- Investigational New Drug application for non-small cell lung cancer trial with luvelta cleared by
- Patient expansion phase well underway in Phase 2 study of luvelta in combination with bevacizumab; enrollment is expected to complete in the first half of 2024 -
- The randomized portion of REFRαME-O1, the registration-enabling study of luvelta for patients with platinum-resistant ovarian cancer, is active and enrolling -
- As of
- In April, Sutro further bolstered its cash position with
“The Sutro team executed on multiple fronts in the first quarter of 2024, advancing luvelta through the clinic in multiple indications of high unmet need, continuing to progress our pipeline and collaboration programs, and establishing a new licensing relationship with Ipsen. The upfront funding from the Ipsen deal and our recent financing also augmented our strong cash position,” said
Recent Business Highlights and Select Anticipated Milestones
Luveltamab Tazevibulin (luvelta), FolRα-Targeting ADC Franchise:
- Part 1 (dose-optimization) of the registration-directed trial, REFRαME-O1, for treatment of platinum-resistant ovarian cancer (PROC), has completed enrollment. Part 2 (randomized portion) is now enrolling, with an anticipated ~140 sites in ~20 countries planned to be opened by the end of 2024.
- Enrollment of REFRαME-P1, a registration-enabling trial for pediatric patients with CBFA2T3::GLIS2 (CBF/GLIS; RAM phenotype) AML, is expected to be initiated in the second half of 2024.
- An Investigational New Drug (IND) application for the treatment of NSCLC has been cleared by
U.S. Food and Drug Administration (FDA). The Phase 2 trial is expected to begin enrolling patients in the second half of 2024. Initial data is expected in the first half of 2025. - A Phase 2 expansion study in combination with bevacizumab is well underway. Enrollment is expected to be complete in the first half of 2024.
- In
April 2024 , Sutro announced a global licensing agreement for STRO-003, a ROR1-targeting ADC, with Ipsen. Sutro is eligible to receive up to$899 million in upfront and potential milestone payments, including up to$92 million in near-term payments, of which$75 million , including an equity investment, have been received in April. Sutro is also eligible to receive tiered royalties ranging from low double-digit to mid-teen digit percentages on annual global sales of STRO-003. - Sutro plans to submit an IND for STRO-004, a tissue factor-targeting ADC, in 2025.
- Sutro continues to seek to maximize the value of its proprietary cell-free platform by working with partners on programs in multiple disease spaces and geographies and has generated from collaborators an aggregate of approximately
$864 million in payments throughMarch 31, 2024 , including equity investments.
Corporate Updates:
- Additionally, Sutro strengthened its cash position with an underwritten offering of 14,478,764 shares of its common stock at a price of
$5.18 per share, resulting in gross proceeds of$75.0 million . The offering was led by a high-quality group of new and existing healthcare-focused institutional investors.
Upcoming Events: Sutro will participate in two upcoming investor conferences. Webcasts of the presentations will be accessible through the News & Events page of the Investor Relations section of the Company’s website at www.sutrobio.com. Archived replays will be available for at least 30 days after the events.
The Citizens JMP Life Sciences Conference inNew York ,May 13-14, 2024 Jefferies Healthcare Conference inNew York ,June 5-6, 2024
First Quarter 2024 Financial Highlights
Cash,
As of
Unrealized Gain from Increase in Value of Vaxcyte Common Stock
The non-operating, unrealized gain of
Revenue
Revenue was
Operating Expenses
Total operating expenses for the quarter ended
About
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, including enrollment and site activation; timing of announcements of clinical results, trial initiation, and regulatory filings; outcome of regulatory decisions; potential benefits of luvelta and the Company’s other product candidates and platform; timing of payments under our collaboration agreements; potential expansion into other indications and combinations, including the timing and development activities related to such expansion; potential market opportunities for luvelta and the Company’s other product candidates; and the Company’s expected cash runway. 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 and the Company’s ability to successfully leverage Fast Track designation, the market size for the Company’s product candidates to be smaller than anticipated, 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, the value of the Company’s holdings of Vaxcyte common stock, 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
Contact
(650) 823-7681
ewhite@sutrobio.com
Selected Statements of Operations Financial Data (Unaudited) (In thousands, except share and per share amounts) | |||||||||||||||||||
Three Months Ended | |||||||||||||||||||
2024 | 2023 | ||||||||||||||||||
Revenue | $ | 13,008 | $ | 12,674 | |||||||||||||||
Operating expenses | |||||||||||||||||||
Research and development | 56,878 | 39,399 | |||||||||||||||||
General and administrative | 12,721 | 15,512 | |||||||||||||||||
Total operating expenses | 69,599 | 54,911 | |||||||||||||||||
Loss from operations | (56,591 | ) | (42,237 | ) | |||||||||||||||
Interest income | 4,096 | 2,560 | |||||||||||||||||
Unrealized gain (loss) on equity securities | 3,679 | (6,992 | ) | ||||||||||||||||
Non-cash interest expense related to the sale of future royalties | (7,184 | ) | - | ||||||||||||||||
Interest and other income (expense), net | (2,213 | ) | (2,986 | ) | |||||||||||||||
Loss before provision for income taxes | (58,213 | ) | (49,655 | ) | |||||||||||||||
Provision for income taxes | - | 395 | |||||||||||||||||
Net loss | $ | (58,213 | ) | $ | (50,050 | ) | |||||||||||||
Net loss per share, basic and diluted | $ | (0.95 | ) | $ | (0.85 | ) | |||||||||||||
Weighted-average shares used in computing basic and diluted loss per share | 61,457,793 | 58,723,432 |
Selected Balance Sheets Financial Data (Unaudited) (In thousands) | ||||||||
2024(1) | ||||||||
Assets | ||||||||
Cash, cash equivalents and marketable securities | $ | 267,602 | $ | 333,681 | ||||
Investment in equity securities | 45,616 | 41,937 | ||||||
Accounts receivable | 31,300 | 36,078 | ||||||
Property and equipment, net | 20,630 | 21,940 | ||||||
Operating lease right-of-use assets | 21,594 | 22,815 | ||||||
Other assets | 16,660 | 14,285 | ||||||
Total Assets | $ | 403,402 | $ | 470,736 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Accounts payable, accrued expenses and other liabilities | $ | 54,028 | $ | 64,293 | ||||
Deferred revenue | 66,815 | 74,045 | ||||||
Operating lease liability | 28,070 | 29,574 | ||||||
Debt | - | 4,061 | ||||||
Deferred royalty obligation related to the sale of future royalties | 156,465 | 149,114 | ||||||
Total liabilities | 305,378 | 321,087 | ||||||
Total stockholders’ equity | 98,024 | 149,649 | ||||||
Total Liabilities and Stockholders’ Equity | $ | 403,402 | $ | 470,736 |
(1) The condensed balance sheet as of
(2) The condensed balance sheet as of
Source:
2024 GlobeNewswire, Inc., source