Sutro Biopharma(STRO)

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Sutro Biopharma (STRO) Investor Presentation - Slideshow
2022-06-13 18:16
| --- | --- | --- | |-----------------------------------------------------------|-------|-------| | | | | | | | | | | | | | Company Overview June 2022 Sutro Biopharma NASDAQ: STRO | | | Forward Looking Statements This presentation and the accompanying oral presentation contain "forward-looking" statements that are based on our management's beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact c ...
Sutro Biopharma(STRO) - 2022 Q1 - Quarterly Report
2022-05-09 20:34
PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) Sutro Biopharma reported a net loss of **$39.1 million** for Q1 2022, an increase from **$30.4 million** in Q1 2021, due to decreased revenue and higher operating expenses [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2022, total assets decreased to **$303.7 million** from **$341.4 million** at year-end 2021, primarily due to reduced marketable securities and stockholders' equity Condensed Balance Sheet Highlights (in thousands) | Account | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $28,901 | $30,414 | | Marketable securities (current & non-current) | $163,199 | $199,118 | | Total current assets | $228,742 | $218,515 | | Total assets | $303,675 | $341,408 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $38,760 | $41,736 | | Total liabilities | $83,303 | $88,844 | | Total stockholders' equity | $220,372 | $252,564 | | Total Liabilities and Stockholders' Equity | $303,675 | $341,408 | [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) For Q1 2022, revenues significantly decreased to **$5.9 million** from **$14.7 million** year-over-year, leading to a wider net loss of **$39.1 million** Statement of Operations Summary (in thousands, except per share data) | Metric | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Revenues | $5,897 | $14,660 | | Research and development | $29,990 | $22,562 | | General and administrative | $15,039 | $11,107 | | Loss from operations | ($39,132) | ($19,009) | | Net loss | ($39,110) | ($30,359) | | Net loss per share, basic and diluted | ($0.84) | ($0.66) | [Condensed Statements of Comprehensive Loss](index=5&type=section&id=Condensed%20Statements%20of%20Comprehensive%20Loss) Comprehensive loss for Q1 2022 increased to **$39.9 million** from **$30.5 million** in Q1 2021, driven by a higher net loss and unrealized losses on securities Comprehensive Loss Summary (in thousands) | Metric | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Net loss | $(39,110) | $(30,359) | | Unrealized loss on available-for-sale securities | $(838) | $(129) | | **Comprehensive loss** | **$(39,948)** | **$(30,488)** | [Condensed Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Statements%20of%20Stockholders%27%20Equity) Total stockholders' equity decreased by **$32.2 million** to **$220.4 million** as of March 31, 2022, primarily due to the net loss for the quarter - Stockholders' equity declined by **$32.2 million** during Q1 2022, mainly due to a net loss of **$39.1 million**[15](index=15&type=chunk) [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was **$35.3 million** in Q1 2022, resulting in a **$1.5 million** net decrease in cash and equivalents Cash Flow Summary (in thousands) | Activity | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(35,255) | $(30,430) | | Net cash provided by (used in) investing activities | $32,982 | $(121,730) | | Net cash provided by financing activities | $760 | $1,826 | | **Net decrease in cash, cash equivalents and restricted cash** | **$(1,513)** | **$(150,334)** | [Notes to Unaudited Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) The notes detail the company's accumulated deficit, liquidity, revenue sources, and the renegotiation of the Tasly License Agreement post-quarter end - The company has an accumulated deficit of **$372.5 million** as of March 31, 2022, but believes its unrestricted cash, cash equivalents, and marketable securities of **$192.1 million** are sufficient to fund operations for at least the next 12 months[23](index=23&type=chunk)[24](index=24&type=chunk)[25](index=25&type=chunk) Revenue by Collaborator (in thousands) | Collaborator | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Bristol Myers Squibb Company ("BMS") | $2,165 | $1,239 | | Merck Sharp & Dohme Corporation ("Merck") | $1,064 | $11,883 | | EMD Serono | $1,897 | $220 | | Vaxcyte | $771 | $1,318 | | **Total revenue** | **$5,897** | **$14,660** | - The company did not recognize the **$40.0 million** upfront payment from the Tasly License Agreement as of March 31, 2022, because Tasly requested to renegotiate terms in February 2022[97](index=97&type=chunk) - Subsequent to the quarter end, on April 18, 2022, the Tasly agreement was amended, changing the upfront payment to **$25.0 million** with an additional **$15.0 million** in escrow contingent on regulatory milestones[128](index=128&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes the Q1 2022 revenue decrease to lower Merck collaboration revenue and explains increased operating expenses due to higher headcount and clinical development activities - The company's two most advanced wholly-owned product candidates are STRO-002 for ovarian and endometrial cancers, and STRO-001 for B-cell malignancies[133](index=133&type=chunk) Financial Results Comparison (in thousands) | Metric | Q1 2022 | Q1 2021 | Change (%) | | :--- | :--- | :--- | :--- | | Revenues | $5,897 | $14,660 | (60)% | | Research and development | $29,990 | $22,562 | 33% | | General and administrative | $15,039 | $11,107 | 35% | | Loss from operations | $(39,132) | $(19,009) | 106% | - The decrease in revenue was primarily due to a **$10.8 million** decrease from Merck, related to the completion of performance obligations under the 2018 agreement[156](index=156&type=chunk) - As of March 31, 2022, the company had **$192.1 million** in cash, cash equivalents, and marketable securities, which is believed sufficient to fund operations for at least the next twelve months[162](index=162&type=chunk)[169](index=169&type=chunk) - The COVID-19 pandemic is causing increased costs and delays in material availability, though patient enrollment and treatment remain on track[141](index=141&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to market risks, primarily interest rate sensitivities on its investment portfolio and equity price risk from its Vaxcyte common stock holding - The company's primary market risks are interest rate sensitivity and equity price risk from its investment in Vaxcyte common stock[185](index=185&type=chunk) - As of March 31, 2022, the company held **$37.7 million** in Vaxcyte common stock, where a hypothetical 10% decrease in market price would reduce fair value by **$3.8 million**[186](index=186&type=chunk)[187](index=187&type=chunk) - The company's outstanding debt of **$25.3 million** bears a floating interest rate, but a 100 basis point change would not materially impact interest expense[189](index=189&type=chunk) [Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2022, with no material changes in internal control over financial reporting - The CEO and CFO concluded that as of March 31, 2022, the company's disclosure controls and procedures were effective at a reasonable assurance level[191](index=191&type=chunk) - No changes in internal control over financial reporting occurred during Q1 2022 that materially affected, or are reasonably likely to materially affect, internal controls[192](index=192&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=36&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings that management believes would have a material adverse effect on its business - The company is not presently a party to any legal proceedings that would have a material adverse effect on its business[194](index=194&type=chunk) [Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) The company outlines significant risks including its history of losses, dependence on early-stage product candidates, need for additional funding, and challenges with its unproven platform and manufacturing - The company has a history of significant losses (**$372.5 million** accumulated deficit as of March 31, 2022) and may never achieve profitability[197](index=197&type=chunk)[200](index=200&type=chunk) - The business is highly dependent on the success of its proprietary product candidates, STRO-001 and STRO-002, which are in early stages of clinical development[197](index=197&type=chunk)[217](index=217&type=chunk) - The COVID-19 pandemic is impacting the availability of routine materials, causing sourcing difficulties and modified manufacturing schedules, which could potentially delay clinical trials[197](index=197&type=chunk)[201](index=201&type=chunk)[205](index=205&type=chunk) - The company's approach is based on novel XpressCF® and XpressCF+® platforms, which are unproven and may not result in marketable products, as no cell-free platform product has FDA approval[223](index=223&type=chunk)[239](index=239&type=chunk) - The company relies on third-party manufacturers for components and faces risks related to their compliance, quality, and supply capacity, as well as risks in scaling its own internal manufacturing[201](index=201&type=chunk)[253](index=253&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=88&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - There were no unregistered sales of equity securities in the quarter[427](index=427&type=chunk) [Defaults Upon Senior Securities](index=88&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - There were no defaults upon senior securities[427](index=427&type=chunk) [Mine Safety Disclosures](index=88&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[428](index=428&type=chunk) [Other Information](index=88&type=section&id=Item%205.%20Other%20Information) The company reported no other information for the period - None[429](index=429&type=chunk) [Exhibits](index=89&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including CEO and CFO certifications and Inline XBRL data files - The exhibits include certifications from the Principal Executive Officer and Principal Financial Officer pursuant to Sarbanes-Oxley Act Sections 302 and 906, as well as Inline XBRL documents[432](index=432&type=chunk)
Sutro Biopharma (STRO) Investor Presentation - Slideshow
2022-04-13 16:21
STRO-002 Clinical Trial Results and Strategy - In the dose expansion cohort of the STRO-002 trial for ovarian cancer, an overall response rate (ORR) of 333% was observed in all 33 evaluable patients[52] - A higher ORR of 471% was seen in patients starting at the 52 mg/kg dose level[52] - Exploratory analysis suggests that a tumor proportion score (TPS) > 25% correlated with higher response, demonstrating a 400% ORR (10 out of 25 patients)[68, 76] and 538% ORR (7/13) in patients at the 52 mg/kg starting dose[76] - 855% of treatment-emergent adverse events (TEAEs) were Grade 1-2, indicating a manageable safety profile[72, 76] - The company plans to initiate a pivotal trial in ovarian cancer by year-end 2022 and has dosed the first patient in the endometrial cancer cohort in November 2021[13] STRO-001 Clinical Trial and Development - STRO-001 is undergoing Phase 1 dose escalation studies, with the latest reported dose levels at 50 mg/kg in both multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) cohorts[91] - In the NHL cohort, the median number of prior therapies was 5 (range 1-12)[94] - Interim data from the NHL cohort showed partial responses in two DLBCL patients who had progressed on CAR-T therapy[96] Financial Position and Partnerships - The company reported $2295 million in cash, cash equivalents, and marketable securities as of December 31, 2021[99] - Projected cash runway extends into the second half of 2023, based on current business plans and assumptions[99] - Funding received from collaborators totaled approximately $446 million through December 31, 2021[99]
Sutro Biopharma(STRO) - 2021 Q4 - Annual Report
2022-02-28 21:32
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-38662 SUTRO BIOPHARMA, INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 47-0926186 (State or other jurisdiction o ...
Sutro Biopharma (STRO) Investor Presentation - Slideshow
2022-01-15 21:14
STRO-002 Clinical Trial Updates - Interim data from the dose expansion cohort of the STRO-002 Phase 1 study in advanced ovarian cancer showed a 333% objective response rate (ORR) in all 33 evaluable patients, unenriched for FolRα expression[52] - A higher response rate of 471% ORR was observed in patients starting at the 52 mg/kg dose level of STRO-002[52] - Exploratory analysis suggests that a Tumor Proportion Score (TPS) > 25% correlated with a higher response rate, demonstrating a 400% ORR (10/25) in patients at the 52 mg/kg starting dose[68, 76] - The company plans to initiate a pivotal trial in ovarian cancer by year-end 2022[13] - First patient dosed in endometrial cancer cohort in November 2021[13] - First patient dosed in bevacizumab combination trial in Q1 2022[13] STRO-001 Clinical Trial Updates - STRO-001 is undergoing Phase 1 dose escalation study with NHL update at ASH 2020[88] - As of October 2021, the last reported doses levels were of 50 mg/kg in the multiple myeloma (MM) cohort and 42 mg/kg in the non-Hodgkin's lymphoma (NHL) cohort[91] Financial Status - The company reported $2542 million in cash, cash equivalents, and marketable securities as of September 30, 2021[99] - Projected cash runway into 2H 2023, based on current business plans and assumptions[99] - Funding received from collaborators of approximately $434 million through September 30, 2021[99]
Sutro Biopharma(STRO) - 2021 Q3 - Quarterly Report
2021-11-09 23:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number: 001-38662 SUTRO BIOPHARMA, INC. (Exact Name of Registrant as Specified in its Charter) (State or other jurisd ...
Sutro Biopharma(STRO) - 2021 Q2 - Quarterly Report
2021-08-06 21:36
Financial Performance - The company reported a net loss of $36.5 million for the six months ended June 30, 2021, with an accumulated deficit of $264.4 million as of the same date [138]. - The company reported a net loss of $6.2 million for the three months ended June 30, 2021, compared to a net income of $29.9 million in the same period in 2020, representing a decrease of $36.0 million [155]. - The company reported a net cash decrease of $149.8 million for the six months ended June 30, 2021 [192]. - Cash used in operating activities for the six months ended June 30, 2021, was $35.7 million, reflecting a net loss of $36.5 million [193]. - Cash provided by financing activities for the six months ended June 30, 2021, was $1.8 million, primarily from $1.4 million of proceeds from common stock options [197]. - Cash provided by financing activities for the six months ended June 30, 2020, was $107.1 million, mainly from $91.4 million of net proceeds from a public offering [198]. Revenue and Collaborations - The company has no products approved for commercial sale and has not generated any revenue from commercial product sales [140]. - The company derives revenue primarily from collaboration agreements, with no revenue from commercial product sales to date [141]. - Total revenue increased by $18.6 million, or 196%, during the three months ended June 30, 2021, compared to the same period in 2020, reaching $28.0 million [155]. - Total revenue increased by $26.1 million, or 157%, during the six months ended June 30, 2021, compared to the same period in 2020, driven by a $22.0 million increase from Merck [169]. - Revenue from Merck Sharp & Dohme Corporation increased by $12.9 million, or 184%, during the three months ended June 30, 2021, totaling $19.9 million [156]. - The company earned a $15.0 million contingent payment from Merck in Q2 2021 for initiating an IND enabling toxicology study [177]. - The company has entered into collaborations with Merck, Celgene (BMS), and EMD Serono to develop multi-target product candidates [131]. Expenses - Research and development expenses for the three months ended June 30, 2021, were $25.3 million, an increase of $8.1 million or 47% compared to $17.2 million in the same period in 2020 [160]. - Total operating expenses for the six months ended June 30, 2021, were $71.5 million, an increase of $19.3 million or 37% compared to $52.2 million in the same period in 2020 [166]. - Research and development expense rose by $13.0 million, or 37%, during the six months ended June 30, 2021, primarily due to higher personnel-related expenses and clinical trial costs [171]. - General and administrative expenses rose to $12.5 million for the three months ended June 30, 2021, reflecting an increase of $3.9 million or 45% compared to $8.6 million in the same period in 2020 [161]. - General and administrative expense increased by $6.3 million, or 36%, during the six months ended June 30, 2021, mainly due to higher personnel-related expenses and facility-related costs [172]. - The company expects significant increases in operating expenses as it continues to develop product candidates and seek regulatory approvals [138]. - The company expects research and development expenses to increase in the future as it advances product candidates through clinical trials and expands its pipeline [146]. Clinical Trials - The Phase 1 trial for STRO-001 has enrolled patients and is ongoing, with no ocular toxicity signals observed and the maximum tolerated dose not yet reached [132]. - As of April 23, 2021, the Phase 1 trial for STRO-002 had enrolled 39 ovarian cancer patients, with 31 patients evaluable for RECIST responses [133]. - In the STRO-002 trial, 10 out of 31 evaluable patients met criteria for response, including 1 complete response and 9 partial responses [136]. - The median duration of response for confirmed responders in the STRO-002 trial was 5.8 months, with a median progression-free survival of 7.2 months [136]. - The COVID-19 pandemic has caused minor delays in clinical trial enrollment but overall patient treatment remains on track [139]. Cash and Securities - As of June 30, 2021, the company had cash, cash equivalents, and marketable securities totaling $283.4 million, with an outstanding debt of $24.8 million [176]. - As of June 30, 2021, the company had cash, cash equivalents, and marketable securities totaling $283.4 million, down from $326.5 million as of December 31, 2020 [208]. - The company held equity securities valued at $35.3 million as of June 30, 2021, consisting solely of common stock of Vaxcyte [208]. - A hypothetical 10% decrease in the market price of equity investments as of June 30, 2021, would decrease the fair value by $3.5 million [209]. - The company had $24.8 million in debt outstanding as of June 30, 2021, with a floating interest rate that could be as high as 8.07% [211]. - The debt matures on March 1, 2024, and will be interest-only through March 1, 2022 [211]. Future Outlook - The company anticipates needing additional financing to advance its product candidates and fund operations in the foreseeable future [190]. - The company is classified as an emerging growth company and expects to cease this status by December 31, 2021 [202]. - The company has not entered into any off-balance sheet arrangements [199]. - There have been no material changes to critical accounting policies since the last annual report [204].
Sutro Biopharma (STRO) Investor Presentation - Slideshow
2021-05-21 22:43
| --- | --- | --- | --- | |-------|-------|-------|-------| | | | | | | | | | | Forward Looking Statements This presentation and the accompanying oral presentation contain "forward-looking" statements that are based on our management's beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our future financial performance, business ...
Sutro Biopharma(STRO) - 2021 Q1 - Quarterly Report
2021-05-06 22:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number: 001-38662 SUTRO BIOPHARMA, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 47-0926186 (State ...
Sutro Biopharma (STRO) Presents At 20th Annual Needham Virtual Healthcare Conference - Slideshow
2021-04-15 23:25
Company Strategy & Technology - Sutro Biopharma is expanding cell-free technology beyond ADCs, building strategic partnerships, and creating new modalities for extended value creation[8] - The company utilizes an industry-leading cell-free protein synthesis platform with GMP production yields consistent and scalable end-products[12] - Sutro's cell-free synthesis platform allows for the creation of hundreds of protein variants in weeks, enabling empirical selection of the best lead candidate[18] STRO-002 Program (Ovarian and Endometrial Cancers) - STRO-002 is a FolRα-targeting ADC with a DAR of 4, designed with a potentially dual mechanism of action[28] - In a Phase 1 dose-escalation study, 34 patients were treated at clinically active doses (≥ 2.9 mg/kg Q3W) of STRO-002[30] - In the RECIST-evaluable population (N=31), 10 patients met the criteria for response, with an objective response rate of 20%[36] - Clinical benefit was observed in a heavily pre-treated patient population, with a disease control rate of 74% at 12 weeks in the RECIST-evaluable population[43] STRO-001 Program (Lymphomas and Multiple Myeloma) - STRO-001 is a CD74-targeting ADC with a DAR of 2, designed to minimize bystander effects in hematological cancers[57] - In the NHL cohort, a total of 21 patients have been treated with STRO-001, and 18 patients were evaluable for response as of October 30, 2020[62] - Interim data showed partial responses in two DLBCL patients who had progressed on CAR-T therapy[67] Financial Status - The company reported $326.5 million in cash, cash equivalents, and marketable securities as of year-end 2020[73] - The projected cash runway extends into 2H 2023, not including potential monetization of Vaxcyte shares or future business development[73] - Sutro Biopharma has received approximately $398 million in funding from collaborators through year-end 2020[73]