On August 4, 2022 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicines company, reported recent business highlights and second quarter 2022 financial results (Press release, Sangamo Therapeutics, AUG 4, 2022, View Source [SID1234617647]).
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"We made meaningful progress advancing our clinical-stage programs in the second quarter," said Sandy Macrae, Chief Executive Officer of Sangamo. "We are engaging in pivotal study-enabling activities in two of our clinical stage programs and are preparing to complete dosing of the first cohort in our TX200 program, which recently received Orphan Medicinal Product Designation from the European Commission. Coupled with strong advances in our preclinical pipeline, we believe this progress positions us well to advance the development of potentially transformational genomic medicines for patients in need and to generate long-term value for our shareholders."
Recent Business Highlights
Fabry disease – Received endorsement to progress into the Ph1/2 study’s expansion phase; continued to recruit patients and activate sites; Phase 3 planning progresses.
In June, the Safety Monitoring Committee endorsed progressing the Phase 1/2 STAAR study evaluating isaralgagene civaparvovec, our wholly owned gene therapy product candidate for the treatment of Fabry disease, from the dose escalation phase into the expansion phase at the dose level of 5e13 vg/kg.
We expect to dose two additional patients imminently, and have multiple patients in screening, including both male and female candidates.
Enzyme replacement therapy (ERT) withdrawal was completed for an additional two patients previously dosed in the STAAR study, achieving a total of four patients to date who have successfully been withdrawn.
A total of 16 study sites are now open and recruiting, including the first sites in Canada, Italy and Australia.
We plan to provide updated results from the STAAR study in the second half of 2022, including at the Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium, taking place August 30-September 2, 2022.
We continue to actively prepare for a potential pivotal Phase 3 trial.
Sickle cell disease – Completed transition of program back to Sangamo; advanced manufacturing activities in anticipation of dosing in Q3; Phase 3 planning progresses.
We completed the transition of Sanofi’s rights and obligations under the collaboration developing BIVV003, formerly known as SAR445136, our zinc finger nuclease gene-edited cell therapy candidate for the treatment of sickle cell disease, back to Sangamo on June 28, 2022.
Manufacturing of product candidates using improved methods progressed in the Phase 1/2 study. These improved manufacturing methods have been shown in internal experiments to increase the number of long-term progenitor cells in the final product.
Dosing of the next patient is anticipated in the third quarter of 2022.
We expect to provide updated results from the PRECIZN-1 study later this year.
Phase 3 enabling activities and manufacturing readiness are in progress.
Hemophilia A – Pfizer advised us that it continues to expect resumption of dosing in Q3 2022; pivotal data read-out expected in late 2023 or early 2024.
Pfizer advised us that it continues to anticipate resuming the dosing of additional patients in the Phase 3 AFFINE trial of giroctocogene fitelparvovec, an investigational gene therapy we are developing with Pfizer for patients with moderately severe to severe hemophilia A, in the third quarter of 2022.
A pivotal data readout is estimated in late 2023 or early 2024.
Over 50% of the patients have been enrolled in the Phase 3 AFFINE trial.
Renal Transplant Rejection – Received Orphan Medicinal Product Designation from the European Commission; progressed manufacturing and clinical activities ahead of anticipated Q3 dosing.
Since we dosed the first patient in the Phase 1/2 STEADFAST study evaluating TX200, our wholly owned autologous CAR-Treg cell therapy treating patients receiving an HLA-A2 mismatched kidney from a living donor, the product candidate continues to be generally well tolerated, with no treatment related adverse events.
We completed manufacturing of the dose for the second patient, who recently received a kidney transplant. Dosing of this second patient is expected later in the third quarter of 2022.
We plan to complete dosing of the first cohort, comprised of three patients, by the end of 2022.
The European Commission granted Orphan Medicinal Product Designation to TX200, for treatment in solid organ transplantation, following a positive opinion from the European Medicines Agency’s Committee for Orphan Medicinal Products.
American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) – Profiled significant pre-clinical progress across Sangamo’s innovative pipeline and platform.
Presented seven posters and one oral presentation at ASGCT (Free ASGCT Whitepaper) on May 16-19, 2022, including pre-clinical updates across our CAR-Treg autoimmune cell therapy platform, innovations in our genome engineering platform and advances in our AAV capsid engineering program.
Second Quarter 2022 Financial Results
Consolidated net loss for the second quarter ended June 30, 2022, was $43.2 million, or $0.29 per share, compared to a net loss of $47.2 million, or $0.33 per share, for the same period in 2021.
Revenues
Revenues for the second quarter ended June 30, 2022, were $29.4 million, compared to $27.9 million for the same period in 2021.
The increase of $1.5 million in revenues was primarily attributed to an increase of $1.3 million in revenue related to our collaboration agreement with Novartis and an increase of $0.8 million in revenue related to our collaboration agreement with Sanofi. These increases were partially offset by a decrease of $0.7 million in revenue related to our collaboration agreement with Biogen.
Total operating expenses on a GAAP basis for the second quarter ended June 30, 2022, were $75.1 million, compared to $76.6 million for the same period in 2021. Non-GAAP operating expenses, which exclude stock-based compensation expense, for the second quarter ended June 30, 2022, were $67.2 million, compared to $67.1 million for the same period in 2021.
The decrease in total operating expenses on a GAAP basis was primarily due to the timing of certain research and development activities.
Cash, cash equivalents and marketable securities
Cash, cash equivalents and marketable securities as of June 30, 2022, were $363.7 million, compared to $464.7 million as of December 31, 2021. Since the beginning of the second quarter, we have raised approximately $43.1 million in net proceeds under our previously announced at the market offering program.
Financial Guidance for 2022 Reiterated (initial guidance provided on February 24, 2022)
On a GAAP basis, we continue to expect total operating expenses in the range of approximately $320 million to $350 million in 2022, which includes non-cash stock-based compensation expense.
We continue to expect non-GAAP total operating expenses, excluding estimated non-cash stock-based compensation expense of approximately $40 million, in the range of approximately $280 million to $310 million in 2022.
Upcoming Events
Sangamo plans to participate in the following events in the third quarter:
Scientific / Medical Conferences
Society for the Study of Inborn Errors of Metabolism (SSIEM), August 30-September 2, 2022, Freiburg, Germany
Prion 2022, September 13-16, 2022, Gottingen, Germany
Investor Conferences
Wedbush PacGrow Healthcare Conference, August 9-10, 2022 [9:10-9:40am EDT]
H.C. Wainwright 24th Annual Global Investment Conference, September 12-14, 2022
Jefferies Cell and Genetic Medicine Summit, September 29-30, 2022
Access links for these investor conferences will be available on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. Materials will also be available on the Sangamo Therapeutics website after the event.
Conference Call to Discuss Second Quarter 2022 Results
The Sangamo management team will discuss these results on a conference call today, Thursday August 4, 2022, at 4:30 p.m. Eastern Time.
Participants should register for, and access, the call using this link. While not required, it is recommended you join 10 minutes prior to the event start. Once registered, participants will be given the option to either dial into the call with the number and unique passcode provided, or to use the dial-out option to connect their phone instantly.
The link to access the live webcast can also be found on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations.
A replay will be available following the conference call, accessible under Events and Presentations.