On March 17, 2022 Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported financial results for the fiscal year ended December 31, 2021 (Press release, Marker Therapeutics, MAR 17, 2022, View Source [SID1234610338]).

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"In 2021, we completed enrollment of the first 20 patients in our Phase 2 AML trial investigating our lead product candidate, MT-401," said Peter L. Hoang, Marker’s President and Chief Executive Officer. "We also developed a new nine-day manufacturing process which increased the potency and antigen specificity and diversity of our products and significantly reduced the time it takes to manufacture our patient-specific T cell therapies. In February 2022, we reported initial results from the six-patient safety lead-in phase of the Phase 2 AML trial, which demonstrated that MT-401 was well-tolerated and satisfied the safety requirements with FDA. We expect to report topline data from the active disease group in the main phase of the Phase 2 trial next quarter. In addition, we look forward to expanding our pipeline beyond AML and expect to file INDs for lymphoma and pancreatic cancer by the end of the year."

PROGRAM UPDATES AND EXPECTED MILESTONES

Acute Myeloid Leukemia (AML)

MT-401

In February 2022, Marker announced the initial results of the safety lead-in stage of its Company-sponsored Phase 2 AML trial evaluating MT-401, Marker’s lead MultiTAA-specific T cell product candidate. Results from the safety lead-in demonstrate that MT-401 was well-tolerated, eliminated measurable residual disease (MRD) in one MRD positive patient and induced epitope spreading across multiple AML-associated antigens in that patient.
The safety lead-in satisfied safety requirements with the FDA and the main Phase 2 stage of the AML trial began enrolling in July 2021.
Enrollment of the first 20 patients of the Phase 2 AML trial was completed in Q4 2021.
Topline readout of Group 2 active disease is anticipated in Q2 2022.
Off-the-Shelf (MT-401-OTS)

Marker announced in February 2022 that it intends to expand its AML program with the development of MT-401-OTS, a scalable, off-the-shelf product candidate with the potential to match patients to treatment in under three days. Marker’s open Investigational New Drug application (IND) for MT-401 for the treatment of AML includes approval of an off-the-shelf program. The Company is in the process of developing a patient cell bank inventory and expects to dose the first patient with MT-401-OTS in 2023.
Additional Clinical Programs (MT-601)

Marker recently announced that the Company intends to file INDs for MT-601, Marker’s second MultiTAA-specific T cell product candidate, in lymphoma and pancreatic cancer in 2022. The Company expects to initiate these trials in 2023.
In January 2022, Marker announced that the U.S. Food and Drug Administration granted Orphan Drug designation to MT-601 for the treatment of pancreatic cancer.
BUSINESS UPDATES

On December 9, 2021, Marker announced the appointment of Katharine Knobil, M.D., to the Company’s Board of Directors.
Marker began manufacturing MT-401 for its Phase 2 AML trial at the Company’s cGMP manufacturing facility in the fourth quarter of 2021.
The Company developed and is implementing a new nine-day MultiTAA-specific T cell manufacturing process for its current Company-sponsored Phase 2 AML trial as well as future clinical trials using a patient-specific manufacturing approach. The new T cell manufacturing process is designed to improve potency, increase antigen specificity and diversity and significantly reduce manufacturing time.
FISCAL YEAR 2021 FINANCIAL RESULTS

Cash Position and Guidance: At December 31, 2021, Marker had cash, cash equivalents and restricted cash of $43.5 million. The Company believes that its existing cash, cash equivalents and restricted cash will fund its operating expenses and capital expenditure requirements into the first quarter of 2023.

R&D Expenses: Research and development expenses were $27.8 million for the year ended December 31, 2021, compared to $18.9 million for the year ended December 31, 2020.

G&A Expenses: General and administrative expenses were $12.9 million for the year ended December 31, 2021, compared to $10.5 million for the year ended December 31, 2020.

Net Loss: Marker reported a net loss of $41.9 million for the year ended December 31, 2021, compared to a net loss of $28.7 million for the year ended December 31, 2020.

On March 17, 2022 X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a leader in the discovery and development of novel CXCR4-targeted small molecule therapeutics to benefit people with diseases of the immune system, reported financial results for the fourth quarter and twelve months ended December 31, 2021, and provided a corporate update (Press release, X4 Pharmaceuticals, MAR 17, 2022, View Source [SID1234610310]).

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"We are very pleased with our many accomplishments in 2021, particularly completing enrollment in the pivotal 4WHIM Phase 3 clinical trial in WHIM syndrome, the first indication we are pursuing for our oral, first-in-class CXCR4 inhibitor, mavorixafor," commented Paula Ragan, Ph.D., President and Chief Executive Officer of X4 Pharmaceuticals. "We also continued enrolling and treating patients in both our chronic neutropenia and Waldenström’s macroglobulinemia Phase 1b clinical trials, which are designed to expand the potential market opportunities for mavorixafor, and we look forward to reporting key clinical and regulatory updates for these programs throughout the year."

Dr. Ragan continued, "Our clinical and research efforts into the potential of CXCR4 antagonism have also resulted in the discovery of several novel WHIM-causing CXCR4 mutations associated with expanded disease characteristics, which we believe further underscore WHIM syndrome as an underrecognized condition and strengthen our confidence in prevalence being potentially higher than the current estimates of WHIM patients in the U.S. We look ahead to the remainder of 2022 with great excitement, as we continue to anticipate top-line data from 4WHIM by the end of the year, and additional clinical and research data throughout the year, further supporting the broad clinical and commercial potential of mavorixafor across multiple indications."

Fourth Quarter 2021 Highlights
•Completed enrollment in the ongoing pivotal 4WHIM Phase 3 clinical trial of mavorixafor in patients with WHIM (Warts, Hypogammaglobulinemia, Infections, Myelokathexis) syndrome. Thirty-one adult and pediatric patients have been enrolled in the 4WHIM trial, which was originally designed to enroll 18 – 28 patients. Top-line data from the 4WHIM trial are expected in the fourth quarter of 2022.
•Presented a wide range of clinical and research data at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting supporting the potential use of mavorixafor across a number of immunodeficiencies and certain cancers:

Exhibit 99.1
◦Ongoing studies across a wide variety of diseases, including Waldenström’s macroglobulinemia (WM), clear cell renal cell carcinoma, WHIM syndrome, and chronic idiopathic neutropenia, showed that oral administration of mavorixafor increased blood neutrophils, lymphocytes, and monocytes regardless of the presence or absence of CXCR4 mutations.
◦Mavorixafor efficacy has been clinically observed with short-term and long-term treatment both alone and in combination with other therapies, including axitinib, ibrutinib, and granulocyte-colony stimulating factor (G-CSF).
◦Additional data from the Phase 2 open-label extension study of mavorixafor in WHIM patients continued to show durable increases in neutrophils, lymphocytes, and monocytes; decreased frequency, severity, and duration of infections; fewer hospital/doctor visits; and sustained improvements in warts. Chronic daily administration of mavorixafor continued to be well tolerated (median treatment duration = 148.4 weeks).
◦Clinical and laboratory research resulted in the identification of a novel missense CXCR4 mutation, D84H, that further supports the company’s WHIM prevalence estimate of at least 1,000 to 3,500 patients in the U.S.
◦Initial results from the ongoing mavorixafor Phase 1b clinical trial in people with chronic neutropenia concurrently treated with granulocyte colony stimulating factor (g-CSF) and mavorixafor demonstrated elevations in white blood cells and absolute neutrophil, lymphocyte, and monocyte counts (n=4); enrollment continues, with additional data expected in the second or third quarter of 2022.
◦In December 2021, interim results reported from the ongoing Phase 1b clinical trial in WM from the low- (200 mg) and mid-level (400 mg) dose groups (October 2021 data cut) showed a 100% overall response rate (n=10, median treatment duration of 272.5 days), sustained decreases in serum IgM (n=14), and trends towards normalization of hemoglobin levels (n=14 at baseline, n=3 at 12 months).
▪As of March 2022, cohort B evaluating 600 mg of mavorixafor in combination with ibrutinib met the safety requirements to allow for the dose escalation of patients enrolled in cohort A and previously treated at low- and mid-level doses. All eligible patients are being escalated to receive 600 mg of mavorixafor once daily in combination with ibrutinib. Additional data from this trial are expected in the second half of 2022.

Upcoming Presentations
Clinical Immunology Society (CIS)
X4 will present three posters at the CIS 2022 Annual Meeting: Immune Deficiency and Dysregulation North American Conference, March 31 – April 3, 2022:
•PATH4WARD: A Genetic Testing Program to Aid in Molecular Diagnosis of Congenital Neutropenia and Other Primary Immunodeficiencies Including WHIM Syndrome.
•Characterization of CXCR4(S341Y) Variant of Uncertain Significance in the Setting of Infections, Hypogammaglobulinemia, and Warts.
•4WHIM: Evaluating the Oral CXCR4 Antagonist Mavorixafor in Patients With WHIM Syndrome via a Global Phase 3, Randomized, Placebo-Controlled Trial With Open-label Extension.

American Association for Cancer Research (AACR) (Free AACR Whitepaper)
X4 will present emerging preclinical data on mavorixafor’s ability to significantly enhance the tumor cell killing activity of the leading commercial and clinical Bruton Tyrosine Kinase Inhibitors (BTKi) including

Exhibit 99.1
ibrutinib, zanubrutinib, pirtobrutinib (LOXO-305) and nemtabrutinib (ARQ-531), at the 2022 AACR (Free AACR Whitepaper) Annual Meeting, taking place April 8 – 13, 2022.
•e-Poster #6093: Mavorixafor Enhances Efficacy of Bruton Tyrosine Kinase Inhibitors by Overcoming the Protective Effect of Bone Marrow Stroma on Tumor Cells in Waldenström’s Macroglobulinemia.
Session: OPO.TB06.01 – Tumor Microenvironment
E-posters are expected to be released at 12:00 PM CT on Friday, April 8.

Fourth Quarter and Full Year 2021 Financial Results
•Cash, Cash Equivalents & Restricted Cash: X4 had $83.1 million in cash, cash equivalents, and restricted cash as of December 31, 2021. The company expects that its cash and cash equivalents will fund company operations into the fourth quarter of 2022.
•Research and Development (R&D) Expenses were $12.2 million and $50.6 million for the fourth quarter and full year ended December 31, 2021, as compared to $12.3 million and $41.9 million for the comparable periods in 2020. R&D expenses include $0.7 million and $2.7 million of certain non-cash expenses for the quarter and full year ended December 31, 2021, respectively.
•General and Administrative Expenses (G&A) were $7.1 million and $24.7 million for the fourth quarter and full year ended December 31, 2021, as compared to $5.4 million and $20.9 million for the comparable periods in 2020. G&A expenses include $0.9 million and $3.5 million of certain non-cash expenses for the quarter and full year ended December 31, 2021, respectively.
•Net Loss: X4 reported a net loss of $30.2 million and $88.7 million for the quarter and full year ended December 31, 2021, as compared to a net loss of $18.4 million and $62.1 million for the comparable periods in 2020. Net loss for the current quarter and full year period includes a non-cash goodwill impairment charge of $9.8 million. There was no goodwill impairment charge in the prior year periods. Net losses include $1.6 million and $6.2 million of stock-based compensation expense for the quarter and full year ended December 31, 2021, respectively. Net losses included $1.4 million and $5.4 million of stock-based compensation expense for the quarter and full year ended December 31, 2020, respectively.

Conference Call and Webcast
X4 will host a conference call and webcast today at 8:30 am EDT to discuss financial results and business highlights. The conference call can be accessed by dialing (866) 721-7655 from the United States or (409) 216-0009 internationally, followed by the conference ID: 9772687. The live webcast can be accessed on the investor relations section of X4 Pharmaceuticals’ website at www.x4pharma.com. Following the completion of the call, a webcast replay of the conference call will be available on the website.

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.