On March 15, 2022 Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, reported financial results for the fourth quarter and full year ended December 31, 2021 and provided recent business highlights (Press release, Shattuck Labs, MAR 15, 2022, View Source [SID1234610109]).

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"We took a very important step in 2021 toward validating the Agonist Redirected Checkpoint (ARC) platform as a new class of biologic medicine, through sharing initial clinical data from our SL-172154 and SL-279252 programs at the 36th annual meeting of the Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). The observation of initial anti-tumor activity and dose-dependent activation of CD40 and OX40 are differentiating features of ARCs that bode well for the next stage of clinical development," said Taylor Schreiber, M.D., Ph.D., and Chief Executive Officer of Shattuck. "With SL-172154, we are pleased with the safety profile, evidence of target saturation, and potent dose-dependent CD40 activation, which prompted our combination strategy aimed to demonstrate significant anti-tumor activity. Based on the clinical data to date and evolving development landscape, we believe SL-172154 could emerge as both a first-in-class and best-in-class CD47 inhibitor and CD40 agonist."

Fourth Quarter 2021 Recent Business Highlights and Other Recent Developments

ARC Clinical-Stage and Preclinical Pipeline

SL-172154 (SIRPα-Fc-CD40L)

Announced Initial Data from SL-172154 Phase 1 Dose-Escalation Clinical Trial in Platinum-Resistant Ovarian Cancer Demonstrating Favorable Safety Profile, High Target Occupancy, and Unique Pharmacodynamic Activity at the 36th Annual SITC (Free SITC Whitepaper) Meeting: The Phase 1 trial is an open-label, multi-center, dose-escalation trial to evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154 administered intravenously in patients with platinum-resistant ovarian cancer. Data reported at the 36th Annual SITC (Free SITC Whitepaper) Meeting was in 15 evaluable patients, across four dose levels on two schedules: schedule 1 (day 1, 8, 15, 29, then every two weeks) at 0.1 and 0.3 mg/kg and schedule 2 (weekly) at 0.3, 1.0, and 3.0 mg/kg. SL-172154 was well tolerated through 3.0 mg/kg, and no dose-limiting toxicities were observed. Preferential binding to CD47 on leukocytes, compared to red blood cells, was observed and exceeded 80% of CD47 expressing leukocytes in most patients at doses of 1.0 and 3.0 mg/kg. Dose-dependent CD40 receptor occupancy was also observed, which approached 100% of CD40 expressing cells at the 3.0 mg/kg dose level and correlated with multiple signs of CD40 activation. Specifically, dose-dependent margination of CD40 expressing B cells and monocytes was observed following each infusion, and large increases in multiple serum cytokines, including IL-12, were also reported. Shattuck is continuing dose escalation to 10.0 mg/kg.
Combination Trial with SL-172154 with Liposomal Doxorubicin Expected to Begin in 2022: A Phase 1B trial of SL-172154 in combination with liposomal doxorubicin to evaluate safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamics in patients with advanced, platinum-resistant ovarian cancer is expected to begin enrollment in 2022. Initial combination data from the trial are expected in the first half of 2023. Additional combination trials with SL-172154 in ovarian cancer and novel agents are currently being planned.
Initiated Phase 1A/B Clinical Trial in AML and HR-MDS with SL-172154: Shattuck is conducting a Phase 1A/B clinical trial evaluating the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154, as both monotherapy and in combination. In acute myeloid leukemia (AML), Shattuck plans to evaluate SL-172154 in combination with both azacitidine and venetoclax. In both HR-MDS and TP53 mutant AML, Shattuck plans to evaluate SL-172154 in combination with azacitidine. Initial data from the trial are expected in the first half of 2023.
Closed Enrollment of Intratumorally Administered SL-172154 Phase 1 Clinical Trial in Squamous Cell Carcinoma of the Head and Neck or Skin to Focus on Intravenous Administration Strategy: Based on the totality of the safety and biomarker data collected to date in our ongoing Phase 1A clinical trial in ovarian cancer patients, we have decided to focus development of SL-172154 as an intravenously administered product candidate. As of February 24, 2022, Shattuck has closed enrollment of the Phase 1 clinical trial for SL-172154 in patients with squamous cell carcinoma of the head and neck (HNSCC) or skin (CSCC) to further focus all development of SL-172154 as an intravenously administered product candidate. Shattuck did not observe dose-limiting toxicities and did not reach a maximum tolerated dose in this trial. Data from the trial are expected in the first half of 2022. Shattuck may continue further development of HNSCC and/or CSCC in an intravenous administration trial of SL-172154 following selection of a recommended Phase 2 dose in Shattuck’s ovarian cancer trial.
SL-279252 (PD1-Fc-OX40L)

Announced Initial Data from Ongoing SL-279252 Phase 1 Dose-Escalation Clinical Trial in Advanced Solid Tumors Demonstrating Evidence of Anti-Tumor Activity and Dose-Dependent Pharmacodynamic Activity at the 36th Annual SITC (Free SITC Whitepaper) Meeting: The Phase 1 trial is an open-label, multi-center, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity and pharmacodynamic effects of SL-279252 in patients with advanced solid tumors and lymphoma. SL-279252 was well tolerated across a dose-range of 0.0001 mg/kg through 6.0 mg/kg, and dose-dependent margination of CD4+OX40+ T cells was the primary pharmacodynamic effect observed and had not plateaued through the 6.0 mg/kg dose level. Monotherapy anti-tumor activity was observed at doses of 1.0 mg/kg and higher, including a confirmed partial response in a PD-1 and CTLA-4 inhibitor experienced ocular melanoma patient who remained on therapy for over 12 months. Shattuck continues to dose patients, primarily selecting for patients with PD-L1 expressing tumors, at 12.0 mg/kg and plans to continue dose escalation to 24.0 mg/kg, to fully characterize pharmacokinetic, pharmacodynamic, and anti-tumor activity. Additional dose-escalation data from the trial are expected in the second half of 2022.
Preclinical

Presented Continued Preclinical Development of SL-9258 at the TIGIT Therapies Digital Summit in December 2021: Preclinical data for SL-9258 (TIGIT-Fc-LIGHT), a dual TIGIT inhibitor and HVEM/LTβR agonist, were presented at the TIGIT Therapies Summit in December 2021. These data, from studies in a mouse model, provided preclinical evidence for anti-tumor activity of the murine equivalent of SL-9258 in PD-1 acquired resistant tumors and increased tumor rejection in comparison to TIGIT blocking antibodies.
Upcoming Events

American Association for Cancer Research Annual Meeting (AACR) (Free AACR Whitepaper), April 8-13
Poster presentation on the preclinical development of SL-9258
Poster presentation on the preclinical development of GADLEN compounds
Shattuck plans to attend the following investor conferences. Details of the presentations and webcasts will be announced prior to the events.
21st Annual Needham Healthcare Conference, April 11-14
8th Annual Berenberg Conference USA 2022, May 23-25
Fourth Quarter 2021 Financial Results

Cash Position: As of December 31, 2021, cash, cash equivalents and short-term investments were $268.8 million, as compared to $335.4 million as of December 31, 2020.
Collaboration Revenue: Revenue for the fourth quarter of 2021, was $30.1 million, as compared to $1.3 million for the fourth quarter of 2020. Revenue for the year ended December 31, 2021 was $30.0 million, as compared to $9.9 million for the year ended December 31, 2020. The increase in revenue was due to the recognition of all remaining deferred revenue related to the Collaboration Agreement with Takeda Pharmaceuticals in the fourth quarter of 2021.
Research and Development (R&D) Expenses: R&D expenses were $16.2 million for the fourth quarter of 2021, as compared to $9.8 million for the fourth quarter of 2020. R&D expenses for the year ended December 31, 2021 were $56.6 million, as compared to $37.5 million for the year ended December 31, 2020. This increase was primarily due to clinical development, personnel-related costs, and laboratory capabilities.
General and Administrative (G&A) Expenses: G&A expenses were $4.6 million for the fourth quarter of 2021, as compared to $3.6 million for the fourth quarter of 2020. General and administrative expenses for the year ended December 31, 2021 were $18.7 million, as compared to $9.4 million for the year ended December 31, 2020. This increase was primarily due to personnel-related costs to support the operational expansion and costs associated with being a public company.
Net Income/Loss: Net income was $7.8 million for the fourth quarter of 2021, or $0.19 per basic share and $0.18 per diluted share, as compared to a net loss of $12.0 million for the fourth quarter of 2020, or $0.31 per basic and diluted share. Net loss for the year ended December 31, 2021 was $45.0 million, or $1.07 per basic and diluted share, as compared to $36.6 million, or $2.36 per basic and diluted share, for the year ended December 31, 2020.
2022 Financial Guidance

Shattuck believes its cash, cash equivalents and short-term investments will be sufficient to fund its operations into the second half of 2024, which is beyond results from its Phase 1 clinical trials of SL-172154 and SL-279252. This cash runway guidance is based on the Company’s current operational plans and excludes any additional funding that may be received or business development or additional clinical development activities that may be undertaken.

About SL-172154
SL-172154 (SIRPα-Fc-CD40L) is an investigational ARC fusion protein designed to simultaneously inhibit the CD47/SIRPα checkpoint interaction and activate the CD40 costimulatory receptor to bolster an anti-tumor immune response in patients with advanced cancer. Two Phase 1 clinical trials are ongoing, the first for patients with advanced and platinum-resistant ovarian cancer (NCT04406623) and the second for patients with AML and HR-MDS (NCT05275439).

About SL-279252

SL-279252 (PD1-Fc-OX40L) is an investigational ARC fusion protein designed to simultaneously inhibit the PD-1/PD-L1 interaction and activate the OX40 receptor in patients with advanced cancers. A Phase 1 trial in patients with solid tumors and lymphoma is ongoing (NCT03894618).

On March 15, 2022 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported financial results for the year ended December 31, 2021 (Press release, Ideaya Biosciences, MAR 15, 2022, View Source [SID1234610108]).

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"We are encouraged by the early clinical activity and the tolerability profile in our clinical-stage programs, including our Phase 1 MAT2A inhibitor, IDE397, in MTAP-deletion patients, and our Phase 2 PKC inhibitor, darovasertib, in MUM and other GNAQ/11 patients. As these data mature, we are evaluating multiple expansion opportunities for these clinical programs, including various combination therapies. We are also aggressively advancing our preclinical programs toward the clinic – including our potential first-in-class PARG inhibitor, IDE161, for which are targeting an IND in Q4 2022, and our potential first-in-class Pol Theta helicase inhibitor, for which we are collaborating with GSK with IND-enabling studies in H1 2022," said Yujiro S. Hata, Chief Executive Officer and President of IDEAYA Biosciences.

Program Updates
Key highlights for IDEAYA’s pipeline programs include:

IDE397 (MAT2A)
IDEAYA is evaluating IDE397, a potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2a (MAT2A), in patients having solid tumors with methylthioadenosine phosphorylase (MTAP) deletion, a patient population estimated to represent approximately 15% of solid tumors. IDEAYA is leading early clinical development of IDE397. Subject to exercise of its option, GlaxoSmithKline (GSK) will lead later stage global clinical development. Highlights:

Actively enrolling patients into Cohort 6 of the Phase 1 clinical trial IDE397-001 (NCT04794699)
Patients are being identified by next generation sequencing (NGS) or by MTAP immunohistochemistry (IHC) assay with confirmatory NGS
Evaluating IDE397 in patients with MTAP deletion across multiple solid tumor types, including non-small cell lung cancer, pancreatic cancer, thymic cancer, adenoid cystic carcinoma, esophagogastric cancer and bladder cancer
IDE397 has been generally well tolerated, with no observed drug-related serious adverse events, no observed dose limiting toxicities and without observing the maximum tolerated dose through Cohort 5
Observed dose-proportional pharmacokinetic exposures across dose ranges of Cohort 1 through Cohort 5 of the Phase 1 dose escalation; achieved active exposure targets established from preclinical models at doses of Cohort 4 and Cohort 5
Observed exposure-dependent pharmacodynamic modulation of S-adenosyl methionine (SAM) in evaluable plasma samples across dose ranges of Cohort 1 through Cohort 5
Observed exposure-dependent pharmacodynamic modulation of symmetric dimethyl arginine (SDMA) in evaluable tumor biopsies from Cohort 4 and Cohort 5
Observed preliminary signals of clinical activity in MTAP-deletion patients in early dose escalation cohorts, including pharmacodynamic modulation and tumor shrinkage
Submitted a clinical protocol amendment to the FDA to support monotherapy cohort expansion in NSCLC, esophagogastric cancer, as well as one or more basket cohorts, and to support potential combinations, including taxane and other combination agents
Targeting IDE397 monotherapy cohort expansion and initiation of combination cohorts mid-year 2022, with an aggregate of 150 or more patients across expansion cohorts; the timing of the monotherapy expansion cohorts and combination cohorts may be influenced by the timing of when a MTD is observed
Targeting delivery of IDE397 option data package to GSK mid-year 2022, subject to initiation of expansion cohorts or establishing the MTD; the option data package will trigger an evaluation period for GSK to make an opt-in decision; subject to GSK election to opt-in and HSR clearance, the company is entitled to receive a $50 million opt-in payment from GSK, ongoing development costs will be shared as 80% GSK / 20% IDEAYA, and IDEAYA is entitled to potential development and regulatory milestones aggregate up to $465 million; upon commercialization, IDEAYA is entitled to 50% of U.S. net profits and tiered royalties on global non-U.S. net sales ranging from high single digit to sub-teen double digit percentages, as well as certain commercial milestones of up to $475 million
Demonstrated robust preclinical PK / PD in in vivo models, with sustained target inhibition and biological impact, as evidenced for example, by modulation of alterations to pre-mRNA splicing profile
Observed preclinical in vivo efficacy of IDE397 in combination with standard of care agents, including with taxanes showing enhanced TGI in pancreatic cancer PDX models, and with novel combination agents; evaluating additional IDE397 combination strategies
PARG
IDEAYA is advancing preclinical research for an inhibitor of poly (ADP-ribose) glycohydrolase (PARG) in patients having tumors with a defined biomarker based on genetic mutations and/or molecular signature. PARG is a novel target in the same clinically validated biological pathway as poly (ADP-ribose) polymerase (PARP). IDEAYA owns or controls all commercial rights in its PARG program. Highlights:

Ongoing IND-enabling studies for IDE161, a potential first-in-class PARG inhibitor development candidate for patients having tumors with homologous recombination deficiencies (HRD), including BRCA1 and BRCA2, and potentially other genetic alterations
Targeting IND for IDE161 in the fourth quarter of 2022
Exercised option for an exclusive worldwide license from Cancer Research Technology Ltd., also known as Cancer Research UK (CRUK), and University of Manchester; following the option exercise, IDEAYA holds an exclusive worldwide license to patent rights covering a broad class of PARG inhibitors
Demonstrated preclinical in vivo efficacy as monotherapy, including dose-dependent efficacy with tumor regression or stasis in ovarian, gastric and breast cancer CDX models, and tumor regressions in multiple breast cancer PDX models with defined genetic and subtyping profiles
Observed in vivo efficacy with enhanced TGI or tumor regressions relative to niraparib, a PARPi, in multiple CDX models, including in a niraparib-resistant CDX model, as well as in niraparib resistant breast cancer PDX models
Showed pharmacological inhibition of PARG in a panel of homologous recombination deficient cell lines and in CDX and PDX models; study data reported at AACR (Free AACR Whitepaper) 2021
Pol Theta
IDEAYA’s DNA Polymerase Theta, (Pol Theta) program targets tumors with BRCA or other homologous recombination deficiency, or HRD, mutations. IDEAYA and GSK are collaborating on ongoing preclinical research, including small molecules and protein degraders, and GSK will lead clinical development for the Pol Theta program. Highlights:

Demonstrated in vivo efficacy with tumor regression in BRCA2 -/- xenograft model with IDEAYA Pol Theta Helicase inhibitor in combination with niraparib, a GSK PARP inhibitor
Targeting IND-enabling studies for a Pol Theta helicase inhibitor in the first half of 2022 in collaboration with GSK
Potential for up to $20 million in aggregate milestone payments from GSK for advancing a Pol Theta Helicase inhibitor from preclinical to early Phase 1 clinical
Werner Helicase
IDEAYA is advancing preclinical research for an inhibitor targeting Werner Helicase for tumors with high microsatellite instability (MSI). IDEAYA and GSK are collaborating on ongoing preclinical research, and GSK will lead clinical development for the Werner Helicase program. Highlights:

Observed dose-dependent cellular viability effect and dose-dependent cellular PD response in multiple endogenous MSI high cell lines
Demonstrated efficacy and PD response in relevant MSI high in vivo models
Targeting selection of a Werner Helicase development candidate in 2023
Potential for up to $20 million in aggregate milestone payments from GlaxoSmithKline for advancing a Werner Helicase inhibitor from preclinical to early Phase 1 clinical
Other Synthetic Lethality Pipeline Programs
IDEAYA is advancing additional preclinical research programs to identify small molecule inhibitors for an MTAP-synthetic lethality target, as well as for multiple potential first-in-class synthetic lethality programs for patients with solid tumors characterized by proprietary biomarkers or gene signatures.

Darovasertib (IDE196)
IDEAYA continues to execute on its clinical trial strategy to evaluate darovasertib (IDE196), a potent and selective PKC inhibitor.

IDEAYA is evaluating darovasertib in combination with crizotinib, a cMET inhibitor, in metastatic uveal melanoma (MUM). The company is also clinically evaluating darovasertib as a combination with crizotinib in GNAQ/11 mutant skin melanoma in an ongoing arm of the current clinical trial, and in adjuvant primary uveal melanoma (UM) as monotherapy through an investigator sponsor clinical trial (IST). IDEAYA is also evaluating other potential darovasertib expansion opportunities, including in cMET driven tumors and in KRAS-mutation tumors.

Darovasertib / Crizotinib Combination Therapy
IDEAYA is continuing patient enrollment into the darovasertib / crizotinib combination arm of the Phase 1/2 clinical trial under clinical trial collaboration and supply agreements with Pfizer. Highlights:

As of March 1, 2022, the company has enrolled 53 MUM patients into the darovasertib/crizotinib combination arm, and is continuing patient enrollment in the dose expansion cohort of this combination arm
IDEAYA presented darovasertib and crizotinib clinical combination data in December 2021. As of data and analyses cutoff on November 25, 2021, twenty-two heavily pre-treated MUM patients (91% with prior therapies, and 59% with 2 or more prior therapies) had enrolled in the darovasertib and crizotinib combination arm at the expansion dose, with sixteen evaluable patients who had received one or more tumor scans and six patients who were awaiting their 1st tumor scan. Thirteen patients had received two or more tumor scans for evaluation of potential response. The reported preliminary data, based on an unlocked database, showed robust clinical activity with manageable side effect profile:
100% Disease Control Rate (DCR): 16 of 16 evaluable patients with >1 post-baseline scan showed tumor shrinkage as determined by target lesion size reduction
31% Overall Response Rate (ORR): 4 of 13 patients with > 2 post-baseline scans had a confirmed partial response (PR) as determined by RECIST 1.1 based on investigator or central review; and no patients have come off-treatment prior to the 2nd scan
46% of patients (6 of 13) with > 2 post-baseline scans observed >30% tumor reduction, including one patient with an unconfirmed PR as determined by RECIST 1.1 is awaiting follow-on tumor scan
Observed side effect profile in MUM patients (n=22) showed a low rate of drug-related serious adverse events (SAE’s) and predominantly Grade 1 or 2 drug-related adverse events; eighteen patients experienced a drug-related AE, of which six patients observed Grade 3, and no patients observed Grade 4 or Grade 5
These data provide clinical proof-of-concept for the darovasertib and crizotinib synthetic lethal combination treatment, and are consistent with the company’s translational research discovery that Phase 1 clinical response to darovasertib monotherapy associated with low cMET activity, as measured by gene signature score
The company is targeting a clinical data update for darovasertib and crizotinib combination in mid-2022, including tolerability and clinical efficacy. IDEAYA is also planning to seek FDA regulatory guidance for potential registration-enabling trial design to evaluate darovasertib and crizotinib combination in MUM in mid-2022. The timing of the clinical data and FDA regulatory guidance may be influenced by data maturity, including observation of median duration of response (DOR) or median progression free survival (mPFS).
Expanded relationship with Pfizer under a clinical collaboration and supply agreement to support clinical evaluation of darovasertib and crizotinib combination in a potential registration-enabling clinical trial in MUM, subject to FDA feedback and guidance
Associated cMET expression and activation to observed clinical response based on a retrospective analysis of human clinical biopsies from the Novartis darovasertib Phase 1 clinical trial, supporting cMET expression / activation as potential combination agent
Observed preclinical synergies between darovasertib and crizotinib in relevant cellular models under conditions simulating a tumor microenvironment in the liver, the site of approximately 90% of uveal melanoma metastases; study data reported at AACR (Free AACR Whitepaper) 2021
Darovasertib Monotherapy
IDEAYA has completed enrollment into its ongoing Phase 1/2 clinical trial evaluating darovasertib as monotherapy in MUM patients.

IDEAYA is planning to initiate an Investigator Sponsored Trial, with St. Vincent’s Hospital Sydney Limited to evaluate IDE196 as monotherapy in a neo-adjuvant / adjuvant setting in (non-metastatic) uveal melanoma (UM) patients. Data from this clinical trial may offer proof of concept on its hypothesis that earlier treatment of UM patients with IDE196, prior to tumor metastasis, may lead to improved patient outcomes.

Darovasertib – Other Potential Indications
IDEAYA is evaluating the potential for darovasertib in other oncology indications, including in cMET-driven tumors and in KRAS-mutation tumors. The company is also evaluating darovasertib for potential treatment of GNAQ mutation-mediated rare diseases, including Sturge-Weber Syndrome (SWS) and Port Wine Stains (PWS), neurocutaneous disorders characterized by capillary malformations and associated with mutations in GNAQ. Highlights:

Expanded its relationship with Pfizer under a clinical collaboration and supply agreement for clinical evaluation of darovasertib and crizotinib combination therapy in cMET-driven tumors, such as NSCLC or HCC, subject to preclinical validation studies
Evaluating darovasertib in combination with a KRAS inhibitor in preclinical studies in KRAS-driven solid tumors
General

IDEAYA continues to monitor Covid-19 and its potential impact on clinical trials and timing of clinical data results. Initiation of clinical trial sites, patient enrollment and ongoing monitoring of enrolled patients, including obtaining patient computed tomography (CT) scans, may be impacted for IDEAYA clinical trials evaluating IDE397 and darovasertib; the specific impacts are currently uncertain.

Corporate Updates

IDEAYA’s net losses were $49.8 million and $34.5 million for the years ended December 31, 2021 and December 31, 2020, respectively. As of December 31, 2021, the company had an accumulated deficit of $176.7 million.

As of December 31, 2021, IDEAYA had cash, cash equivalents and marketable securities of $368.1 million. IDEAYA believes that its cash, cash equivalents and marketable securities will be sufficient to fund its planned operations into 2025. These funds will support the company’s efforts through potential achievement of multiple preclinical and clinical milestones across multiple programs.

Our updated corporate presentation is available on our website, at our Investor Relations page: View Source

Financial Results

As of December 31, 2021, IDEAYA had cash, cash equivalents and short-term and long-term marketable securities totaling $368.1 million. This compared to cash, cash equivalents and short-term and long-term marketable securities of $283.6 million at December 31, 2020. The increase was primarily due to $86.0 million in net proceeds received from issuance of common stock in an underwritten public offering on July 12, 2021 and $57.3 million in net proceeds under the ATM Program received through December 31, 2021, offset by cash used in operations and purchases of property and equipment.

Collaboration revenue for the three months ended December 31, 2021 totaled $3.0 million compared to $10.6 million for the same period in 2020. Collaboration revenue was recognized for the performance obligations satisfied through December 31, 2021 under the GSK Collaboration Agreement.

Research and development (R&D) expenses for the three months ended December 31, 2021 totaled $16.1 million compared to $12.1 million for the same period in 2020. The increase was primarily due to higher personnel-related expenses, laboratory supplies expenses and consulting fees.

General and administrative (G&A) expenses for the three months ended December 31, 2021 totaled $5.2 million compared to $3.8 million for the same period in 2020. The increase was primarily due to higher personnel-related expenses, software expenses and consulting fees.

The net loss for the three months ended December 31, 2021 was $18.2 million compared to $5.1 million for the same period in 2020. Total stock compensation expense for the three months ended December 31, 2021 was $2.1 million compared to $1.0 million for the same period in 2020.

The net loss for the year ended December 31, 2021 was $49.8 million compared to $34.5 million for the same period in 2020. Total stock compensation expense for the year ended December 31, 2021 was $8.2 million compared to $3.6 million for the same period in 2020.

On March 15, 2022 Philogen reported that it is presenting a ePoster entitled "A novel tumor-targeting cytokine-based therapy in combination with lomustine displays promising anti-tumor activity against glioblastoma" (Presentation, Philogen, MAR 15, 2022, View Source [SID1234610107]).

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On March 15, 2022 Philogen reported its attendance at the AACR (Free AACR Whitepaper) Annual Meeting on April 8-13, 2022 (Press release, Philogen, MAR 15, 2022, View Source [SID1234610106]).

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Aureliano Zana, 3rd year PhD student at Philogen, is presenting an ePoster entitled "Fibroblast Activation Protein triggers release of drug payload from non-internalizing small molecule-drug conjugates in solid tumors"

Andrea Galbiati, Senior Scientist at Philogen, is presenting an ePoster entitled "A novel dimeric small molecule-radio conjugate targeting fibroblast activation protein with high and prolonged tumor uptake"

Lisa Nadal, Junior Project Manager at Philogen, is presenting an ePoster entitled "A novel IL12-based immunocytokine targeting fibroblast activation protein (FAP) for the treatment of cancer"

On March 15, 2022 Philogen S.p.A., a clinical-stage biotechnology company focused on antibody-based therapeutics, reported that it will announce its Full Year Results for the year ended 31 December 2021 following a Board of Director’s meeting to be held on 28 March 2022 (Press release, Philogen, MAR 15, 2022, View Source [SID1234610105]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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