SANA Sana Biotechnology Inc.

23.7
+0.13  (+1%)
Previous Close 23.57
Open 23.64
52 Week Low 16.09
52 Week High 44.6
Market Cap $4,453,011,368
Shares 187,890,775
Float 86,120,424
Enterprise Value $3,912,828,559
Volume 1,328,266
Av. Daily Volume 1,006,580
Stock charts supplied by TradingView

Latest News

  1. SEATTLE, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ:SANA), a company focused on creating and delivering engineered cells as medicines, today announced that it will webcast its presentation at the Morgan Stanley 19th Annual Global Healthcare Conference at 2:00 p.m. PT on Monday, September 13, 2021. The presentation will feature a business overview and update by Steve Harr, Sana's President and Chief Executive Officer.

    The webcast will be accessible on the Investor Relations page of Sana's website at https://sana.com/. A replay of the presentation will be available at the same location for 30 days following the conference.

    About Sana Biotechnology
    Sana Biotechnology, Inc. is focused on creating and delivering engineered…

    SEATTLE, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ:SANA), a company focused on creating and delivering engineered cells as medicines, today announced that it will webcast its presentation at the Morgan Stanley 19th Annual Global Healthcare Conference at 2:00 p.m. PT on Monday, September 13, 2021. The presentation will feature a business overview and update by Steve Harr, Sana's President and Chief Executive Officer.

    The webcast will be accessible on the Investor Relations page of Sana's website at https://sana.com/. A replay of the presentation will be available at the same location for 30 days following the conference.

    About Sana Biotechnology

    Sana Biotechnology, Inc. is focused on creating and delivering engineered cells as medicines for patients. We share a vision of repairing and controlling genes, replacing missing or damaged cells, and making our therapies broadly available to patients. We are more than 320 people working together to create an enduring company that changes how the world treats disease. Sana has operations in Seattle, Cambridge, and South San Francisco. For more information about Sana Biotechnology, please visit https://sana.com/.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements about Sana Biotechnology, Inc. (the "Company," "we," "us," or "our") within the meaning of the federal securities laws, including those related to the Company's vision, the Company's participation in the Morgan Stanley 19th Annual Global Healthcare Conference and the subject matter of the Company's presentation at that conference. All statements other than statements of historical facts contained in this press release, including, among others, statements regarding the Company's strategy, expectations, cash runway and future financial condition, future operations, and prospects, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "design," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "positioned," "potential," "predict," "seek," "should," "target," "will," "would" and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results to vary materially, including, among others, the risks inherent in drug development such as those associated with the initiation, cost, timing, progress and results of the Company's current and future research and development programs, preclinical and clinical trials, as well as the economic, market and social disruptions due to the ongoing COVID-19 public health crisis. For a detailed discussion of the risk factors that could affect the Company's actual results, please refer to the risk factors identified in the Company's SEC reports, including but not limited to its Annual Report on Form 10-K dated March 24, 2021 and Quarterly Report on Form 10-Q dated August 4, 2021. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.

    Investor Relations:

    Nicole Keith

    investor.relations@sana.com

    Media:

    Morgan Warners, Finsbury Glover Hering

    media@sana.com



    Primary Logo

    View Full Article Hide Full Article
  2. GAITHERSBURG, Md., Aug. 9, 2021 /PRNewswire/ -- MaxCyte, Inc. (NASDAQ:MXCT) (LSE: MXCT, MXCN), a leading provider of cell-engineering platform technologies, today announced the signing of a clinical and commercial license with Sana Biotechnology, Inc. (NASDAQ:SANA), a company focused on creating and delivering engineered cells as medicines.

    Under the terms of the agreement, Sana Biotechnology obtains non-exclusive clinical and commercial rights to use MaxCyte's Flow Electroporation® technology and ExPERT™ platform. In return, MaxCyte is entitled to receive platform licensing fees and program-related milestone payments.

    Doug Doerfler, President and CEO of MaxCyte, said: "We are delighted to support Sana's ex vivo cell therapy programs and recognize…

    GAITHERSBURG, Md., Aug. 9, 2021 /PRNewswire/ -- MaxCyte, Inc. (NASDAQ:MXCT) (LSE: MXCT, MXCN), a leading provider of cell-engineering platform technologies, today announced the signing of a clinical and commercial license with Sana Biotechnology, Inc. (NASDAQ:SANA), a company focused on creating and delivering engineered cells as medicines.

    Under the terms of the agreement, Sana Biotechnology obtains non-exclusive clinical and commercial rights to use MaxCyte's Flow Electroporation® technology and ExPERT™ platform. In return, MaxCyte is entitled to receive platform licensing fees and program-related milestone payments.

    Doug Doerfler, President and CEO of MaxCyte, said: "We are delighted to support Sana's ex vivo cell therapy programs and recognize the potential of the company's novel hypoimmune cell platform to advance treatments for serious diseases. This agreement represents an important achievement for MaxCyte as we continue to expand the use of our next-generation technology platform to support the development of innovative treatments." 

    MaxCyte's ExPERT instrument portfolio represents the next generation of leading, clinically-validated, electroporation technology for complex and scalable cell engineering. By delivering high transfection efficiency, seamless scalability and enhanced functionality, the ExPERT platform delivers the high-end performance essential to enable the next wave of biological and cellular therapeutics.

    About MaxCyte

    MaxCyte is a leading provider of cell-engineering platform technologies to advance innovative cell-based research, development and potential commercialization of next-generation cell therapies. The Company's existing customer base ranges from large biopharmaceutical companies — including 20 of the top 25 pharmaceutical companies based on 2020 global revenue — to hundreds of biotechnology companies and academic translational centers. MaxCyte has granted 14 strategic platform licenses to commercial cell therapy developers that allow for more than 75 clinical programs. Founded in 1998, MaxCyte is headquartered in Gaithersburg, Maryland, US.

    MaxCyte Contacts:







    MaxCyte Inc.

    Doug Doerfler, Chief Executive Officer

    Amanda Murphy, Chief Financial Officer

    +1 301-944-1660





    Nominated Adviser and Joint Corporate Broker

    Panmure Gordon

    Emma Earl / Freddy Crossley

    Corporate Broking

    Rupert Dearden

    +44 (0)20 7886 2500

    Joint Corporate Broker

    Numis Securities Limited

    James Black / Duncan Monteith / Matthew  O'Dowd

    +44 (0)20 7260 1000





    Joint Corporate Broker

    Stifel Nicolaus Europe Limited

    Healthcare Investment Banking

    Nicholas Moore / Ben Maddison / Samira Essebiyea

    Corporate Broking

    Nick Adams

    +44 (0)20 7710 7600





    UK IR Adviser

    Consilium Strategic Communications

    Mary-Jane Elliott

    Chris Welsh

    +44 (0)203 709 5700

    maxcyte@consilium-comms.com

    US IR Adviser

    Gilmartin Group

    David Deuchler, CFA

    +1 415-937-5400 

     ir@maxcyte.com





    US Media Relations

    Jamie Lacey-Moreira

    PressComm PR, LLC

    +1 410-299-3310

    jamielacey@presscommpr.com

    Cision View original content:https://www.prnewswire.com/news-releases/maxcyte-signs-clinical-and-commercial-license-with-sana-biotechnology-301350765.html

    SOURCE Maxcyte, Inc.

    View Full Article Hide Full Article
  3. Presented data showing immune evasion and survival after transplantation of allogeneic cells into primates without immune suppression at ISSCR 2021

    Entered long-term lease to establish manufacturing facility in San Francisco Bay Area

    Q2 2021 cash position of $930.8 million

    SEATTLE, Aug. 04, 2021 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ:SANA), a company focused on creating and delivering engineered cells as medicines, today reported financial results and business highlights for the second quarter of 2021.

    "We continue to be pleased with the progress across our in vivo and ex vivo technology platforms and programs as well as our progress in recruiting great people and building the infrastructure necessary to achieve our long-term…

    Presented data showing immune evasion and survival after transplantation of allogeneic cells into primates without immune suppression at ISSCR 2021

    Entered long-term lease to establish manufacturing facility in San Francisco Bay Area

    Q2 2021 cash position of $930.8 million

    SEATTLE, Aug. 04, 2021 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ:SANA), a company focused on creating and delivering engineered cells as medicines, today reported financial results and business highlights for the second quarter of 2021.

    "We continue to be pleased with the progress across our in vivo and ex vivo technology platforms and programs as well as our progress in recruiting great people and building the infrastructure necessary to achieve our long-term vision of using engineered cells as medicines," said Steve Harr, Sana's President and Chief Executive Officer. "In the second quarter, we presented data demonstrating the survival and immune evasion for transplanted hypoimmune cells into non-human primates without immunosuppression, an important step in enabling the use of engineered cells as medicines more broadly across multiple diseases. We also signed a long-term lease to enable the build out of a clinical trial and commercial manufacturing facility capable of supporting our broad pipeline. I would particularly like to thank the Sana team, who despite the ongoing complex operating environment of COVID continues to make progress in moving our product candidates forward, with a goal of beginning human studies for multiple medicines per year beginning as early as next year."

    Recent Corporate Highlights

    • Presented data showing survival of transplanted stem cells in non-human primates without immunosuppression at a plenary session at the International Society for Stem Cell Research 2021 Virtual Annual Meeting. The transplanted cells incorporated Sana's hypoimmune gene modifications that enable immune evasion, demonstrating a key step toward widespread treatment of disease using engineered cells.
    • Announced a lease agreement to develop a 163,000 square foot manufacturing facility in Fremont, California to support the manufacture of late-stage clinical development and early commercial product candidates across our technology platforms.

    Second Quarter 2021 Financial Results

    GAAP Results

    • Cash Position: Cash, cash equivalents, and marketable securities as of June 30, 2021 were $930.8 million compared to $412.0 million as of December 31, 2020, an increase of $518.8 million. Sana successfully completed its initial public offering in February 2021 and issued 27.0 million shares of common stock, including 3.5 million shares pursuant to the full exercise of the underwriters' option to purchase additional shares, at a price of $25.00 per share, for net proceeds of $626.4 million.
    • Research and Development Expenses: For the three and six months ended June 30, 2021, research and development expense, inclusive of non-cash expenses, was $45.0 million and $86.9 million, respectively, compared to $30.0 million and $56.4 million for the same periods in 2020. The increases of $15.0 million and $30.5 million for the three and six months ended June 30, 2021, respectively, were due to an increase in personnel expenses related to increased headcount to expand Sana's research and development capabilities, costs for preclinical studies, costs for laboratory supplies, and facility costs. Research and development expenses include non-cash stock-based compensation of $3.1 million and $5.8 million for the three and six months ended June 30, 2021, respectively, and $0.9 million and $1.6 million for the same periods in 2020.
    • Research and Development Related Success Payments and Contingent Consideration: For the three and six months ended June 30, 2021, we recognized a gain of $76.0 million and an expense of $51.0 million, respectively, in connection with the change in the estimated fair value of the success payment liabilities and contingent consideration, compared to $51.9 million and $52.8 million for the same periods in 2020. For the three and six months ended June 30, 2021, we recognized a gain of $83.2 million and an expense of $32.4 million, respectively, in connection with the change in the estimated fair value of the success payment liabilities, compared to expenses of $37.9 million and $38.5 million for the same periods in 2020. The decreases of $121.1 million and $6.1 million during the three and six months ended June 30, 2021, respectively, were due to changes in our market capitalization and stock price during the relative periods. For the three and six months ended June 30, 2021, we recognized expenses of $7.2 million and $18.6 million, respectively, in connection with the change in the estimated fair value of contingent consideration and $14.0 million and $14.3 million, respectively, for the same periods in 2020. The decrease of $6.8 million during the three months ended June 30, 2021 and the increase of $4.3 million during the six months ended June 30, 2021 were due to changes in the discount rate and scientific progress made toward the achievement of milestones during the relative periods.
    • General and Administrative Expenses: General and administrative expenses for the three and six months ended June 30, 2021, inclusive of non-cash expenses, were $12.5 million and $24.3 million, respectively, compared to $6.0 million and $12.0 million for the same periods in 2020. The increases of $6.5 million and $12.3 million in the three and six months ended June 30, 2021, respectively, were primarily due to increased personnel-related expenses attributable to an increase in headcount to build our infrastructure, legal fees to support our patent portfolio and license arrangements, insurance associated with being a public company, consulting fees, and facility costs. General and administrative expenses include stock-based compensation of $1.8 million and $3.3 million for the three and six months ended June 30, 2021, respectively, and $0.2 million and $0.3 million for the same periods in 2020.
    • Net Income (Loss): Net income for the three months ended June 30, 2021 was $18.7 million, or $0.10 per share, and net loss for the six months ended June 30, 2021 was $161.9 million, or $1.08 per share, compared to net losses of $87.8 million, or $7.18 per share, and $120.7 million, or $10.47 per share, for the same periods in 2020.

    Non-GAAP Measures

    • Non-GAAP Operating Cash Burn: Non-GAAP operating cash burn for the six months ended June 30, 2021 was $89.8 million compared to $56.9 million for the six months June 30, 2020. Non-GAAP operating cash burn is the decrease in cash, cash equivalents, and marketable securities excluding cash inflows from financing activities, cash outflows from business development activities, and the purchase of property and equipment.
    • Non-GAAP Research and Development Expenses: Non-GAAP research and development expenses for the three and six months ended June 30, 2021 were $45.0 million and $86.9 million, respectively, compared to $28.9 million and $55.0 million for the same periods in 2020. Non-GAAP research and development expenses excludes one-time costs to acquire technology.
    • Non-GAAP Net Loss: Non-GAAP net loss for the three and six months ended June 30, 2021 was $57.3 million, or $0.32 per share, and $110.9 million, or $0.74 per share, compared to $34.8 million, or $2.85 per share, and $66.4 million, or $5.76 per share, for the same periods in 2020. Non-GAAP net loss excludes one-time costs to acquire technology and non-cash expenses related to the change in the estimated fair value of contingent consideration and success payment liabilities.

    A discussion of non-GAAP measures, including a reconciliation of GAAP and non-GAAP measures, is presented below under "Non-GAAP Financial Measures."

    About Sana

    Sana Biotechnology, Inc. is focused on creating and delivering engineered cells as medicines for patients. We share a vision of repairing and controlling genes, replacing missing or damaged cells, and making our therapies broadly available to patients. We are more than 320 people working together to create an enduring company that changes how the world treats disease. Sana has operations in Seattle, Cambridge, and South San Francisco.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements about Sana Biotechnology, Inc. (the "Company," "we," "us," or "our") within the meaning of the federal securities laws, including those related to the Company's vision, progress, and business plans; expectations for its development programs, product candidates and technology platforms, including its pre-clinical, clinical and regulatory development plans and timing expectations; the ability to make hypoimmune-modified induced pluripotent stem cells that survive and evade the immune system without immunosuppression; the ability to treat diseases using the Company's hypoimmune platform technology; its manufacturing plans and strategy; and expectations with respect to the manufacturing capabilities of the facility. All statements other than statements of historical facts contained in this press release, including, among others, statements regarding the Company's strategy, expectations, cash runway and future financial condition, future operations, and prospects, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "design," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "positioned," "potential," "predict," "seek," "should," "target," "will," "would" and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results to vary materially, including, among others, the risks inherent in drug development such as those associated with the initiation, cost, timing, progress and results of the Company's current and future research and development programs, preclinical and clinical trials, as well as the economic, market and social disruptions due to the ongoing COVID-19 public health crisis. For a detailed discussion of the risk factors that could affect the Company's actual results, please refer to the risk factors identified in the Company's SEC reports, including but not limited to its Annual Report on Form 10-K dated March 24, 2021 and Quarterly Report on Form 10-Q dated August 5, 2021. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.

    Investor Relations:

    Nicole Keith

    investor.relations@sana.com 

    Media:

    Morgan Warners, Finsbury Glover Hering

    media@sana.com 



    Sana Biotechnology, Inc.

    Unaudited Selected Consolidated Balance Sheet Data

      June 30, 2021  December 31, 2020 
      (in thousands) 
    Cash, cash equivalents, and marketable securities $930,770  $411,995 
    Total assets  1,259,837   730,296 
    Contingent consideration  140,457   121,901 
    Success payment liabilities  108,963   76,494 
    Total liabilities  353,940   298,583 
    Convertible preferred stock  -   852,897 
    Total stockholders' equity (deficit)  905,897   (421,184)



    Sana Biotechnology, Inc.

    Unaudited Consolidated Statements of Operations

      Three Months Ended June 30,  Six Months Ended June 30, 
      2021  2020  2021  2020 
      (in thousands, except per share data) 
    Operating expenses (gains):                
    Research and development $44,996  $29,991  $86,876  $56,397 
    Research and development related success payments and contingent consideration  (76,025)  51,906   51,025   52,820 
    General and administrative  12,477   6,009   24,298   11,964 
    Total operating expenses (gains)  (18,552)  87,906   162,199   121,181 
    Gain (loss) from operations  18,552   (87,906)  (162,199)  (121,181)
    Interest income, net  130   79   251   474 
    Other income, net  1   19   14   24 
    Net income (loss) $18,683  $(87,808) $(161,934) $(120,683)
    Net income (loss) per share - basic $0.10  $(7.18) $(1.08) $(10.47)
    Weighted-average shares outstanding - basic  179,899   12,232   149,683   11,526 
    Net income (loss) per share - diluted $0.09  $(7.18) $(1.08) $(10.47)
    Weighted-average shares outstanding - diluted  190,508   12,232   149,683   11,526 



    Sana Biotechnology, Inc.

    Changes in the Estimated Fair Value of Success Payments and Contingent Consideration

      Success Payment

    Liability(1)
      Contingent

    Consideration(2)
      Total Success Payment Liability and Contingent Consideration 
      (in thousands) 
    Liability balance as of December 31, 2020 $76,494  $121,901  $198,395 
    Changes in fair value - expense (gain)  115,657   11,393   127,050 
    Liability balance as of March 31, 2021  192,151   133,294   325,445 
    Changes in fair value - expense (gain)  (83,188)  7,163   (76,025)
    Liability balance as of June 30, 2021 $108,963  $140,457  $249,420 
    Total change in fair value for the six months ended June 30, 2021 $32,469  $18,556  $51,025 



    (1)Cobalt Biomedicine, Inc. (Cobalt) and the Presidents of Harvard College (Harvard) are entitled to success payments pursuant to the terms of their agreements. The success payments are recorded at fair value and remeasured at each reporting period with changes in the estimated fair value recorded in changes in research and development related success payments and contingent consideration on the statement of operations.
    (2)Cobalt is entitled to contingent consideration upon the achievement of certain milestones pursuant to the terms of the agreement. Contingent consideration is recorded at fair value and remeasured at each reporting period with changes in the estimated fair value recorded in changes in research and development related success payments and contingent consideration on the statement of operations.

    Non-GAAP Financial Measures

    To supplement the financial results presented in accordance with generally accepted accounting principles in the United States (GAAP), Sana uses certain non-GAAP financial measures to evaluate its business. Sana's management believes that these non-GAAP financial measures are helpful in understanding Sana's financial performance and potential future results, as well as providing comparability to peer companies and period over period. In particular, Sana's management utilizes non-GAAP operating cash burn, non-GAAP research and development expense and non-GAAP net loss and net loss per share. Sana believes the presentation of these non-GAAP measures provides management and investors greater visibility into the Company's ongoing actual costs to operate its business, including actual research and development costs unaffected by non-cash valuation changes and one-time expenses for acquiring technology, as well as facilitating a more meaningful comparison of period-to-period activity. Sana excludes these items because they are highly variable from period to period and, in respect of the non-cash expenses, provides investors with insight into the actual cash investment in the development of its therapeutic programs and platform technologies.

    These are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with Sana's financial statements prepared in accordance with GAAP. These non-GAAP measures differ from GAAP measures with the same captions, may be different from non-GAAP financial measures with the same or similar captions that are used by other companies, and do not reflect a comprehensive system of accounting. Sana's management uses these supplemental non-GAAP financial measures internally to understand, manage, and evaluate Sana's business and make operating decisions. In addition, Sana's management believes that the presentation of these non-GAAP financial measures is useful to investors because they enhance the ability of investors to compare Sana's results from period to period and allows for greater transparency with respect to key financial metrics Sana uses in making operating decisions. The following are reconciliations of GAAP to non-GAAP financial measures:



    Sana Biotechnology, Inc.

    Unaudited Reconciliation of Change in Cash, Cash Equivalents, and Marketable Securities to Non-GAAP Operating Cash Burn

      Six Months Ended June 30, 
      2021  2020 
      (in thousands) 
    Beginning cash, cash equivalents, and marketable securities $411,995  $138,982 
    Ending cash, cash equivalents, and marketable securities  930,770   503,375 
    Change in cash, cash equivalents, and marketable securities  518,775   364,393 
    Cash paid to purchase property and equipment  16,596   8,290 
    Change in cash, cash equivalents, and marketable securities, excluding capital expenditures  535,371   372,683 
    Adjustments:        
    Cash paid to acquire technology(1)  1,246   - 
    Cash paid to satisfy contingent liability(2)  -   6,000 
    Net proceeds received from the initial public offering of common stock  (626,405)  - 
    Net cash received from the sale of convertible preferred stock  -   (435,543)
    Operating cash burn - Non-GAAP $(89,788) $(56,860)



    (1)The non-GAAP adjustment of $1.2 million for the six months ended June 30, 2021 was the payment of the holdback amount related to the acquisition of Cytocardia, Inc. in November 2019.
    (2)The non-GAAP adjustment of $6.0 million for the six months ended June 30, 2020 was the payment of a contingent liability due to Harvard in connection with the closing of the Series B convertible preferred stock financing.



    Sana Biotechnology, Inc.

    Unaudited Reconciliation of GAAP to Non-GAAP Research and Development Expense

      Three Months Ended June 30,  Six Months Ended June 30, 
      2021  2020  2021  2020 
      (in thousands) 
    Research and development expense - GAAP $44,996  $29,991  $86,876  $56,397 
    Adjustments:                
    Change in the estimated fair value of contingent liability(1)  -   (1,070)  -   (1,443)
    Research and development expense - Non-GAAP $44,996  $28,921  $86,876  $54,954 

    (1) The contingent liability was recorded in connection with the Harvard license agreement and paid in June 2020.



    Sana Biotechnology, Inc.

    Unaudited Reconciliation of GAAP to Non-GAAP Net Loss and Net Loss Per Share

      Three Months Ended June 30,  Six Months Ended June 30, 
      2021  2020  2021  2020 
      (in thousands, except per share data) 
    Net income (loss) - GAAP $18,683  $(87,808) $(161,934) $(120,683)
    Adjustments:                
    Change in the estimated fair value of the success payment liabilities(1)  (83,188)  37,929   32,469   38,481 
    Change in the estimated fair value of contingent consideration(2)  7,163   13,977   18,556   14,339 
    Change in the estimated fair value of contingent liability(3)  -   1,070   -   1,443 
    Net loss - Non-GAAP $(57,342) $(34,832) $(110,909) $(66,420)
    Net income (loss) per share - GAAP(4) $0.10  $(7.18) $(1.08) $(10.47)
    Adjustments:                
    Change in the estimated fair value of the success payment liabilities(1)  (0.46)  3.10   0.22   3.34 
    Change in the estimated fair value of contingent consideration(2)  0.04   1.14   0.12   1.24 
    Change in the estimated fair value of contingent liability(3)  -   0.09   -   0.13 
    Net loss per share - Non-GAAP $(0.32) $(2.85) $(0.74) $(5.76)
    Weighted-average shares outstanding - basic  179,899   12,232   149,683   11,526 



    (1)For the three and six months ended June 30, 2021, the gain related to the Cobalt success payment liability was $66.6 million and the expense was $25.1 million, respectively, and for the three and six months ended June 30, 2020 the expenses were $33.5 million and $33.9 million, respectively. For the three and six months ended June 30, 2021 the gain related to the Harvard success payment liability was $16.6 million and the expense was $7.3 million, respectively, and for the three and six months ended June 30, 2020 the expenses were $4.4 million and $4.6, respectively.
    (2)The contingent consideration was recorded in connection with the acquisition of Cobalt.
    (3)The contingent liability was recorded in connection with the Harvard license agreement and paid in June 2020.
    (4)Diluted net income per share for the three months ended June 30, 2021 was $0.09.

     



    Primary Logo

    View Full Article Hide Full Article
  4. Facility to Support Allogeneic CAR T, Gene Therapy, and Stem Cell-Derived Therapies

    Facility Able to Support Clinical Trial and Early Commercial Launches of Multiple Programs

    State-of-the-Art Manufacturing Facility to be Located in San Francisco Bay Area

    SEATTLE, July 14, 2021 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ:SANA), a company focused on creating and delivering engineered cells as medicines, today announced that it has entered into a lease agreement to develop a 163,000 square foot manufacturing facility in Fremont, California. This facility will support the manufacture of Sana's late-stage clinical development and early commercial product candidates across the multiple technologies in Sana's pipeline.

    "Manufacturing…

    Facility to Support Allogeneic CAR T, Gene Therapy, and Stem Cell-Derived Therapies

    Facility Able to Support Clinical Trial and Early Commercial Launches of Multiple Programs

    State-of-the-Art Manufacturing Facility to be Located in San Francisco Bay Area

    SEATTLE, July 14, 2021 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ:SANA), a company focused on creating and delivering engineered cells as medicines, today announced that it has entered into a lease agreement to develop a 163,000 square foot manufacturing facility in Fremont, California. This facility will support the manufacture of Sana's late-stage clinical development and early commercial product candidates across the multiple technologies in Sana's pipeline.

    "Manufacturing remains a key bottleneck to the development and broad accessibility of cell- and gene-based medicines. This facility is a key component in enabling our aspirations to rapidly innovate, consistently manufacture, and scale production of these medicines," said Steve Harr, Sana's President and CEO. "Sana is making significant investments to create the scientific insights, supply chain stability, and operational capabilities to transform the potentially disruptive scientific insights of the cell and gene therapy field into important medicines for patients."

    The facility will be designed to provide manufacturing capabilities across Sana's portfolio, including allogeneic T cell, viral vector, and pluripotent stem cell production. The Fremont location allows close proximity to Sana's existing technical and scientific capabilities and access to a strong biotechnology talent base. As part of the company's holistic manufacturing strategy, Sana also intends to work with contract manufacturing partners to advance its product candidates to the clinic as early as next year.  

    About Sana Biotechnology

    Sana Biotechnology, Inc. is focused on creating and delivering engineered cells as medicines for patients. We share a vision of repairing and controlling genes, replacing missing or damaged cells, and making our therapies broadly available to patients. We are more than 300 people working together to create an enduring company that changes how the world treats disease. Sana has operations in Seattle, Cambridge, and South San Francisco. For more information about Sana Biotechnology, please visit https://sana.com/.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements about Sana Biotechnology, Inc. (the "Company," "we," "us," or "our") within the meaning of the federal securities laws, including those related to the Company's vision, progress, and business plans; expectations for its development programs, product candidates and technology platforms, including its pre-clinical, clinical and regulatory development plans and timing expectations; its manufacturing plans and strategy; and expectations with respect to the manufacturing capabilities of the facility. All statements other than statements of historical facts contained in this press release, including, among others, statements regarding the Company's strategy, expectations, cash runway and future financial condition, future operations, and prospects, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "design," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "positioned," "potential," "predict," "seek," "should," "target," "will," "would" and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results to vary materially, including, among others, the risks inherent in drug development such as those associated with the initiation, cost, timing, progress and results of the Company's current and future research and development programs, preclinical and clinical trials, as well as the economic, market and social disruptions due to the ongoing COVID-19 public health crisis. For a detailed discussion of the risk factors that could affect the Company's actual results, please refer to the risk factors identified in the Company's SEC reports, including but not limited to its Annual Report on Form 10-K dated March 24, 2021 and Quarterly Report on Form 10-Q dated May 5, 2021. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.

    All product and company names herein may be trademarks of their registered owners.

    Investor Relations:

    Nicole Keith

    investor.relations@sana.com

    Media:

    Morgan Warners, Finsbury Glover Hering

    media@sana.com



    Primary Logo

    View Full Article Hide Full Article
  5. First demonstration of the survival of allogeneic iPSCs transplanted into an immunocompetent non-human primate model without the need for immune suppression

    Transplanting allogeneic cells into a primate without immune suppression represents a key step toward widespread treatment of disease using engineered cells

    SEATTLE, June 26, 2021 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ:SANA), a company focused on creating and delivering engineered cells as medicines, today presented data showing survival of transplanted stem cells without immunosuppression in non-human primates (NHPs). The transplanted cells were induced pluripotent stem cells (iPSCs) with Sana's hypoimmune gene modifications that enable immune evasion. Data were presented…

    First demonstration of the survival of allogeneic iPSCs transplanted into an immunocompetent non-human primate model without the need for immune suppression

    Transplanting allogeneic cells into a primate without immune suppression represents a key step toward widespread treatment of disease using engineered cells

    SEATTLE, June 26, 2021 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ:SANA), a company focused on creating and delivering engineered cells as medicines, today presented data showing survival of transplanted stem cells without immunosuppression in non-human primates (NHPs). The transplanted cells were induced pluripotent stem cells (iPSCs) with Sana's hypoimmune gene modifications that enable immune evasion. Data were presented by Sonja Schrepfer, M.D., Ph.D., Head of Hypoimmune Platform at Sana, during the plenary session on Cellular Therapy and Tissue Engineering at the International Society for Stem Cell Research 2021 Virtual Annual Meeting.

    "These findings represent a major breakthrough in cell transplantation, as demonstration of immune evasion and durable cell survival in non-human primates with a healthy immune system has not been achieved before," said Steve Harr, Sana's President and Chief Executive Officer. "Since the debut of organ, tissue, and cellular transplantation, immune rejection of allogeneic transplants has been a significant challenge preventing widespread utilization of these therapies. Our team has now shown the potential of these gene-modified cells in multiple animal models, and the next step is to apply this technology in humans in several therapeutic contexts, with our first investigational new drug (IND) application as early as next year."

    Transplanting cells or tissues from a donor to a different recipient currently requires intense immunosuppression to prevent rejection of the transplant. Sana's hypoimmune (HIP) platform's goal is to eliminate the need for immunosuppression by cloaking cells from immune recognition. The platform disrupts major histocompatibility (MHC) class I and MHC class II expression to hide cells from the adaptive immune system, which includes antibody and T cell responses. However, these changes make cells susceptible to innate immune cell killing, in particular by natural killer (NK) cells. Sana's HIP platform additionally provides for the overexpression of CD47, a molecule that protects HIP-modified cells from innate cell killing involving either NK cells or macrophages. HIP-modified pluripotent stem cells can serve as the starting material for manufacturing cell-based therapeutics, differentiating into specialized cell types. Sana's goal is to use these HIP-modified cells to replace damaged or missing cells in the body in a number of different diseases, including cancer, type I diabetes, cardiac disease, and others.

    In this study, allogeneic iPSCs were transplanted intramuscularly into healthy NHPs without immunosuppression (n=8), split into two cohorts. The first cohort received unmodified allogeneic iPSCs, while the second cohort received HIP-modified allogeneic iPSCs. The unmodified cells disappeared rapidly in all NHPs, with significant T cell activation and antibody production. The HIP-modified iPSCs survived in all four monkeys for the duration of the study (up to four months at data lock), and there was no evidence of a systemic immune response, including no T cell activation, antibody production, or NK cell activity (p<0.007 comparing cell survival, p<0.0001 comparing T cell activation and antibody production).

    Six weeks after the initial dose, the dosing was reversed, or crossed over, so that the NHPs received the opposite type of cells in another site in the body. Unmodified iPSCs again evoked a rapid systemic immune response in all NHPs, with activation of T cells and antibody production, and disappeared within days. Importantly, HIP-modified cells continued to survive in another site in the body, despite the immune response against unmodified cells. Separately, HIP-modified iPSCs were transplanted into the four NHPs that had previous T cell and antibody responses to unmodified cells. In these animals, there was no evidence of immune response and the HIP modified cells again survived through the end of the study (p<0.006 comparing cell survival, p<0.0001 comparing T cell activation and antibody production). These data, showing survival for HIP-modified iPSCs despite either an ongoing or pre-existing immune response, suggest the potential to use HIP-modified cells in patients with auto-immune disorders and to re-administer HIP-modified cells.  

    "We have previously shown that our hypoimmune platform can create cells that evade the adaptive and innate immune systems in mouse models, and we are thrilled to now show this immune evasion in a model that better simulates the complexity of the human immune environment," said Sonja Schrepfer, M.D., Ph.D. "The next step is to move this technology into human testing, where it has the potential to impact patients with a broad array of diseases."

    Sana intends to submit the data behind its presentation for publication in a peer-reviewed journal.

    About Sana

    Sana Biotechnology, Inc. is focused on creating and delivering engineered cells as medicines for patients. We share a vision of repairing and controlling genes, replacing missing or damaged cells, and making our therapies broadly available to patients. We are more than 300 people working together to create an enduring company that changes how the world treats disease. Sana has operations in Seattle, Cambridge, and South San Francisco. For more information about Sana Biotechnology, please visit https://sana.com/.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements about Sana Biotechnology, Inc. (the "Company," "we," "us," or "our") within the meaning of the federal securities laws, including those related to the Company's vision, progress, and business plans; expectations for its development programs, product candidates and technology platforms, including its pre-clinical, clinical and regulatory development plans and timing expectations; expectations for the presentation or publication of data, including in medical or scientific journals; the ability to make HIP-modified iPSCs that evade the innate and adaptive immune system or that persist without immunosuppression; and the ability to treat diseases using the hypoimmune platform technology. All statements other than statements of historical facts contained in this press release, including, among others, statements regarding the Company's strategy, expectations, cash runway and future financial condition, future operations, and prospects, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "design," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "positioned," "potential," "predict," "seek," "should," "target," "will," "would" and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results to vary materially, including, among others, the risks inherent in drug development such as those associated with the initiation, cost, timing, progress and results of the Company's current and future research and development programs, preclinical and clinical trials, as well as the economic, market and social disruptions due to the ongoing COVID-19 public health crisis. For a detailed discussion of the risk factors that could affect the Company's actual results, please refer to the risk factors identified in the Company's SEC reports, including but not limited to its Annual Report on Form 10-K dated March 24, 2021 and Quarterly Report on Form 10-Q dated May 5, 2021. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.

    Sana Biotechnology and the Sana Biotechnology logo are trademarks of Sana Biotechnology, Inc. or its subsidiaries.

    Investor Relations:

    Nicole Keith

    investor.relations@sana.com

    Media:

    Morgan Warners, Finsbury Glover Hering

    media@sana.com



    Primary Logo

    View Full Article Hide Full Article
View All Sana Biotechnology Inc. News