1stOncology™: Cancer Intelligence Service – Page 6082 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

CORRECTION: Athenex to Provide Corporate and Financial Update for the Fourth Quarter and Full Year 2021, on March 16, 2022

On March 14, 2022 Athenex (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that the Company will provide a corporate and financial update for the fourth quarter and full year 2021, on Wednesday, March 16, 2022 (Press release, Athenex, MAR 14, 2022, View Source [SID1234610042]). Athenex’s management team will host a conference call and live audio webcast at 4:30 p.m. Eastern Time.

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!

Please note the call is being rescheduled from the previously announced date of March 15 at 8:00 a.m. Eastern Time.

To participate in the call, dial either the domestic or international number fifteen minutes before the conference call begins:

The live conference call and replay can also be accessed via audio webcast here and on the Investor Relations section of the Company’s website under "Events and Presentations", located at View Source

Biogen and Eisai amend collaboration agreements on Alzheimer’s disease treatments

On March 14, 2022 Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) reported that the companies have amended their existing collaboration agreement on aducanumab, which is commercialized in the United States as ADUHELM (aducanumab-avwa). Effective as of January 1, 2023, Eisai will receive a tiered royalty based on net sales of ADUHELM rather than sharing global profits and losses (Press release, Eisai, MAR 14, 2022, View Source [SID1234610041]). The royalty rate starts at 2% and reaches 8% when annual sales exceed $1 billion. Effective immediately Biogen’s existing final decision-making rights on ADUHELM have converted to sole decision making and commercialization rights worldwide. Overall, economic arrangements for both companies in 2022 are expected to remain materially unchanged with Eisai’s share of expenses capped at an agreed amount for the costs related to development, commercialization and manufacturing of ADUHELM for the period from January 1, 2022, to December 31, 2022. Once the tiered royalty model commences on January 1, 2023, Eisai will not participate in ADUHELM’s economics beyond these royalties.

The companies will continue to jointly develop and commercialize the investigational therapy lecanemab. Eisai continues to serve as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product, and Eisai having final decision-making authority. Both companies share economics equally with Eisai booking all sales for lecanemab and Biogen reflecting its 50% share of profits and losses. The supply agreement related to lecanemab has been extended from five to 10 years. Biogen will manufacture the lecanemab drug substance in its Solothurn, Switzerland facility with the goal of providing reliable commercial supply worldwide.

"This amended collaboration agreement will increase operational efficiency and agility in addressing market developments, including the final determination of CMS on coverage of ADUHELM," said Michel Vounatsos, Chief Executive Officer at Biogen. "In addition we are pleased to be expanding our agreement with Eisai through a new long-term manufacturing contract."

"The collaboration between both companies has resulted in the approval of ADUHELM in the U.S. as the first treatment to address a defining pathology of Alzheimer’s disease, which is a significant step into a new chapter of Alzheimer’s therapy." said Haruo Naito, Chief Executive Officer at Eisai Co., Ltd. "We believe this new arrangement will be more effective and enable more focused execution with the goal of maximizing the value of both ADUHELM and lecanemab. Eisai will increase its focus on lecanemab and remains committed to bringing a new treatment option expeditiously to patients in need worldwide."

Results for the 12- and 18-month periods ended 31 December 2021

On March 14, 2022 Abcam plc (Nasdaq: ABCM; AIM: ABC) (‘Abcam’, the ‘Group’ or the ‘Company’), a global leader in the supply of life science research tools, reported its final results for the 18-month period ended 31 December 2021 (the ‘period’) (Press release, Abcam, MAR 14, 2022, View Source [SID1234610040]). The Group’s accounting reference date changed from 30 June to 31 December during the year1, therefore these financial statements report on both a 12-and 18-month period.

Excludes the amortisation of the fair value of assets relating to the inventory acquired in connection with the acquisition of BioVision.

** Adjusted figures exclude impairment of intangible assets, systems and process improvement costs, acquisition costs, amortisation of fair value adjustments, integration and reorganisation costs, amortisation of acquisition intangibles, share-based payments and employer tax contributions thereon, the tax effect of adjusting items and credits from patent box claims. Such excluded items are described as ‘adjusting items’. Further information on these items is shown in note 4 to the consolidated financial statements.

*** In previous reporting periods, share-based payments have not been included within adjusting items. With the approval of the Profitable Growth Incentive Plan (‘PGIP’) during CY2021, management considers it to be more appropriate and more consistent with its closest comparable companies to include all share-based payments in adjusting items. To aid comparison with our previous presentation of results, we have included the adjusted operating margin in the table above on a like-for-like basis, excluding this change (‘Like-for-like’).

**** Net Cash comprises cash and cash equivalents less borrowings.

CY2021 FINANCIAL HIGHLIGHTS1,2

• Revenue growth of +22% (+17% reported) at constant exchange rates, compared to CY2020, including a 1%pt contribution from the acquisition of BioVision o +38% total in-house CER revenue growth (including Custom Products & Licensing3 and £2.6m of incremental revenue from BioVision) (+32% reported) o Revenue from in-house products and services contributed 61% of total revenue (including Custom Products & Licensing3 and £2.6m of incremental revenue from BioVision)
• Adjusted2 gross margin increased by over 200 basis points to 72.2% (CY2020: 70.0%), benefiting from the contribution of higher margin in-house products and volume leverage resulting from the increase in revenue
• Adjusted2 operating profit of £60.4m (excluding share-based payments), equating to an adjusted operating margin of 19.2% (CY2020: 18.8%)
• Adjusted2 operating margin on a like-for-like4 basis improved over 300 basis points to 16.5% in H2 ’21 (JulDec), from 13.3% in H1 ’21 (Jan-Jun)
• Statutory reported operating profit inc
• Net cash inflow from operating activities increased to £62.9m (CY2020: £58.9m)

BUSINESS HIGHLIGHTS
• Focus on serving customers’ needs globally as research activity levels continued to normalise and demand for Abcam products increased
• Positive customer transactional Net Promotor Score (‘tNPS’) of +56 (CY2021) and product satisfaction rates at all-time highs
• Completed the acquisition of BioVision, Inc (‘BioVision’), a leading innovator of biochemical and cell-based assays, in October 2021, for cash consideration of $340m (on a cash free, debt free basis)
• High employee engagement, with the business ranked in the Top 5 in the Glassdoor UK Employees’ Choice Awards in January 2022, for the second year running
• Strengthened and expanded leadership in commercial and operational teams with senior hires in Commercial, Brand, China, and Supply Chain
• Expanded the Group’s global presence, with the opening of new and enlarged sites in China, the US (Massachusetts, California, Oregon), Singapore, and Australia
• Upgraded supply chain systems at three locations, implemented new data architecture, and began transition to a new e-commerce platform, with completion of the digital transformation due in 2022
• Completed the secondary US listing on Nasdaq’s Global Market in October 2020 (supplementing existing listing on AIM on the London Stock Exchange)
• Expanded Asia, digital, and life science industry experience on the Board of Directors, with the appointments of Bessie Lee, Mark Capone and Sally Crawford, as Non-Executive Directors

SHARE TRADING, LIQUIDITY AND LISTING
• Following our listing on Nasdaq in October 2020, the number of Abcam shares traded as ADSs on Nasdaq has doubled. While only 10% of our shares trade in the US market, it represents 25% of liquidity
• The Board continues to review options to increase share liquidity and intends to consult with shareholders on these options in due course

CY2022 GUIDANCE
• Global lab activity continues to recover, though some uncertainty remains
• CY2022 trading performance YTD is in line with our expectations
• Expect total CER5 revenue growth of c.20% (including BioVision) with mid-teens organic CER revenue growth
• Expect continued adjusted gross margin improvement from the contribution of higher margin in-house products and full year impact of the BioVision acquisition
• Expect total adjusted operating cost growth (including depreciation and amortisation) at mid-teens percentage, as we slow rate of investment and leverage recent investments

LONG TERM GOALS TO CY2024
• CY2024 revenue goal target range increased by £25m to £450m-£525m, adjusted to incorporate BioVision6 and current operating performance
• Adjusted operating margin and ROCE targets remain unchanged Commenting on today’s results, Alan Hirzel, Abcam’s Chief Executive Officer, said: "I am grateful to everyone at Abcam for their dedicated effort through this most challenging time and thank our customers and partners for their ongoing trust and support. We have had another successful year operationally and financially despite the ongoing challenges. As we look ahead to 2022, we expect to create more innovation and success out of the past two years of investment as we installed elements of Abcam’s long term growth strategy.

The scientific community remains our guide and with their support we are becoming a more influential and trusted brand globally." Analyst and investor meeting and webcast: Abcam will host a conference call and webcast for analysts and investors today at 13:00 GMT/ 09:00 EDT. For details, and to register, please visit corporate.abcam.com/investors/reports-presentations A recording of the webcast will be made available on Abcam’s website, corporate.abcam.com/investors

2. These results include discussion of alternative performance measures which include revenues calculated at Constant Exchange Rates (CER) and adjusted financial measures. CER results are calculated by applying prior period’s actual exchange rates to this period’s results. Adjusted financial measures are explained in note 2 and reconciled to the most directly comparable measure prepared in accordance with IFRS in note 4 to the interim financial statements.

3. Custom Products & Licensing (CP&L) revenue comprises custom service revenue, revenue from the supply of IVD products and royalty and licence income.

4. In previous reporting periods, share-based payments have not been included within adjusting items. With the approval of the Profitable Growth Incentive Plan (‘PGIP’) during CY2021, management considers it to be more appropriate and more consistent with its closest comparable companies to include all share-based payments in adjusting items. To aid comparison with our previous presentation of results, we also calculate adjusted operating margin on a like-for-like basis, excluding this change (‘Like-for-like’).

5. Average CY2021 exchange rates to GBP as follows: USD: 1.378; EUR: 1.159, RMB: 8.891, JPY: 150.7 6. Last 12-month BioVision recurring revenues of £17.8m at point of acquisition, adjusted for non-recurring COVID-19 related revenues, and sales to Abcam during that period. The information communicated in this announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No. 596/2014. This announcement shall not constitute an offer to sell or solicitation of an offer to buy any securities. This announcement is not an offer of securities for sale in the United States, and the securities referred to herein may not be offered or sold in the United States absent registration except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the U.S. Securities Act of 1933, as amended. Any public offering of such securities to be made in the United States will be made by means of a prospectus that may be obtained from the issuer, which would contain detailed information about the company and management, as well as financial statements.

Genocea to Present at the 32nd Annual Oppenheimer Healthcare Conference

On March 14, 2022 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported that Chip Clark, President and Chief Executive Officer, will present a corporate overview at the 32nd Annual Oppenheimer Healthcare Conference on Thursday, March 17th at 8:40 A.M. ET (Press release, Genocea Biosciences, MAR 14, 2022, View Source [SID1234610039]).

A live webcast of the presentation will be available under the "Events and Presentations" tab of the investor relations section of the Genocea website at View Source A replay of the webcast will be archived for 90 days following the presentation.

DiaMedica Therapeutics Provides a Business Update and Announces Fourth Quarter 2021 Financial Results

On March 14, 2022 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, reported a business update and released financial results for the year ended December 31, 2021 (Press release, DiaMedica, MAR 14, 2022, View Source [SID1234610038]). Management will host a conference call Tuesday, March 15, 2022, at 8:00AM Eastern Time / 7:00AM Central Time, to discuss its business update and full year financial results.

"Our clinical, regulatory, financial and team building achievements in 2021 have laid a solid foundation for success," said Rick Pauls, CEO of DiaMedica. "In 2022, our team is focused on executing on our Phase 2/3 ReMEDy2 trial of DM199 in acute ischemic stroke to reach the blinded interim analysis in 2023."

Pivotal Phase 2/3 ReMEDy Trial of DM199 for Acute Ischemic Stroke Initiated & Building Out Hospital Study Site Network

The Phase 2/3 ReMEDy2 trial is a randomized, double-blind, placebo-controlled Phase 2/3 adaptive trial designed to enroll 350 patients at approximately 75 sites in the United States. Patients enrolled in the study will be treated with either DM199 or placebo within 24 hours of the onset of acute ischemic stroke (AIS) symptoms. The study excludes patients treated with tissue plasminogen activator (tPA) and those with large vessel occlusions. The study population is representative of the approximately 80% of AIS patients who do not have treatment options today, primarily due to the short treatment window of up to 4.5 hours from symptom onset required for administration of tPA.

The ReMEDy2 trial will evaluate the effects of DM199 on both stroke recoveries post AIS, as measured by the well-established modified Rankin Scale (mRS), and the incidence of AIS recurrence at day 90 as two separate, independent, primary endpoints, with each statistically powered for success. 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. DiaMedica is actively working to open study sites.

DiaMedica Participates in International Stroke Conference and Received Strong Endorsement From Neurologists

The Company recently exhibited at the American Heart Association’s 2022 International Stroke Conference in New Orleans, LA. DiaMedica presented two abstracts at the conference highlighting the beneficial effects of DM199 on stroke recurrence in the Company’s ReMEDy1 Phase 2 trial as well as the design of the Company’s current pivotal Phase 2/3 ReMEDy2 trial of DM199 in AIS with Scott Kasner, M.D., national principal investigator for the ReMEDy2 trial. DiaMedica also had the opportunity to discuss DM199 and the ReMEDy2 trial with many of the attending neurologists DiaMedica’s Chief Medical Officer, Kirsten Gruis, M.D., commented, "We received encouraging feedback on DM199, its mechanism of improving collateral circulation, its potential benefit for AIS patients and observed safety profile. What is unique about the drug and trial design is that we plan to assess two separate clinically meaningful endpoints, stroke recoveries and prevention of ischemic stroke recurrence, across the same study population giving us potentially two separate endpoints to assess clinical benefit. We are also planning an interim analysis after 40% of patients are enrolled or approximately 140 patients have completed their 90-day follow-up period."

Addition of Chief Medical Officer and Chief Commercial Officer

DiaMedica recently announced the addition of two key senior executives to the leadership team. Dr. Kirsten Gruis, Chief Medical Officer, is a board-certified neurologist with 20 years of experience in both clinical medicine and drug development in large and small biopharmaceutical companies. Dom Cundari, Chief Commercial Officer, has over thirty years of experience launching innovative products and building and managing commercial organizations in multiple therapeutic areas at Genentech, including Activase for AIS.

Last Patient Dosed in REDUX Phase 2 CKD Basket Trial

Enrollment in the Phase 2 REDUX basket trial of DM199 in chronic kidney disease (CKD) has been completed as of December 31, 2021. DM199 continues to be generally safe and well tolerated in CKD patients.

The Company expects that the final data will be consistent with the interim data from REDUX which was presented at the American Society of Nephrology’s annual Kidney Week meeting in November 2021. Noting that the overall and individual sample sizes are small, the IgA Nephropathy (IgAN) cohort demonstrated a statistically significant geometric mean reduction of 34% in albuminuria in participants with moderate to severe baseline albuminuria. The trial also demonstrated early signals of potential disease modification with the APRIL and IgA1 biomarkers decreasing 35% and 22%, respectively, in all participants, regardless of baseline albuminuria. The hypertensive African American cohort, demonstrated a clinically meaningful geometric mean reduction of over 50% in the patients with moderate to severe baseline albuminuria and large reductions in systolic/diastolic blood pressure levels of -19/-13 mmHg at the 2 µg/kg dose level.

CKD represents an attractive development opportunity for DM199 and the Company is evaluating next steps for this program.

Financial Results

Research and development (R&D) expenses increased slightly to $8.8 million for the year ended December 31, 2021, up from $8.2 million in the prior year. This increase was primarily due to a combination of costs incurred for the Company’s pivotal Phase 2/3 ReMEDy2 trial and increased personnel costs associated with adding staff to support R&D operations. This increase was partially offset by decreased costs incurred for the Company’s earlier ReMEDy1 Phase 2 acute ischemic stroke trial, which completed during 2020, and decreased costs for the REDUX trial, as the number of enrollments in the REDUX trial declined throughout 2021 as the study neared completion.

General and administrative (G&A) expenses were $4.9 million and $4.5 million for the years ended December 31, 2021 and 2020, respectively. This increase was due to a number of factors, including increased costs associated with professional services, the payment to Catalent of a milestone obligation under a technology license agreement with Catalent, increased directors and officers liability insurance costs and increased personnel costs to support the Company’s expanding clinical programs. These increases were partially offset by reduced non-cash, share-based compensation costs.

Balance Sheet and Cash Flow

As of December 31, 2021, DiaMedica had cash, cash equivalents and marketable securities of $45.1 million, working capital of $43.9 million and shareholders’ equity of $44.0 million, compared to $27.5 million in cash, cash equivalents and marketable securities, $25.9 million in working capital and shareholders’ equity of $26.0 million as of December 31, 2020. The increases in combined cash, cash equivalents and marketable securities and in working capital are due primarily to the net proceeds from the Company’s September 2021 private placement, partially offset by cash used in operating activities during 2021.

Net cash used in operating activities for the year ended December 31, 2021 was $12.3 million compared to $9.2 million for the year ended December 31, 2020. This increase relates primarily to the increase in the net loss, partially offset by non-cash share-based compensation and the effects of the changes in operating assets and liabilities.

Conference Call and Webcast Information

DiaMedica Management will host a conference call and webcast to discuss its business update and 2021 financial results on Tuesday, March 15, 2021, 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 March 22, 2022, by dialing (800) 770-2030 (US Toll Free) and entering the replay passcode: 4814247.

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 FDA granted Fast Track Designation to DM199 for the treatment of acute ischemic stroke.