MGTA Magenta Therapeutics Inc.

7.79
+0.92  (+13%)
Previous Close 6.87
Open 7.05
52 Week Low 5.885
52 Week High 14.2
Market Cap $456,239,057
Shares 58,567,273
Float 44,285,984
Enterprise Value $194,552,165
Volume 1,085,171
Av. Daily Volume 253,228
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Upcoming Catalysts

Drug Stage Catalyst Date
MGTA-117
Conditioning for stem cell transplant
Phase 1/2
Phase 1/2
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MGTA-145 and plerixafor
Multiple Myeloma
Phase 2
Phase 2
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MGTA-145 and plerixafor
Acute Myeloid Leukemia (AML), Acute Lymphocytic Leukemia (ALL) and Myelodysplastic Syndromes (MDS)
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
MGTA-145 and plerixafor
Sickle Cell Disease
Phase 2
Phase 2
Phase 2 trial to be initiated 4Q 2021.

Latest News

  1. –  Phase 1/2 clinical trial expected to open in Q4 2021 in patients with relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) –

    Magenta Therapeutics, Inc. (NASDAQ:MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplant to more patients, announced today that its Investigational New Drug (IND) application for MGTA-117 is active with the U.S. Food and Drug Administration (FDA). The company expects to open the Phase 1/2 clinical trial in Q4 2021 to evaluate its MGTA-117 antibody-drug conjugate (ADC) targeted conditioning program.

    "We are very pleased that our collaboration with the FDA has resulted in the clearance of the MGTA-117 IND. We have…

    –  Phase 1/2 clinical trial expected to open in Q4 2021 in patients with relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) –

    Magenta Therapeutics, Inc. (NASDAQ:MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplant to more patients, announced today that its Investigational New Drug (IND) application for MGTA-117 is active with the U.S. Food and Drug Administration (FDA). The company expects to open the Phase 1/2 clinical trial in Q4 2021 to evaluate its MGTA-117 antibody-drug conjugate (ADC) targeted conditioning program.

    "We are very pleased that our collaboration with the FDA has resulted in the clearance of the MGTA-117 IND. We have addressed the FDA's request for a bioassay to be incorporated into the clinical trial protocol," said Jason Gardner, D.Phil., President and Chief Executive Officer, Magenta Therapeutics. "Improving conditioning treatments is essential for broadening patient accessibility to the curative potential of stem cell transplant and gene therapies. We have designed MGTA-117 specifically to replace toxic radiation and chemotherapy-based conditioning agents used in current medical practice. This program holds significant potential for patients across several disease areas."

    The multi-center, open label Phase 1/2 clinical trial with single-dose escalating cohorts will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of MGTA-117 as a single agent in relapsed/refractory AML and MDS patients. Magenta will continue to engage with the FDA to transition the trial to the intended primary target population of hematopoietic stem cell transplant-eligible AML and MDS patients. In addition, Magenta has planned gene therapy clinical trial collaborations with AVROBIO and Beam Therapeutics to evaluate the potential utility of MGTA-117 for conditioning gene therapy patients without the use of non-selective busulfan or other toxic chemotherapies.

    About MGTA-117

    Magenta's MGTA-117 program is the company's lead targeted conditioning product candidate, an antibody-drug conjugate (ADC) designed to selectively deplete hematopoietic stem cells (HSCs) from patients prior to transplant or HSC-based gene therapy to reduce the need for high-dose or high-intensity chemotherapeutic agents or, in the case of gene therapy applications, to potentially eliminate the need for chemotherapeutic agents altogether. MGTA-117 targets the CD117 receptor, which is highly expressed on the cell surface of HSCs and leukemia cells, making it a promising target for conditioning across broad sets of diseases, including certain blood cancers, hemoglobinopathies (sickle cell disease and beta thalassemia) and inherited metabolic disorders.

    About Magenta Therapeutics

    Magenta Therapeutics is a clinical-stage biotechnology company developing medicines to bring the curative power of stem cell transplants to more patients with blood cancers, genetic diseases and autoimmune diseases. Magenta is combining leadership in stem cell biology and biotherapeutics development with clinical and regulatory expertise, a unique business model and broad networks in the stem cell transplant community to revolutionize immune reset for more patients.

    Magenta is based in Cambridge, Massachusetts. For more information, please visit www.magentatx.com.

    Follow Magenta on Twitter: @magentatx.

    Forward-Looking Statement

    This press release may contain forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws, including express or implied statements regarding Magenta's future expectations, plans and prospects, including, without limitation, statements regarding the anticipated timing of clinical trials, expectations and plans for pre-clinical and clinical data, communications with the FDA, the design of product candidates and their potential benefits, the development of product candidates and advancement of preclinical programs, the plans, timing, progress and success of collaborations, as well as other statements containing the words "anticipate," "believe," "continue," "could," "endeavor," "estimate," "expect," "anticipate," "intend," "may," "might," "plan," "potential," "predict," "project," "seek," "should," "target," "will" or "would" and similar expressions that constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995. The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical studies; the development of biomarker assays ; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials; the expected timing of submissions for regulatory approval or review by governmental authorities; discussions with governmental agencies such as the FDA; regulatory approvals to conduct trials or to market products; whether Magenta's cash resources will be sufficient to fund Magenta's foreseeable and unforeseeable operating expenses and capital expenditure requirements; risks, uncertainties and assumptions regarding the impact of the continuing COVID-19 pandemic on Magenta's business, operations, strategy, goals and anticipated timelines, Magenta's ongoing and planned preclinical activities, Magenta's ability to initiate, enroll, conduct or complete ongoing and planned clinical trials, Magenta's timelines for regulatory submissions and Magenta's financial position; and other risks concerning Magenta's programs and operations are described in additional detail in its Annual Report on Form 10-K filed on March 3, 2021, as updated by Magenta's most recent Quarterly Report on Form 10-Q, and its other filings made with the Securities and Exchange Commission from time to time. Although Magenta's forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Magenta. As a result, you are cautioned not to rely on these forward-looking statements. Any forward-looking statement made in this press release speaks only as of the date on which it is made. Magenta undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

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  2. –  Progress in addressing the FDA's recommendations regarding bioassay and dose escalations to clear the current clinical hold on the company's Investigational New Drug Application to initiate MGTA-117 Phase 1/2 clinical trial –

    – Enrollment complete for Phase 2 clinical trial evaluating MGTA-145 plus plerixafor in patients with multiple myeloma; final clinical data expected in Q4 2021 –

    –  Plans to initiate Phase 2 clinical trial of MGTA-145 plus plerixafor for mobilization and collection of stem cells in patients with sickle cell disease in Q4 2021 –

    –  Ended Q2 2021 with approximately $207.8 million in cash, cash equivalents and marketable securities, and updates guidance that cash reserves are expected to fund the company's operating

    –  Progress in addressing the FDA's recommendations regarding bioassay and dose escalations to clear the current clinical hold on the company's Investigational New Drug Application to initiate MGTA-117 Phase 1/2 clinical trial –

    – Enrollment complete for Phase 2 clinical trial evaluating MGTA-145 plus plerixafor in patients with multiple myeloma; final clinical data expected in Q4 2021 –

    –  Plans to initiate Phase 2 clinical trial of MGTA-145 plus plerixafor for mobilization and collection of stem cells in patients with sickle cell disease in Q4 2021 –

    –  Ended Q2 2021 with approximately $207.8 million in cash, cash equivalents and marketable securities, and updates guidance that cash reserves are expected to fund the company's operating plan into Q3 2023 –

    Magenta Therapeutics, Inc. (NASDAQ:MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplants to more patients, today reported financial results for the second quarter ended June 30, 2021, and recent program highlights.

    "The Magenta team has been hard at work prioritizing the advancement of our program portfolio, now with multiple clinical trials underway, including the two Phase 2 clinical trials of MGTA-145. We plan to initiate a Phase 1/2 trial of MGTA-117 in patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS), assuming we are successful in resolving the clinical hold on our Investigational New Drug (IND) Application, and we also plan to initiate a Phase 2 clinical trial of MGTA-145 plus plerixafor for mobilization and collection of stem cells in patients with sickle cell disease," said Jason Gardner, D.Phil., President and Chief Executive Officer, Magenta Therapeutics. "We remain laser-focused on developing transformative mobilization and conditioning treatments for the many patients who stand to benefit."

    Business Highlights:

    • In Q2 2021, Magenta welcomed three additions to its Executive Team: Caren Deardorf as Chief Commercial Officer; Thomas Beetham as Chief Legal Officer; and David Nichols as Chief Technical Officer.
    • In May 2021, Magenta closed an $86.4 million private placement financing.

    Program Highlights:

    MGTA-145 Stem Cell Mobilization and Collection

    Recent and Planned Activity:

    • Enrollment is complete for Phase 2 clinical trial in multiple myeloma. This 25-patient, investigator-initiated, Phase 2 open-label clinical trial, led by Surbhi Sidana, M.D., Assistant Professor of Medicine in the Division of Blood and Marrow Transplantation and Cellular Therapy at Stanford University School of Medicine, is designed to evaluate the ability of MGTA-145, in combination with plerixafor, to mobilize and collect stem cells for autologous stem cell transplant in patients with multiple myeloma.
      • Preliminary trial data presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, held June 4-8, 2021, showed that all patients (15/15) treated as of the data cut-off date with MGTA-145 and plerixafor met the primary endpoint of sufficient stem cell mobilization and collection for transplant. As of the cut-off date, all patients (12/12) transplanted with MGTA-145 and plerixafor successfully engrafted, and six patients had completed their day-100 follow-up with demonstrated durable engraftment.
      • This trial has broad and clinically representative inclusion criteria and incorporates patients that represent the general transplant-eligible population of patients with multiple myeloma.
      • Patients enrolled in this trial included those patients with risk factors that could impact stem cell mobilization and collection, such as myeloma-directed therapies that are known to impact stem cell collection, previous malignancy treated with chemotherapy and/or radiation, and other co-morbid conditions. As indicated previously, mobilization agents may be less effective in patients with multiple risk factors.
      • Final clinical data from this trial are anticipated in Q4 2021 and are expected to be presented at a scientific congress.
    • Enrollment is ongoing in the Phase 2 clinical trial in collaboration with the National Marrow Donor Program®/Be The Match®, evaluating MGTA-145, in combination with plerixafor, in the mobilization and collection of stem cells from allogeneic donors for transplant in patients with AML, acute lymphocytic leukemia (ALL) and MDS. Initial data from this trial are expected in Q4 2021.
    • Initiation of a Phase 2 clinical trial in sickle cell disease in collaboration with bluebird bio is planned for Q4 2021 to evaluate the utility of MGTA-145, in combination with plerixafor, for the mobilization and collection of stem cells in patients with sickle cell disease where mobilization and collection is difficult and there is a clear unmet medical need.

    MGTA-117 Targeted Conditioning

    Recent and Planned Activity:

    • Magenta announced the receipt of a clinical hold letter from the U.S. Food and Drug Administration (FDA) related to its IND Application filed in June 2021 to initiate a Phase 1/2 clinical trial of MGTA-117 in patients with AML and MDS.
    • The FDA is requiring that Magenta develop an additional bioassay to be used in conjunction with the pharmacokinetics/pharmacodynamics model to inform dose escalation decisions in addition to safety monitoring. This was the only clinical hold item identified by the FDA and is not related to the toxicology or manufacturing of MGTA-117.
    • Magenta has initiated the development of the bioassay and intends to work closely with the FDA to reach resolution of the clinical hold.
    • Upon successful resolution of the clinical hold, Magenta anticipates starting the Phase 1/2 dose escalation study and evaluating the safety, pharmacokinetics and pharmacodynamics of MGTA-117 as a single agent with possible anti-tumor therapeutic benefit in a relapsed/refractory AML and MDS patient population. As previously disclosed, Magenta expects to work with the FDA on an ongoing basis to transition the study to targeted conditioning in the primary target population of hematopoietic stem cell transplant-eligible AML and MDS patients after adequate data related to the safety, pharmacokinetics and pharmacodynamics of MGTA-117 have been collected in the relapsed/refractory AML and MDS patient population.
    • As the program progresses, Magenta also plans to explore MGTA-117 as a targeted conditioning agent prior to the delivery of gene-corrected cells associated with ex vivo gene therapy.

    Additional Business Update:

    The company also announced today that Mike Bonney resigned from the company's Board of Directors and its committees, effective August 3, 2021, to focus on his newly expanded role as Executive Chair of Alnylam Pharmaceuticals, Inc. The resignation was not the result of any disagreement with the company nor any of its affiliates on any matter relating to the company's operations, policies or practices. In connection with Mr. Bonney's resignation, the size of the Board was reduced from 10 members to nine members and Alison Lawton, currently a member of the Board, was appointed Chair of the Board, and Jeff Albers, also a current member of the Board, was appointed to the Board's audit committee.

    "I would like to thank Mike for his contribution to Magenta's success through the years," commented Dr. Gardner. "We are grateful for his support and wish him the very best in the future. We are also extremely pleased to announce the expansion of Alison's role as Chair, bringing us more than 30 years of experience in the biopharmaceutical industry, as an executive and board member, as well as in a wide range of operational roles."

    Financial Results:

    Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2021 were $207.8 million, compared to $148.8 million as of December 31, 2020. Magenta anticipates that its cash, cash equivalents and marketable securities will be sufficient to fund operations and capital expenditures into Q3 2023.

    Research and Development Expenses: Research and development expenses were $11.1 million in Q2 2021, compared to $12.6 million in Q2 2020. The decrease was driven primarily by the completion of the GMP manufacturing activities to support the IND Application for MGTA-117 and future clinical trials.

    General and Administrative Expenses: General and administrative expenses were $6.5 million for Q2 2021, compared to $7.4 million for Q2 2020.

    Net Loss: Net loss was $16.9 million for Q2 2021, compared to net loss of $19.1 million for Q2 2020.

    About Magenta Therapeutics

    Magenta Therapeutics is a clinical-stage biotechnology company developing medicines to bring the curative power of stem cell transplants to more patients with blood cancers, genetic diseases and autoimmune diseases. Magenta is combining leadership in stem cell biology and biotherapeutics development with clinical and regulatory expertise, a unique business model and broad networks in the stem cell transplant community to revolutionize immune reset for more patients.

    Magenta is based in Cambridge, Massachusetts. For more information, please visit www.magentatx.com.

    Follow Magenta on Twitter: @magentatx.

    Forward-Looking Statement

    This press release may contain forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws, including express or implied statements regarding Magenta's future expectations, plans and prospects, including, without limitation, statements regarding expectations and plans for presenting pre-clinical and clinical data, the development of a biomarker assay, working with the FDA to resolve the clinical hold on the MGTA-117 Phase 1/2 clinical trial, projections regarding future revenues and financing performance, long-term growth, cash, cash equivalents and marketable securities, the anticipated timing of clinical trials and regulatory filings, the initiation of clinical trials or the results of ongoing and planned clinical trials, the development of product candidates and advancement of preclinical programs, the potential benefits of product candidates, the timing, progress and success of collaborations, as well as other statements containing the words "anticipate," "believe," "continue," "could," "endeavor," "estimate," "expect," "anticipate," "intend," "may," "might," "plan," "potential," "predict," "project," "seek," "should," "target," "will" or "would" and similar expressions that constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995. The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical studies; the development of biomarker assays; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials; the expected timing of submissions for regulatory approval or review by governmental authorities; discussions with governmental agencies such as the FDA; regulatory approvals to conduct trials or to market products; whether Magenta's cash resources will be sufficient to fund Magenta's foreseeable and unforeseeable operating expenses and capital expenditure requirements; risks, uncertainties and assumptions regarding the impact of the continuing COVID-19 pandemic on Magenta's business, operations, strategy, goals and anticipated timelines, Magenta's ongoing and planned preclinical activities, Magenta's ability to initiate, enroll, conduct or complete ongoing and planned clinical trials, Magenta's timelines for regulatory submissions and Magenta's financial position; and other risks concerning Magenta's programs and operations are described in additional detail in its Annual Report on Form 10-K filed on March 3, 2021, as updated by Magenta's most recent Quarterly Report on Form 10-Q, and its other filings made with the Securities and Exchange Commission from time to time. Although Magenta's forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Magenta. As a result, you are cautioned not to rely on these forward-looking statements. Any forward-looking statement made in this press release speaks only as of the date on which it is made. Magenta undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

    Magenta Therapeutics, Inc.       
                     
    STATEMENTS OF OPERATIONS       
    (unaudited)      
    (In thousands, except share and per share data)       
                 
        Three Months Ended June 30,   Six Months Ended June 30,
       

     

     

     

     

     

     

     

    Operating expenses:                
    Research and development  

     $                   11,129

     

     $                   12,610

     

     $                   22,857

     

     $                   26,573

    General and administrative  

                            6,481

     

                            7,402

     

                          13,450

     

                          14,683

    Total operating expenses  

                          17,610

     

                          20,012

     

                          36,307

     

                          41,256

    Loss from operations  

                         (17,610)

     

                         (20,012)

     

                         (36,307)

     

                         (41,256)

    Interest and other income, net  

                               682

     

                               933

     

                            1,890

     

                            2,166

    Net loss  

     $                  (16,928)

     

     $                  (19,079)

     

     $                  (34,417)

     

     $                  (39,090)

    Net loss per share, basic and diluted  

     $                      (0.32)

     

     $                      (0.48)

     

     $                      (0.67)

     

     $                      (0.99)

    Weighted average common shares outstanding, basic and diluted  

                   53,705,289

     

                   39,611,837

     

                   51,150,391

     

                   39,488,137

                     
                     
    BALANCE SHEET DATA      
    (unaudited)      
    (In thousands)       
                 
        June 30, 2021    December 31, 2020        
    Cash, cash equivalents and marketable securities  

     $                 207,805

     

     $                 148,835

           
    Working capital  

                        199,103

     

                        140,097

           
    Total assets  

                        220,378

     

                        161,619

           
    Stockholders' equity   

                        202,892

     

                        143,906

           

     

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  3. Magenta Therapeutics, Inc. (NASDAQ:MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplants to more patients, today announced that the company will participate in the following August investor conferences:

    • BTIG Virtual Biotechnology Conference, presentation at 12:00 p.m. ET on Monday, August 9
    • 2021 Wedbush PacGrow Healthcare Virtual Conference, panel: So Let it Be (Re)Written - Updates in Gene Modulation at 9:10 a.m. ET on Tuesday, August 10

    Additional information can be found on the Magenta Therapeutics website at https://investor.magentatx.com/events-and-presentations.

    About Magenta Therapeutics

    Magenta Therapeutics is a clinical-stage biotechnology company developing…

    Magenta Therapeutics, Inc. (NASDAQ:MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplants to more patients, today announced that the company will participate in the following August investor conferences:

    • BTIG Virtual Biotechnology Conference, presentation at 12:00 p.m. ET on Monday, August 9
    • 2021 Wedbush PacGrow Healthcare Virtual Conference, panel: So Let it Be (Re)Written - Updates in Gene Modulation at 9:10 a.m. ET on Tuesday, August 10

    Additional information can be found on the Magenta Therapeutics website at https://investor.magentatx.com/events-and-presentations.

    About Magenta Therapeutics

    Magenta Therapeutics is a clinical-stage biotechnology company developing medicines designed to bring the curative power of stem cell transplant to more patients with blood cancers, genetic diseases and autoimmune diseases. Magenta is combining leadership in stem cell biology and biotherapeutics development with clinical and regulatory expertise, a unique business model and broad networks in the stem cell transplant community to revolutionize immune reset for more patients.

    Magenta is based in Cambridge, Mass. For more information, please visit www.magentatx.com.

    Follow Magenta on Twitter: @magentatx.

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    • Sema4 Holdings Corp ("Sema4") to debut on Nasdaq as a publicly traded company dedicated to transforming healthcare by applying artificial intelligence and machine learning to multidimensional, longitudinal clinical and genomic data to build dynamic models of human health
    • Business combination expected to result in ~$500 million in cash proceeds to Sema4 to accelerate organic and inorganic growth
    • Combined company to trade on Nasdaq under ticker "SMFR"

    STAMFORD, Conn., July 22, 2021 (GLOBE NEWSWIRE) -- Sema4, a patient-centered health intelligence company leveraging AI and machine learning to derive data-driven insights, today announced the completion of its business combination with CM Life Sciences (NASDAQ:CMLF), a special purpose acquisition…

    • Sema4 Holdings Corp ("Sema4") to debut on Nasdaq as a publicly traded company dedicated to transforming healthcare by applying artificial intelligence and machine learning to multidimensional, longitudinal clinical and genomic data to build dynamic models of human health

    • Business combination expected to result in ~$500 million in cash proceeds to Sema4 to accelerate organic and inorganic growth
    • Combined company to trade on Nasdaq under ticker "SMFR"

    STAMFORD, Conn., July 22, 2021 (GLOBE NEWSWIRE) -- Sema4, a patient-centered health intelligence company leveraging AI and machine learning to derive data-driven insights, today announced the completion of its business combination with CM Life Sciences (NASDAQ:CMLF), a special purpose acquisition company (SPAC) sponsored by affiliates of Casdin Capital, LLC and Corvex Management LP. The resulting combined company, Sema4 Holdings Corp ("Sema4"), will commence trading of its shares of common stock and warrants on the Nasdaq Global Select Market under the ticker symbols "SMFR" and "SMFRW" on July 23, 2021. The merger was approved by the stockholders of CM Life Sciences on July 21, 2021.

    Eric Schadt, Ph.D., Founder and Chief Executive Officer of Sema4, and Sema4's current executive team will continue to lead the combined company. Sema4 intends to use the influx of capital – approximately $500 million in cash proceeds – to support its organic operating needs and capitalize on inorganic opportunities to accelerate growth through the acquisition of complementary businesses.

    "The completion of our merger with CM Life Sciences, and being listed on Nasdaq as a publicly traded company, is a major milestone for Sema4 and our employees, partners, and patients," said Dr. Schadt. "With the capital raised from this successful transaction, we are well positioned to help further close the gap between the practice of medicine and the availability of more clinically actionable guidance in order to improve the standard of care. We look forward to continuing to develop and scale our innovative health intelligence platform to enable health systems in delivering precision medicine as the standard of care."

    "With the merger now complete, Sema4 can really step on the gas and accelerate its powerful business model," said Eli Casdin, former Chief Executive Officer of CM Life Sciences. "This is a unique company set to transform healthcare by leveraging genomic and clinical data with artificial intelligence and machine learning to deliver an enhanced understanding of disease and wellness. I'm excited to be a partner with Eric and his extraordinary team as they embark on this next chapter as a public company."

    "Sema4 is a unique business with a rarely seen combination of impressive scale, growth, and innovation," said Keith Meister, former Chairman of CM Life Sciences. "The additional capital from this transaction will help Sema4 further advance its relationships and partnerships with health systems and biopharmaceutical entities over the next several years. While there are many companies seeking to harness the potential of big data in healthcare, Sema4 has built a differentiated data ecosystem and platform driving personalized medicine and improved health outcomes."

    Following the business combination, the Sema4 Board of Directors includes several prominent executives previously unaffiliated with Sema4: Eli Casdin, Emily Leproust, Chief Executive Officer of Twist Biosciences (NASDAQ:TWST), Jason Ryan, most recently Chief Operating and Financial Officer of Magenta Therapeutics (NASDAQ:MGTA), and Nat Turner, co-founder of Flatiron Health (a Roche company). They join directors Dennis Charney, Michael Pellini, Joshua Ruch, Dr. Schadt, and Rachel Sherman.

    Advisors

    Goldman Sachs & Co. LLC and J.P. Morgan Securities LLC served as financial advisors to Sema4. Fenwick & West LLP served as legal advisor to Sema4.

    Jefferies LLC acted as sole financial advisor, lead capital markets advisor, and sole placement agent to CM Life Sciences, with Cowen and Company, LLC also acting as a capital markets advisor. White & Case LLP served as legal advisor to CM Life Sciences.

    About Sema4

    Sema4 is a patient-centered health intelligence company dedicated to advancing healthcare through data-driven insights. Sema4 is transforming healthcare by applying AI and machine learning to multidimensional, longitudinal clinical and genomic data to build dynamic models of human health and defining optimal, individualized health trajectories. Centrellis™, our innovative health intelligence platform, is enabling us to generate a more complete understanding of disease and wellness and to provide science-driven solutions to the most pressing medical needs. Sema4 believes that patients should be treated as partners, and that data should be shared for the benefit of all.

    For more information, please visit sema4.com and connect with Sema4 on Twitter, LinkedIn, Facebook and YouTube.

    About CM Life Sciences

    Prior to the business combination, CM Life Sciences was founded to take advantage of a dynamic life science sector buoyed by innovation yet fragmented, where many companies were under-resourced and under-scaled. Significant and under-appreciated opportunities for consolidation were ready for engagement by a team versed in the trends and themes, and who could bring together the strongest of the new companies and management teams to capitalize on near- and far-term opportunities. 

    Forward Looking Statements

    This press release contains certain forward-looking statements within the meaning of the federal securities laws, including statements regarding the anticipated benefits of the business combination and the anticipated use of proceeds from the business combination. These forward-looking statements generally are identified by the words "believe," "project," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to: (i) the ability to implement business plans, forecasts, and other expectations after the completion of the business combination, and identify and realize additional opportunities, (ii) the risk of downturns and a changing regulatory landscape in the highly competitive healthcare industry and (iii) the size and growth of the market in which Sema4 operates. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of CM Life Sciences' definitive proxy statement on Schedule 14A filed with the U.S. Securities and Exchange Commission (the "SEC") on July 2, 2021 and other documents filed by Sema4 from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Sema4 assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Sema4 does give any assurance that Sema4 will achieve its expectations.

    Sema4 Investor Relations Contact:

    David Deuchler

    Gilmartin Group

    investors@sema4.com

    Sema4 Media Contact:

    Radley Moss

    Sema4

    radley.moss@sema4.com

    CM Life Sciences Media Contact:

    Alexandria Fisk

    Casdin Capital

    afisk@casdincapital.com 



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  4. Magenta Therapeutics, Inc. (NASDAQ:MGTA) today announced that it has received a clinical hold letter from the U.S. Food and Drug Administration (FDA) related to its Investigational New Drug Application (IND) filed in June 2021 to initiate a Phase 1/2 clinical trial of MGTA-117 in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

    The FDA is requiring that Magenta develop an additional bioassay to be used in conjunction with the PK/PD model to inform dose escalation decisions in addition to safety monitoring. This was the only clinical hold item identified by the FDA and does not relate to the toxicology or manufacturing of MGTA-117. Magenta has initiated the development of the bioassay and intends to work closely…

    Magenta Therapeutics, Inc. (NASDAQ:MGTA) today announced that it has received a clinical hold letter from the U.S. Food and Drug Administration (FDA) related to its Investigational New Drug Application (IND) filed in June 2021 to initiate a Phase 1/2 clinical trial of MGTA-117 in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

    The FDA is requiring that Magenta develop an additional bioassay to be used in conjunction with the PK/PD model to inform dose escalation decisions in addition to safety monitoring. This was the only clinical hold item identified by the FDA and does not relate to the toxicology or manufacturing of MGTA-117. Magenta has initiated the development of the bioassay and intends to work closely with the FDA to determine the application of the bioassay for dose escalation. The FDA has indicated its willingness to continue its engagement on this issue through its "Type A" meeting structure, which Magenta anticipates will help facilitate communication and resolution of the clinical hold.

    "We are actively developing the bioassay requested by the FDA and do not expect significant technical challenges in its completion. We expect to request a ‘Type A' meeting in the coming weeks and, if successful in resolving this remaining issue, we would anticipate opening the study in Q4 2021," said Jason Gardner, D.Phil., President and Chief Executive Officer, Magenta Therapeutics. "We are greatly appreciative of the FDA's continued engagement as we seek to commence the Phase 1/2 clinical trial of MGTA-117 and develop this potentially first-in-class medicine to improve conditioning options for patients across a number of disease areas."

    The Phase 1/2 clinical trial of MGTA-117 is intended as an initial evaluation of its safety, pharmacokinetics (PK) and pharmacodynamics (PD) as a single agent in the relapsed/refractory AML and MDS patient population. Magenta anticipates transitioning the study to transplant-eligible patients after adequate data related to the safety, PK and PD of MGTA-117 have been collected in the relapsed/refractory AML and MDS patient population. Magenta also expects to develop MGTA-117 as a targeted conditioning agent for patients with genetic diseases prior to delivery of ex vivo gene therapies.

    Magenta ended Q2 2021 with more than $200 million in cash following its recent financing in May 2021 and anticipates being able to execute on its existing plans.

    About MGTA-117

    Magenta's MGTA-117 program is the Company's lead targeted conditioning product candidate, an antibody-drug conjugate (ADC) designed to selectively deplete hematopoietic stem cells (HSCs) from patients prior to transplant or HSC-based gene therapy to reduce the need for high-dose or high-intensity chemotherapeutic agents or, in the case of gene therapy applications, to potentially eliminate the need for chemotherapeutic agents altogether. MGTA-117 targets the CD117 receptor, which is highly expressed on the cell surface of HSCs and leukemia cells, making it a promising target for conditioning across broad sets of diseases, including certain blood cancers, hemoglobinopathies (sickle cell disease and beta thalassemia) and inherited metabolic disorders.

    About Magenta Therapeutics

    Magenta Therapeutics is a clinical-stage biotechnology company developing medicines designed to bring the curative power of stem cell transplant to more patients with blood cancers, genetic diseases and autoimmune diseases. Magenta is combining leadership in stem cell biology and biotherapeutics development with clinical and regulatory expertise, a unique business model and broad networks in the stem cell transplant community to revolutionize immune reset for more patients.

    Magenta is based in Cambridge, Mass. For more information, please visit www.magentatx.com.

    Follow Magenta on Twitter: @magentatx.

    Forward-Looking Statement

    This press release may contain forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws, including express or implied statements regarding Magenta's future expectations, plans and prospects, including, without limitation, statements regarding expectations and plans for the development of a biomarker assay, working with the FDA to resolve the clinical hold, the anticipated timing of regulatory filings and clinical trials, the transition of the Phase 1/2 trial to transplant-eligible patients, the development of product candidates and advancement of preclinical programs, the potential benefits of our product candidates, as well as other statements containing the words "anticipate," "believe," "continue," "could," "endeavor," "estimate," "expect," "anticipate," "intend," "may," "might," "plan," "potential," "predict," "project," "seek," "should," "target," "will" or "would" and similar expressions that constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995. The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical studies; the development of biomarker assays; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials; the expected timing of submissions for regulatory approval or review by governmental authorities; discussions with governmental agencies such as the FDA; regulatory approvals to conduct trials or to market products; whether Magenta's cash resources will be sufficient to fund Magenta's foreseeable and unforeseeable operating expenses and capital expenditure requirements, risks, uncertainties and assumptions regarding the impact of the continuing COVID-19 pandemic on Magenta's business, operations, strategy, goals and anticipated timelines, Magenta's ongoing and planned preclinical activities, Magenta's ability to initiate, enroll, conduct or complete ongoing and planned clinical trials, Magenta's timelines for regulatory submissions and Magenta's financial position; and other risks concerning Magenta's programs and operations are described in additional detail in its Annual Report on Form 10-K filed on March 3, 2021, as updated by Magenta's most recent Quarterly Report on Form 10-Q, and its other filings made with the Securities and Exchange Commission from time to time. Although Magenta's forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Magenta. As a result, you are cautioned not to rely on these forward-looking statements. Any forward-looking statement made in this press release speaks only as of the date on which it is made. Magenta undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

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