On February 28, 2022 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, and Sanwa Kagaku Kenkyusho Co., Ltd. ("Sanwa"), an established, fully integrated pharmaceutical company headquartered in Nagoya, Japan, reported that the parties have entered into a strategic partnership to exclusively develop and commercialize paltusotine in Japan (Press release, Crinetics Pharmaceuticals, FEB 28, 2022, View Source [SID1234609209]). Paltusotine is Crinetics’ investigational, orally available nonpeptide somatostatin receptor type 2 (SST2) agonist being evaluated as a treatment for acromegaly and neuroendocrine tumors (NETs), including NETs complicated by carcinoid syndrome.

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Under the terms of this agreement, Crinetics will receive $13.0 million upfront and will be eligible to receive milestone payments related to the achievement of certain development, regulatory and commercial goals. In addition, upon market approval of paltusotine in Japan, Crinetics will be eligible to receive tiered royalties based on net product sales. Sanwa will have an exclusive right to develop and commercialize the product in Japan and will be responsible for leading the development and commercialization of paltusotine for acromegaly and NETs in Japan. Also, Sanwa will assume all costs associated with clinical trials and regulatory applications associated with these processes. Crinetics retains all rights to develop and commercialize paltusotine outside Japan.

There are approximately 10,000 acromegaly patients and 11,000 NETs patients in Japan and, as in the United States, somatostatin analogues are the first-line medical therapy for individuals for whom surgery is either not prescribed or is not curative. Shusaku Isono, President and Chief Executive Officer of Sanwa Kagaku Kenkyusho Co., Ltd. said "Through this license agreement, we will make our best effort with Crinetics to provide a new oral treatment option for acromegaly and NETs patients in Japan."

"In Sanwa, we met a company that shares our vision of developing, as the first indication for paltusotine, a once-daily oral therapy for acromegaly that will establish a new class of medicine to allow patients to live full lives free of the burden of painful monthly injections," added Scott Struthers, Ph.D., founder and Chief Executive Officer of Crinetics. "With the promise of additional indications for NETs, we look forward to a long and productive relationship with our colleagues at Sanwa and are pleased to have the external validation that such a high-quality partnership provides."

Crinetics is currently enrolling patients in its Phase 3 PATHFNDR program, which is evaluating the safety and efficacy of once-daily oral paltusotine in a wide cross section of acromegaly patients in the United States and Europe. In Japan, Sanwa expects to initiate Phase 1 development with paltusotine in 2022.

ABOUT ACROMEGALY
Acromegaly is a serious disease generally caused by a pituitary adenoma, a benign tumor in the pituitary that secretes growth hormone. Excess GH secretion causes excess secretion of IGF-1 from the liver. Together, excess of these hormones leads to the symptoms and physical manifestations of acromegaly, including abnormal growth of hands and feet, alteration of facial features, arthritis, carpal tunnel syndrome, joint aches, deepening of voice due to enlarged vocal cords, fatigue, sleep apnea, enlargement of heart, liver and other organs, and changes in glucose and lipid metabolism. Surgical removal of pituitary adenomas, if possible, is the preferred initial treatment for most acromegaly patients. Pharmacological treatments are used for patients that are not candidates for surgery, or when surgery is unsuccessful in achieving treatment goals. Approximately 50% of patients with acromegaly prove to be candidates for pharmacological treatment. Long-acting somatostatin-receptor ligands (SRLs) are the most common initial pharmacologic treatment; however, these drugs require monthly depot injections with large gauge needles that are commonly associated with pain, injection site reactions, and increased burden of therapy on the lives of patients.

ABOUT NEUROENDOCRINE TUMORS AND CARCINOID SYNDROME
Carcinoid syndrome is a group of symptoms that presents in some individuals with neuroendocrine tumors (NETs). NETs are a rare, slow-growing type of cancer that arises most often in the digestive tract. Carcinoid syndrome is most common in patients with NETs that develop in the lung and gastrointestinal tract and metastasize to the liver. In these cases, the liver is unable to filter the hormones secreted by the NETs, causing them to be circulated systemically and inducing the symptoms of carcinoid syndrome which commonly include diarrhea and flushing.

ABOUT PALTUSOTINE
Paltusotine is an investigational, orally available nonpeptide agonist that is designed to be highly selective for the somatostatin receptor type 2 (SST2). It was designed by the Crinetics discovery team to provide a once-daily option for patients with acromegaly and neuroendocrine tumors. A previously completed Phase 1 trial of paltusotine showed clinical proof of concept by providing evidence of potent suppression of the growth hormone axis in healthy volunteers. In Phase 2 trials, paltusotine maintained IGF-1 levels in acromegaly patients who switched from injectable depot medications to once-daily oral paltusotine. IGF-1 is the primary biomarker endocrinologists use to manage their acromegaly patients.

On February 28, 2022 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, reported fourth quarter and full year 2021 financial results and business highlights (Press release, Biomea Fusion, FEB 28, 2022, View Source [SID1234609110]).

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"I am proud of all that we, TEAM FUSION, accomplished in 2021 laying a firm foundation to enable our ambitious clinical development strategy for BMF-219, our irreversible covalent menin inhibitor. In January 2022, we began dosing our first patient in our initial Phase I leukemia study of BMF-219, and we are aiming to initiate human studies in up to seven different tumor types as well as diabetes over the next 12 months," said Thomas Butler, Biomea’s CEO and Chairman of the Board. "We also have made significant progress advancing our lead preclinical programs and plan to announce our second irreversible covalent inhibitor pipeline candidate in the coming months. We anticipate that the next 12 months will be enormously productive and catalyst rich for Biomea Fusion."

Clinical and Regulatory Highlights Last 12 months

Enrolled first patient in first-in-human Phase I clinical trial evaluating BMF-219, Biomea’s irreversible covalent menin inhibitor, in patients with relapsed/refractory (r/r) acute leukemias, including those with MLL1/KMT2A gene rearrangements or NPM1 mutations.
Announced 2022 clinical development plan, which includes initiating studies with BMF-219 in up to seven cancers and diabetes, subject to the submission and clearance of additional Investigational New Drug applications (INDs). These studies plan to evaluate patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), multiple myeloma (MM), diffuse large B-Cell lymphoma (DLBCL), non-small cell lung cancer (NSCLC), pancreatic cancer, and colorectal cancer (CRC). Preclinical data suggests the menin complex plays a critical role in MYC-dependent oncogenic signaling, whereby menin enhances MYC-mediated transcription to promote cancer progression. Inhibition of menin is a novel approach to cancer treatment. Nonclinical studies of BMF-219 have shown sustained potent abrogation of menin-dependent cancers.
Published preclinical abstract at ASH (Free ASH Whitepaper) 2021, highlighting impact of BMF-219 on MYC activity and substantial growth inhibition compared to other menin inhibitors in DLBCL. BMF-219 was observed to elicit broad impact on the complexes surrounding menin resulting in strong modulation of MYC expression, highlighting potential in multiple cancer types.
Expanded the Phase I study to include two additional tumor types, one with diffuse large B-cell lymphoma (DLBCL) patients and one with multiple myeloma (MM) patients.
Corporate Highlights Last 12 months

Completed initial public offering, with net proceeds of $152.8 million.
Opened Biomea R&D Innovation Center in Redwood City, accelerating the discovery and development of additional irreversible covalent programs via the company’s proprietary FUSION System.
Grew the Biomea Fusion team to 51 employees and expanded the executive team with the hires of Chief Financial Officer, Franco Valle, and Chief Medical Officer, Steve Morris, M.D.
Strengthened board of directors with the appointments of Michael J. M. Hitchcock, Ph.D., a tenured employee and long-time advisor to Gilead Sciences and Adjunct Professor of Microbiology at the University of Nevada Medical School; and Sumita Ray, J.D., Chief Legal and Administrative Officer at Calithera Biosciences, Inc.
Expected Milestones in 2022

Initiate enrollment of patients with MM and DLBCL in Phase I clinical trial of BMF-219.
Announce further preclinical data for BMF-219 in liquid and solid tumors.
Announce preclinical validation for BMF-219 in diabetes.
Announce second irreversible covalent inhibitor pipeline candidate in the first half of 2022.
Submission of an IND for BMF-219 in diabetes in the second half of 2022.
Submission of an IND for BMF-219 in KRAS-mutant solid tumors, including patients with non-small cell lung cancer (NSCLC), pancreatic cancer, and colorectal cancer (CRC) in the fourth quarter of 2022.
Fourth Quarter and Full Year 2021 Financial Results

Net Income/Loss: Biomea reported a net loss attributable to common stockholders of $41.6 million for year ended December 31, 2021, compared to a net loss of $5.3 million for the same period in 2020.
R&D Expenses: Research and development expenses were $28.0 million for the year ended December 31, 2021, compared to $3.7 million for the same period in 2020. The increase of $24.3 million was primarily due to an increase in personnel-related expenses, as well as an increase in preclinical and clinical development costs, including manufacturing and external consulting, related to the Company’s lead product candidate, BMF-219.
G&A Expenses: General and administrative expenses were $13.7 million for the year ended December 31, 2021, compared to $1.7 million for the same period in 2020. The increase of $12.0 million was primarily due to higher personnel-related expenses and other corporate costs to support the Company’s expanding operations as well as additional costs incurred as a public company.
Cash, Cash Equivalents, Restricted Cash, and Investments: As of December 31, 2021, the Company had cash, cash equivalents, restricted cash, and investments of $175.7 million.

On February 28, 2022 Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, reported financial results for the year ended December 31, 2021 and provided clinical and business updates (Press release, Pain Therapeutics, FEB 28, 2022, View Source [SID1234609142]).

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"In second half 2021, we initiated two separate Phase 3 clinical studies with our lead drug candidate, simufilam, in patients with Alzheimer’s disease," said Remi Barbier, President & CEO. "This was a large, complex endeavor. We deeply appreciate every member of the team inside and outside the Company who contributed to this effort. Our challenge for 2022 and beyond is to enroll over 1,700 patients into our Phase 3 clinical program. With this evolution, we intend to prove once again that we are a small company capable of doing big things."

Cassava Sciences’ Phase 3 studies are now recruiting patients with mild to moderate Alzheimer’s disease. Drug has been shipped to nearly 100 clinical trial sites across North America, with additional sites planned in the U.S. and overseas. Over 200 patients have been screened to date.

"We are encouraged by our clinical investigators’ high level of enthusiasm," said Jim Kupiec, MD, Chief Clinical Development Officer. "Looking ahead, we see continued collaboration with the clinical community to ensure qualifying patients with Alzheimer’s disease are successfully enrolled into our Phase 3 studies."

"Our balance sheet has $233.4 million of cash, against expected cash use of $25 to $35 million in first half 2022, depending on patient enrollment rates and the timing of certain legal expenses," said Eric Schoen, Chief Financial Officer. "Higher cash use may indicate faster enrollment rates."

Net loss for full year 2021 was $32.4 million, or $0.82 per share, compared to a net loss of $6.3 million, or $0.24 per share, in 2020. Net cash used in operations full-year 2021 was $30.2 million, consistent with previous guidance. An additional $22.2 million was used primarily for an all-cash purchase of office property in Austin, Texas, which is expected to serve as Cassava Sciences’ corporate headquarters in 2022 and beyond.

Financial Highlights

At December 31, 2021, cash and cash equivalents were $233.4 million, compared to $93.5 million at December 31, 2020, with no debt.

Net cash used in operations full-year 2021 was $30.2 million, net of reimbursements received from the National Institutes of Health (NIH) grant awards. An additional $22.2 million was used primarily for the purchase of office property in Austin, Texas, which is expected serve as the Company’s corporate headquarters in 2022 and beyond.

Net cash use for operations for the first half of 2022 is expected to be approximately $25 to $35 million, driven primarily by expenses for our ongoing Phase 3 program in Alzheimer’s disease.

Research and development (R&D) expenses for the year ended December 31, 2021 were $24.8 million compared to $3.1 million for the same period in 2020. This increase was due primarily to costs related to manufacture of clinical trial supplies for and the initiation of a Phase 3 clinical program with simufilam, costs of an on-going open-label study and cognition maintenance extension study with simufilam, as well as increased personnel expenses compared to the prior year. These expenses are net of grant funding received from NIH, which is recorded as a reduction in R&D expenses.

Research grant funding reimbursements of $3.9 million were received from NIH and recorded as a reduction in R&D expenses. This compared to $4.2 million of NIH grant receipts received for 2020.

General and administrative (G&A) expenses for the year ended December 31, 2021 were $8.1 million compared to $3.7 million for 2020. This increase was primarily due to higher legal fees, personnel costs, insurance costs and depreciation and amortization as compared to 2020.
Overview of Phase 3 Clinical Program – RETHINK-ALZ and REFOCUS-ALZ
The Phase 3 program consists of two double-blind, randomized, placebo-controlled studies of simufilam in patients with mild-to-moderate Alzheimer’s disease. Both Phase 3 studies have Special Protocol Assessments (SPA) from FDA. Both Phase 3 studies were initiated in Fall 2021.

The RETHINK-ALZ Phase 3 study is designed to evaluate the safety and efficacy of oral simufilam 100 mg in enhancing cognition and slowing functional decline over 52 weeks. Secondary objectives include the assessment of simufilam’s effect on neuropsychiatric symptoms and caregiver burden. This randomized, double-blind, placebo-controlled study plans to enroll approximately 750 patients with mild-to-moderate Alzheimer’s disease in the U.S. and Canada and, eventually, overseas.

Details of the RETHINK-ALZ Phase 3 study include:

Subjects to be randomized (1:1) to simufilam 100 mg or placebo twice daily.
The co-primary efficacy endpoints are ADAS-Cog12, a cognitive scale, and ADCS-ADL, a functional scale; both are standard clinical tools in trials of Alzheimer’s disease.
A secondary efficacy endpoint is iADRS, a widely used clinical tool in trials of Alzheimer’s disease that combines cognitive and functional scores from ADAS-Cog & ADCS-ADL.
Other secondary endpoints include plasma biomarkers of disease and NPI, a clinical tool to assess dementia-related behavior.
The REFOCUS-ALZ Phase 3 study is designed to evaluate the safety and efficacy of oral simufilam 100 mg and 50 mg over 76 weeks. This randomized, double-blind, placebo-controlled study plans to enroll approximately 1,000 patients with mild-to-moderate Alzheimer’s disease in the U.S. and Canada and, eventually, overseas.

Details of the REFOCUS-ALZ Phase 3 study, include:

Subjects to be randomized (1:1:1) to simufilam 100 mg, 50 mg, or placebo twice daily.
The co-primary efficacy endpoints are ADAS-Cog12, a cognitive scale, and ADCS-ADL, a functional scale; both are standard clinical tools in trials of Alzheimer’s disease.
A secondary efficacy endpoint is iADRS, a widely used clinical tool in trials of Alzheimer’s disease that combines cognitive and functional scores from ADAS-Cog & ADCS-ADL.
Other secondary endpoints include CSF, plasma and imaging biomarkers of disease and NPI, a clinical tool to assess dementia-related behavior.
Open-label Study

In March 2020, we initiated a long-term, open-label study to evaluate simufilam, our lead drug candidate, in patients with mild-to-moderate Alzheimer’s disease. The study is intended to monitor the long-term safety and tolerability of simufilam 100 mg twice daily for 12 or more months. Another study objective is to measure changes in cognition and biomarkers.

In September 2021, the open-label study reached its final target enrollment of approximately 200 subjects with Alzheimer’s disease. We expect to announce full study results second half 2022.

The study protocol has pre-specified interim analyses, including cognition measurements at 6, 9 and 12 months. ADAS-Cog scores improved 1.6 points, 3.0 points and 3.2 points from baseline in the first 50 study participants who completed, respectively, 6, 9 and 12 months of open-label treatment with simufilam. It is understood that cognition data from an open-label study has limitations compared to efficacy data from a fully completed, large, randomized controlled trial.

In 2022, we may conduct one or more ad hoc interim analyses on measurements of cognition on the open-label study.

Another objective of this study is to measure changes in levels of biomarkers in patients treated with open label simufilam. In July 2021, we announced positive biomarker data at 6 months. Biomarker data were analyzed from cerebrospinal fluid (CSF) collected from 25 study participants who agreed to undergo a lumbar puncture at baseline and again after 6 months of treatment. In this cohort of 25 study participants, simufilam robustly improved CSF biomarkers of disease pathology (t-tau and p-tau181 decreased 38% and 18%, respectively); CSF biomarkers of neurodegeneration (neurogranin and NfL, decreased 72% and 55%, respectively); and CSF biomarkers of neuroinflammation (sTREM2 and YKL-40, decreased 65% and 44%, respectively).

In 2022, we expect to measure changes in levels of biomarkers in patients treated with open label simufilam for 12 months.

Cognition Maintenance Study (CMS)
In May 2021, we initiated a Cognition Maintenance Study (CMS). This is a double-blind, randomized, placebo-controlled study of simufilam in patients with mild-to-moderate Alzheimer’s disease. Study participants are randomized (1:1) to simufilam or placebo for six months. To enroll in the CMS, patients must have previously completed 12 months or more of open-label treatment with simufilam. The CMS is designed to evaluate simufilam’s effects on cognition and health outcomes in Alzheimer’s patients who continue with drug treatment versus patients who discontinue drug treatment. The target enrollment for the CMS is approximately 100 subjects. Over 60 subjects have been enrolled in the CMS and 30 have completed the study.

SavaDx
Our investigational diagnostic product candidate, called SavaDx, is an early-stage program focused on detecting the presence of Alzheimer’s disease from a small sample of blood. For business, technical and personnel reasons, we continue to prioritize the development of simufilam, our lead drug candidate, over SavaDx. The regulatory pathway for SavaDx may eventually include formal analytical validation studies and clinical studies that support evidence of sensitivity, specificity and other variables in various healthy and diseased patient populations. We have not conducted such studies and do not expect to conduct such studies in 2022.

SavaDx is currently designed as an antibody-based detection system for altered filamin A (FLNA). In 2022, we plan to evaluate a new approach to detect FLNA without the use of antibodies.

About Simufilam
Simufilam (sim-uh-FILL-am) is a proprietary, small molecule (oral) drug that restores the normal shape and function of altered filamin A (FLNA) protein in the brain. Altered FLNA in the brain disrupts the normal function of neurons, leading to Alzheimer’s pathology, neurodegeneration and neuroinflammation. The underlying science for simufilam is published in peer-reviewed journals, including Journal of Neuroscience, Neurobiology of Aging, Journal of Biological Chemistry, Neuroimmunology and Neuroinflammation and Journal of Prevention of Alzheimer’s Disease.
Cassava Sciences owns worldwide development and commercial rights to its research programs in Alzheimer’s disease, and related technologies, without royalty obligations to any third party.

On February 28, 2022 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported that it will report its fourth quarter and full-year 2021 financial results on Thursday, March 3, 2022 (Press release, Gossamer Bio, FEB 28, 2022, View Source [SID1234609161]).

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In connection with the earnings release, Gossamer’s management team will host a live conference call and webcast at 4:30 p.m. ET on Thursday, March 3, 2022, to discuss the Company’s financial results and provide a corporate update.

A replay of the audio webcast will be available for 30 days on the Investors section of the Company’s website, www.gossamerbio.com.

On February 28, 2022 Sutro Biopharma, Inc. ("Sutro" or the "Company") (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 cancer therapeutics, reported its financial results for the full year 2021, its recent business highlights, and a preview of anticipated select milestones in 2022 (Press release, Sutro Biopharma, FEB 28, 2022, View Source [SID1234609179]).

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"We are proud of the achievements at Sutro, as our proprietary cell-free platform has enabled five clinical-stage product candidates, including our internal programs, STRO-002 and STRO-001, and our collaborator programs, CC-99712, M1231, and VAX-24," said Bill Newell, Sutro’s Chief Executive Officer. "We’ve made significant strides in the development of STRO-002 for ovarian cancer by completing the enrollment of the Phase 1 trial late last year. We intend to work with regulatory agencies on a registrational path forward for patients with ovarian cancer, utilizing our Fast Track Designation. Additionally, we are exploring the therapeutic benefit of STRO-002 in other tumor types. We are currently enrolling patients in an endometrial cohort and plan to initiate a NSCLC study later this year. We continue to explore all strategies to accelerate the development of STRO-002 to provide a potential new therapy for patients suffering from advanced cancers with limited durable treatment options."

Recent Business Highlights and Anticipated 2022 Select Milestones

STRO-002, FolRα-Targeting Antibody-Drug Conjugate (ADC): STRO-002 is being studied in the clinic, in both the United States and Europe, for patients with ovarian cancer and endometrial cancer.

The Phase 1 dose-expansion cohort for patients with advanced ovarian cancer was initiated in January 2021 and enrollment was completed in November 2021.
Sutro reported initial data for the dose-expansion cohort in January 2022 at a Company KOL Virtual Event, providing data on efficacy and safety, and initial insights on a potential go-forward dosing regimen and biomarker enrichment strategy.
Additional data on efficacy, safety, and durability from the dose-expansion cohort are expected to be reported in the second half of 2022.
Regulatory discussions on a potential registrational study for patients with advanced ovarian cancer are planned for around mid-year 2022.
Sutro is enrolling patients in a combination study of STRO-002 with bevacizumab for patients with advanced ovarian cancer and a dose-expansion study of STRO-002 for patients with endometrial cancer.
STRO-001, CD74-Targeting ADC: The Phase 1 study for patients with B‑cell malignancies, including patients with non-Hodgkin’s lymphoma and multiple myeloma, continues in dose escalation.

Dose escalation is ongoing to achieve a recommended phase 2 dose (RP2D), with the last reported doses of 5.0 mg/kg in the multiple myeloma (MM) cohort and 5.0 mg/kg in the non-Hodgkin’s lymphoma (NHL) cohort.
Additional Pipeline Programs: Research and preclinical development are underway for several internal candidates.

Sutro announced multiple discovery and preclinical candidates, including ADCs targeting ROR1 and Tissue Factor, a 5T4-CD3 bispecific T-Cell Engager (TCE), and cytokine derivatives, including IFNα, IL-12, and IL-18.
Discovery and preclinical work on these programs are underway to determine Sutro’s next programs to advance to the clinic.
Collaboration Updates: 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 received from collaborators an aggregate of approximately $446 million in payments, including equity investments, through December 31, 2021.

Sutro is manufacturing initial drug supply for the potential clinical development of the Merck cytokine derivative program, which is focused on two distinct cytokine derivative molecules for the treatment of cancer.
Sutro continues to manufacture clinical trial materials for Bristol Myers Squibb’s (BMS) CC-99712, a BCMA‑targeting ADC, for treatment of multiple myeloma, as BMS continues its Phase 1 clinical trial, which has been expanded to include a study in combination with a gamma secretase inhibitor.
Sutro will supply cell-free extract to Vaxcyte for the clinical supply of VAX-24, which is designed to prevent invasive pneumococcal disease. Vaxcyte announced in February 2022 that the first participants were dosed in the Phase 1/2 clinical study of VAX-24.
Sutro plans to support BioNova Pharmaceuticals (BioNova) in clinical trial initiations for STRO-001 in the Greater China market and provide clinical drug supply as needed.
Under the licensing agreement with Tasly Biopharmaceuticals (Tasly) to develop and commercialize STRO-002 in Greater China, Tasly is obligated to make an initial payment of $40 million to Sutro. In February 2022, Tasly indicated to Sutro that it would like to discuss and renegotiate the terms of the agreement. Based on the currently ongoing discussions, Sutro believes that substantial uncertainty exists as to whether Tasly will timely deliver the initial payment to Sutro, despite Sutro having performed its related obligations upon execution of the agreement. Accordingly, Sutro is considering all remedies available. Of note, no new or updated clinical data have been shared by Sutro with Tasly subsequent to the STRO-002 initial dose-expansion data release by Sutro in January 2022.
Full Year 2021 Financial Highlights

Cash, Cash Equivalents and Marketable Securities
As of December 31, 2021, Sutro had cash, cash equivalents and marketable securities of $229.5 million, as compared to $326.5 million as of December 31, 2020, with projected runway into the second half of 2023, based on current business plans and assumptions. The above balances do not include the value associated with Sutro’s holdings of Vaxcyte common stock.

Unrealized Loss from Decrease in Value of Vaxcyte Common Stock
As of December 31, 2021, Sutro held approximately 1.6 million shares of Vaxcyte common stock, with a fair value of $37.2 million. The non-operating, unrealized loss of $4.5 million in 2021 was due to the decrease since December 31, 2020 in the estimated fair value of Sutro’s holdings of Vaxcyte common stock. In 2020, Sutro recorded an unrealized gain of $41.5 million related to its Vaxcyte common stock holdings. 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 $61.9 million for the year ended December 31, 2021, as compared to $42.7 million for the same period in 2020, related principally to the Merck, BMS, and EMD Serono collaborations. Future collaboration revenue from Merck, BMS, and EMD Serono, and from any additional 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 year ended December 31, 2021 were $160.4 million, as compared to $113.8 million for the same period in 2020. The 2021 period includes non-cash expenses for stock-based compensation of $23.2 million and depreciation and amortization of $4.8 million, as compared to $11.9 million and $4.3 million, respectively, in the comparable 2020 period. Total operating expenses for the year ended December 31, 2021 were comprised of research and development expenses of $104.4 million and general and administrative expenses of $56.0 million, which are expected to increase in 2022 as Sutro’s internal product candidates advance in clinical development and additional general and administrative expenses are incurred as a public company.