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Sutro Biopharma Reports Second Quarter 2024 Financial Results, Business Highlights and Select Anticipated Milestones

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Sutro Biopharma (NASDAQ: STRO) reported its Q2 2024 financial results and business highlights. Key points include:

  • Updated data from the Phase 1b study of luvelta with bevacizumab to be presented at ESMO 2024
  • Phase 3 trial of luvelta for platinum-resistant ovarian cancer is underway
  • Registration-enabling trial for pediatric AML patients expected in H2 2024
  • Phase 2 trial for NSCLC treatment to start in H2 2024
  • As of June 30, 2024, Sutro had $426.0 million in cash, equivalents, and marketable securities
  • Q2 2024 revenue was $25.7 million, up from $10.4 million in Q2 2023
  • Total operating expenses for Q2 2024 were $74.4 million

Sutro Biopharma (NASDAQ: STRO) ha annunciato i risultati finanziari e le principali novità del secondo trimestre del 2024. I punti chiave includono:

  • Dati aggiornati dallo studio di Fase 1b di luvelta con bevacizumab che saranno presentati all'ESMO 2024
  • È in corso uno studio di Fase 3 di luvelta per il cancro ovarico resistente al platino
  • Studio abilitante alla registrazione per pazienti pediatrici affetti da AML previsto nella seconda metà del 2024
  • Studio di Fase 2 per il trattamento del NSCLC che inizierà nella seconda metà del 2024
  • Al 30 giugno 2024, Sutro aveva 426,0 milioni di dollari in contante, equivalenti e titoli negoziabili
  • I ricavi del Q2 2024 sono stati di 25,7 milioni di dollari, in aumento rispetto ai 10,4 milioni di dollari del Q2 2023
  • Le spese operative totali per il Q2 2024 erano di 74,4 milioni di dollari

Sutro Biopharma (NASDAQ: STRO) informó sobre sus resultados financieros y aspectos destacados del negocio del segundo trimestre de 2024. Los puntos clave incluyen:

  • Datos actualizados del estudio de Fase 1b de luvelta con bevacizumab que se presentarán en ESMO 2024
  • En curso un ensayo de Fase 3 de luvelta para cáncer de ovario resistente al platino
  • Ensayo habilitante para el registro de pacientes pediátricos con AML previsto para la segunda mitad de 2024
  • Ensayo de Fase 2 para el tratamiento de NSCLC que comenzará en la segunda mitad de 2024
  • Al 30 de junio de 2024, Sutro contaba con 426,0 millones de dólares en efectivo, equivalentes y valores negociables
  • Los ingresos del Q2 2024 fueron de 25,7 millones de dólares, un aumento respecto a los 10,4 millones de dólares en el Q2 2023
  • Los gastos operativos totales para el Q2 2024 fueron de 74,4 millones de dólares

Sutro Biopharma (NASDAQ: STRO)가 2024년 2분기 재무 결과 및 사업 하이라이트를 보고했습니다. 주요 내용은 다음과 같습니다:

  • ESMO 2024에서 발표될 luvelta와 베바시주맙의 1b상 업데이트 데이터
  • 플래티넘 내성 난소암에 대한 luvelta의 3상 시험이 진행 중입니다
  • 소아 AML 환자를 위한 등록 가능 시험이 2024년 하반기에 예상됩니다
  • NSCLC 치료를 위한 2상 시험이 2024년 하반기에 시작될 예정입니다
  • 2024년 6월 30일 기준으로 Sutro는 4억 2600만 달러의 현금, 현금성 자산 및 시장성 유가증권을 보유하고 있습니다
  • 2024년 2분기 매출은 2570만 달러로, 2023년 2분기 1040만 달러에서 증가했습니다
  • 2024년 2분기 총 운영 비용은 7440만 달러였습니다

Sutro Biopharma (NASDAQ: STRO) a publié ses résultats financiers et les moments forts de son activité pour le deuxième trimestre 2024. Les points clés incluent :

  • Données mises à jour de l'étude de Phase 1b de luvelta avec le bévacizumab qui seront présentées à l'ESMO 2024
  • Essai de Phase 3 de luvelta pour le cancer de l'ovaire résistant au platine en cours
  • Essai facilitant l'enregistrement pour les patients pédiatriques atteints d'AML prévu pour le second semestre 2024
  • Essai de Phase 2 pour le traitement du NSCLC qui débutera au second semestre 2024
  • Au 30 juin 2024, Sutro avait 426,0 millions de dollars en liquidités, équivalents et titres négociables
  • Les revenus du T2 2024 étaient de 25,7 millions de dollars, contre 10,4 millions de dollars au T2 2023
  • Les dépenses d'exploitation totales pour le T2 2024 se sont élevées à 74,4 millions de dollars

Sutro Biopharma (NASDAQ: STRO) berichtete über die Finanzzahlen und Geschäftshighlights für das zweite Quartal 2024. Wichtige Punkte sind:

  • Aktualisierte Daten aus der Phase 1b-Studie von luvelta mit Bevacizumab, die auf dem ESMO 2024 präsentiert werden
  • Die Phase-3-Studie von luvelta bei platinresistentem Eierstockkrebs ist im Gange
  • Eine zur Registrierung befähigende Studie für pädiatrische AML-Patienten wird für die zweite Hälfte 2024 erwartet
  • Eine Phase-2-Studie zur Behandlung von NSCLC soll in der zweiten Hälfte 2024 starten
  • Zum 30. Juni 2024 hatte Sutro 426,0 Millionen Dollar in bar, gleichwertigen Mitteln und handelbaren Wertpapieren
  • Der Umsatz im Q2 2024 betrug 25,7 Millionen Dollar, ein Anstieg von 10,4 Millionen Dollar im Q2 2023
  • Die gesamten Betriebskosten für Q2 2024 betrugen 74,4 Millionen Dollar
Positive
  • Revenue increased to $25.7 million in Q2 2024, up from $10.4 million in Q2 2023
  • Strong cash position of $426.0 million as of June 30, 2024
  • Phase 3 trial of luvelta for platinum-resistant ovarian cancer is underway
  • Multiple clinical trials and data readouts expected in the near future
  • Global licensing agreement for STRO-003 with Ipsen announced in April 2024
Negative
  • Operating expenses increased to $74.4 million in Q2 2024, up from $56.6 million in Q2 2023
  • Net loss likely increased due to higher operating expenses despite revenue growth

Insights

Sutro Biopharma's Q2 2024 results reveal a strong financial position with $426.0 million in cash and equivalents. The 147% year-over-year revenue increase to $25.7 million is impressive, primarily driven by collaborations. However, operating expenses surged by 31.4% to $74.4 million, mainly due to increased R&D spending. This burn rate is concerning but not alarming given the robust cash reserves.

The company's pipeline progress, particularly with luvelta, is promising. Multiple ongoing and planned clinical trials across various indications demonstrate potential for future value creation. The Ipsen partnership for STRO-003 and plans for STRO-004 IND submission in 2025 further diversify the company's prospects.

Investors should monitor the upcoming data presentations and trial initiations as key catalysts. While the financial runway appears solid, the increasing expenses warrant attention in the coming quarters.

Sutro's luvelta (FRα-targeting ADC) program shows significant progress across multiple indications. The ongoing Phase 3 trial for platinum-resistant ovarian cancer and the planned registration-enabling trial for pediatric AML patients with the CBFA2T3::GLIS2 fusion gene are particularly noteworthy. These target high-need patient populations with treatment options.

The expansion into NSCLC is a strategic move, broadening luvelta's potential market. The combination study with bevacizumab could potentially enhance efficacy in ovarian cancer patients. Upcoming data presentations at ESMO 2024 and in H1 2025 will be important in assessing luvelta's clinical profile and market potential.

The diverse pipeline, including STRO-003 (ROR1-targeting ADC) and STRO-004 (tissue-factor targeting exatecan ADC), showcases Sutro's expertise in ADC development. This multi-pronged approach in oncology could mitigate risks associated with single-asset dependency.

Sutro's business strategy demonstrates a balanced approach between internal development and strategic partnerships. The global licensing agreement with Ipsen for STRO-003 validates their technology platform and provides potential for future milestone payments and royalties. Their track record of generating $970 million in aggregate payments from collaborators underscores the value of their cell-free platform.

The appointment of Barbara Leyman as Chief Business Development Officer signals a focus on maximizing partnership opportunities, which could lead to additional non-dilutive funding. The addition of Sukhi Jagpal to the board strengthens financial oversight and M&A expertise, potentially positioning the company for future strategic transactions.

Investors should watch for new partnership announcements and the progression of existing collaborations. The company's ability to balance pipeline advancement with strategic deals will be important for long-term value creation and financial sustainability.

- Sutro will present updated data from the ongoing Phase 1b study of luvelta in combination with bevacizumab in a poster presentation at ESMO 2024; expansion study is ongoing with data expected in the first half of 2025 -

- REFRαME-O1 Part 2 (randomized portion) of the Phase 3 trial of luvelta for treatment of platinum-resistant ovarian cancer (PROC) is underway -

- REFRαME-P1, a registration-enabling trial of luvelta for pediatric patients with CBFA2T3::GLIS2 (CBF/GLIS; RAM phenotype) AML, is expected to be initiated in the second half of 2024 -

- A Phase 2 trial of luvelta for the treatment of NSCLC is expected to initiate in the second half of 2024, with initial data expected in the first half of 2025 -

- As of June 30, 2024, Sutro had $426.0 million, composed of cash, cash equivalents and marketable securities of $375.6 million and approximately 0.7 million shares of Vaxcyte common stock with a fair value of $50.4 million -

SOUTH SAN FRANCISCO, Calif., Aug. 13, 2024 (GLOBE NEWSWIRE) -- Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today reported its financial results for the second quarter of 2024, its recent business highlights, and a preview of select anticipated milestones.

“We continue to make meaningful progress with the development of luvelta across multiple indications, including enrollment of a patient expansion cohort in combination with bevacizumab, nearing initiation of our second registration-enabling trial, REFRaME-P1, for pediatric patients with a rare form of acute myeloid leukemia (AML) and approaching site activation of a Phase 2 trial in non-small cell lung cancer (NSCLC),” said Bill Newell, Sutro’s Chief Executive Officer. “We plan to share supplemental data from our Phase 1b trial of luvelta in combination with bevacizumab at the ESMO meeting in September.”

Mr. Newell added, “We are off to strong start in our new partnership with Ipsen for STRO-003 and continue to advance our preclinical pipeline of next-generation ADCs, including our tissue-factor targeting exatecan ADC, STRO-004. In parallel, we are exploring new partnership opportunities to maximize the potential of our platform and pipeline, led by our new Chief Business Development Officer Barbara Leyman. Additionally, we are delighted to welcome Sukhi Jagpal to our Board, as he brings a wealth of invaluable financial and strategic expertise.”

Recent Business Highlights and Select Anticipated Milestones

Luveltamab Tazevibulin (luvelta), FRα-Targeting ADC Franchise:

  • Sutro will present updated data from the Phase 1b study of luvelta in combination with bevacizumab for patients with ovarian cancer in a poster presentation at the European Society for Medical Oncology (ESMO) Congress 2024 to be held September 13-17 in Barcelona, Spain.
    • Title: Luveltamab tazevibulin, an antifolate receptor alpha (FRα) antibody-drug conjugate (ADC), in combination with bevacizumab (bev) in patients with recurrent high-grade epithelial ovarian cancer (EOC): STRO-002-GM2 phase 1 study
    • Date: Saturday, September 14, 2024
  • Part 2 (randomized portion) of the Phase 3 trial, REFRαME-O1, for treatment of platinum-resistant ovarian cancer (PROC), is underway.
  • 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.
  • A Phase 2 expansion study in combination with bevacizumab is ongoing, with data expected in the first half of 2025.
  • A Phase 2 trial for the treatment of NSCLC is expected to initiate in the second half of 2024, with initial data expected in the first half of 2025.

Additional Pipeline Development and Collaboration Updates:

  • In April 2024, Sutro announced a global licensing agreement for STRO-003, a ROR1-targeting ADC, with Ipsen.
  • Sutro plans to submit an IND for STRO-004 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 $970 million in payments through June 30, 2024, including equity investments.

Corporate Updates:

  • In August, Sutro strengthened its Board of Directors with the appointment of Sukhi Jagpal, MBA, CPA, CBV. Mr. Jagpal brings 20 years of experience in the life sciences industry, with expertise in financial management, communication, and organizational effectiveness, including financial analysis, mergers and acquisitions, and cost optimization.
  • In July, Sutro appointed Barbara Leyman, Ph.D., as Chief Business Development Officer, with a focus on building value and executing the Company’s business development strategy, in addition to serving on Sutro’s senior management team.

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.

  • Wedbush PacGrow Healthcare Conference in New York, August 13-14, 2024
  • Wells Fargo Healthcare Conference in Boston, September 4-6, 2024

Second Quarter 2024 Financial Highlights

Cash, Cash Equivalents and Marketable Securities and Vaxcyte Common Stock
As of June 30, 2024, Sutro had $426.0 million, composed of cash, cash equivalents and marketable securities of $375.6 million and approximately 0.7 million shares of Vaxcyte common stock with a fair value of $50.4 million.  

Unrealized Gain from Increase in Value of Vaxcyte Common Stock
The non-operating, unrealized gain of $4.8 million for the quarter ended June 30, 2024 was due to the increase since March 31, 2024 in the estimated fair value of Sutro’s holdings of Vaxcyte common stock. Vaxcyte common stock held by Sutro will be remeasured at fair value based on the closing price of Vaxcyte’s common stock on the last trading day of each reporting period, with any non-operating, unrealized gains and losses recorded in Sutro’s statements of operations.

Revenue
Revenue was $25.7 million for the quarter ended June 30, 2024, as compared to $10.4 million for the same period in 2023, with the 2024 amount related principally to the Astellas collaboration and the Vaxcyte agreement. Future collaboration and license revenue under existing agreements, and from any additional collaboration and license partners, will fluctuate as a result of the amount and timing of revenue recognition of upfront, milestones, and other agreement payments.

Operating Expenses
Total operating expenses for the quarter ended June 30, 2024 were $74.4 million, as compared to $56.6 million for the same period in 2023. The 2024 quarter includes non-cash expenses for stock-based compensation of $6.2 million and depreciation and amortization of $1.8 million, as compared to $6.7 million and $1.7 million, respectively, in the comparable 2023 period. Total operating expenses for the quarter ended June 30, 2024 were comprised of research and development expenses of $62.0 million and general and administrative expenses of $12.4 million.

About Sutro Biopharma  
Sutro Biopharma, Inc., is a clinical-stage company relentlessly focused on the discovery and development of precisely designed cancer therapeutics, to transform what science can do for patients. Sutro’s fit-for-purpose technology, including cell-free XpressCF®, provides the opportunity for broader patient benefit and an improved patient experience. Sutro has multiple clinical stage candidates, including luveltamab tazevibulin, or luvelta, a registrational-stage folate receptor alpha (FolRα)-targeting ADC in clinical studies. A robust pipeline, coupled with high-value collaborations and industry partnerships, validates Sutro’s continuous product innovation. Sutro is headquartered in South San Francisco. For more information, follow Sutro on social media @Sutrobio, or visit www.sutrobio.com.  

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 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. 

Sutro Biopharma, Inc.
Selected Statements of Operations Financial Data
(Unaudited)
(In thousands, except share and per share amounts)
 Three Months EndedSix Months Ended 
 June 30,June 30, 
 2024  2023  2024  2023 
Revenues$25,706  $10,412  $38,714  $23,086 
Operating expenses               
Research and development 62,020   41,592   118,898   80,991 
General and administrative 12,371   14,999   25,092   30,511 
Total operating expenses 74,391   56,591   143,990   111,502 
Loss from operations (48,685)  (46,179)  (105,276)  (88,416)
Interest income 4,911   2,842   9,007   5,402 
Unrealized gain on equity securities 4,808   8,321   8,487   1,329 
Non-cash interest expense related to the
sale of future royalties
 (7,286)  (442)  (14,470)  (442)
Interest and other income (expense), net (1,758)  (2,915)  (3,971)  (5,901)
Loss before provision for income taxes (48,010)  (38,373)  (106,223)  (88,028)
Provision for income taxes 8   151   8   546 
Net loss$(48,018) $(38,524) $(106,231) $(88,574)
Net loss per share, basic and diluted$(0.59) $(0.64) $(1.49) $(1.49)
Weighted-average shares used in computing
basic and diluted loss per share
 81,224,628   60,339,475   71,341,211   59,535,918 


Sutro Biopharma, Inc.
Selected Balance Sheets Financial Data
(Unaudited)
(In thousands)
 June 30,
2024(1)
  December 31,
2023(2)
 
Assets       
Cash, cash equivalents and marketable securities$375,568  $333,681 
Investment in equity securities 50,424   41,937 
Accounts receivable 6,950   36,078 
Property and equipment, net 19,414   21,940 
Operating lease right-of-use assets 20,333   22,815 
Other assets 16,354   14,285 
Total Assets$489,043  $470,736 
Liabilities and Stockholders’ Equity       
Accounts payable, accrued expenses and other liabilities$50,782  $64,293 
Deferred revenue 95,654   74,045 
Operating lease liability 26,526   29,574 
Debt -   4,061 
Deferred royalty obligation related to the sale of future royalties 163,905   149,114 
Total liabilities 336,867   321,087 
Total stockholders’ equity 152,176   149,649 
Total Liabilities and Stockholders’ Equity$489,043  $470,736 


(1) The condensed balance sheet as of June 30, 2024 was derived from the unaudited financial statements included in the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the Securities and Exchange Commission on August 13, 2024.
(2) The condensed balance sheet as of December 31, 2023 was derived from the unaudited financial statements included in the Company's Annual Report on Form  10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission on March 25, 2024.
   

FAQ

What were Sutro Biopharma's (STRO) Q2 2024 financial results?

Sutro Biopharma reported Q2 2024 revenue of $25.7 million and total operating expenses of $74.4 million. The company had $426.0 million in cash, equivalents, and marketable securities as of June 30, 2024.

What are the upcoming milestones for Sutro Biopharma's (STRO) luvelta drug?

Sutro will present updated data from the Phase 1b study of luvelta at ESMO 2024. A Phase 3 trial for platinum-resistant ovarian cancer is underway, and a registration-enabling trial for pediatric AML patients is expected to start in H2 2024. Additionally, a Phase 2 trial for NSCLC treatment is set to begin in H2 2024.

When will Sutro Biopharma (STRO) initiate the Phase 2 trial of luvelta for NSCLC?

Sutro Biopharma expects to initiate the Phase 2 trial of luvelta for the treatment of NSCLC in the second half of 2024, with initial data expected in the first half of 2025.

What is the status of Sutro Biopharma's (STRO) partnership with Ipsen?

In April 2024, Sutro announced a global licensing agreement with Ipsen for STRO-003, a ROR1-targeting ADC. The company reports a strong start to this new partnership.

Sutro Biopharma, Inc.

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Biotechnology
Biological Products, (no Disgnostic Substances)
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United States of America
SOUTH SAN FRANCISCO