On May 12, 2021 Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) reported certain differences between its financial forecast on November 5, 2020, for the fiscal year ended March 31, 2021 (April 1, 2020, to March 31, 2021) and the actual results announced today (Press release, Sysmex, MAY 12, 2021, View Source [SID1234579879]). Furthermore, at a meeting of the Managing Board on May 12, 2021, Sysmex resolved to award dividends from surplus as described below, with a record date of March 31, 2021. We intend to propose this payment of dividends from surplus at the General Meeting of Shareholders scheduled for June 25, 2021.

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1. Change from Financial Forecasts
(1) Consolidated Financial Results for Fiscal Year from April 1, 2020, to March 31, 2021

(2) Reason
Consolidated net sales fell below our previous forecast mainly due the impact of the COVID-19 pandemic, which has been more prolonged than expected and led to lower-than-expected sales in the Americas and the Asia Pacific region. On the profit front, lower sales and a deteriorating cost of sales ratio caused gross profit to fall, but selling, general and administrative expenses declined because of restrictions on activities amid the COVID-19 pandemic. As a result, operating profit, profit before tax, and profit attributable to owners of the parent exceeded our previous forecast2.

Dividend from Surplus
(1) Dividend

(2) Reason
In terms of returns to shareholders, we intend to provide a stable dividend on a continuous basis and aim for a consolidated payout ratio of 30% under our basic policy of sharing the successes of our operations in line with business performance.

In accordance with this policy, we have set the ordinary year-end dividend for the fiscal year ended March 31, 2021, at ¥36 per share. Accordingly, annual total dividends will be ¥72 and the consolidated payout ratio will be 45.4%.

On May 12, 2021 Novasep, a leading supplier of services and technologies for the life sciences industry, reported a further expansion of its Highly Potent Active Pharmaceutical Ingredients (HPAPIs) manufacturing capabilities on its Le Mans (72 – France) site (Press release, NOVASEP, MAY 12, 2021, View Source [SID1234580012]). This new step underlines customers’ confidence in Novasep’s expertise in HPAPIs & ADCs and reinforces Novasep’s position as a leading CDMO for the production of innovative and targeted molecules to treat cancer.

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This site, which has already benefitted from significant investment, continues to exhibit strong growth as a result of longstanding collaborations with major pharmaceutical companies & new partnerships with biotechnology innovators. To support this growth and sustain the increase in both clinical & commercial production capacity, Novasep is recruiting more than 30 people on this site, combined with an investment of more than €4 million.

Novasep has been a key partner to innovators in the ADC arena for more than 15 years. With a strong pipeline of customer’s clinical drug candidates leading to a number of recent ADC drug approvals, Novasep’s strategy of offering integrated development and manufacturing services for both payloads & bioconjugation is now bearing fruit. The state-of-the-art bioconjugation facility, launched in 2017 with an investment of €12 million, delivers cGMP ADC batches to customers and was successfully inspected by the ANSM (French regulatory drug authorities) in 2021. This demonstrates once again Novasep’s ability to offer flexible and reliable manufacturing solutions to oncology drug innovators, leveraging specialist technologies and expertise.

Dr. Michel Spagnol, Chairman and CEO of Novasep said "We are pleased to continue our development in strategic markets such as HPAPIs and ADCs, and to participate in the fight against cancer for the benefit of patients. Specifically, this expansion allows us to create more than 30 full-time jobs in Le Mans".

On May 12, 2021 Aptose Biosciences Inc. (Nasdaq: APTO; TSX: APS), a clinical-stage company developing highly differentiated therapeutics that target the underlying mechanisms of cancer, reported that the Aptose management team will participate in upcoming investor conferences (Press release, Aptose Biosciences, MAY 12, 2021, View Source [SID1234579766]):

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2021 RBC Capital Markets Global Healthcare Virtual Conference

Date: Wednesday, May 19, 2021
Time: 11:30 AM – 11:55 AM EDT
Format: Fireside Chat moderated by Gregory J. Renza, M.D., Equity Research – Biotechnology

Conference Information: Link
Jefferies Virtual Healthcare Conference

Date: Wednesday, June 2, 2021
Time: 2:00 PM – 2:25 PM EDT
Format: Aptose Slide Presentation and Webcast

Conference Information: Link
The Aptose management team also will be hosting 1×1 meetings during the events.

On May 12, 2021 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported financial results and business highlights for the first quarter of 2021 (Press release, Hookipa Pharma, MAY 12, 2021, View Source [SID1234579783]).

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"We had a strong start to the year as we drive our pipeline forward to deliver a new class of arenavirus-based immunotherapeutics. As we shared at AACR (Free AACR Whitepaper), one initial dose of our lead oncology candidates, HB-201 or HB-202, each induced a robust increase in antigen-specific T cells, including an increase of up to 8% of antigen-specific circulating CD8+ T cells, in people with advanced Human Papillomavirus 16-positive (HPV16+) cancers," said Joern Aldag, Chief Executive Officer at HOOKIPA. "We believe these data are impressive, and they are consistent with the pre-clinical data published in Cell Reports Medicine in March. Both data sets highlight the potential of our engineered arenavirus platform to redefine success in cancer immunotherapy. As our clinical programs progress, we’re excited about the oral abstract presentation at ASCO (Free ASCO Whitepaper) (#2502) and other future data presentations at upcoming conferences."

Program Highlights

In April 2021, HOOKIPA announced positive preliminary Phase 1 immunogenicity data for its lead oncology candidates, HB-201 and HB-202, for the treatment of advanced HPV16+ cancers, reinforcing the promising anti-tumor activity reported from the Phase 1/2 clinical trial in December 2020. The preliminary immunogenicity data demonstrated a robust increase in HPV16+-specific T cells, including an increase of up to 8% of antigen-specific circulating CD8+ T cells, after one dose of HB-201 or HB-202. Early HB-201 monotherapy data also highlighted immune system activation of increasing interferon-gamma and other immune stimulatory cytokines with a single dose. The data were presented at a late-breaker poster session at the virtual American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

In March, Cell Reports Medicine published pre-clinical data on HOOKIPA’s arenaviral therapeutics. The peer-reviewed article showed that intravenous HB-201 administration induced single digit percentage of antigen-specific CD8+ T cells, while alternating administration of HB-201 and HB-202 induced a potent CD8+ T cell response, exceeded 50% of the circulating T cell pool. The two-vector cancer therapeutic approach also resulted in tumor cures and long-term immunity in a pre-clinical setting.

HOOKIPA’s prophylactic Cytomegalovirus, or CMV, vaccine candidate, HB-101, continued to enroll patients awaiting kidney transplantation in a Phase 2 clinical trial. We expect to conclude trial enrollment in mid-2021 and to report additional safety, immunogenicity, and efficacy data from evaluable patients in the second half of 2021.
Upcoming Milestones

Oral abstract presentation at ASCO (Free ASCO Whitepaper) (#2502 at 3:00pm EDT on June 7): First report of the safety/tolerability and preliminary antitumor activity of HB-201 and HB-202, an arenavirus-based cancer immunotherapy, in patients with HPV16+ cancers
Initial HB-201/HB-202 Phase 1/2 efficacy data in HPV16+ cancers in mid-2021
Additional HB-101 CMV Phase 2 efficacy data in H2 2021
Advancing our HB-300 to IND for the treatment of metastatic prostate cancer
HBV and HIV collaboration with Gilead Sciences advancing towards clinical studies
First Quarter 2021 Financial Results

Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of March 31, 2021 was $128.1 million compared to $143.2 million as of December 31, 2020. The decrease was primarily attributable to cash used in operating activities.

Revenue was $5.3 million for the three months ended March 31, 2021, and $3.7 million for the three months ended March 31, 2020. The increase was primarily due to higher cost reimbursements received under the Collaboration Agreement with Gilead and the recognition of cost reimbursements initially recognized as deferred revenue.

Research and Development Expenses: HOOKIPA’s research and development expenses were $20.2 million for the three months ended March 31, 2021, compared to $11.5 million for the three months ended March 31, 2020.

The primary drivers of the increase in direct research expenses were an increase in clinical trial expenses of $1.5 million and an increase in manufacturing and quality control expenses of $4.6 million.

The increase was mainly due to the progress in our HB-201 and HB-202 clinical trial, the increased patient recruitment in our HB-201 and HB-202 clinical trial, monitoring and testing activities and manufacturing and quality control work in preparation of a further extension of the trial. Manufacturing and quality control expenses were also driven by the progress towards clinical development in our Gilead partnered programs. This increase in HB-201/HB-202 and Gilead related direct expenses was partially offset by a decrease in direct costs related to our HB-101 program due to slower patient recruitment as a result of the COVID pandemic.

The increase in internal research and development expenses was mainly due to an increase of personnel-related research and development expenses, resulting primarily from a higher headcount, while stock-based compensation expenses included in personnel-related research and development expenses decreased. In addition, an increase in facility related costs and an increase in other internal costs contributed to the overall increase in internal research and development expenses.

General and Administrative Expenses: General and administrative expenses for the three months ended March 31, 2021 were $4.3 million, compared to $4.6 million for the three months ended March 31, 2020. The decrease was primarily due to a decrease in personnel-related expenses, partially offset by an increase in professional and consulting fees. The decrease in personnel-related expenses resulted from decreased stock compensation expenses, partially offset by increased salaries and a growth in headcount in our general and administrative functions.

Net Loss: HOOKIPA’s net loss was $17.2 million for the three months ended March 31, 2021 compared to a net loss of $10.9 million for the three months ended March 31, 2020. This increase was due to an increase in research and development expenses, partially offset by an increase in revenues from collaboration and licensing, a decrease in general and administrative expenses, and an increase in grant income.

On May 12, 2021 Qu Biologics Inc., a private clinical stage biopharmaceutical company developing Site Specific Immunomodulators (SSIs), a novel platform of immunotherapies designed to restore innate immune function, reported that expanded its patent portfolio to include the perioperative use of Qu’s SSIs to overcome immune dysfunction in patients undergoing cancer surgery (Press release, Qu Biologics, MAY 12, 2021, View Source [SID1234579799]).

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It has long been observed that "immune paralysis" is a phenomenon that occurs following the physical stress of surgery performed for the removal of cancer. During this post-surgical period, cells of the immune system are suppressed, and this immune suppression provides a dangerous window of opportunity for any cancer cells that have been left behind to spread or metastasize unchecked. As a result, post-operative immune dysfunction can lead to cancer recurrence in cancer patients who have undergone surgery to remove their tumours. There are currently no effective treatments that prevent or relieve this post-surgical immune suppression, leaving patients vulnerable to cancer recurrence and metastasis.

The unique ability of Qu’s SSIs to simultaneously program multiple important immune cells to effectively fight malignancy was hypothesized to offer a potential solution for this critical problem. To test this hypothesis, Qu scientists worked with Dr. Rebecca Auer, a world renown surgical oncologist at the Ottawa Hospital Research Institute, whose research is focused on determining how to overcome post-surgical immune dysfunction to improve outcomes of cancer patients. Preclinical studies performed in Dr. Auer’s lab showed that perioperative administration of Qu’s lung-directed SSI preserved anti-cancer immunity and markedly reduced lung metastases in a surgical model.

Dr. Auer is enthusiastic about the prospect of leading a clinical trial to test the perioperative application of SSIs to improve cancer outcomes, "Post-surgical immune suppression continues to present a critical challenge in oncology. To date very few trials have been conducted in the perioperative period, specifically designed to alleviate this immune dysfunction, which can adversely impact outcomes for patients having undergone cancer excision surgery. Given the large number of patients who undergo surgery for cancer every year, this is a significant unmet clinical need. I am hopeful that the SSI approach can transform perioperative management of cancer patients." Immunologist Dr. Shirin Kalyan, Qu’s Vice President of Scientific Innovation, said, "We have previously shown that SSI treatment, given in the absence of surgery, overcomes cancer-induced immune suppression through innate immune training and NK cell activation, and increases susceptibility of cancer cells to be targeted by immune effector cells. The new evidence from Dr. Auer’s lab that shows perioperative SSI treatment can also serve to overcome post-surgical immune suppression is really akin to hitting two birds with one stone for cancer immunotherapy."

Dr. Hal Gunn, Qu’s CEO, said, "We are very excited about this important discovery. Since the large majority of cancer patients undergo surgery, perioperative SSI treatment has the potential to transform outcomes for cancer surgery patients. Qu looks forward to working with Dr. Auer and her colleagues in conducting a Phase 2 clinical trial to assess the unique potential of SSIs in the context cancer surgery and we welcome discussions with potential investors and licensing partners."