On March 17, 2022 Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing a diversified pipeline of targeted therapies for patients with cancer, reported on recent and upcoming business highlights and announced its financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Cullinan Oncology, MAR 17, 2022, View Source [SID1234610307]).

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"Cullinan Oncology is dedicated to developing new standards of care in cancer therapy and we made considerable progress toward this goal in 2021, including advancing additional programs into the clinic, adding new assets to our pipeline, and deepening our oncology expertise with new additions to our board and leadership team," said Nadim Ahmed, Chief Executive Officer of Cullinan Oncology. "In the fourth quarter of 2021, we reported compelling data from the ongoing Phase 1/2a trial of our lead program, CLN-081. We were also pleased to announce in January of this year that the FDA granted CLN-081 Breakthrough Therapy Designation, a distinction that further supports its differentiated clinical profile in NSCLC patients with EGFR exon 20 insertion mutations. We look forward to providing a regulatory update in the coming weeks."

Mr. Ahmed continued, "Additionally, we initiated clinical trials for two other differentiated oncology programs, CLN-619 and CLN-049, while further expanding our pipeline with the addition of an HPK1 degrader collaboration with the Icahn School of Medicine at Mount Sinai. Finally, we expanded our late-stage oncology expertise and leadership with the recent appointments of Dr. Jeff Jones as Chief Medical Officer and Dr. Anne-Marie Martin as an independent director. Finishing the year with over $430 million of cash and investments, we remain well positioned to continue advancing our broad pipeline of first- and/or best-in-class oncology molecules as we work toward our mission of developing new therapeutic solutions for people living with cancer."

Portfolio Highlights

CLN-081 (Pearl): During the fourth quarter of 2021, Cullinan reported updated Phase 1/2a data for CLN-081 in NSCLC patients harboring epidermal growth factor (EGFR) exon 20 insertion mutations who have previously received platinum-based systemic chemotherapy. The update included safety and efficacy data from 73 patients treated across all five dose levels (30 – 150mg BID). At the 100mg BID dose level, 35 of 36 (97%) response evaluable patients achieved a best response of partial response or stable disease, with 14 (39%) patients achieving a confirmed partial response. Among patients enrolled in the initial Phase 1 cohort at 100mg BID (n=13), the estimated median duration of response was greater than 15 months and the estimated median progression free survival was 12 months. In January 2022, Cullinan announced that CLN-081 received Breakthrough Therapy Designation. Cullinan will provide a regulatory update on CLN-081 in the first quarter of 2022.

CLN-049 (Florentine): CLN-049 is a FLT3/CD3-bispecific T cell-engaging antibody in an IgG format for the treatment of acute myeloid leukemia (AML). CLN-049 targets the extracellular domain of FLT3, regardless of mutant or wild type-based expression. In December 2021, patient dosing was initiated in a first-in-human clinical trial evaluating CLN-049 in patients with relapsed/refractory AML. A more extensive preclinical characterization of CLN-049 has been published in the Journal for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (JITC), titled, "A Novel IgG-based FLT3xCD3 Bispecific Antibody for the Treatment of AML and B-ALL." Initial clinical data are expected by mid-2023.

CLN-619 (MICA): CLN-619 is a first-in-class monoclonal antibody that stabilizes MICA/MICB on the tumor cell surface to promote an antitumor response via activation of both natural killer (NK) cells and certain T cells, with broad therapeutic potential across multiple cancer indications. In December 2021, patient dosing was initiated in a first-in-human clinical trial evaluating CLN-619 in patients with advanced tumors. The trial design includes parallel evaluation of CLN-619 as a monotherapy and in combination with checkpoint inhibitor therapy in separate modules. Initial clinical data are expected by mid-2023.

Preclinical Portfolio: Continued advancement of five additional oncology programs with the following highlights:

Preclinical data across five distinct programs will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting, including CLN-049, CLN-619, CLN-617 (Amber), CLN-978 (NexGem) and Opal (additional information can be found in this press release on our company website).

Cullinan recently announced a collaboration with the Icahn School of Medicine at Mount Sinai to develop oral protein degraders targeting hematopoietic progenitor kinase 1 (HPK1), a key regulator of immune cell activation and a high-priority target in immune-oncology. Preclinical research has shown that a degrader approach to targeting HPK1 may be more effective at controlling tumor growth than inhibition of HPK1 kinase activity.

In 2021, Cullinan advanced two programs into IND-enabling studies: CLN-617, a cytokine fusion protein uniquely combining IL-12 and IL-2 with a collagen binding domain for retention in the tumor microenvironment (TME), and CLN-978, a novel CD19/CD3-bispecific construct with extended serum half-life and high potency against target cells expressing very low levels of CD19. Cullinan expects to submit INDs for both programs by the end of the first half of 2023.

Organizational Announcements: Expanded late-stage oncology expertise with appointments of Jeffrey Jones, M.D., MPH, MBA as Chief Medical Officer and Anne-Marie Martin, Ph.D., as an independent director. Dr. Jones joins from Bristol Myers Squibb Company, where he held positions of increasing responsibility in oncology clinical development. Dr. Martin is currently the Senior Vice President, Global Head of the Experimental Medicine Unit at GlaxoSmithKline plc. and joins Cullinan with over 25 years of translational medicine and clinical research expertise.

Fourth Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents and investments were $430.9 million as of December 31, 2021. We expect that this balance will be sufficient to fund operations through 2024.

R&D Expenses: Research and development (R&D) expenses were $20.9 million for the fourth quarter of 2021, compared to $12.7 million for the third quarter of 2021. R&D expenses in the fourth and third quarters of 2021 included $2.6 million and $2.5 million of equity-based compensation expenses, respectively. The increase in R&D expenses is primarily related to expanded clinical and chemistry, manufacturing, and controls (CMC) activity for CLN-081 and discovery and development of our preclinical programs.

G&A Expenses: General and administrative (G&A) expenses were $13.5 million for the fourth quarter of 2021, compared to $5.7 million for the third quarter of 2021. G&A expenses in the fourth and third quarters of 2021 included $9.6 million and $2.1 million of equity-based compensation expenses, respectively. The increase in G&A expenses is primarily related to a non-recurring charge to equity-based compensation expense due to the transition of our chief executive officer.

Net Loss: The Company’s net loss (before items attributable to noncontrolling interest) was $34.4 million for the fourth quarter of 2021, compared to $18.4 million for the third quarter of 2021. The increase in net loss related primarily to CLN-081 CMC investment, R&D portfolio advancement, and non-recurring equity-based compensation expenses.

Full Year 2021 Financial Results

R&D Expenses: R&D expenses were $57.8 million for the year ended December 31, 2021, compared to $43.2 million for the year ended December 31, 2020. R&D expenses for the full years 2021 and 2020 included $8.9 million and $5.9 million of equity-based compensation expenses, respectively. The increase in R&D expenses is primarily related to expanded trial enrollment, CMC activities, and a sub-licensing fee relating to CLN-081, as well as increases in pre-clinical and CMC costs to support IND enabling activities for other programs.

G&A Expenses: G&A expenses were $29.1 million for the year ended December 31, 2021, compared to $17.1 million for the year ended December 31, 2020. G&A expenses for the full years 2021 and 2020 included $15.4 million and $9.0 million of equity-based compensation expenses, respectively. The increase in G&A expenses is primarily related to a non-recurring charge to equity-based compensation expense in the fourth quarter due to the transition of our chief executive officer, as well as increased headcount, legal expenses, insurance costs, and IT systems upgrades to support our operations as a public company.

Net loss: The Company’s net loss (before items attributable to non-controlling interest) was $67.5 million for the year ended December 31, 2021, compared to $59.5 million for the year ended December 31, 2020. Net loss for the year ended December 31, 2021 included $18.9 million of revenue from the upfront payment pursuant to the license agreement with Zai Lab (Shanghai) Co., Ltd. for the development and commercialization rights to CLN-081 in Greater China, $3.0 million of sub-licensing expense associated with that transaction, and $24.4 million of non-cash equity-based compensation expense.

On March 17, 2022 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of MasterKey therapies, reported financial results for the fourth quarter and full year ended December 31, 2021 and provided a corporate update (Press release, Black Diamond Therapeutics, MAR 17, 2022, View Source [SID1234610304]).

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"At Black Diamond, we are on a mission to expand the reach of precision cancer medicines and are pleased with the work we have accomplished in 2021 as demonstrated by the breadth of our MasterKey inhibitor pipeline," said David Epstein, Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "In the year ahead, our priorities are to execute on the Phase 1 trial of BDTX-1535 and continue to advance our pipeline using our proprietary MAP drug discovery engine as we focus on our early stage programs, including CNS-BRAF (BDTX-4933). We believe our differentiated MasterKey therapies and novel approach to targeting oncogenic mutations can bring meaningful clinical benefit to patients not adequately served by today’s approved therapies."

Recent Developments

BDTX-1535:

In March 2022, Black Diamond initiated the Phase 1 study of BDTX-1535 for the treatment of glioblastoma multiforme (GBM) and non-small cell lung cancer (NSCLC) including those with central nervous system (CNS) metastases, following the U.S. Food and Drug Administration (FDA)’s allowance of the investigational new drug (IND) application for the study in January 2022.
In October 2021, the Company presented preclinical data at the ANE AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), showing that in cell-based assays, BDTX-1535 achieved potent and selective inhibition of a range of EGFR mutations expressed in NSCLC and demonstrated a favorable brain-penetrant pharmacokinetic (PK) profile in animal models. Additionally, BDTX-1535 showed dose-dependent tumor growth inhibition and complete regression in an allograft mouse model harboring EGFR C797S acquired resistance mutation.
The Company expects to provide a clinical update on the Phase 1 study of BDTX-1535 in the second half of 2023.
BDTX-189:

The Company is actively enrolling patients in the safety expansion cohort of the Phase 1 study of BDTX-189 in order to inform the future development of the program.
The Company expects to provide further guidance on the BDTX-189 program in 2022.
CNS-BRAF Program (BDTX-4933):

Black Diamond is developing a CNS-penetrant BRAF inhibitor against a family of Class I, II, III canonical and non-canonical mutations. The Company’s CNS-BRAF development candidate, BDTX-4933, is designed to be highly selective and potent, with the ability to avoid paradoxical activation.
In October 2021, the Company presented preclinical data at the ANE International Conference for a lead compound from the BRAF program, demonstrating potent inhibition of a family of Class II/III BRAF mutations shown in cell-based assays.
Black Diamond initiated IND-enabling studies for this program in the first quarter of 2022.
MAP Drug Discovery Engine:

Black Diamond is continuing to develop its Mutation-Allostery-Pharmacology (MAP) Drug Discovery Engine, predicting and validating novel oncogenic mutant families from population level tumor genomics, and exploring opportunities beyond oncology and small molecules to bring therapies to underserved patients.
In October 2021, Black Diamond shared multiple preclinical data presentations from its pipeline programs at the ANE International Conference including BDTX-1535, CNS-BRAF (BDTX-4933) and FGFR program compounds. The data showcased the potential breadth of coverage of oncogenic mutations across each program’s therapeutic area in animal models. Collectively, the presentations support the promise of the MAP Drug Discovery Engine’s algorithmic approach to targeting oncogenic mutations.
Corporate:

In February 2022, Black Diamond appointed Elizabeth Montgomery as its Chief People Officer, who joined the Company with nearly two decades of expertise and experience in developing strong corporate culture at a number of life sciences organizations.
Financial Highlights

Cash Position: Black Diamond ended 2021 with approximately $209.8 million in cash, cash equivalents, and investments compared to $315.1 million as of December 31, 2020. Net cash used in operations was $100.1 million for the year ended December 31, 2021 compared to $52.1 million for the year ended December 31, 2020.
Research and Development Expenses: Research and development (R&D) expenses were $19.7 million for the fourth quarter of 2021, compared to $17.8 million for the same period in 2020. Research and development expenses were $96.8 million for the year ended December 31, 2021, compared to $48.2 million for the year ended December 31, 2020. The increase in R&D expenses was primarily due to an increase in headcount and increased spend across preclinical and clinical development.
General and Administrative Expenses: General and administrative (G&A) expenses were $6.4 million for the fourth quarter of 2021, compared to $5.4 million for the same period in 2020, and $30.0 million for the year ended December 31, 2021, compared to $21.4 million for the year ended December 31, 2020. The increase in G&A expenses was primarily due to an increase in personnel and other corporate-related costs.
Net Loss: Net loss for the fourth quarter of 2021 was $25.9 million, as compared to $22.6 million for the same period in 2020. Net loss for the year ended December 31, 2021 was $125.6 million compared to $67.3 million for the year ended December 31, 2020.
Financial Guidance

Black Diamond ended 2021 with approximately $209.8 million in cash, cash equivalents and investments, which the Company believes is sufficient to fund its anticipated operating expenses and capital expenditure requirements into 2024.

On March 17, 2022 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune and inflammatory diseases, reported financial results for the fourth quarter and year ended December 31, 2021 (Press release, Alpine Immune Sciences, MAR 17, 2022, View Source [SID1234610303]).

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"2021 was a period of significant growth at Alpine with the advancement of all three of our clinical programs into significant stages of development," said Mitchell H. Gold, MD, Executive Chairman and Chief Executive Officer of Alpine. "As a result we secured $176 million in additional capital through a PIPE financing, the achievement of milestones as part of our AbbVie collaboration and an upfront payment from our recently announced discovery partnership with Horizon Therapeutics."

Dr. Gold added: "2022 looks to be a transformative year for Alpine with several important readouts anticipated across our programs, including the completion of dose escalation for davoceticept monotherapy and initiation of expansion cohorts; as well as the completion of the phase 1 healthy volunteer study for ALPN-303 and initiation of one or more patient-based studies in autoantibody-related diseases by the end of the year."
Full Year 2021 and Recent Clinical and Corporate Updates
•Davoceticept (ALPN-202): Conditional CD28 costimulator and dual checkpoint inhibitor
◦Davoceticept monotherapy dose escalation data (NEON-1) will be presented in an oral presentation at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on April 12, 2022. Initial findings of davoceticept’s tolerability and clinical activity were previously reported in an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
◦NEON-1 monotherapy expansion cohorts in patients with cutaneous melanoma and PD-L1+ tumors projected to be initiated in the first half of 2022.
◦Announced partial clinical hold on the NEON-2 trial combining davoceticept with pembrolizumab. Participants previously enrolled can continue to receive davoceticept and pembrolizumab; the NEON-1 monotherapy trial was not affected.
•ALPN-303: Dual APRIL/BAFF inhibitor
◦Began a first-in-human, phase 1 study of ALPN-303 in healthy volunteers in the fourth quarter of 2021; initial safety, pharmacokinetic, and pharmacodynamic findings anticipated by mid-2022.
◦Preclinical data, highlighting the differentiation and potential best-in-class profile of ALPN-303, were presented in two oral presentations at the European Alliance of Associations for Rheumatology and American College of Rheumatology Convergence 2021 meetings.
◦Plan to initiate studies in systemic lupus erythematosus (SLE) and potentially additional autoantibody-related diseases in the second half of 2022.
•Acazicolcept (ALPN-101): Dual CD28/ICOS inhibitor
◦Received $45 million in pre-option exercise development milestones as part of the Option and License Agreement with AbbVie, bringing total upfront and milestone payments received through December 31, 2021, to $105 million.
◦Continue to enroll Synergy, a phase 2 trial of acazicolcept in patients with SLE.

◦With collaborators at the French National Institute of Health and Medical Research (INSERM), demonstrated that acazicolcept decreased manifestations of systemic sclerosis in preclinical mouse models (Arthritis Res Ther 24: 13, 2022)

•General Corporate
◦Announced an exclusive license and collaboration agreement with Horizon Therapeutics plc for the development and commercialization of up to four preclinical candidates generated from Alpine’s unique discovery platform, which included $40 million in upfront payments ($25 million cash and $15 million equity investment at a 25% premium to the 30-day volume-weighted average share price) and eligibility to receive up to $1.5 billion in total, through future milestone-based payments.

◦Raised $91 million in a private placement, led by Frazier Life Sciences Public Fund with participation from Decheng Capital, BVF Partners, TCG X, Avidity Partners, OrbiMed, Omega Fund, and Logos Capital, among others.
Fourth Quarter and Full Year 2021 Financial Results
As of December 31, 2021, we had cash, cash equivalents, and investments totaling $215.4 million. Net cash used in operating activities for the year ended December 31, 2021 was $15.2 million compared to net cash provided by operating activities of $30.1 million for the year ended December 31, 2020. The Company recorded net losses of $50.3 million and $27.9 million for the years ended December 31, 2021 and 2020, respectively.
Collaboration revenue for the fourth quarter ended December 31, 2021 was $4.5 million compared to $5.6 million for the fourth quarter ended December 31, 2020. Collaboration revenue for the year ended December 31, 2021 was $23.4 million compared to $9.3 million for the year ended December 31, 2020. The amounts were primarily attributable to the revenue recognized under our AbbVie Agreement.

Research and development expenses for the fourth quarter ended December 31, 2021 were $15.4 million compared to $9.1 million for the fourth quarter ended December 31, 2020. Research and development expenses for the year ended December 31, 2021 were $58.7 million compared to $27.2 million for the year ended December 31, 2020. The increases were primarily attributable to our Synergy and NEON studies, contract manufacturing and process development of our product candidates primarily for acazicolcept and ALPN-303, increased personnel costs and other direct research activities.

General and administrative expenses for the fourth quarter ended December 31, 2021 were $4.5 million compared to $3.0 million for the fourth quarter ended December 31, 2020. General and administrative expenses for the year ended December 31, 2021 were $14.6 million compared to $10.9 million for the year ended December 31, 2020. The increase was primarily attributable to increases in professional and legal services and personnel costs.
The Company expects that its current cash resources, combined with the $25 million up-front payment received from Horizon in January 2022 and the potential $30 million in pre-option exercise milestones payable under its option and license agreement with AbbVie, for the development and commercialization of acazicolcept, will be sufficient to fund its planned operations into 2024.

On March 17, 2022 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported corporate updates and financial results for the fourth quarter and fiscal year ended December 31, 2021 (Press release, CymaBay Therapeutics, MAR 17, 2022, View Source [SID1234610302]).

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Sujal Shah, President and CEO of CymaBay, stated, "2021 was a year of growth for CymaBay and included accomplishments that position CymaBay for long-term success. A non-dilutive, risk-sharing development financing agreement of up to $100 million signed with Abingworth in July, together with a $75 million public equity offering in November support the completion of our ongoing Phase 3 program for seladelpar in PBC. We now have over 120 sites activated across over 20 countries in our global registration study, RESPONSE, and expect these efforts to continue and ultimately drive the completion of enrollment in the first half of 2022. We have seen a high level of interest in our long-term safety study, ASSURE, where we have enrolled more than 120 patients from our prior studies of seladelpar in PBC. We were also excited to share additional data at The Liver Meeting 2021 that we believe demonstrate improved benefit of seladelpar between one to two years of treatment, and differentiation from other existing treatments in a population of PBC patients with more advanced disease."

"Heading into 2022, we are well positioned to deliver on our laser focus of improving the lives of patients with PBC. Although the pandemic and recent global unrest have presented our entire industry with evolving challenges, I am confident we have assembled talent across the organization that will allow us to achieve both our near-term goals and our longer-term vision of establishing a pipeline of opportunities for patients with unmet need. Despite these challenges, we have seen steady progress since re-initiating our development program in PBC in 2021. I’m also proud of the relationships we have established with patient communities, the medical community, and high-quality investors that all support the work we are dedicated to day-in and day-out."

Recent Corporate Highlights

Continued enrollment in RESPONSE, a 52-week, placebo-controlled, randomized, global, Phase 3 registrational study evaluating the safety and efficacy of seladelpar in patients with PBC. This study is targeting enrollment of 180 patients who have an inadequate response to, or intolerance to, ursodeoxycholic acid, in a 2:1 randomization to oral, once daily seladelpar 10 mg or placebo. The primary outcome measure is the responder rate at 52 weeks. A responder is defined as a patient who achieves an alkaline phosphatase level < 1.67 times the upper limit of normal with at least a 15% decrease from baseline and has a normal level of total bilirubin. Additional key outcomes of efficacy will compare the rate of normalization of alkaline phosphatase at 52 weeks and the level of pruritus at 6-months for patients with moderate to severe pruritus at baseline assessed by a numerical rating scale recorded with an electronic diary. To date we have over 120 sites activated across more than 20 countries.
Continued enrollment in ASSURE, an open-label, long-term study of seladelpar in patients with PBC intended to collect additional long-term safety data to support registration. To date we have enrolled over 120 patients in the study, building our already extensive safety database for seladelpar treated PBC patients.
Supported enrollment efforts in a Phase 2a proof-of-pharmacology study to evaluate the potential for MBX-2982, a GPR119 agonist, to prevent hypoglycemia in patients with type 1 diabetes. The study is being conducted by the AdventHealth Translational Research Institute in Orlando, Florida and fully funded by The Leona M. and Harry B. Helmsley Charitable Trust with CymaBay retaining full rights to MBX-2982.
Announced that results of analyses from two clinical studies of seladelpar were delivered during The Liver Meeting Digital Experience 2021 (TLMdX) of the American Association for the Study of Liver Diseases (AASLD), as follows:
Oral presentation titled "Long-Term Safety and Efficacy of Seladelpar in Patients with Primary Biliary Cholangitis" delivered by Dr. Marlyn J. Mayo, MD, highlighting the efficacy and safety of seladelpar during 2 years of treatment in patients with primary biliary cholangitis (PBC).
A clinical presentation titled "Efficacy and Safety of Seladelpar in Patients with Compensated Cirrhosis and Evidence of Portal Hypertension due to Primary Biliary Cholangitis" delivered by Dr. Cynthia Levy, MD, highlighting the treatment effects of seladelpar in compensated cirrhotic patients with portal hypertension after 3 months, which led to ALP changes of -30% in the 5 mg and -45% in the 10 mg groups.
Continued to grow our team from 40 to 59 employees during the year, including the hiring of two executive officers; Dr. Dennis Kim as Chief Medical Officer, a physician-scientist trained in endocrinology who brings significant clinical development and executive experience and Lewis Stuart as Chief Commercial Officer, an executive who brings a diverse set of experiences launching products in both the pharmaceutical and molecular diagnostics healthcare sectors.
Expanded the Board of Directors composition by appointing Thomas Wiggans a biopharma industry veteran and Janet Dorling a senior commercial executive at Gilead. Recently appointed Dr. Éric Lefebvre, the Chief Medical Officer of Pliant Therapeutics, to the Board.
Executed a non-dilutive financing transaction with Abingworth LLP for the development of seladelpar in PBC. CymaBay will receive up to $100 million of funding for seladelpar development costs, of which $75 million has been received to date. CymaBay has an option to receive an additional $25 million after the completion of enrollment of CymaBay’s Phase 3 RESPONSE clinical trial.
Completed public equity offering in November 2021, CymaBay sold 15,625,000 shares of common stock at $4.00 per share and pre-funded warrants to purchase 3,125,000 shares of common stock at $3.9999 per share. After deducting underwriting commissions and other estimated offering expenses, net proceeds of the offering were $70.5 million.
Held $194.6 million in cash, cash equivalents and short-term investments as of December 31, 2021. We believe that cash and investments on hand, together with committed capital available through the development financing agreement with Abingworth, is sufficient to fund CymaBay’s operating plan through 2023.

Fourth Quarter and Year Ended December 31, 2021 Financial Results

Research and development expenses for the three months ended December 31, 2021 and 2020 were $18.4 million and $10.7 million, respectively. Research and development expenses for the twelve months ended December 31, 2021 and 2020 were $64.5 million and $35.9 million, respectively. Research and development expenses in the three and twelve months ended December 31, 2021 were higher than the corresponding periods in 2020 primarily due to an increase in clinical trial activities associated with the development of seladelpar in PBC. In particular, cost increases were primarily driven by an expansion of our site activation, patient enrollment, and other clinical trial activities associated with RESPONSE and ASSURE, our two active global late-stage clinical trials in PBC.
General and administrative expenses for the three months ended December 31, 2021 and 2020 were $6.1 million and $5.2 million, respectively. General and administrative expenses for the twelve months ended December 31, 2021 and 2020 were $23.0 million and $16.7 million, respectively. General and administrative expenses in the three and twelve months ended December 31, 2021 were higher than the corresponding periods in 2020 due to higher employee compensation associated with the hiring of additional personnel and an increase in consulting and other expenses upon resumption of development of seladelpar in the second half of 2020.
Net loss for the three months ended December 31, 2021 and 2020 was $26.5 million and $15.8 million, or ($0.34) and ($0.23) per diluted share, respectively. Net loss for the twelve months ended December 31, 2021 and 2020 was $90.0 million and $51.0 million, or ($1.27) and ($0.74) per diluted share, respectively. Net loss was higher largely due to increases in clinical operating expenses, which were incurred following the resumption of our clinical development of seladelpar in PBC during the second half of 2020. We expect our operating expenses to increase in the future as we continue to execute on our clinical development plans.
Conference Call Details

CymaBay will host a conference call today at 4:30 p.m. ET to discuss fourth quarter and fiscal year end 2021 financial results and provide a business update. To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID# 13726915. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source

On March 17, 2022 Scilex Holding Company ("Scilex"), a majority-owned subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento"), a commercial biopharmaceutical company focused on developing and commercializing non-opioid therapies for patients with acute and chronic pain, and Vickers Vantage Corp. I (Nasdaq: VCKA; VCKAW) ("VCKA"), a special purpose acquisition company sponsored by Vickers Venture Fund VI Pte Ltd and Vickers Venture Fund VI (Plan) Pte Ltd, reported that they have entered into a definitive business combination agreement ("BCA"). Prior to the closing of the transaction, VCKA will be redomesticated as a Delaware corporation. Upon closing of the transaction, the combined company (the "Combined Company") will be renamed Scilex Holding Company, and its common stock and warrants are expected to be listed on Nasdaq under the ticker symbols "SCLX" and "SCLXW", respectively (Press release, Sorrento Therapeutics, MAR 17, 2022, View Source [SID1234610301]). The boards of directors of each of VCKA, Scilex and Sorrento have unanimously approved the proposed transaction. The closing of the transaction, which is expected to occur by the third quarter of 2022, is subject to the approval of VCKA’s shareholders and the satisfaction or waiver of certain other customary closing conditions.

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"We are thrilled to have the opportunity to partner with the team at Scilex. We believe Scilex is a uniquely compelling company with excellent non-opioid pain management therapies, which we expect may become cornerstone therapies for treating many acute and chronic pain conditions worldwide," said Dr. Jeffrey Chi, Chief Executive Officer and Chairman of VCKA and Vice Chairman of Vickers Venture Partners.

More than 60% of U.S. opioid prescriptions are for the treatment of chronic low back pain (CLBP)1 despite the fact that opioids are associated with serious and potentially life-threatening side effects and have not demonstrated efficacy in the treatment of CLBP.2,3,4 In 2018, more than 67,000 drug overdose deaths occurred in the United States5 of which almost 47,000 (70%) were opioid-related. Over 70% of the 70,630 deaths in 2019 involved an opioid.6 Provisional data released by the Centers for Disease Control and Prevention showed drug overdose deaths rose by nearly 29% over a 12-month period ending in April 2021, to an estimated 100,306.7

"Scilex was advanced through key milestones, and we are proud of Scilex’s continued path of success, most notably with the FDA approval and commercialization of ZTlido along with the highly significant positive top-line pivotal Phase 3 results of SP-102 (SEMDEXA) previously announced in December 2021," said Henry Ji, Ph.D., Chairman and Chief Executive Officer of Sorrento and Executive Chairman of Scilex. "With Scilex on its way to becoming a publicly-traded entity, our unique model continues to demonstrate the multiple ways in which we are generating value at Sorrento, including equity stakes in public and private entities, royalties and milestone payments due to us from certain proprietary products, pharma collaborations worldwide to advance core programs, and most importantly, our rapidly progressing and advanced wholly-owned pipeline which we see as our major value driver going forward. In addition to Sorrento’s advanced pipeline of oncology, immunology and virology assets, its wholly and majority owned subsidiaries are an additional source of value and Scilex is now set to join the growing list of publicly-traded entities in which Sorrento is an investor, which also include Celularity Inc., which was funded by Sorrento at its inception."

The Combined Company is expected to have funds of up to $140 million held in VCKA’s trust account at closing before expenses, assuming no redemptions from Vickers Vantage Corp I’s existing public shareholders, and will be led by Scilex’s experienced management team, headed by Jaisim Shah, Chief Executive Officer. The Combined Company might raise additional capital through a PIPE or other financing method as it might see fit for the business, although there are no specific plans for such an offering at this time.

"I am proud of the many landmark milestones delivered by the Scilex team this past year, including completion of our phase 3 study for SP-102 (SEMDEXA) and a highly successful pivotal Phase 3 program demonstrating robust efficacy and safety in sciatica patients and the upcoming expected initiation of broad Phase 1 and 2 non-opioid programs for SP-102 (SEMDEXA) with both first-in-class and best-in-class potential in multiple areas of acute and chronic pain with high unmet patient need. We believe the efficacy and safety profile demonstrated by SP-102 (SEMDEXA) to date and the observed duration of effect represent important differentiating features of this potentially first-to-market non-opioid candidate for the many millions of sciatica patients who are confronting this very painful condition. I would like to thank the team at VCKA and existing shareholders and all of the teams at Scilex and Sorrento and our advisors for their dedication in preparing for this business combination. Today’s transaction will allow us to continue to pursue our vision to enhance lives for millions of patients with acute and chronic pain conditions," said Jaisim Shah, Chief Executive Officer of Scilex.

Available proceeds from the transaction are expected to fund commercialization plans for SP-102 (SEMDEXA), if approved, along with potential Phase 3 and Phase 2 clinical development programs. Scilex also intends to pursue additional indications for SP-102 (SEMDEXA) in the future. Scilex also plans to use the funding from the transaction to bolster the continued build out of the commercial team, enhance business development activities and support general corporate activities.

A corporate presentation describing Scilex’s development plans can be found at www.scilexholding.com.

Key Transaction Terms

Assuming no redemptions from VCKA’s shareholders, it is estimated that the current stockholders of Scilex will own approximately 88% of the outstanding shares of the Combined Company, assuming no debt adjustment. As part of the transaction, Scilex’s existing equity holders will roll 100% of their equity into the Combined Company. In connection with the transactions, VCKA’s sponsors have agreed to cancel 40% of their private warrants if redemptions exceed 75%.

The Combined Company is expected to have funds of up to $140 million held in VCKA’s trust account at closing before expenses, assuming no redemptions from VCKA’s shareholders, which is expected to occur by the third quarter of 2022. The close of the transaction is subject to the approval of VCKA’s shareholders and the satisfaction or waiver of certain other customary closing conditions.

The boards of directors of each of VCKA, Scilex and Sorrento have unanimously approved the proposed transaction.

The description of the transaction contained herein is only a summary and is qualified in its entirety by reference to the definitive agreement relating to the transaction. A copy of the definitive agreement, this press release and a corporate presentation will be filed by VCKA and Sorrento with the Securities and Exchange Commission (the "SEC") as exhibits to a Current Report on Form 8-K, which can be accessed through the SEC’s website at www.sec.gov.

Loeb & Loeb, LLP is serving as legal counsel to VCKA. Paul Hastings LLP is serving as legal counsel to Scilex.