On May 12, 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 quarter ended March 31, 2022 and provided recent business highlights (Press release, Shattuck Labs, MAY 12, 2022, View Source [SID1234614381]).

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"We are now completing the monotherapy dose-escalation study for SL-172154 in ovarian cancer patients and are focused on the initiation and rapid clinical execution of multiple combination studies in both hematologic and solid tumors. This expansion is a critical step in establishing SL-172154 as both a first- and best-in-class CD47 inhibitor and CD40 agonist, and we continue to expect SL-172154 to differentiate from other CD47 inhibitors and CD40 agonists in terms of safety, pharmacodynamic activity, and efficacy in combinations. The next 18 months are shaping up to be a defining period for establishing CD47 inhibition as a key macrophage checkpoint in multiple indications, and we look forward to providing initial combination data from SL-172154 in the first half of 2023," said Taylor Schreiber, M.D., Ph.D., and Chief Executive Officer of Shattuck.

First Quarter 2022 Recent Business Highlights and Other Recent Developments

ARC Clinical-Stage Pipeline and Preclinical Pipeline

SL-172154 (SIRPα-Fc-CD40L)

Continued Enrollment of SL-172154 Phase 1A Dose-Escalation Clinical Trial in Platinum-Resistant Ovarian Cancer: This open-label, multi-center, dose-escalation clinical trial is evaluating the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154 administered intravenously in patients with platinum resistant ovarian cancer. Full dose-escalation data from the trial are expected in the first half of 2023.
Phase 1B Clinical Trial of SL-172154 in Combination with Liposomal Doxorubicin Expected to Begin in the Second Half of 2022: This clinical trial will evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamics effects of SL-172154 in combination with liposomal doxorubicin in patients with advanced, platinum-resistant ovarian cancer and is anticipated to begin enrollment in the second half of 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.
Enrollment Continues in SL-172154 Phase 1A/B Clinical Trial in Acute Myeloid Leukemia (AML) and Higher-Risk Myelodysplastic Syndromes (HR-MDS): The trial is evaluating the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154, as both monotherapy and in combination. In both HR-MDS and TP53 mutant AML, SL-172154 will be combined with azacitidine. In AML, SL-172154 will be evaluated in combination with both azacitidine and venetoclax. Initial data from the monotherapy and combination dose escalation portions of the trial are expected in the first half of 2023.
Data for Intratumorally Administered SL-172154 Phase 1 Clinical Trial in Squamous Cell Carcinoma of the Head and Neck or Skin to be Presented in the Second Half of 2022: Shattuck anticipates presenting data from the clinical trial in the second half of 2022. Shattuck may continue further development of SL-172154 in squamous cell carcinoma of the head and neck (HNSCC) or skin (CSCC) via intravenous administration following selection of a recommended Phase 2 dose in ovarian cancer.
SL-279252 (PD1-Fc-OX40L)

Continued Enrollment of SL-279252 Phase 1 Dose-Escalation Clinical Trial in Advanced Solid Tumors: Enrollment of patients with primarily PD-L1 selected tumors continues in the Phase 1 open-label, multi-center, dose-escalation clinical trial to evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity and pharmacodynamic effects of SL-279252 in patients with advanced solid tumors and lymphoma. Top-line data from all treated subjects across the full dose range are anticipated in the second half of 2022.
Preclinical

Presented Preclinical Data on SL-9258 at AACR (Free AACR Whitepaper) in April: Preclinical data for SL-9258 (TIGIT-Fc-LIGHT), a dual TIGIT inhibitor and HVEM/LTβR agonist, were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR) (Free AACR Whitepaper) in April 2022. 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. In these preclinical models, TIGIT-Fc-LIGHT outperformed TIGIT blocking antibodies independent of PD-L1 or DNAM-1 (CD226) expression. TIGIT-Fc-LIGHT was also evaluated and well tolerated in non-human primates and observed similar on-target pharmacodynamic activity to what was characterized in the mouse model. Together, these results suggest that TIGIT-Fc-LIGHT may provide clinical benefit to patients that are refractory to conventional checkpoint blockade therapy.
Presented Preclinical Data at AACR (Free AACR Whitepaper) on GADLEN Platform: Shattuck also presented preclinical data highlighting the potential of GADLENs to direct gamma delta T cells to kill tumor cells and, in the process, further elucidate tumor cell markers which are important for the therapeutic activity of gamma delta T cell-based therapies. Butyrophilin heterodimeric fusion proteins from Shattuck’s GADLEN platform showed enhanced tumor cell killing targeting CD19 and CD20 and demonstrated preclinical proof of concept in the treatment of cancer.
Clinical Pipeline Product Candidate to be Selected in 2022: As Shattuck looks to advance its preclinical pipeline, a new product candidate from the ARC or GADLEN platform is anticipated to be selected in the second half of 2022.
Upcoming Events

H.C. Wainwright 2022 Global Investment Conference

Management will participate in investor one-on-one meetings and give a corporate presentation during the H.C. Wainwright 2022 Global Investment Conference from May 24-26, 2022. A live and archived audio webcast of the presentation will be available by visiting the Events & Presentations section of the Company’s website.

First Quarter 2022 Financial Results

Cash Position: As of March 31, 2022, cash and cash equivalents and short-term investments were $239.2 million, as compared to $321.2 million as of March 31, 2021.
Research and Development (R&D) Expenses: R&D expenses were $19.2 million for the quarter ended March 31, 2022, as compared to $10.3 million for the quarter ended March 31, 2021. This increase was primarily driven by increases in process development costs and manufacturing of trial materials and personnel-related costs.
General and Administrative (G&A) Expenses: G&A expenses were $5.0 million for the quarter ended March 31, 2022, as compared to $4.4 million for the quarter ended March 31, 2021. This increase was primarily driven by increases in compensation related and other operating costs.
Net Income/Loss: Net loss was $24.5 million for the quarter ended March 31, 2022, or $0.58 per basic and diluted share, as compared to a net loss of $11.8 million for the quarter ended March 31, 2021, or $0.28 per basic and diluted share.
2022 Financial Guidance

Shattuck believes its cash and cash equivalents and short-term investments will be sufficient to fund its operations into the second half of 2024, 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 May 12, 2022 Bio-Techne Corporation (NASDAQ: TECH) and Nonagen Bioscience reported an agreement for R&D Systems, a Bio-Techne brand, to exclusively manufacture Nonagen Bioscience’s Oncuria bladder cancer diagnostic panel using xMAP Luminex technology (Press release, Bio-Techne, MAY 12, 2022, View Source [SID1234614380]).

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Oncuria is the first-of-its-kind multiplex protein-based urine test to provide early and accurate detection, therapy choice, and disease monitoring of bladder cancer. The Luminex-based multiplex assay panel combines Bio-Techne’s high-quality reagents and over 40 years of industry-leading immunoassay experience with Nonagen’s diagnostic expertise to create a powerful solution to advance bladder cancer treatment strategies. The partnership demonstrates Bio-Techne’s commitment to supporting laboratory developed tests (LDTs) to bring clinical diagnostic tools to the market.

Nonagen Bioscience and Bio-Techne are targeting the last quarter of calendar 2022 to make Oncuria available as an LDT.

The US Food and Drug Administration (FDA) granted Oncuria a Breakthrough Device Designation in September 2021, for predicting response to Bacillus Calmette-Guérin (BCG) therapy, a first-line treatment for bladder cancer. The designation enables close collaboration with, and expedited review of the assay by the FDA. It also provides formal acknowledgement of Oncuria’s utility and potential clinical benefit.

"We’re excited to partner with Bio-Techne to make Oncuria available as a laboratory developed test (LDT), given their extensive biomarker discovery expertise," said Nonagen Bioscience CEO Charles Joel Rosser, MD, MBA. "Bio-Techne also shares our passion for translating research discoveries into innovative diagnostics, to improve the detection and management of cancer."

"We look forward to working with Nonagen to develop this game-changing immunoassay in the fight against bladder cancer," said Will Geist, President of Bio-Techne’s Protein Sciences division. "Nonagen’s deep experience in diagnostic and testing research is complementary to Bio-Techne’s extensive immunoassay expertise and world-class manufacturing capabilities, creating an ideal partnership for this important bladder cancer detection assay."

About Bladder Cancer
As the 6th most common cancer in the United States1 and a highly recurrent disease, bladder cancer is a major health concern that places an immense burden on healthcare systems. Up to 77% of early-stage bladder tumors that are treated with current approaches (tumor resection and/or intravesical BCG or chemotherapy) will recur.2 More than half of patients who receive BCG therapy as the first-line treatment for bladder cancer will fail to respond. In addition, in 20% of patients, the disease grows and extends during or after BCG therapy.3,4

This is where the exceptional sensitivity and rapid biomarker quantification capabilities of the Oncuria diagnostic assay are poised to play a vital role. The ability to quickly and accurately detect the presence of bladder cancer and monitor disease activity can help improve patient outcomes.

On May 12, 2022 Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, reported financial results for the first quarter ended March 31, 2022 and provided an update on pipeline programs (Press release, Synlogic, MAY 12, 2022, View Source [SID1234614379]).

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"We are pleased to share this progress as we seek to advance our novel phenylketonuria (PKU) program towards Phase 3 initiation," said Synlogic President and Chief Executive Officer Aoife Brennan, M.B. Ch.B. "We believe that we have a unique opportunity to advance a potential treatment for the 55,000 people around the globe with PKU, of whom more than 75% remain in need of additional treatment options – either monotherapy or adjunctive. We are pleased with the progress across our additional programs with expected milestones in 2022, including our homocystinuria (HCU) and enteric hyperoxaluria programs, as well as research progress including our ongoing collaborations with Ginkgo Bioworks and Roche."

Anticipated Upcoming Milestones

Report additional Phase 2 data and final candidate selection for PKU program in H2 2022

Initiate the Phase 3 trial for the PKU program in H1 2023 with Phase 3 readiness activities currently underway

Share data from the Phase 1 trial in healthy volunteers for SYNB1353 in H2 2022

Share proof of concept data for SYNB8802 for enteric hyperoxaluria in H2 2022
Recent Business Highlights

Michael Jensen joined Synlogic as CFO in March 2022

Participation and data presentations at scientific congresses described below:

PKU and HCU program data were presented at inborn errors of metabolism congresses including the Society for Inherited Metabolic Disorders (SIMD) Annual Meeting, the Genetic Metabolic Dietitians International (GMDI) 2022 Conference, and the Garrod Symposium 2022

From Synlogic’s Research team, five different programs were represented at the 2022 Synthetic Biology: Engineering, Evolution & Design (SEED) Conference covering preclinical and clinical work in PKU, HCU, enteric hyperoxaluria, inflammatory bowel disease (IBD), and gout

From Process Development & Manufacturing Sciences (PDMS) at Synlogic, a presentation at the 2022 18th Annual Protein Engineering & Cell Therapy Summit (PEGS) Boston Conference & Expo
First Quarter 2022 Financial Results

As of March 31, 2022, Synlogic had cash, cash equivalents and short-term investments of $120.5 million.

Revenue was $0.2 million for the three months ended March 31, 2022. Revenue in 2022 was associated with the ongoing research collaboration with Roche for the discovery of a novel Synthetic Biotic for the treatment of IBD. There was no revenue for the three months ended March 31, 2021.

For the three months ended March 31, 2022, Synlogic reported a consolidated net loss of $15.7 million, or $0.22 per share, compared to a consolidated net loss of $15.0 million, or $0.36 per share, for the corresponding period in 2021.

Research and development expenses were $11.7 million for the three months ended March 31, 2022 compared to $11.2 million for the corresponding period in 2021.

General and administrative expenses were $4.3 million for the three months ended March 31, 2022 compared to $3.9 million for the corresponding period in 2021.

Financial Outlook

Based upon its current operating plan and balance sheet as of March 31, 2022, Synlogic expects to have sufficient cash to be able to fund operations into 2024.

Investor & Industry Conference Participation

Synlogic will participate in the following upcoming investor and industry conferences:

RBC Capital Markets Global Healthcare Conference. Dr. Brennan will provide a Company presentation on Wednesday, May 18, 2022 at 8:30 am ET during the RBC Capital Markets Global Healthcare Conference to be held in New York City from May 17-18, 2022.

The H.C. Wainwright Global Investment Conference. Chief Financial Officer Michael Jensen and Chief Business Officer Molly Harper will provide a company presentation on Wednesday, May 25, 2022 at 10:30 am ET during the H.C. Wainwright Global Investment Conference taking place from May 23- 26, 2022 in Miami, Florida.

BIO International Convention. Synlogic will participate in the BIO International Convention taking place from June 13-16, 2022 in San Diego, California, including a company presentation by Ms. Harper.
Live webcasts of the presentations, if available, will be accessible under the "Event Calendar" in the Investors & Media section of the Synlogic website. Archived versions will be available afterwards at the same location.

Conference Call & Webcast Information

Synlogic will host a conference call and live webcast at 8:30 a.m. ET today, May 12, 2022. To access the live webcast, please visit the "Event Calendar" page within the Investors and Media section of the Synlogic website. Investors may listen to the call by dialing +1 (844) 815-2882 from locations in the United States or (213) 660-0926 from outside the United States. The conference ID number is 5149412. A replay will be available for 30 days on the Investors and Media section of the Synlogic website.

On May 12, 2022 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported pipeline and business progress and first quarter 2022 financial results (Press release, Nuvalent, MAY 12, 2022, View Source [SID1234614378]).

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"At Nuvalent, we’re building a fully integrated biotech company with the goal to design, develop, and deliver a portfolio of best-in-class therapies for patients with cancer. We view 2022 as a critical year of execution and we have already made meaningful progress across our pipeline. Enrollment is progressing well in the ongoing Phase 1 portion of our ARROS-1 Phase 1/2 trial of NVL-520 for advanced ROS1-positive NSCLC and other solid tumors, and following the recently announced clearance of the IND for NVL-655, we are on track for planned initiation of our ALKOVE-1 Phase 1/2 study for advanced ALK-positive NSCLC and other solid tumors in the second quarter of 2022," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "By year-end, our team has the potential to have delivered four novel development candidates since company formation, with two clinical trials underway. With an exceptional team and strong foundation in place, I am confident in our ability to bring precisely targeted therapies that can enable deeper and more durable responses to patients with cancer."

Upcoming Pipeline Milestones
ALKOVE-1 Trial of NVL-655 for Patients with ALK-positive Non-Small Cell Lung Cancer (NSCLC) Expected to Begin in Second Quarter of 2022: Nuvalent has received confirmation from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) application for NVL-655 has been cleared. The company is on track to initiate the ALKOVE-1 Phase 1/2 study of NVL-655 for patients with advanced ALK-positive NSCLC and other solid tumors, anticipated in the second quarter of 2022. NVL-655 is a novel ALK-selective inhibitor designed to address the clinical challenges of emergent treatment resistance, CNS adverse events, and brain metastases that may limit the use of currently available ALK kinase inhibitors.
Selection of Two Additional Development Candidates from Discovery Pipeline Targeted in 2022: Nuvalent continues to advance its pipeline expansion efforts with multiple discovery-stage research programs. The company expects to select development candidates for its programs directed toward ALK IXDN compound resistance mutations and HER2 Exon 20 insertions in 2022.
Recent Business Highlights
Appointed Anna Protopapas as Chair of Board of Directors: Nuvalent appointed Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics, as Chair of its Board of Directors in March 2022. Ms. Protopapas joined Mersana in March 2015 and has a substantial track record of executive leadership and business growth in the field of oncology. Her broad industry experience ranges from global development to commercial expertise with a focus on building companies from start-ups to leaders in their categories.
Presented Expanded Preclinical Profiles of NVL-520 and NVL-655 at AACR (Free AACR Whitepaper) 2022: Nuvalent presented new preclinical data supporting the potential for broad clinical utility of NVL-520 and NVL-655 across an expanded set of ROS1 and ALK fusion partners, resistance mutations, and tumor types beyond NSCLC.
Upcoming Investor Conference Presentations
2022 H.C. Wainwright Hybrid Global Investment Conference: Dr. Porter will conduct an in-person corporate presentation during the 2022 H.C. Wainwright Hybrid Global Investment Conference on Wednesday May 25, 2022 at 4:00 p.m. ET. The conference is being held May 23-26, 2022, with in-person presentations and meetings in Miami, FL. A live webcast will be available in the Investors section of the company’s website at www.nuvalent.com and will be archived for 30 days following the presentation.
First Quarter 2022 Financial Results
Cash Position: Cash, cash equivalents and marketable securities were $272.7 million as of March 31, 2022. Nuvalent continues to expect the existing cash, cash equivalents, and marketable securities to be sufficient to fund its planned operations into 2024.
R&D Expenses: Research and development (R&D) expenses were $12.7 million for the first quarter of 2022.
G&A Expenses: General and administrative (G&A) expenses were $5.0 million for the first quarter of 2022.
Net Loss: Net loss for the first quarter of 2022 was $17.5 million, or $0.36 per share.

On May 12, 2022 vTv Therapeutics Inc. (Nasdaq:VTVT) reported financial results for the first quarter ended March 31, 2022, and provided an update on the progress of its clinical programs (Press release, vTv Therapeutics, MAY 12, 2022, View Source [SID1234614377]).

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Recent Achievements and Outlook

Corporate

Strategic Focus. We are prioritizing the development of our lead program TTP399, a novel, oral liver selective glucokinase activator, as a potential treatment for patients with type 1 diabetes ("T1D"), as well as continuing to support our currently partnered programs. Given the strategic focus on these programs, we have paused our development activities in the United States on HPP737 while we evaluate strategic options for it. As part of this planned strategic focus, the Company has reduced its workforce. We are actively seeking to raise capital through licensing TTP399 in regions outside of North America and Europe and are also actively seeking licensing deals for HPP737 and other assets. We are currently in active discussions with respect to financing, partnering, and licensing transactions for the further development of TTP399.
Type 1 Diabetes

Mechanistic Study of Ketoacidosis with TTP399. In October 2021, we announced positive results from the Mechanistic study indicating no increased risk of ketoacidosis with TTP399 during acute insulin withdrawal in patients with T1D. Patients with type 1 diabetes taking TTP399 experienced no increase in ketone levels relative to placebo during a period of acute insulin withdrawal, indicating that treatment with TTP399 presents no increased risk of ketoacidosis. In addition, patients taking TTP399 had improved fasting plasma glucose levels and experienced fewer hypoglycemic events relative to those taking placebo, consistent and supportive of the previously announced phase 2 Simplici-T1 Study results. Full study results will be published in the Diabetes Obesity and Metabolism journal in conjunction with the 82nd American Diabetes Association Scientific Sessions on June 6th, 2022.

Pivotal Study Planning. The Company is planning two pivotal, placebo-controlled clinical trials of TTP399 in subjects withT1D and has engaged with the Food and Drug Administration ("FDA") on the optimal clinical trial designs for these studies. The studies will recruit a total of approximately 1000 patients and at least one of the studies will be one year of treatment. The FDA and the company have agreed on the primary endpoint for the studies as the difference between placebo and TTP399-treated group in number of hypoglycemia events. These pivotal studies are expected to start in 3Q 2022.
First Quarter 2022 Financial Results

Cash Position: The Company’s cash position as of March 31, 2022, was $12.1 million compared to $13.4 million as of December 31, 2021.

Revenue: Revenue in first quarter of 2022 was $2.0 million and relates to an increase in the transaction price for a license performance obligation, that was fully recognized due to the satisfaction of a development milestone under the amended license agreement with Huadong. The revenue for the fourth quarter of 2021 was immaterial.

R&D Expenses: Research and development expenses were $3.1 million and $5.4 million in each of the three months ended March 31, 2022 and December 31, 2021, respectively. The changes are attributable to (i) decreases of $2.0 million for a license payment to Novo Nordisk for the completion of TTP399 phase 2 studies in Q4 2021, (ii) decreased severance costs of $0.7 million and payroll costs of $0.1 million in connection with the Company’s restructuring plan that occurred in Q4 2021, (iii) decreased spending of $0.5 million related to the multiple ascending dose study for HPP737 offset by (iv) increases of $1.3 million due to manufacturing and analytical work related to chemistry manufacturing and control "CMC" for pivotal TTP399 studies, and the progression of TTP399 toxicology studies in Q1 2022.

G&A Expenses: General and administrative expenses were consistent between periods at $5.3 million and $5.7 million for each of the three months ended March 31, 2022, and December 31, 2021. However, individual changes in the quarters are attributable to (i) lower payroll costs of $0.4 million and lower severance costs of $0.7 million due to the Company’s restructuring plan that occurred in December 2021 and separation agreement with the Company’s former CEO in Q1 2022, (ii) lower shared-based expense of $0.6 million due to the modification of awards related to the retirement and separation agreements with several key employees that occurred in Q4 2021, offset by (iii) higher other G&A operating costs of $0.2 million and (iv) increases of $1.1 million in legal expense.

Other Income/(Expense): Other expense for the three months ended March 31, 2022, was $2.7 million and was driven by an unrealized loss related to the Company’s investment in Reneo Pharmaceuticals, Inc. ("Reneo"), as well as gains related to a reduction in the fair value of the outstanding warrants to purchase shares of our own stock issued to a related party ("Related Party Warrants"). Other income for the three months ended December 31, 2021, was $1.6 million and was driven by changes in the fair value of our investment in Reneo, as well as the gains related to a reduction in fair value of the Related Party Warrants.
Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $9.4 million for the first quarter of 2022 compared to net loss before non-controlling interest of $9.5 million for the fourth quarter of 2021. The decrease in net loss before Non-Controlling Interest was attributable to (i) increases in other expense of $4.3 million driven by changes in the fair value of our investment in Reneo, as well as the gains related to a reduction in the fair value of the outstanding warrants to purchase shares of our own stock issued to a related party, offset by (ii) lower R&D expenses of $2.3 million, and (iii) higher revenue of $2.0 million due to an increase in the transaction price for a license performance obligation, that was fully recognized due to the satisfaction of a development milestone under the amended license agreement with Huadong.
Net Loss Per Share: Diluted net loss per share was ($0.10) for the three months ended March 31, 2022 compared to diluted net loss per share of ($0.11) for the three months ended December 31, 2021, based on weighted-average diluted shares of 66.9 million and 66.8 million for the three-month periods ended March 31, 2022 and December 31, 2021, respectively.