Claudin18.2 CAR T Cells (CT041) Receives Approval to Initiate A Confirmatory Phase II Clinical Trial for advanced GC/GEJ in China

On March 3, 2022 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T cell therapies for the treatment of hematologic malignancies and solid tumors, reported that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China has approved the initiation of the CT041 confirmatory Phase II clinical trial for the treatment of patients with Claudin18.2 (CLDN18.2) positive advanced gastric /gastroesophageal junction cancer (GC/GEJ) who have failed at least 2 prior lines of systemic therapies (Press release, Carsgen Therapeutics, MAR 3, 2022, View Source [SID1234609496]). The trial aims to evaluate the efficacy and safety of CT041 for the treatment of advanced GC/GEJ.

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As of this announcement, CT041 is the world’s first and only CAR T-cell product candidate entering a confirmatory Phase II clinical trial for the treatment of solid tumors.

Professor Lin Shen M.D., Vice President of Peking University Cancer Hospital, Director of Department of Gastrointestinal Oncology, Director of Phase I Clinical Study Ward and Deputy Director of Beijing Institute for Cancer Research, the principal investigator, commented that, "Gastric cancer is one of the most common and deadly cancers in China, with an annual incidence about 500,000. However, the treatment options for gastric cancer patients who have failed at least two prior lines are very limited. The median progression-free survival (mPFS) of available therapies, including anti-PD-1 monoclonal antibody, is merely about two months[1], indicating an urgent unmet medical need for more innovative and effective drugs. In the early study of CT041 led by our center, as presented in the ESMO (Free ESMO Whitepaper) 2021, the mPFS of CT041 was over 5 months, which is very promising data. We are eager to start the study and will try our best to develop effective cellular therapies for cancer patients."

Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics Holdings Limited, commented that, "I would like to thank all the investigators and patients for their efforts in the clinical trials of CT041. With the approval of CT041 to initiate the confirmatory Phase II clinical trial of gastric cancer, we are one step further to successfully obtain the CT041 marketing authorization. With our continuous research and development, we believe that CT041 has a great potential to change the treatment paradigm for advanced gastric cancer worldwide."

About CT041

CT041 is an autologous CAR T-cell product candidate against the protein CLDN18.2 that has the potential to be the first-in-class globally. CT041 targets the treatment of CLDN18.2 positive solid tumors with a primary focus on GC/GEJ and pancreatic cancer (PC). CT041 has demonstrated promising therapeutic efficacy and favorable safety in ongoing clinical trials. CARsgen believes that CT041 has the potential to become a backbone therapy for GC/GEJ and PC and benefit a large population of patients worldwide.

As of the date of this announcement, CT041 is the only CLDN18.2-targeted CAR T-cell product candidate that is being studied in clinical trials with IND approvals from the FDA and the NMPA and CTA approval from Health Canada. In addition to the investigator-initiated trials in China, CARsgen has initiated a Phase Ib clinical trial for advanced GC/GEJ and PC in China and a Phase 1b clinical trial for advanced gastric or pancreatic adenocarcinoma in North America. In 2020 and 2021, CT041 received Orphan Drug designation from the FDA for the treatment of GC/GEJ and Orphan Medicinal Product designation from the EMA for the treatment of advanced GC. In November 2021, CT041 was granted PRIME Eligibility by the EMA for the treatment of advanced GC. In January 2022, CT041 was granted Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of advanced GC/GEJ with CLDN18.2 positive tumor. CARsgen intends to conduct a pivotal Phase 2 clinical trial in North America in 2022.

Citius Pharmaceuticals, Inc. to Present at Upcoming March 2022 Conferences

On March 3, 2022 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products with a focus on oncology, anti-infective products in adjunct cancer care, unique prescription products, and stem cell therapies, reported that it will be presenting at two investor conferences in March 2022 (Press release, Citius Pharmaceuticals, MAR 3, 2022, View Source [SID1234609495]).

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Leonard Mazur, Executive Chairman of Citius, will discuss recent business developments and upcoming milestones. Registered participants will be able to view an on-demand corporate presentation through the conference websites and access an archived webcast of the presentations following each conference under "Events" in the Investors section of the Citius website.

34th Annual ROTH Conference

Date:

March 13-15, 2022

Location:

Ritz-Carlton, Laguna Niguel in Dana Point, California

Event website:

Conference registration

Interested parties may schedule 1-on-1 meetings with Citius management by registering through the event platform or contacting the Company’s investor relations team.

Maxim’s 2022 Virtual Growth Conference

Date:

March 28-30, 2022

Location:

Virtual

Event website:

Conference registration

Archived webcasts of the presentations will be accessible under "Events" in the Investors section of the Citius website

Curaleaf Reports Fourth Quarter and Fiscal Year End 2021 Results

On March 3, 2022 Curaleaf Holdings, Inc. (CSE: CURA) (OTCQX: CURLF) ("Curaleaf" or the "Company"), a leading international provider of consumer products in cannabis, reported its financial and operating results for the fourth quarter and year ended December 31, 2021 (Press release, Curaleaf Holdings, MAR 3, 2022, View Source [SID1234609494]). All financial information is provided in U.S. dollars unless otherwise indicated.

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A webcast of the call can be accessed on the investor relations section of the Curaleaf website at ir.curaleaf.com
The teleconference will be available for replay starting at approximately 7:00 P.M. ET on March 3, 2022, and will end at 7:00 P.M. ET on March 10, 2022

Boris Jordan, Executive Chairman of Curaleaf, commented, "2021 was another exceptional year for Curaleaf. We reached a significant milestone by generating over 90% revenue growth and exceeding $1.2 billion of total revenue for the first time. We continued to deliver gross and Adjusted EBITDA margin expansion and ended the year with one of the strongest balance sheets in the industry to support our ongoing growth strategies. In addition, we announced strategic acquisitions that have strengthened our ability to continue gaining share in key U.S. markets as well as internationally. Looking to 2022, we remain focused on executing our plan for strong, above market revenue growth and margin accretion, and believe we are incredibly well positioned to benefit from significant near-term catalysts such as the anticipated launch of New Jersey’s adult use market."

Joe Bayern, Chief Executive Officer of Curaleaf, stated, "In 2021, we made significant progress strengthening all areas of our business including growing our retail and wholesale distribution, introducing new products, expanding our cultivation and production capacity, and entering new markets such as Europe. I believe our focus and strong execution in 2021 set us up extraordinarily well for the significant growth opportunities that lie ahead in 2022 and beyond. I am incredibly proud of the hard work and dedication of all our team members who have made our continued success possible. I believe Curaleaf is better positioned than ever to capitalize on the massive and growing cannabis opportunity."

Fourth Quarter 2021 Operating Highlights

Added eight new retail dispensaries including five in Florida, two in Colorado, and one in Arizona.
Entered into a definitive agreement to acquire Tryke Companies, a vertically integrated MSO in Nevada, Arizona, and Utah.
Entered into a definitive agreement to acquire Natural Remedy Patient Center, LLC, a Safford, Arizona dispensary.
Entered into a definitive agreement to acquire Bloom Dispensaries, a single state operator in Arizona.
Completed the offering of $475 million aggregate principal amount of 8.0% Senior Secured Notes due 2026 and retired all prior indebtedness, increasing liquidity and materially reducing the average interest rate on the Company’s outstanding debt.
Signed a national distribution agreement with Southern Glazer’s Wine & Spirits to bring Curaleaf’s Hemp and Select CBD product lines into Southern Glazer’s distribution network.
Full Year 2021 Operating Highlights

Significantly expanded retail, wholesale, and cultivation operations through organic growth and strategic acquisitions.
Increased retail locations from 96 to 117 as of December 31, 2021.
Reached approximately 2,300 active wholesale accounts as of December 31, 2021, an increase of over 90% from year end 2020.
Grew cultivation sites from 23 to 25.
Expanded total cultivation and production capacity by over 2.5 million square feet to approximately 4.4 million square feet.
Significant focus on R&D activities drove the introduction of 147 new products in our markets, with approximately 11% of full year 2021 revenue generated by new products launched in the last 12 months.
Entered the European market through the successful acquisition of EMMAC Life Sciences Group and subsequently rebranded to Curaleaf International.
Completed the acquisition of Los Sueños Farms, the largest outdoor grow in Colorado.
Post Fourth Quarter 2021 Highlights

Completed the acquisition of Bloom Dispensaries adding four retail locations and two cultivation and processing facilities totaling 63,500 square feet in Arizona.
Continued to organically expand our retail footprint, opening two additional dispensaries in Florida and three in Pennsylvania. As of March 3, 2022, Curaleaf retail operations totaled 126 nationwide.

Total revenue was a record $320 million for the fourth quarter of 2021, an increase of 1% from $317 million in the third quarter of 2021 and 39% from $230 million in the fourth quarter of 2020. The Company’s year-over-year revenue growth primarily reflects continued organic growth driven by new retail store openings, the addition of new wholesale partner accounts, product launches, and the expansion of cultivation and production facilities.

Retail revenue was $226 million, compared with $225 million in the third quarter of 2021, and up 37% from $165 million in the fourth quarter of 2020. Retail revenue represented 71% of total revenue. Curaleaf’s year-over-year retail revenue growth was supported by 21 new stores added in 2021.

Wholesale revenue was $94 million, an increase of 2% from the third quarter of 2021 and 46% year-over-year and represented 29% of total revenue. Wholesale revenue growth was supported by the addition of new wholesale partner accounts, which increased by more than 90% from year-end 2020 to approximately 2,300 total accounts.

Gross profit on cannabis sales was $159 million for the fourth quarter of 2021, an increase of 10% from $144 million in the third quarter of 2021 and 45% from $110 million in the fourth quarter of 2020. Gross profit margin was 49.7%, an increase of approximately 410 basis points from the prior quarter and 190 basis points from the fourth quarter of 2020. The increase in gross margin reflects continued efficiency in the Company’s cultivation and processing facilities and improving economies of scale. In addition, the sequential increase in gross margin partially reflects a loss on inventory related to the Eureka, California facility divestiture and the write down of certain other inventory in the third quarter of 2021, which did not recur.

Net loss attributable to Curaleaf Holdings, Inc. was $28 million, compared with a net loss of $55 million in the third quarter of 2021 and $37 million in the fourth quarter of 2020. The year-over-year improvement in net loss was primarily driven by an approximately $20 million increase in operating income and $2 million of lower income tax expense, partially offset by $15 million of higher other expense, net.

Adjusted EBITDA was $80 million for the fourth quarter of 2021, an increase of 12% from $71 million in the third quarter of 2021 and 48% from $54 million in the fourth quarter of 2020. Adjusted EBITDA margin was 24.9%, an increase of 240 basis points from 22.5% in the prior quarter and 140 basis points from 23.5% in the fourth quarter of 2020. The sequential increase in Adjusted EBITDA primarily reflects higher gross profit margin driven by continued efficiency in the Company’s cultivation and processing facilities and improving economies of scale. On a year-over-year basis, the increases in Adjusted EBITDA and Adjusted EBITDA margin primarily reflect higher revenue and gross profit margin partially offset by higher SG&A expense related to increased headcount ahead of new store openings and marketing in support of new product rollouts.

Total revenue for the year ended 2021 was a record $1,210 million, an increase of 93% from $627 million for the year ended 2020.

Retail revenue was $860 million for the year ended 2021, an increase of 103% from $423 million for the year ended 2020. The increase in retail revenue was primarily driven by organic growth from new store openings, expansion of cultivation and production capacity, and new product introductions. Retail revenue growth in 2021 also reflects a full year of revenue recognized from the Company’s acquisition of GR Companies, Inc. ("Grassroots"), which closed in July 2020, and to a lesser extent, the partial year benefit of the acquisitions of EMMAC Life Sciences Limited ("EMMAC") in August 2021 and Los Sueños Farms and related entities ("Los Sueños") in October 2021.

Wholesale revenue was $347 million, an increase of 113% from $163 million for the year ended 2020. Growth in wholesale revenue was primarily due to organic growth from wholesale partner account additions, new product introductions such as Select Squeeze, Select Fresh, Clique by Select, and Select Snooze Bites, and increased cultivation and production capacity. Wholesale revenue growth also reflected the above-mentioned acquisitions of Grassroots, EMMAC and Los Sueños.

Gross profit on cannabis sales was $586 million for the year ended 2021, an increase of 113% from $275 million in 2020. Gross profit margin was 48.5% an increase of approximately 160 basis points from 46.9% in 2020. The increases in gross profit and gross margin were primarily driven by revenue growth and the continued improvement in the operating capacity and efficiency of the Company’s cultivation and processing facilities.

Net loss, attributable to Curaleaf Holdings, Inc., for the year ended 2021 was $102 million, compared with a net loss of $57 million for the year ended 2020. The $103 million increase in operating income in 2021 was offset primarily by $69 million of higher total other expense, net, and $86 million of higher income tax expense. The year-over-year increase in total other expense, net, was primarily due to an approximately $38 million gain on investment in 2020 that did not recur, $27 million of higher interest expense net of interest income, and $11 million of higher other expenses, partially offset by $9 million of lower impairment charges on intangible assets.

Adjusted EBITDA for the year ended 2021 was $298 million, an increase of 107% from $144 million in 2020. Adjusted EBITDA margin was 24.6%, an increase of 160 basis points from 23.0% in the prior year. The increases in Adjusted EBITDA and Adjusted EBITDA margin primarily reflect higher revenue and gross profit margin partially offset by higher SG&A expense related to increased headcount in support of new store openings and marketing in support of new product rollouts.

Balance Sheet and Cash Flow

As of December 31, 2021, the Company had $299 million of cash and $436 million of outstanding debt net of unamortized debt discounts.

During the fourth quarter of 2021, Curaleaf invested $55 million, net in capital expenditures, focused on cultivation, processing, and selective retail expansion in strategic markets. For the year ended 2021, Curaleaf invested $172 million, net in capital expenditures.

Shares Outstanding

As of December 31, 2021, and September 30, 2021, the Company’s weighted average subordinate voting shares outstanding amounted to 707,450,310 and 703,545,262 shares, respectively.

As of December 31, 2021, and September 30, 2021, Company’s issued and outstanding subordinate voting shares plus multiple voting shares amounted to 708,340,434 and 704,818,302 shares, respectively.

Other

The Company has made an immaterial restatement to the initial purchase accounting for the Select acquisition. Adjustments have been made to all of the comparative period financial statements presented herein, which reflect a decrease in intangible assets, deferred tax liability, and amortization expense, as well as an increase in goodwill and income tax expense, as applicable. The net impact of these adjustments on the Company’s Consolidated Statements of Profits and Losses for the year ended December 31, 2020, was a positive $4.6 million to Net loss attributable to Curaleaf Holdings, Inc. Additional detail will be provided in the Company’s Consolidated Annual Financial Statements.

Non-IFRS Financial and Performance Measures

Curaleaf reports its financial results in accordance with IFRS and uses a number of financial measures and ratios when assessing its results and measuring overall performance. Some of these financial measures and ratios are not calculated in accordance with IFRS. Curaleaf refers to certain Non-IFRS financial measures and ratios such as "Gross Profit on Cannabis Sales", "Gross Margin on Cannabis Sales", "Adjusted EBITDA", and "Adjusted EBITDA Margin". These measures do not have any standardized meaning prescribed by IFRS and may not be comparable to similar measures presented by other issuers. The Company defines "Gross Profit on Cannabis Sales" as retail and wholesale revenues less cost of goods sold. "Gross Margin on Cannabis Sales" is defined by Curaleaf as gross profit on cannabis sales divided by retail and wholesale revenues. "Adjusted EBITDA" is defined by Curaleaf as earnings before interest, taxes, depreciation and amortization less share-based compensation expense and other add-backs related to business development, acquisition, financing and reorganization costs. "Adjusted EBITDA Margin" is defined by Curaleaf as Adjusted EBITDA divided by total revenue. Curaleaf considers these measures to be an important indicator of the financial strength and performance of our business. We believe the adjusted results presented provide relevant and useful information for investors because they clarify our actual operating performance, make it easier to compare our results with those of other companies and allow investors to review performance in the same way as our management. Since these measures are not calculated in accordance with IFRS, they should not be considered in isolation of, or as a substitute for, our reported results as indicators of our performance, and they may not be comparable to similarly named measures from other companies. The tables provided in this press release contained in the sections "Gross Profit on Cannabis Sales" and "Adjusted EBITDA" (pgs. 3-7) provide reconciliations of Non-IFRS measures to the most directly comparable IFRS measures.

CancerIQ Raises $14M Series B Funding to Improve Access to Innovations in Cancer Early Detection and Prevention

On March 3, 2022 CancerIQ, the platform powering early cancer detection and prevention across broad patient populations, reported it closed a $14 million Series B financing round co-led by Merck Global Health Innovation Fund (Merck GHI) and Amgen Ventures (Press release, CancerIQ, MAR 3, 2022, View Source [SID1234609493]). McKesson Ventures, OSF Ventures (the investment arm of OSF HealthCare, a current CancerIQ customer), as well as CancerIQ’s Series A lead investor, HealthX Ventures, also participated in the Series B round.

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The new funding comes one month after a report from the President’s Cancer Panel calling for "urgent and immediate action" to close gaps in cancer screening, risk assessment, and timely follow-up care — particularly among diverse, uninsured or underinsured, and rural populations.

Systemic access barriers have created stark inequality when it comes to preventive cancer care in the United States. For example, Black women are more likely to be diagnosed with advanced stages of breast cancer and 41% more likely to die of the disease than white women. These issues are compounded by the 9.5 million screenings missed during the COVID-19 pandemic, which has led to an increase in late-stage cancer diagnoses that are more costly and have a greater impact on quality of life and outcomes than early-stage diagnoses.

Two Black female co-founders are on a mission to solve this problem.

"The cancer research community has made great strides in cancer prevention and treatment," said Olufunmilayo (Funmi) Olopade, MD, Co-founder and Chief Scientific Advisor of CancerIQ. "But now we must accelerate and scale the clinical pipeline, so a diverse population of patients — those receiving care at academic medical centers and community hospitals alike — can benefit from these advances." Dr. Olopade served on the National Cancer Advisory Board and is one of the field’s foremost authorities on cancer genetics and precision oncology.

"CancerIQ’s vision is to end cancer as we know it by eliminating health disparities and democratizing access to the latest advances in cancer early detection and prevention," added Feyi Olopade Ayodele, Co-founder and CEO of CancerIQ. "We started by making genetic testing more accessible and connecting patients to the right preventive services at the right time. This latest round of funding will help CancerIQ reach more patients and connect to more innovations that promise to transform cancer from a deadly disease to a manageable condition."

CancerIQ’s precision health platform, which is being used by clinicians at more than 180 locations across the country, makes it easy to determine a patient’s individual risk of cancer based on family history, genetics, behavior, and other factors, and then connect them to the corresponding care pathways. Those pathways range from MRIs, prophylactic surgeries and vaccinations to at-home screening kits, multi-cancer early detection (MCED) tests, lifestyle interventions and other services such as clinical trials, educational materials, and social resources. CancerIQ is embedded directly into EMR workflows so clinicians in any care setting have the latest genomics research, clinical guidelines, and life sciences innovations at their fingertips.

"CancerIQ’s platform creates the critical infrastructure needed to bring cancer-focused precision health into the actual clinical workflow for every clinician, at every heath system," said Taha Jangda, General Partner, HealthX Ventures. "This enables clinicians across service lines to perform cancer risk stratification much sooner in the care journey, and to steer patients down a precision pathway to prevention and early detection. This is needed now more than ever given the backlog of cancer screenings from the pandemic."

The new funding will help CancerIQ grow its precision health platform, strengthen its partnership ecosystem, and expand its health system network. Following a recent series of key executive hires, the company also plans to hire 50 team members to meet the rising demand for more efficient and innovative cancer prevention services.

"CancerIQ is poised to address a critical need in cancer care. Through early detection and addressing health care disparities, it is possible to provide patients better access to today’s innovations" said Joel Krikston, Managing Director and Head of Strategic Innovation Alliances, Merck GHI Fund. "We are committed to partnering with innovative companies to improve the quality of health outcomes for all patients, and we look forward to furthering this mission with CancerIQ."

Known Medicine Partners with Duke University to Predict Lung Cancer Response to Drug Treatments

On March 3, 2022 Known Medicine, a rising biotechnology powerhouse aimed to discover new cancer drugs, reported a partnership with Duke University to predict drug efficacy for lung cancer patients (Press release, Duke University, MAR 3, 2022, View Source [SID1234609492]). This collaboration will enable Known Medicine to optimize and validate their novel ODINTM platform. Duke University collaborator, Kamran Mahmood, MD, MPH, is the lead collaborator on this initiative. Together, Known Medicine and Duke University aim to determine if Known Medicine’s novel platform can be used to predict actual clinical outcomes in 75 patients.

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"We are incredibly grateful for the opportunity to partner with Dr. Kamran Mahmood and the greater Duke University community. As one of the leading cancer institutes in the country, this partnership allows us to generate clinical, biological, and computational insights to improve cancer patient lives," said Andrea Mazzocchi, PhD, CEO and co-founder at Known Medicine.

"This collaboration with start-up Known Medicine will enable clinicians to provide personalized therapy to their patients. We are excited to be part of the Known Medicine community and look forward to future collaborations and projects to improve patient care and treatment for lung cancer," said Mahmood, Associate Professor of Medicine at Duke.

Known Medicine generates thousands of 3-dimensional (3D) micro-tumors from a single patient tumor or malignant pleural effusion sample. Each micro-tumor is then treated with a different drug or combination of drugs. High-content images are obtained and analyzed to observe the response to treatment and identify the best treatment for each cancer.

Known Medicine is able to take the experiment out of the patient by testing hundreds of drugs in parallel on their micro-tumor platform while observing how the patient-specific cancer cells respond. Their machine learning-based analysis relies on high-content images of these 3D micro-tumors to better understand why cells respond to one treatment over another. Functional outcomes are combined with high dimensional -omics datasets to identify the best patients for existing drugs, and the best potential new drug candidates.