On August 11, 2020 Medicure Inc. ("Medicure" or the "Company") (TSXV: MPH) (OTC: MCUJF), a cardiovascular pharmaceutical company, reported its results from operations for the quarter ended June 30, 2020 (Press release, Medicure, AUG 11, 2020, View Source [SID1234563455]).

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Quarter Ended June 30, 2020 Highlights:

Net income for the quarter ended June 30, 2020 was $19,000 compared to net loss of $957,000 for the quarter ended June 30, 2019; and

Adjusted earnings before interest, taxes, depreciation and amortization (EBITDA1) for the quarter ended June 30, 2020 was $263,000 compared to adjusted EBITDA of $103,000 for the quarter ended June 30, 2019; and

Recorded total net revenue from the sale of products of $2.7 million during the quarter ended June 30, 2020 compared to $6.3 million for the quarter ended June 30, 2019;

Recorded total net revenue from the sale of AGGRASTAT of $2.6 million during the quarter ended June 30, 2020 compared to $6.2 million for the quarter ended June 30, 2019.
Financial Results

Net revenues for the three months ended June 30, 2020 were $2.7 million compared to $6.3 million for the three months ended June 30, 2019. Net revenues from AGGRASTAT for the three months ended June 30, 2020 were $2.6 million compared to $6.2 million for the three months ended June 30, 2019. ZYPITAMAGTM contributed $103,000 for the three months ended June 30, 2020 compared to $9,000 for the three months ended June 30, 2019. Additionally, SNP, which was first sold commercially during 2020, contributed $17,000, during the three months ended June 30, 2020. The Company did not earn any revenues from ReDSTM during the three months ended June 30, 2020 compared to net revenue of $51,000 for the three months ended June 30, 2019.

Net revenues for the six months ended June 30, 2020 were $5.7 million compared to $11.2 million for the six months ended June 30, 2019. Net revenues from AGGRASTAT for the six months ended June 30, 2020 were $5.3 million compared to $11.0 million for the six months ended June 30, 2019. ZYPITAMAGTM contributed $266,000 for the six months ended June 30, 2020 compared to $9,000 for the six months ended June 30, 2019. Additionally, SNP, which was first sold commercially during 2020, contributed $48,000, during the six months ended June 30, 2020. Revenues from ReDSTM for the six months ended June 30, 2020 totaled $89,000 compared to net revenue of $154,000 for the six months ended June 30, 2019.

There was a significant decrease in the volume of the AGGRASTAT sold in Q2 2020 compared to Q2 2019, due mainly to COVID-19. The Company is beginning to see increases in demand for ZYPITAMAGTM and expects growth in ZYPITAMAGTM revenues going forward. The Company continues to show strong patient market share with AGGRASTAT, however, the market share is offset by the lower discounted prices for AGGRASTAT in the first half of 2020.

Adjusted EBITDA for the three months ended June 30, 2020 was $263,000 compared to $103,000 for the three months ended June 30, 2019. The increase in adjusted EBITDA for the three months ended June 30, 2020 is the result of lower selling and research and development expenses, partially offset by lower revenues during the three months ended June 30, 2020 when compared to the same period in 2019.

Adjusted EBITDA for the six months ended June 30, 2020 was negative $1.0 million compared to negative $1.6 million for the six months ended June 30, 2019. The improvement in adjusted EBITDA for the six months ended June 30, 2020 is the result of lower selling and research and development expenses, partially offset by lower revenues during the six months ended June 30, 2020 when compared to the same period in 2019.

During the three months ended June 30, 2020, the Company recorded $325,000 in government assistance resulting from the Canada Emergency Wage Subsidy. The funding has been recorded as a reduction of the related salary expenditures with $248,000 recorded within selling expenses, $43,000 recorded within general and administrative expenses and $34,000 recorded with research and development expenses. Additionally, during the three months ended June 30, 2020, the Company recorded a recovery totaling $677,000 within research and development expenses pertaining to fees previously paid to the United States Food and Drug Administration ("FDA") for which the FDA has subsequently granted a waiver.

Net income for the three months ended June 30, 2020 was $19,000 or $0.00 per share compared to net loss of $957,000 or $0.06 per share for the three months ended June 30, 2019. The change in the net income for the three months ended June 30, 2020 is the result of lower selling and research and development expenses and a gain on foreign exchange, partially offset by lower revenues experienced during the three months ended June 30, 2020 when compared to the three months ended June 30, 2019.

Net loss for the six months ended June 30, 2020 was $1.4 million or $0.13 per share compared to $3.7 million or $0.24 per share for the six months ended June 30, 2019. The change in the net loss for the six months ended June 30, 2020 is the result of lower selling and research and development expenses and a gain on foreign exchange, partially offset by lower revenues and higher cost of goods sold, primarily from increased amortization of intangible assets, experienced during the six months ended June 30, 2020 when compared to the six months ended June 30, 2019.

At June 30, 2020, the Company had unrestricted cash totaling $11.2 million down from the $13.0 million of unrestricted cash held as of December 31, 2019. Cash flows used in operating activities for the six months ended June 30, 2020 totaled $1.8 million compared to $7.1 million for the six months ended June 30, 2019.

All amounts referenced herein are in Canadian dollars unless otherwise noted.

Notes

(1) The Company defines EBITDA as "earnings before interest, taxes, depreciation, amortization and other income or expense" and Adjusted EBITDA as "EBITDA adjusted for non-cash and non-recurring items". The terms "EBITDA" and "Adjusted EBITDA", as it relates to the three and six months ended June 30, 2020 and 2019 results prepared using IFRS, do not have any standardized meaning according to IFRS. It is therefore unlikely to be comparable to similar measures presented by other companies.

Conference Call Info:

Topic: Medicure’s Q2 2020 Results

Call date: Wednesday, August 12, 2020

Time: 7:30 AM Central Time (8:30 AM Eastern Time)

Canada toll: 1 (416) 764-8659

North American toll-free: 1 (888) 664-6392

Passcode: not required

Webcast: This conference call will be webcast live over the internet and can be accessed from the Medicure investor relations page at the following link: View Source

You may request international country-specific access information by e-mailing the Company in advance. Management will accept and answer questions related to the financial results and operations during the question-and-answer period at the end of the conference call. A recording of the call will be available following the event at the Company’s website.

On August 11, 2020 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for population sequencing and cancer, reported that it has commenced an underwritten public offering of $100 million of its common stock (Press release, Personalis, AUG 11, 2020, View Source [SID1234563451]). In addition, Personalis expects the underwriters to be granted a 30-day option to purchase up to an additional $15 million of common stock from a selling stockholder on the same terms and conditions. Personalis will not receive any proceeds from any sale of shares by the selling stockholder.

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The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.

BofA Securities, Citigroup and Cowen are acting as joint book-running managers. BTIG, Needham & Company and Oppenheimer & Co. are acting as co-managers.

A shelf registration statement relating to the shares being sold in this offering was filed with the U.S. Securities and Exchange Commission on July 2, 2020, and was declared effective on July 10, 2020. The offering will be made only by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available for free on the SEC’s website located at View Source When available, electronic copies of the preliminary prospectus supplement and accompanying prospectus relating to the proposed public offering may be obtained from BofA Securities, Inc., Attention: Prospectus Department, NC1‐004‐03‐43, 200 North College Street, 3rd floor, Charlotte, NC 28255‐0001, or by emailing [email protected]; Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 631‐274‐2806.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On August 11, 2020 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported Chairman and Chief Executive Officer, Kevin Hrusovsky, will participate in a virtual fireside chat discussion at the Canaccord Genuity 40th Annual Growth Conference on August 13 at 10:00 a.m., EDT. Hrusovsky will also host virtual one-on-one and group meetings with institutional investors that day (Press release, Quanterix, AUG 11, 2020, View Source [SID1234563450]).

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A live webcast of the conversation will be available on the investor section of the Quanterix website at View Source Replays of the webcast will be available on the Quanterix website for 90 days following the conference.

On August 11, 2020 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended June 30, 2020 and provided an update on clinical developments (Press release, Cel-Sci, AUG 11, 2020, View Source [SID1234563449]):

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CEL-SCI reached the targeted threshold of 298 events (deaths) required to conduct the data evaluation for its global pivotal Phase 3 head and neck cancer study of Multikine* (Leukocyte Interleukin, Inj.) immunotherapy. The study is currently in the database lock and analysis phase. CEL-SCI will be advised of the results when the analysis is finalized, and the study results will be announced to the public and investors at that time.
CEL-SCI initiated the development of an immunotherapy with the potential to treat the COVID-19 coronavirus using its patented LEAPS peptide technology. The initial animal experiments showed that after only one injection, LEAPS COVID-19 conjugates induced antibody responses faster and in much higher titers than expected against a non-mutating region of the virus that causes COVID-19. These animal experiments provide the basis for moving forward into animal challenge studies with live virus SARS-CoV-2, the causative agent of COVID-19, at the University of Georgia Vaccine Center.
CEL-SCI signed a collaboration agreement with the University of Georgia’s Center for Vaccines and Immunology to develop the LEAPS COVID-19 immunotherapy. Initial studies with COVID-19 aim to replicate prior successful preclinical experiments of LEAPS against the H1N1pandemic flu virus in mice conducted at and in collaboration with the National Institutes for Allergies and Infectious Diseases (NIAID). These studies demonstrated improvement in both morbidity and mortality of H1N1 infected animals treated with the LEAPS-H1N1 construct as compared to controls. CEL-SCI believes its COVID-19 approach is unique for two reasons: 1) LEAPS focuses on a non-changing part of the virus; and 2) LEAPS has both anti-viral and anti-inflammatory attributes. The goal is to develop a more successful treatment for infected patients.
CEL-SCI raised approximately $27.0 million in gross proceeds during the nine months ended June 30, 2020 through the sale of common stock through public offerings and the exercise of warrants.
"Our goal is to create the first non-toxic cancer drug that is effective in increasing survival. This is the first cancer drug in decades that would be used to improve the success rate of the current first ‘intent to cure’ head and neck cancer standard of care treatment. Now that the long Phase 3 study is finished, the organizations who run the study are responsible for cleaning up/collecting all final data and analyzing it. This is a very big job since the study ran for 9.5 years in 100 hospitals in 24 countries. Once we know the final study results, we will share them with our shareholders. We believe that our Multikine will help these patients," stated CEL-SCI CEO, Geert Kersten.

During the nine months ended June 30, 2020, the Company’s cash increased by approximately $11.7 million. Significant components of this increase include approximately $14.0 million in net proceeds from the sale of common stock through public offerings, approximately $12.1 million in proceeds from the exercise of warrants and options and employee stock purchases of approximately $0.2 million, offset by net cash used to fund the Company’s regular operations, including its Phase 3 clinical trial, of approximately $11.7 million, approximately $1.6 million of equipment and leasehold improvement expenditures, approximately $0.7 million for payments of stock issuance costs and approximately $0.6 million in lease payments.

CEL-SCI reported a net loss of $24.7 million for the nine months ended June 30, 2020 versus a net loss of $17.3 million for the nine months ended June 30, 2019. CEL-SCI reported a net loss of $10.2 million for the quarter ended June 30, 2020 versus a net loss of $12.1 million for the quarter ended June 30, 2019.

On August 11, 2020 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases, reported financial results for the quarter ended June 30, 2020 (Press release, Gamida Cell, AUG 11, 2020, View Source [SID1234563448]). The company also highlighted progress with omidubicel, an advanced cell therapy in Phase 3 clinical development as a potentially life-saving treatment option for patients in need of bone marrow transplant, and GDA-201, a natural killer (NK) cell immunotherapy in Phase 1 development in patients with non-Hodgkin lymphoma (NHL).

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Omidubicel, an investigational advanced cell therapy for allogeneic bone marrow transplant

During the quarter, Gamida Cell reported that its Phase 3 study of omidubicel met its primary endpoint, demonstrating a highly statistically significant reduction (p < 0.001) in time to neutrophil engraftment, a key milestone in recovery from a bone marrow transplant. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA).

"The primary endpoint data for omidubicel underscore its potential to become an important treatment option for patients by providing a reliable graft source that can enable rapid neutrophil engraftment, which has been linked to other important outcomes such as fewer infections and hospitalizations," stated Julian Adams, Ph.D., chief executive officer of Gamida Cell. "We look forward to reporting secondary endpoints from the study and to initiating the biologics license application, or BLA, for omidubicel to the FDA on a rolling basis, both in the fourth quarter of this year."

Program highlights for omidubicel:

Initial data from collaboration with CIBMTR to be presented: Next month, Gamida Cell will report initial data from an observational study that includes data contemporaneous to the Phase 3 study of omidubicel. This study utilizes data from the CIBMTR 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 outcomes evaluated in the analyses are consistent with those in the Phase 3 study of omidubicel. These data will be highlighted in a poster presentation at the Cord Blood Connect Meeting, which is being held virtually on September 10 and September 17.
Initiated expanded access program for omidubicel: Gamida Cell reported that it has initiated an open-label, single-arm study to provide access to omidubicel for patients with high-risk hematologic malignancies who are in need of a bone marrow transplant and meet protocol criteria. This study is currently open at three sites in the U.S., and additional sites are expected to open in the coming months.
Reported positive Phase 3 data for omidubicel: In May, Gamida Cell announced that the international, randomized Phase 3 study of omidubicel achieved its primary endpoint of time to neutrophil engraftment. The study was designed to evaluate the safety and efficacy of omidubicel in 125 patients with high-risk hematologic malignancies undergoing a bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant. In the intent-to-treat analysis, the median time to neutrophil engraftment was 12 days (95% CI: 10-15 days) for patients who were randomized to omidubicel compared to 22 days (95% CI: 19-25 days) for the comparator group (p<0.001). Omidubicel was generally well tolerated. Among patients who were transplanted per protocol, 96 percent of patients who received omidubicel achieved successful neutrophil engraftment, compared to 88 percent of patients in the comparator group.

Gamida Cell expects to present the full data set, including secondary endpoint data, at a medical meeting in the fourth quarter of 2020. The company also expects to begin submitting the biologics license application for omidubicel to the FDA on a rolling basis in the fourth quarter of 2020.
Continued to focus on activities required to successfully bring omidubicel to patients: Gamida Cell is continuing to advance key activities required to bring omidubicel to patients in a commercial setting, including building out manufacturing infrastructure, assembling an experienced commercial team with expertise in cell therapy and transplant, establishing hospital services and patient assistance programs, and exploring coverage and reimbursement models to enable access.
GDA-201, an innate NK cell immunotherapy

"We are encouraged by data from the Phase 1 study of GDA-201, which has shown a high complete response rate in patients with non-Hodgkin lymphoma," stated Dr. Adams. "NK cell immunotherapies offer tremendous potential for transforming the care of hematologic malignancies. We are pleased to be pioneering a novel approach that harnesses the power of our cell expansion technology, which uniquely improves antibody-dependent cytotoxicity (ADCC), cytotoxic killing and the in vivo homing potential of GDA-201 to address potential limitations of NK cells."

Program highlights for GDA-201

Continued advancing Phase 1 study of GDA-201: Earlier this year, Gamida Cell reported data from the first 25 patients in its ongoing Phase 1 study in patients with NHL and multiple myeloma, which demonstrated that GDA-201 was clinically active and generally well tolerated. Among the eleven patients with NHL, seven patients achieved a complete response and one patient achieved a partial response. Gamida Cell expects to provide updated data from the study at a medical conference in the fourth quarter of 2020.
Responded to COVID-19 pandemic: Gamida Cell has implemented additional safety measures designed to comply with applicable government guidelines, including shift work to allow for appropriate social distancing. The company now expects to submit an investigational new drug (IND) application for GDA-201 to the FDA in the first half of 2021. The company continues to be on track to initiate a multi-center, Phase 1/2 clinical study in patients with NHL next year.
Corporate Highlights

Executed a public offering: In May, Gamida Cell executed an underwritten public offering resulting in the sale of 15.3 million shares of common stock at $4.50 per share. Aggregate gross proceeds to the company were approximately $69 million before deducting underwriting discounts, commissions and offering expenses.
Appointed Matthew Metivier as vice president, human resources: Today Gamida Cell announced the appointment of Matthew Metivier to the role of vice president, human resources. Mr. Metivier brings more than 20 years of human resources experience, primarily in the life sciences industry. Mr. Metivier brings over 20 years of experience in human resources. Prior to joining Gamida Cell, Mr. Metivier worked at Sage Therapeutics, Inc., most recently as the vice president of human resources, where he helped develop and lead the company’s global human resources strategy. Before joining Sage, Mr. Metivier spent almost a decade at Infinity Pharmaceuticals in multiple human resource roles. He has also held prior human resource positions at various healthcare and high-tech companies, including Idenix Pharmaceuticals (acquired by Merck & Co) and Therion Biologics Corp. Mr. Metivier holds a B.A. in Political Science and Business Studies from Providence College and an MBA from Suffolk University.
Appointed Michele Korfin as chief operating and chief commercial officer: In July, Gamida Cell appointed Michele Korfin to the role of chief operating and chief commercial officer. Ms. Korfin brings over 20 years of experience in oncology, focused on business operations and commercialization of novel therapies, including cell therapy experience as vice president of market access at Kite Pharma, where she oversaw the market access strategy, including payer relations, reimbursement and government affairs for Yescarta, the first approved CAR-T therapy in lymphoma.
Appointed David Fox to Gamida Cell’s board of directors: In July, Gamida Cell appointed David Fox to its board of directors as an independent member. Mr. Fox was most recently a partner at Kirkland & Ellis LLP and served as a member of its Global Executive Management Committee.
Second Quarter 2020 Financial Results

Research and development expenses in the second quarter of 2020 were $9.3 million, compared to $7.3 million for the same period in 2019. The increase was mainly due to clinical activities relating to the advancement of GDA-201 and a decrease in grants received from the Israel Innovation Authority.
Commercial expenses in the second quarter of 2020 were $1.0 million compared to $1.1 million for the same period in 2019. The decrease was mainly attributed to non-cash compensation offset by omidubicel commercial readiness activities.
General and administrative expenses were $2.5 million for the second quarter of 2020 and for the second quarter of 2019.
Finance expense, net, was $2.2 million for the second quarter of 2020, compared to finance income, net, of $16.8 million in the same period in 2019. The increase was primarily due to noncash expenses resulting from revaluation of warrants owned by the company’s shareholders.
Net loss for the second quarter of 2020 was $15.1 million, compared to a net income of $6.0 million in the same period in 2019.
As of June 30, 2020, Gamida Cell had total cash, cash equivalents and available-for-sale securities of $88.6 million, compared to $55.4 million as of December 31, 2019.
2020 Financial Guidance

Gamida Cell expects cash used for ongoing operating activities in 2020 to range from $60 million to $70 million.

Gamida Cell expects that its current cash, cash equivalents and available-for-sale securities will support the company’s ongoing operating activities into the second half of 2021. This cash runway guidance is based on the Company’s current operational plans and excludes any additional funding beyond the follow-on offering that closed in May 2020 and any business development activities that may be undertaken.

Expected 2020-2021 Milestones

Gamida Cell plans to achieve the following milestones during 2020-2021:

Omidubicel

Present data from the Phase 3 study at a medical meeting in the fourth quarter of 2020
Initiate the submission of the BLA to the FDA, on a rolling basis, in the fourth quarter of 2020
Report additional data from the Phase 1/2 study in patients with severe aplastic anemia in the fourth quarter of 2020
Launch omidubicel in 2021, contingent upon FDA approval
GDA-201

Present additional data from the Phase 1 study in the fourth quarter of 2020
Submit company-sponsored IND application to the FDA in the first half of 2021
Initiate a Phase 1/2 clinical study in patients with NHL in 2021
Conference Call Information

Gamida Cell will host a conference call today, August 11, 2020, at 8:30 a.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com. To participate in the live call, please dial 866-930-5560 (domestic) or +1-409-216-0605 (international) and refer to conference ID number 8888903. A recording of the webcast will be available approximately two hours after the event, for approximately 30 days.

About Omidubicel

Omidubicel, 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 both Phase 1/2 and Phase 3 clinical studies (NCT01816230 and NCT02730299), omidubicel demonstrated rapid and durable time to engraftment and was generally well tolerated. Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). 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.

About GDA-201

Gamida Cell applied the capabilities of its NAM-based cell expansion technology to develop GDA-201, an innate natural killer (NK) cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs of NK cells expanded in culture. GDA-201 is in Phase 1 development through an investigator-sponsored study in patients with refractory non-Hodgkin lymphoma and multiple myeloma (NCT03019666).

Omidubicel and GDA-201 are investigational therapies, and their safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.