On September 11, 2019 C4 Imaging LLC is reported the first prostate cancer treatment utilizing Orion, a novel medical device that’s designed to facilitate the use of MRI in improving the accuracy of treatment (Press release, C4 IMAGING, SEP 11, 2019, View Source [SID1234539450]). The procedure was performed by Dr Peter Rossi at the Calaway Young Cancer Center in Glenwood Springs, Colorado.

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"We are thrilled to be first to use Orion HDR MRI Markers in the treatment of a prostate cancer patient," said Peter Rossi MD. "This kind of state-of-the-art care benefits our patients by supporting a treatment plan that is tailored to their individual anatomy. Effective treatment that minimizes the possibility of side effects is key as we approach the care of our patients. We are proud to be a leader in adopting this kind of advanced treatment," Dr. Rossi added.

High Dose Rate (HDR) brachytherapy is a form of radiotherapy and a standard option for the curative treatment of many forms of cancer. It involves temporarily placing an applicator into the patient and then using medical imaging to identify the location in relation to the cancer and surrounding healthy tissue. A radioactive source is placed inside the applicator and irradiates the cancer before being removed. The popularity of HDR has increased in recent years due to its effectiveness and convenience.

The precise positioning of HDR applicators prior to treatment is critical for accurate delivery of therapy. Currently, this placement is usually guided by computed tomography (CT) imaging of metal wires that are temporarily placed inside the applicator. MRI can provide more anatomical detail than CT. The Orion HDR Marker creates a well-defined, positive MRI signal and allows the superior anatomical imaging properties of MRI to be effectively utilized when planning treatment, offering the potential for effective treatment that minimizes the possibility of side effects.

Andrew Bright, President and CEO of C4 Imaging commented, "We’re excited that Dr. Rossi, a nationally recognized leader in brachytherapy, has chosen to adopt Orion to further improve on his ability to provide highly personalized patient care. The Calaway Young Cancer Center exemplifies how cutting-edge technology can be delivered at a regional center of excellence." He added, "We’d also like to acknowledge our commercial partner Theragenics, who, as a longtime leader in serving the brachytherapy community, were instrumental in introducing Dr Rossi and his team to the benefits of Orion."

On September 11, 2019 Heska Corporation (Nasdaq: HSKA; "Heska" or the "Company"), a provider of advanced veterinary diagnostic and specialty healthcare products, reported that it proposes to offer $75.0 million aggregate principal amount of convertible senior notes due 2026, subject to market conditions and other factors (Press release, Heska, SEP 11, 2019, View Source [SID1234539449]). The notes are to be sold only to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. Prior to the close of business on the business day immediately preceding March 15, 2026, the notes will be convertible at the option of the holders only upon the occurrence of certain events and during certain periods. Thereafter, the notes will be convertible at the option of the holders at any time prior to the close of business on the business day immediately preceding the maturity date. Upon conversion, the Company will pay or deliver, as the case may be, cash, shares of the Company’s common stock or a combination thereof, at the Company’s election. The interest rate, initial conversion rate and other terms will be determined by negotiations among J.P. Morgan Securities LLC and Piper Jaffray & Co., the initial purchasers of the notes, and the Company. The Company also expects to grant to the initial purchasers a 13-day option to purchase up to an additional $11.25 million aggregate principal amount of the notes.

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The Company expects to use the net proceeds of the offering (including from any exercise by the initial purchasers of their option to purchase additional notes) to repay all outstanding indebtedness of $12.75 million under its existing credit facility, to fully fund a $2.0 million cash collateral account contemplated to secure its obligations under its credit facility as amended in connection with the offering, to fund its intended expansion efforts, including through acquisitions of complementary businesses or technologies or other strategic transactions, and for working capital and other general corporate purposes. From time to time, the Company evaluates and is currently evaluating potential acquisitions or other strategic transactions. The Company has no current agreements or commitments with respect to any such acquisition or strategic transaction, however, and there can be no assurance that it will be able to enter into any definitive agreements with respect to, or otherwise consummate, any such transaction.

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or sale of, the notes (or any shares of Heska’s common stock issuable upon conversion of the notes) in any state or jurisdiction in which the offer, solicitation, or sale would be unlawful prior to the registration or qualification thereof under the securities laws of any such state or jurisdiction.

On September 11, 2019 Aurora Cannabis Inc. (the "Company" or "Aurora") (NYSE | TSX: ACB), the Canadian company defining the future of cannabis worldwide, reported its financial and operational results for the fourth quarter and fiscal year ended June 30, 2019 (Press release, Aurora Biosciences, SEP 11, 2019, View Source [SID1234539448]).

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"In 2019 Aurora took its place as the global leader in cannabis production, research, innovation, and international market development. We are executing on all our strategic priorities," said Terry Booth, CEO. "Our best in class cultivation methods allow us to grow consistent, high-quality cannabis at scale. Because of this, we’ve delivered solid revenue growth in the fourth quarter. We are working to extend our reach in the U.S. markets. Our partnership with the UFC is a basis to explore CBD-from-hemp and hemp food products. We are also exploring additional opportunities and leveraging our Strategic Advisor. We are focused on building a sustainable, high-margin business while providing patients and consumers with access to safe and reliable medicine."

Glen Ibbott, CFO, added, "We continue to see strong growth in cannabis revenues in both medical and consumer categories. Our cultivation execution continues to drive production costs lower and improve gross margins. Aurora’s diversified product portfolio remains in demand with patients and consumers alike. With the Canadian launch of derivative products in the coming months, we have made the necessary investments to ensure readiness and focus on a variety of value added products. We are very excited to supply an expanded consumer market with premium cannabis and new product forms."

Fourth Quarter 2019 Highlights

(Unless otherwise stated, comparisons are made between Fiscal Q4 2019 and Q3 2019 results and are in Canadian dollars)

Net cannabis revenue up 61% sequentially to $94.6 million
Canadian consumer cannabis revenue up 52% to $44.9 million
Medical cannabis revenue up 10% to $29.7 million
Wholesale revenues of $20.1 million
Cash cost to produce per gram sold declined 20% sequentially to $1.14 per gram in Q4 2019.

Production volume increased 86% sequentially to 29,034 kgs.

Gross margin on cannabis net revenue increased by 3% to 58% sequentially.

Aurora’s medical patient base expanded 10% to 84,729 sequentially. As at the date of this release, Aurora has approximately 89,700 active registered patients, a further increase of 6%.

Adjusted EBITDA loss of $11.7 million represents an improvement of 68% compared to $36.6 million in Q3 2019.
Subsequent Events

Closed an amended and upsized $360 million secured credit facility which includes an accordion feature that enables Aurora to upsize the facility by approximately $40 million,

Sold its remaining 28,833,334 shares of The Green Organic Dutchman Holdings Ltd ("TGOD"), at a price of $3.00 per share for aggregate gross proceeds of $86.5 million, representing an approximate 50% internal rate of return for the Company.
Full Year Fiscal 2019 Highlights

Net revenue of $247.9 million, up 349% compared to the prior year.

Gross margin on cannabis net revenue of 55% in fiscal 2019 versus 65% in fiscal 2018.

Kilograms produced and kilograms sold of 57,442 kgs and 36,628 kgs, up 920% and 629% respectively compared to fiscal 2018.
Q4 2019 Key Financial and Operational Metrics

Net revenue represents our total gross revenue cannabis products effective October 17, 2018.

These terms are defined in the "Cautionary Statement Regarding Certain Performance Measures" section of this MD&A

Refer to the following sections for reconciliation of non-GAAP measures to the IFRS equivalent measure:

Refer to the "Revenue" section for a reconciliation of cannabis net revenue to the IFRS equivalent.

Refer to the "Gross Margin" section for reconciliation to the IFRS equivalent.

Refer to the "Cash Cost of Sales of Dried Cannabis and Cash Cost to Produce Dried Cannabis Sold – Aurora Produced Cannabis"
section for reconciliation to the IFRS equivalent.

Adjusted EBITDA is calculated as net income (loss) excluding interest income (expense), accretion, income taxes, depreciation, amortization,
changes in fair value of inventory sold, changes in fair value of biological assets, share-based compensation, foreign exchange, changes in
fair value of financial instruments, gains and losses on deemed disposal, and non-cash impairment of equity investments, goodwill, and other
assets.

Represents total biological assets and cannabis inventory, exclusive of merchandise, accessories, supplies, and consumables.

During the three months ended June 30, 2019, the Company recorded non-material year-end corrections to: (i) capitalize certain payroll,
share-based compensation and borrowing costs, related to the construction of our production facilities that were incorrectly expensed in
prior periods; and (ii) reverse items that had been over-accrued in prior periods. The net impact of these adjustments to Q4 2019 Adjusted
EBITDA was a $14.9 million reduction in reported operating expenses

Consolidated net revenue increased 52% to $98.9 million in Q4 2019 as compared to $65.1 million in the prior quarter. Consumer cannabis revenues were $44.9 million in Q4 2019, an increase of 52% from the prior quarter and contributed 45% to total consolidated net revenue. Canadian medical cannabis net revenues increased to $25.2 million in Q4 2019, up 9% over the prior quarter. Revenue growth was primarily driven by additional production capacity and supply available for sale from Aurora Sky and Aurora River (Bradford).

Average net selling price of cannabis decreased by $1.08 per gram over the prior quarter from $6.40 in Q3 2019 to $5.32 in Q4 2019. This decrease is primarily attributable to the increase in sale volumes to consumer and bulk wholesale markets which yield lower average net selling prices as compared to medical markets.

Gross margin on cannabis net revenue increased to 58% in Q4 2019, compared to 55% in the prior quarter. Gross margin improvement was driven by the continued decline in cash cost to produce per gram and higher gross margins achieved on bulk sales.

During Q4 2019, Aurora produced 29,034 kilograms of cannabis as compared to 15,590 kilograms in the prior quarter. The 86.2% increase in production output was primarily due to the additional production capacity added by Aurora Sky, River (Bradford), and Ridge (Markham) facilities. Extraction capacity increased from 20,400 kilograms to 26,400 kilograms in Q4 2019. Subsequent to the quarter end, Aurora’s annual extraction capacity further increased to 45,600 kilograms.

Q4 2019 SG&A increased by 9% to $72.9 million, compared to the prior quarter. The change was primarily driven by an increase in fulfillment and shipping costs related to the growth in consumer cannabis sales and continued investment in sales initiatives, distribution network, and partnerships to conduct research, develop products, and drive brand awareness. Aurora will continue to invest in infrastructure and talent required for market share growth in the global medical and consumer cannabis markets but will remain intensely focused doing this as efficiently as possible.

In Q4 2019, adjusted EBITDA loss improved 68% to $11.7 million from $36.6 million in the prior quarter. Developing a profitable and robust global cannabis company is extremely important to Aurora. In fiscal 2019 Aurora was focused on excellence in execution, and the Company’s KPIs show its success in this regard. Furthermore, Aurora has addressed previously identified production bottlenecks and continues to see strong sell-through of the Company’s products at the retail level. However, the Canadian consumer channel continues to experience challenges at the retail level in key markets and resolution of this issue is beyond the Company’s control. Aurora is working closely with all our regulatory and channel partners to streamline distribution as the Company continues to track toward positive adjusted EBITDA on a consolidated basis.

The Company’s operating facilities current annualized run-rate production capacity is in excess of 150,000 kg per annum, based on planted rooms. As the industry leader in purpose-built cultivation, Aurora is focused on producing a consistent supply of high-quality, low-cost product to meet evolving market demand. Aurora is well-positioned to respond to market conditions quickly with shorter lead times, increased harvest cycles and high plant yields.

Outlook

The global cannabis and hemp markets represent a significant opportunity for Aurora and the Company will continue to make the necessary investments today to build long-term value for shareholders. However, Aurora will take a balanced approach to these investments with a focus on operating a sustainable and profitable business.

The introduction of new product formats to the Canadian consumer market this fall represents a significant opportunity for the Company. Aurora expects to have a robust product line-up ready to launch in December. Given the very early stage of development of the consumer market in Canada and international medical markets, management anticipates that quarter to quarter sales volumes and revenues may be volatile. The Company expects adjusted EBITDA to continue to improve in the future due to expected revenue growth, improvements in gross margin and prudent SG&A growth.

The passing of the U.S. Farm Act presents new opportunities in the largest cannabis and hemp-derived CBD market globally, and as such Aurora is committed to establishing a substantial operating footprint in the U.S. As part of the U.S. market strategy, the Company is considering its stakeholders and how various state and federal regulations will affect its business prospects. A number of alternatives to grow Aurora’s presence in the U.S. market are under evaluation and the Company is committed to only engage in activities which are permissible under both state and federal laws. Management believes there are currently market opportunities that are legal at both state and federal levels that can add operating cash flows and be critical pillars of Aurora’s strategy and long-term success.

Conference Call

Aurora will host a conference call tomorrow, September 12, 2019, to discuss these results. Terry Booth, Chief Executive Officer, Glen Ibbott, Chief Financial Officer, Cam Battley, Chief Corporate Officer, and Michael Singer, Executive Chairman, will host the call starting at 9:00 a.m. Eastern time. A question and answer session will follow management’s presentation.

Date:

Thursday, September 12th, 2019

Time:

9:00 a.m. Eastern Time | 7:00 a.m. Mountain Time

Webcast:

https://bit.ly/34gYCj5

Replay:

(416) 849-0833 or (855) 859-2056

until 12:00 midnight Eastern Time Thursday, September 19, 2019

Reference Number:

On September 11, 2019 Oncopeptides AB (Nasdaq Stockholm: ONCO) reported that clinical trial data were presented at the Society of Hematologic Oncology (SOHO) 2019 Annual Meeting in Houston, TX, USA (Press release, Oncopeptides, SEP 11, 2019, View Source [SID1234539447]). In an oral presentation, data from the pivotal Phase 2 HORIZON clinical trial were presented as part of the meeting’s multiple myeloma session. Additionally, two posters focused on the ANCHOR and HORIZON clinical trials evaluating melflufen in RRMM were displayed at the meeting. The data presented are encouraging and show continued momentum for Oncopeptides’ melflufen.

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In the pivotal Phase 2 HORIZON trial for which interim results were presented, melflufen demonstrated promising activity in patients with RRMM, many of whom also have extramedullary disease (EMD). In the study, patients demonstrated an overall response rate (ORR) of 28% and a clinical benefit rate (CBR) of 40%. 86% of patients evaluated achieved disease stabilization (SD) or better. Melflufen was generally well tolerated with manageable toxicity. The data have previously been presented at EHA (Free EHA Whitepaper) annual meeting in Amsterdam.

Dr Christopher Maisel, MD, comments
"These Interim data from the HORIZON clinical trial demonstrate the potential for melflufen to be a novel therapeutic option for patients with RRMM," said Christopher Maisel, MD, of Texas Oncology and Baylor Sammons Cancer Center in Dallas, TX. "I am encouraged by these results, and glad to see that there is a selective alkylator with efficacy and manageable toxicity in RRMM patients, as this patient population remains a significant unmet need."

CEO, Jakob Lindberg comments
"The selection of these data for oral presentation at the esteemed SOHO 2019 Annual Meeting reinforce the scientific rigor of Oncopeptides’ clinical development program supporting our lead candidate melflufen, and we are excited about this first presentation of these interim data to U.S. clinician audiences," said Jakob Lindberg, CEO of Oncopeptides. "As we look toward our planned NDA submission in the first quarter of 2020, we look forward to providing continuing updates on the HORIZON clinical trial at additional upcoming medical congresses."

The ongoing Phase 2 HORIZON clinical trial will serve as the basis for Oncopeptides’ planned submission of a New Drug Application (NDA) to the FDA for accelerated approval of melflufen in the treatment of patients with triple-class refractory multiple myeloma. The company is targeting submission of the NDA in the first quarter of 2020.

The full oral presentation and posters presented at the SOHO 2019 Annual Meeting can be found on the company webpage under:

www.oncopeptides.com / Investors & media / Presentations / SOHO 2019

Oral Presentation: HORIZON (OP-106) Study of Melflufen in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Refractory to Daratumumab and/or Pomalidomide: Updated Efficacy and Safety
Interim data from the pivotal Phase 2 HORIZON clinical trial was featured in an oral presentation by Christopher Maisel, M.D., Baylor Scott & White Charles A. Sammons Cancer Center, Dallas, Texas, USA. The presentation was featured as one of only two oral abstracts selected for the meeting’s official session on multiple myeloma. These interim data from the HORIZON trial were presented as an encore presentation of the results following their initial presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2019 Annual Congress.

Summary of HORIZON Interim Data
Melflufen continues to demonstrate promising activity in patients with RRMM, many of whom also have EMD. According to these interim study results, patients demonstrated an ORR of 28% and a clinical benefit rate (CBR) of 40%.

Median PFS is 4.0 months in the ongoing study and duration of response (DOR) is 4.4 months. The majority of patients evaluated (86%) achieved SD or better.

Treatment was generally well tolerated with manageable toxicity, nonhematologic AEs were infrequent and the rate of discontinuation due to AEs was low. Treatment-related SAEs occurred in 20% of patients and were most commonly febrile neutropenia (5%) and thrombocytopenia (2%).

The median age of patients in the clinical study was 64 years. 62% of patients in the study had high-risk cytogenetics, 29% of patients were ISS stage III and 60% of the patients had EMD. The median number of prior lines of therapy was five and the median time since initial diagnosis was 6.2 years.

All patients in the study were investigator assessed as non-responsive or non-tolerant to immunomodulatory drugs (IMiDs) and proteasome inhibitors (PIs). 36% of patients had received 3+ treatment regimens over the last 12 months. 91% of patients were double class refractory (IMiD + PI) and 79% anti-CD38 mAb refractory. 74% of the patients were triple class (IMiD + PI + Anti-CD38 mAb) refractory and 59% were alkylator refractory. 98% of the patients were refractory in last line of therapy.

About the OP-106 HORIZON Clinical Trial
Patient recruitment in the HORIZON study is ongoing. The interim data presented at SOHO 2019 is based on a data cut-off dated May 6, 2019, with 121 patients treated. 108 patients had received two or more cycles of treatment. The goal is to include 150 patients in the study. The patients in the study are refractory to pomalidomide and/or daratumumab after failing on IMiDs and PIs.

More information can be found at: View Source;rank=2

Poster Presentation: HORIZON (OP-106) Study of Melflufen in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Refractory to Daratumumab and/or Pomalidomide: Updated Efficacy and Safety
Efficacy and safety from the ongoing HORIZON clinical trial was also featured as a poster (Poster MM-250) at the SOHO 2019 Annual Meeting, providing an update on the full clinical trial design, patient characteristics and initial conclusions presented in the corresponding oral presentation.

Poster Presentation: ANCHOR (OP-104) Study of Melflufen and Dexamethasone Plus Bortezomib or Daratumumab in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Refractory to an IMiD and/or a Proteasome Inhibitor (PI): Phase 1 Update
An update on the Phase 1/2 ANCHOR clinical trial evaluating melflufen in combination with either bortezomib or daratumumab for the treatment of RRMM was also selected as a poster presentation (Poster MM-168) at the SOHO 2019 Annual Meeting. According to the data presented, the combination of melflufen with either bortezomib or daratumumab is well tolerated and evolving efficacy is encouraging in both combinations, with 90% of patients still on treatment. The ANCHOR study is ongoing with active recruitment of patients to the 40-mg melflufen dose level.

About the OP-104 ANCHOR study
ANCHOR is a Phase 1/2 trial where melflufen and dexamethasone is dosed in combination with either bortezomib or daratumumab. All patients must have 1-4 prior lines of therapy and be refractory (or intolerant) to an immunomodulary agent (IMiD) or a proteasome inhibitor (PI) or both. The trial is currently open for enrollment at multiple sites globally. More information can be found at:

View Source;rank=4

In the bortezomib combination arm (Regimen A) patients cannot be refractory to a PI and in the daratumumab combination arm (Regimen B) patients cannot be previously exposed to any anti-CD38 therapy. Patients will be treated until documented disease progression or unacceptable toxicity. The primary objective of the phase 1 part of the study is to determine the optimal dose of melflufen, up to a maximum of 40 mg, and dexamethasone in combination with bortezomib or daratumumab. Additional patients per regimen are recruited in the phase 2 part of the trial where the primary objective is ORR.

For further information, please contact:
Jakob Lindberg, CEO of Oncopeptides
E-mail: [email protected]
Telephone: +46 8 615 20 40

Rein Piir, Head of Investor Relations at Oncopeptides
E-mail: [email protected]
Cell phone: +46 70 853 72 92

This information was submitted for publication at 23.55 CET, September 11, 2019

About Melflufen
Melflufen is a lipophilic peptide-conjugated alkylator that rapidly delivers a highly cytotoxic payload into myeloma cells through peptidase activity. It belongs to the novel class Peptidase Enhanced Cytotoxics (PEnC), which is a family of lipophilic peptides that exhibit increased activity via peptidase cleavage and have the potential to treat many cancers. Peptidases play a key role in protein homeostasis and feature in cellular processes such as cell-cycle progression and programmed cell death. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and immediately cleaved by peptidases to deliver an entrapped hydrophilic alkylator payload. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the peptidase cleavage, and induces irreversible DNA damage and apoptosis. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies.

On September 11, 2019 Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics company, and the CIBMTR (Center for International Blood and Marrow Transplant Research) reported the entry into a research agreement to collect and analyze health outcomes data in patients with hematologic malignancies who receive an allogeneic hematopoietic stem cell transplant (HSCT, or bone marrow transplant) from various donor sources (Press release, Gamida Cell, SEP 11, 2019, View Source [SID1234539444]). The CIBMTR is an organization that collaborates with the global scientific community to advance hematopoietic cell transplantation (HCT) and cellular therapy worldwide.

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The newly launched observational study by the CIBMTR and Gamida Cell will include both retrospective and prospective data contemporaneous to the international, randomized, Phase 3 study of omidubicel, Gamida Cell’s investigational advanced cell therapy designed to enhance the life-saving benefits of bone marrow transplant. Topline data from the ongoing Phase 3 study is anticipated in the first half of 2020, and initial data from the multi-year observational study is anticipated next year. Omidubicel has not yet been approved for marketing in the United States or any other jurisdiction.

"We are pleased to announce this collaboration with Gamida Cell, a company aiming to make bone marrow transplant an option for more patients facing life-threatening blood diseases," said Mary M. Horowitz, M.D., M.S., chief scientific director of the CIBMTR. "This collaboration will leverage the CIBMTR’s deep experience collecting and analyzing data on both the short- and long‐term outcomes of patients undergoing a bone marrow transplant. We look forward to contributing to efforts to better understand real-world clinical outcomes."

"This agreement marks the beginning of Gamida Cell’s health outcomes research initiatives, and we are excited to partner with the CIBMTR, an organization with deep expertise in bone marrow transplantation and cellular therapy," stated Julian Adams, Ph.D., chief executive officer of Gamida Cell. "We are committed to improving outcomes for patients who are in need of a bone marrow transplant and look forward to better understanding the variables that influence health outcomes, as well as elucidating how omidubicel may fit into the treatment landscape."

Randomized clinical trials comparing different donor types suggest that clinical outcomes may vary significantly depending on the donor type. The goal of this real-world, observational study is to better understand the variables that influence the health outcomes of patients receiving a transplant from a source other than a fully matched family donor. As part of the research agreement, the CIBMTR will use its registry, which consists of clinical outcomes data on more than 500,000 stem cell transplants, to analyze long‐term safety and efficacy data for patients with hematologic malignancies who underwent a bone marrow transplant with an alternative donor source following myeloablative conditioning. The criteria for inclusion of patients and the endpoints evaluated in the analysis will be consistent with the design of the Phase 3 study of omidubicel.

About Omidubicel
Omidubicel (formerly known as NiCord), the company’s lead clinical program, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers). Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU. In a Phase 1/2 clinical study, omidubicel demonstrated rapid and durable time to engraftment and was generally well-tolerated.1 A Phase 3 study evaluating omidubicel in patients with leukemia and lymphoma is ongoing in the U.S., Europe and Asia.2 Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia.3 The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov.

Omidubicel is an investigational therapy, and its safety and efficacy has not been evaluated by the U.S. Food and Drug Administration or any other health authority.