On May 8, 2019 Sangamo Therapeutics, Inc. (NASDAQ: SGMO), a genomic medicine company, reported first quarter 2019 financial results and recent business highlights (Press release, Sangamo Therapeutics, MAY 8, 2019, View Source [SID1234535972]).
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"With recent encouraging clinical data in hemophilia A gene therapy and ex vivo gene-edited cell therapy for beta thalassemia, we are moving closer to achieving our vision for Sangamo as an integrated genomic medicine company," said Sandy Macrae, CEO of Sangamo. "Our capabilities in gene therapy, ex vivo gene-edited cell therapy, in vivo genome editing and gene regulation enable us to address genetic diseases with appropriate technologies. We are investing in a diverse pipeline of products where we believe this suite of proprietary technologies is clinically relevant, where the underlying biology is well-characterized, and where there is a defined high unmet medical need."
Recent Highlights
Clinical
In partnership with Pfizer, announced phase 1/2 interim data for SB-525, a gene therapy candidate for the treatment of adults with hemophilia A, demonstrating dose-dependent increases in Factor VIII (FVIII) activity in eight patients, with the two patients treated with the 3e13 vg/kg dose reaching normal FVIII levels
Initiated dose expansion of the 3e13 vg/kg dose cohort for the SB-525 hemophilia A program, based on Safety Monitoring Committee recommendations
Announced early data from the first patient in the phase 1/2 clinical trial for ST-400, ex vivo gene-edited cell therapy candidate for the treatment of beta thalassemia being developed in partnership with Sanofi
Corporate
Strengthened balance sheet with April 2019 public offering of common stock raising net proceeds of approximately $136.2 million
Signed option agreement with Brammer Bio, a gene therapy contract development and manufacturing organization, to secure access to large-scale, commercial-grade AAV manufacturing
Research
Publication of data demonstrating high-precision genome editing with new zinc finger nuclease architectures in March 2019 issue of Nature Communications
Presented new preclinical data at 14th International Conference on Alzheimer’s & Parkinson’s Diseases (ADPD) demonstrating significant reduction in tau expression in non-human primates with zinc finger protein transcription-factor (ZFP-TF) gene regulation technology
Presented data detailing zinc finger protein platform enhancements, and several clinical and preclinical genomic medicine programs at 2019 American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, held in Washington, D.C. between April 29th and May 2nd
Presented preclinical data on the development of ZFP-TFs to selectively downregulate expression of pathogenic C9ORF72 repeat expansion-containing transcripts at the TargetALS meeting in Boston on May 2nd
First Quarter 2019 Financial Results
For the first quarter ended March 31, 2019, Sangamo reported a consolidated net loss of $42.2 million, or $0.41 per share, compared to a net loss of $20.2 million, or $0.23 per share, for the same period in 2018. As of March 31, 2019, the Company had cash, cash equivalents, and investments of $351.6 million.
Revenues for the first quarter ended March 31, 2019 were $8.1 million, compared to $12.6 million for the same period in 2018. The decrease was primarily due to a decline of $10.6 million in revenues related to our agreement with Pfizer due to a change in estimate driven by an increase in project scope of the hemophilia A collaboration and the corresponding decrease in the measure of the proportional performance, and also a $2.4 million decrease in revenues related to our agreement with Sanofi (formerly Bioverativ). These decreases were partially offset by an increase of $8.3 million in revenue related to our agreement with Kite Pharma, which took effect in April 2018. First quarter 2019 revenues were primarily generated from Sangamo’s collaboration agreements with Kite, Sanofi and Pfizer.
As anticipated, operating expenses increased in the first quarter ended March 31, 2019, reflecting the Company’s growth through the acquisition of TxCell, increased U.S. headcount in support of growth of the preclinical pipeline and clinical development programs, and manufacturing-related activities. Total operating expenses for the first quarter ended March 31, 2019 were $52.0 million, compared to $33.6 million for the same period in 2018. Research and development expenses were $34.9 million for the first quarter of 2019, compared to $23.5 million for the same period in 2018. The increase was primarily due to manufacturing and clinical trial expenses related to the progress of the Company’s clinical development programs. General and administrative expenses were $17.1 million for the first quarter of 2019, compared to $10.1 million for the same period in 2018.
Financial Guidance for 2019
Operating Expense: Sangamo expects operating expense of $210 to $220 million for the year ending December 31, 2019.
Cash and Investments: Sangamo projects that current cash, cash equivalents, and investments, including net proceeds from the April 2019 common stock offering, should provide funds for operations through year end 2021.
Conference Call
Sangamo will host a conference call today, May 8, 2019, at 5:00 p.m. Eastern Time, which will be open to the public. The call will also be webcast live and can be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations.
The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 7577586. For those unable to listen in at the designated time, a conference call replay will be available for one week following the conference call, from approximately 8:00 p.m. ET on May 8, 2019 to 11:59 p.m. ET on May 15, 2019. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 7577586.