filamin A (FLNA) protein in the brain. Cassava Sciences owns worldwide development and commercial rights to its research programs in Alzheimer’s disease, and related technologies, without royalty obligations to any third party.

On November 7, 2022 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported financial results and operational updates for the quarter ended September 30, 2022 (Press release, ORIC Pharmaceuticals, NOV 7, 2022, View Source [SID1234623268]).

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"We are pleased with the steady enrollment progress across our three ongoing Phase 1b studies and are looking forward to sharing initial clinical data for ORIC-533, ORIC-114 and ORIC-944 in the first half of 2023. Building on the strong enrollment in South Korea for ORIC-114, our brain penetrant EGFR/HER2 exon 20 program, we accelerated plans for the US IND filing and received clearance from the FDA during the third quarter," said Jacob M. Chacko, MD, chief executive officer. "We continue to be encouraged by data demonstrating ORIC-533, our oral small molecule inhibitor of CD73, has therapeutic potential in multiple myeloma and look forward to the presentation of ORIC-533 preclinical data at the 2022 ASH (Free ASH Whitepaper) Annual Meeting next month."

Third Quarter 2022 and Other Recent Highlights

ORIC-114 US IND Filing and FDA Clearance: ORIC continued to expand the clinical development of ORIC-114 by submitting and receiving clearance from the FDA of its US IND application in the third quarter of 2022. A Phase 1b trial with ORIC-114 as a single agent is already underway in South Korea and has been enrolling patients with advanced solid tumors with EGFR or HER2 exon 20 alterations or HER2 amplification and allows patients with CNS metastases that are either treated or untreated but asymptomatic.

ORIC-533 Preclinical Data to be Presented at the 2022 ASH (Free ASH Whitepaper) Annual Meeting: ORIC announced a preclinical poster presentation on its CD73 inhibitor in multiple myeloma will be presented at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held December 10-13, 2022, in New Orleans, LA.

Anticipated Program Milestones

ORIC anticipates the following upcoming milestones:

ORIC-533 (oral CD73 inhibitor): Initial Phase 1b data in 1H 2023
ORIC-114 (brain penetrant EGFR/HER2 exon 20 inhibitor): Initial Phase 1b data in 1H2023
ORIC-944 (allosteric PRC2 inhibitor): Initial Phase 1b data in 1H 2023
Third Quarter 2022 Financial Results

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $218.0 million as of September 30, 2022, which the company expects will fund its current operating plan into the second half of 2024.

R&D Expenses: Research and development (R&D) expenses were $14.7 million for the three months ended September 30, 2022, compared to $12.9 million for the same period in 2021. The increase was primarily driven by a net increase in external expenses related to the advancement of product candidates as well as higher personnel costs. For the nine months ended September 30, 2022, R&D expenses were $45.4 million, compared to $40.1 million for the same period of 2021. The increase was primarily driven by a net increase in external expenses related to the advancement of ORIC-533, ORIC-114, ORIC-944 and other product candidates as well as higher personnel costs, including non-cash stock-based compensation of $0.8 million.

G&A Expenses: General and administrative (G&A) expenses were $6.0 million for the three months ended September 30, 2022, compared to $5.6 million for the same period in 2021. The increase was primarily due to higher personnel costs. For the nine months ended September 30, 2022, G&A expenses were $19.3 million compared to $16.0 million for the same period of 2021. The increase was primarily due to higher personnel costs, including additional non-cash stock-based compensation of $1.1 million.

IPR&D Expenses: In-process research and development (IPR&D) expense of $5.0 million for the three and nine months ended September 30, 2022, was due to a development milestone payment made to Voronoi related to ORIC-114. There were no similar costs in 2021.