Sutro Biopharma Reports First Quarter 2020 Financial Results and Recent Business Highlights and Developments
SOUTH SAN FRANCISCO, Calif., May 11, 2020 /PRNewswire/ -- Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation oncology therapeutics, today reported its financial results for the quarter ended March 31, 2020 and its recent business highlights and developments.
"We are pleased with the encouraging dose escalation safety and anti-tumor activity data from our Phase 1 clinical trial for STRO-002, including data presented during the AACR Virtual Meeting on April 27, 2020," said Bill Newell, Sutro's Chief Executive Officer. "These STRO-002 data demonstrate preliminary evidence of anti-tumor activity, particularly in a heavily pre-treated patient population along with an emerging safety profile that indicates that the product candidate is generally well tolerated. Our two proprietary antibody-drug conjugate (ADC) product candidates, STRO-001 and STRO-002, are progressing in Phase 1 clinical trials. With the ongoing COVID-19 pandemic, Sutro is committed to the health and safety of patients receiving our therapies and our employees and expects our trials and drug supply to remain on track while reducing the risks to our employees as much as possible. Additionally, each of our three current collaborations has yielded a novel oncology product candidate in clinical development or in the late stages of preclinical development, all of which were discovered, developed, and are manufactured using our proprietary and integrated cell-free protein synthesis platform XpressCF(®) and site-specific conjugation platform XpressCF+(TM)."
Recent Business Highlights and Developments
STRO-002 Clinical Program
-- STRO-002 is a potential best-in-class ADC directed against folate
receptor-alpha (FolR ), which is highly expressed in ovarian cancer.
-- The STRO-002 Phase 1 clinical trial is currently in dose-escalation,
with 30 heavily pre-treated patients enrolled through April 20, 2020,
who have recurrent platinum resistant or refractory ovarian cancer
-- Encouraging updated dose-escalation safety and efficacy data were
presented on April 27, 2020:
-- 62% of patients saw a reduction in CA-125 levels of 50% or more or a
normalization of CA-125 levels;
-- 35% of patients who were evaluable for progression have stayed on
study for longer than 24 weeks;
-- 11 patients at 5.2 milligrams per kilogram or higher were
continuing on study and had not yet reached 24 weeks
-- 75% of patients had initial post-baseline scans showing stable
disease or a partial response;
-- 100% of evaluable patients who had a CA-125 reduction of 50% or more
or normalization achieved stable disease (confirmed or unconfirmed)
or a partial response and are still on study; and
-- Generally well-tolerated in this heavily pre-treated patient
population with a median of five prior lines of other therapies--89%
of adverse events were grade 1 or 2--and prophylactic corticosteroid
eye drops have not been necessary
-- Dose escalation in the Phase 1 trial is continuing and while the maximum
tolerated dose has not yet been reached, Sutro is currently exploring
the 5.2 to 6.0 mg/kg dose range, as evaluation of the recommended Phase
2 dose for multiple planned treatment cycles continues.
-- Additional Phase 1 dose-escalation safety and anti-tumor activity data
are expected in the second half of 2020.
-- Dose expansion portion of the Phase 1 clinical trial is expected to
begin enrolling patients in the second half of 2020.
STRO-001 Clinical Program
-- STRO-001 is a potential first-in-class and best-in-class ADC directed
against CD74, which is highly expressed in many B cell malignancies.
-- The STRO-001 Phase 1 clinical trial is currently in dose-escalation,
enrolling patients with multiple myeloma and non-Hodgkin lymphoma
-- Initial safety data of STRO-001 was presented at the EHA Congress in
June 2019, and a safety data update, which included several additional
patients, was released in an abstract in association with the American
Society of Hematology Conference on November 6, 2019.
-- Based on the reported data to date in heavily pre-treated patients,
STRO-001 has been generally well-tolerated and no ocular toxicity
signals have been observed, with no patients receiving prophylactic
corticosteroid eye drops.
-- Dose escalation in the Phase 1 trial is continuing and the maximum
tolerated dose has not yet been reached.
-- Additional Phase 1 dose-escalation safety and efficacy data is expected
in the second half of 2020.
-- Dose expansion portion of the Phase 1 clinical trial is expected to
begin enrolling patients in the first half of 2021.
Cytokine-Derivative Programs (Collaboration with Merck & Co.)
-- Sutro is collaborating with Merck on two research programs to discover
new therapeutics for cancer and autoimmune diseases. Merck has the right
to nominate a third program under this collaboration.
-- In March 2020, Merck extended by one year the research term of the
collaboration's first program, which included a payment to Sutro. The
collaboration is advancing Sutro's novel cytokine-derivative product
candidate towards IND-enabling studies.
BCMA ADC Clinical Program (Collaboration with Bristol Myers Squibb; formerly Celgene)
-- BMS received FDA clearance on its IND application for CC-99712, a novel
ADC therapeutic targeting B-cell maturation antigen (BCMA), for the
treatment of multiple myeloma in the second quarter of 2019.
-- Since trial initiation in the second half of 2019, BMS has been
enrolling patients in a Phase 1 trial focused on patients with relapsed
and refractory multiple myeloma.
-- BMS will be responsible for the worldwide clinical development and
commercialization of CC-99712. Sutro is entitled to development and
regulatory milestone payments and tiered royalties ranging from mid to
high single digit percentages from BMS.
Bispecific ADC Clinical Development Candidate (Collaboration with EMD Serono)
-- In the third quarter of 2019, EMD Serono designated an undisclosed
bispecific ADC as a clinical development candidate with approval to
advance to IND-enabling studies, which triggered a financial milestone
received by Sutro.
-- Sutro is the manufacturer for the bispecific ADC for the early clinical
supply of the candidate and is eligible for further milestones and
royalties. EMD Serono will be responsible for the drug product and the
clinical development and commercialization of this clinical development
candidate.
24-Valent Pneumococcal Conjugate Vaccine (SutroVax Relationship)
-- Under a license from Sutro, SutroVax has right to use the XpressCF(®)
and XpressCF+(TM) platforms to discover and develop vaccine candidates
for the treatment or prophylaxis of infectious diseases.
-- SutroVax is progressing their broader spectrum pneumococcal conjugate
vaccine (SVX-24) through the late stages of preclinical development and
is targeting an IND filing for 2021.
-- SutroVax is responsible for performing all research and development
activities while Sutro provides technical support and supplies
XtractCF(TM) and other materials to SutroVax under a supply agreement.
-- Sutro is eligible to receive four percent (4%) royalties on worldwide
net sales of any licensed vaccine candidates for human health use. Also,
Sutro retains the right to discover and develop vaccines for treatment
or prophylaxis of any disease not caused by an infectious pathogen,
including cancer.
Sutro Unveils Innovative Cancer Therapy Approach Using Precise Tumor Targeted Immunostimulant ADCs at World ADC London
-- On March 4, 2020 at the World ADC London meeting, Sutro announced it has
expanded its ADC technology platform to include tumor targeting
immunostimulant ADCs, or IADCs.
-- Sutro's XpressCF+(TM) Platform has enabled a groundbreaking technology
to engineer homogeneous, dually conjugated ADCs with both
immunostimulant and cytotoxic warheads on a single ADC molecule.
-- Sutro's novel IADCs are designed to deliver two different drugs directly
to the tumor, and not only kill tumor cells but also locally prime an
immune response to the patient's particular tumor cells. Sutro believes
that its IADC approach creates a new therapeutic opportunity by
combining the best features of an ADC with the biology of a personalized
vaccine.
First Quarter 2020 Financial Highlights
Cash, Cash Equivalents and Marketable Securities
As of March 31, 2020, Sutro had cash, cash equivalents and marketable securities of $129.6 million, as compared to $133.5 million as of December 31, 2019, which represents net cash usage of $3.9 million during the first quarter of 2020.
On February 28, 2020, Sutro entered into a loan and security agreement, under which Sutro borrowed $25.0 million, with approximately $9.6 million of such amount used to repay the outstanding principal, interest and final payment fees under a prior loan with the same lenders.
Revenue
Revenue was $7.2 million for the quarter ended March 31, 2020, compared to $8.6 million in the corresponding 2019 quarter, principally related to the Merck, BMS, and EMD Serono collaborations. Future collaboration revenue from Merck, BMS, and EMD Serono, and from any future collaboration partners, will fluctuate as a result of the amount and timing of revenue recognition of upfront, milestones and other collaboration agreement payments.
Operating Expenses
Total operating expenses for the quarter ended March 31, 2020 were $26.3 million, compared to $22.9 million in the corresponding 2019 quarter, including non-cash stock-based compensation of $2.7 million and $2.3 million, and depreciation and amortization expense of $1.1 million and $1.1 million, in the 2020 and 2019 quarters, respectively. Total operating expenses for the first quarter 2020 were comprised of research and development expenses of $17.6 million and general and administrative expenses of $8.7 million, with both expense types expected to increase in 2020 as Sutro's internal product candidates advance in clinical development and additional general and administrative expenses are incurred as a public company.
About Sutro Biopharma
Sutro Biopharma, Inc., located in South San Francisco, is a clinical-stage drug discovery, development and manufacturing company. Using precise protein engineering and rational design, Sutro is advancing next-generation oncology therapeutics.
Sutro's proprietary and integrated cell-free protein synthesis platform XpressCF® and site-specific conjugation platform, XpressCF+(TM), led to the discovery of STRO-001 and STRO-002, Sutro's first two internally-developed ADCs. STRO-001 is a CD74-targeting ADC currently being investigated in a Phase 1 clinical trial of patients with advanced B-cell malignancies, including multiple myeloma and non-Hodgkin lymphoma. STRO-001 was granted Orphan Drug Designation by the FDA for multiple myeloma in October 2018. STRO-002 is a folate receptor alpha (FolR )-targeting ADC, currently being investigated in a Phase 1 clinical trial of patients with ovarian and endometrial cancers. This is the second product candidate to be evaluated in clinical trials resulting from Sutro's XpressCF® and XpressCF+(TM) technology platforms. A third program, CC-99712 (BCMA-targeting ADC), which is part of Sutro's collaboration with Bristol Myers Squibb (formerly Celgene Corporation), is enrolling patients for its Phase 1 clinical trial of patients with multiple myeloma. Sutro's proprietary technology was responsible for the discovery and manufacturing of CC-99712, for which Bristol Myers Squibb has worldwide development and commercialization rights. Sutro is entitled to development and regulatory milestone payments and tiered royalties from Bristol Myers Squibb for this BCMA ADC. Sutro is dedicated to transforming the lives of cancer patients by creating medicines with improved therapeutic profiles for areas of unmet need.
To date, Sutro has designed cytokine-based immuno-oncology therapies, ADCs, vaccines and bispecific antibodies primarily directed at clinically-validated targets for which the current standard of care is suboptimal.
Sutro's platform allows it to accelerate discovery and development of potential first-in-class and best-in-class molecules through rapid and systematic evaluation of protein structure-activity relationships to create optimized homogeneous product candidates.
In addition to developing its own oncology pipeline, Sutro is collaborating with select pharmaceutical and biotech companies to discover and develop novel, next-generation therapeutics. As the pace of clinical development accelerates, Sutro and its partners are developing therapeutics designed to more efficiently kill tumors without harming healthy cells.
Additional multimedia content from Sutro regarding STRO-001 and STRO-002 can be found here and here.
Follow Sutro on Twitter, @Sutrobio, and at www.sutrobio.com to learn more about our passion for changing the future of oncology.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated preclinical and clinical development activities, timing of announcements of clinical results, potential benefits of the company's product candidates and platform and potential market opportunities for the company's product candidates. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although the company believes that the expectations reflected in such forward-looking statements are reasonable, the company cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause the company's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company's ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, the impact of the COVID-19 pandemic on the Company's business, clinical trial sites, supply chain and manufacturing facilities, the Company's ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, the company's ability to fund development activities and achieve development goals, the company's ability to protect intellectual property, and the Company's commercial collaborations with third parties and other risks and uncertainties described under the heading "Risk Factors" in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
Investor Contacts
John Graziano
Solebury Trout
+1 646-378-2942
jgraziano@soleburytrout.com
Xuan Yang
Solebury Trout
+1 646-378-2975
xyang@soleburytrout.com
Media Contacts
David Schull
Russo Partners
(212) 845-4271
david.schull@russopartnersllc.com
Travis Kruse
Russo Partners
(212) 845-4272
travis.kruse@russopartnersllc.com
Sutro Biopharma, Inc.
Selected Statements of Operations Financial Data
(Unaudited)
(In thousands, except share and per share amounts)
Three Months Ended
March 31,
2020 2019
Revenues $
7,152 $
8,629
Operating expenses
Research and development 17,619 15,180
General and administrative 8,713 7,715
Total operating expenses 26,332 22,895
Loss from operations (19,180) (14,266)
Interest income 641 1,176
Interest and other income (expense),
net (1,056) (1,160)
Net loss $
(19,595) $
(14,250)
Net loss per share $
(0.84) $
(0.62)
Weighted-average shares used in
computing 23,197,971 22,865,075
net loss per share
Sutro Biopharma, Inc.
Selected Balance Sheet Financial Data
(Unaudited)
(In thousands)
March 31, December 31,
2020 (1) 2019 (2)
Assets
Cash, cash equivalents and marketable securities $
129,582 $
133,473
Accounts receivable 9,079 6,298
Property and equipment, net 9,527 9,633
Other assets 5,687 6,966
Total Assets $
153,875 $
156,370
Liabilities and Stockholders' Equity
Accounts payable and other liabilities $
9,649 $
13,045
Deferred revenue 37,986 35,660
Debt 24,155 9,876
Total liabilities 71,790 58,581
Total stockholders' equity 82,085 97,789
Total Liabilities and Stockholders' Equity $
153,875 $
156,370
(1) The condensed balance sheet as of March 31, 2020 was derived from the unaudited financial statements included
in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, filed with the Securities
and Exchange Commission on May 11, 2020.
(2) The condensed balance sheet as of December 31, 2019 was derived from the audited financial statements included
in the Company's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and
Exchange Commission on March 16, 2020.
View original content:http://www.prnewswire.com/news-releases/sutro-biopharma-reports-first-quarter-2020-financial-results-and-recent-business-highlights-and-developments-301056920.html
SOURCE Sutro Biopharma
