Cullinan Oncology Provides Corporate Update and Reports Fourth Quarter and Full Year 2022 Financial Results

On March 9, 2023 Cullinan Oncology, Inc. (Nasdaq: CGEM; "Cullinan") a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, reported on recent and upcoming business highlights and announced its financial results for the fourth quarter and full year ended December 31, 2022 (Press release, Cullinan Oncology, MAR 9, 2023, View Source [SID1234628413]).

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"2022 was a year of remarkable execution at Cullinan Oncology, and the momentum with which we ended the year has continued into early 2023. With our partners at Taiho Oncology, we initiated the pivotal study of zipalertinib in the fourth quarter, while continuing to advance enrollment in the Phase 1 trials of CLN-049 and CLN-619, with initial clinical data expected mid-year" said Nadim Ahmed, Chief Executive Officer of Cullinan. "The first two months of 2023 have resulted in similarly exciting developments, as we recently expanded our pipeline through the licensing of U.S. development and commercial rights to CLN-418, a potential first-in-class B7H4x4-1BB bispecific immune activator currently in a Phase 1 study across a variety of solid-tumor indications. This transaction provides us with the opportunity to have six programs in the clinic by the end of the year, as we recently received IND clearance for CLN-978 and also recently filed the IND for CLN-617, consistent with prior guidance. Importantly, our cash position following the CLN-418 transaction provides us with runway into 2026 which gives us the flexibility needed to fund our ongoing development efforts and reach multiple potential value creating milestones."

Portfolio Highlights


Zipalertinib: In the fourth quarter of 2022, Cullinan Oncology, in collaboration with our partners at Taiho Oncology, Inc., initiated a pivotal study of zipalertinib in EGFR exon 20 insertion mutation non-small-cell lung cancer patients progressing after prior systemic therapy. As previously planned, the study will enroll patients at the 100mg BID dose under fasted conditions, and also will include a limited cohort of patients to evaluate safety and efficacy at 150mg BID administered with food.


CLN-049: CLN-049 is a FLT3xCD3 T cell-engaging bispecific antibody being investigated in patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Enrollment continues in the ongoing Phase 1 dose escalation clinical study with initial clinical data expected in mid-2023.


CLN-619: CLN-619 is a monoclonal antibody that stabilizes expression of MICA/MICB on the tumor cell surface to promote tumor cell lysis by both cytotoxic innate and adaptive immune cells. CLN-619 has broad therapeutic potential and is being investigated as both monotherapy and in combination with checkpoint inhibitor therapy in an ongoing Phase 1 dose escalation study in patients with advanced solid tumors with initial clinical data expected in mid-2023.


CLN-418: CLN-418 is a B7H4x4-1BB fully human bispecific immune activator designed to achieve conditional activation of 4-1BB by targeting B7H4, a tumor associated antigen that is highly expressed across multiple cancers with minimal expression on normal tissues. Enrollment is ongoing in a Phase 1 dose escalation study at U.S. and Australian sites in patients with advanced solid tumors with initial clinical data expected in 2024.


In February, Cullinan Oncology licensed the exclusive U.S. development and commercial rights to CLN-418 from Harbour Biomed for an upfront fee of $25 million, with the potential for up to an additional $148 million in development and regulatory milestones and up to $415 million in sales-based milestones, as well as tiered royalties on potential U.S. commercial sales.


CLN-978: CLN-978 is a novel CD19xCD3-bispecific therapeutic with extended serum half-life and robust potency against target cells expressing low levels of CD19. Consistent with prior guidance, Cullinan received FDA clearance of its Investigational New Drug (IND) application for CLN-978 in January and anticipates initiating a Phase 1 clinical study by the end of 2023.


CLN-617: CLN-617 is a cytokine fusion protein uniquely combining IL-12 and IL-2 with a collagen binding domain designed for retention in the tumor microenvironment (TME) following intratumoral injection. Consistent with prior guidance, Cullinan recently filed the IND application for CLN-617 in February 2023 and intends to initiate a Phase 1 clinical study by the end of 2023, pending IND clearance.

Fourth Quarter 2022 Financial Results


Cash Position: Cash and investments were $550.1 million as of December 31, 2022. During the fourth quarter of 2022, Cullinan acquired additional equity in its subsidiary, Cullinan Mica, which holds the worldwide rights to CLN-619, for $33 million, increasing its ownership from 54% to 95% of the entity. In the first quarter of 2023, the Company spent $25 million on the upfront payment under the recently announced licensing agreement for CLN-418 with Harbour Biomed. Cullinan expects its cash resources to provide runway into 2026 based on its current operating plan.


R&D Expenses: Research and development (R&D) expenses were $21.3 million for the fourth quarter of 2022, compared to $19.7 million for the third quarter of 2022. R&D expenses for the fourth and third quarters of 2022 included $2.9 million and $1.1 million of equity-based compensation expenses, respectively. Excluding the impact of equity-based compensation expenses, the decrease in R&D expenses was primarily related to a decrease in preclinical costs, partially offset by increased personnel costs.


G&A Expenses: General and administrative (G&A) expenses were $11.3 million for the fourth quarter of 2022, compared to $10.1 million for the third quarter of 2022. G&A expenses in the fourth and third quarters of 2022 included $4.6 million and $4.2 of equity-based compensation expenses, respectively. The increase in G&A expenses was primarily driven by increased personnel costs.


Net Loss: Net loss (before items attributable to noncontrolling interest) for the fourth quarter of 2022 was $27.1 million, compared with net loss of $24.9 million for the third quarter of 2022. Net losses included the items described above, partially offset by interest income of $3.4 million and $2.4 million and income tax benefit recognized of $1.9 million and $2.5 million in the fourth and third quarters of 2022, respectively.

Full Year 2022 Financial Results


R&D Expenses: R&D expenses were $91.9 million for 2022, compared to $57.8 million for 2021. R&D expenses for 2022 and 2021 included $11.0 million and $8.9 million of equity-based compensation expenses, respectively. The increase in R&D expenses was primarily related to CRO and CMC activities to support our ongoing clinical trials and pre-clinical research and CMC costs to support IND enabling activities.


G&A Expenses: G&A expenses were $40.2 million for 2022, compared to $29.1 million in 2021. G&A expenses in 2022 and 2021 included $16.9 million and $15.4 million of equity-based compensation expenses, respectively. The increase in G&A expenses was primarily driven by increase in personnel and professional services due to increased headcount to support our expanded operations, and non-recurring costs related to the previously announced Cullinan Pearl sale, described below.


Gain on sale of Cullinan Pearl: In June 2022, Cullinan sold its equity interest in its subsidiary, Cullinan Pearl, which has worldwide rights to zipalertinib, excluding Japan and Greater China, to Taiho Pharmaceutical Co., Ltd. (Taiho). Cullinan recognized a gain from the sale of $276.8 million, which includes the upfront payment of $275 million, as well as the impact of net liabilities transferred to Taiho. Cullinan also recognized income tax expenses of $42.1 million as a result of the gain and offsetting operating expenses.


Net Income (Loss): Net income (before items attributable to noncontrolling interest) for 2022 was $109.2 million, compared with a net loss of $67.5 million in 2021. Net income in 2022 was related to the items described above, as well as $6.6 million of interest income. In 2021, operating expenses described above were partially offset by $18.9 million of license revenue.

Histogen Reports Year-End 2022 Results and Provides Business Update

On March 9, 2023 Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company on developing potential first-in-class clinical and preclinical small molecule pan-caspase and caspase selective inhibitors that protect the body’s natural process to restore immune function, reported financial results for the year ended December 31, 2022, and provided an update on its pipeline and other corporate developments (Press release, Conatus Pharmaceuticals, MAR 9, 2023, View Source [SID1234628412]).

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"Our team is very excited about the new direction of the company. We remain focused on the development of emricasan as a potential treatment for acute bacterial skin and skin structure infections (ABSSSI), including those related to methicillin resistant staphylococcus aureus ("MRSA") and our pre-clinical evaluations of our caspase-1 inhibitors that impact the inflammasome pathway," said Steven J. Mento, Ph.D., Interim President and Chief Executive Officer.

Highlights from Year Ended 2022 and Business Updates


Emricasan ABSSSI – Emricasan is an orally available pan-caspase inhibitor designed to reduce the activities of human caspases, which are enzymes that mediate inflammation and apoptosis. Emricasan has completed extensive toxicology testing including chronic toxicology and clean carcinogenicity testing. This drug candidate has previously been shown to be well tolerated in multiple clinical studies involving approximately 1,000 subjects employing multiple doses ranging from 1 mg to 500 mg orally with treatment for up to two years, including a Phase 1 study in mild symptomatic COVID-19 patients to assess safety, tolerability, and preliminary efficacy. In the fourth quarter of 2021, we completed our pre-clinical evaluation of emricasan for the potential treatment of acute bacterial skin infections, including those related to MRSA, and anticipate initiating clinical development activities for the treatment of ABSSSI in the first half of 2023.


Amerimmune Collaboration – In November 2022, in accordance with an arbitration award, we terminated the Amerimmune Collaboration Agreement and all rights to emricasan, CTS-2090, and CTS-2096 were returned to us.


Appointed Alfred P. Spada, Ph.D. as Chief Scientific Officer – In January 2023, Dr. Spada joined Histogen as its Executive Vice President and Chief Scientific Officer. Dr. Spada is a seasoned veteran of pharmaceutical discovery and development with over 35 years of combined experience in large Pharma and Biotech. He most recently served as President and CEO of Aya Biosciences. Prior to joining Aya Biosciences, Dr. Spada was co-founder, EVP of R&D and CSO of Conatus Pharmaceuticals until its merger with Histogen in May 2020. At Conatus, Dr. Spada was responsible for the management of all preclinical and early-stage development activities employed to support the company’s clinical assets. Prior to Conatus, Dr. Spada was the VP of Preclinical and Pharmaceutical Development at Idun Pharmaceuticals until its acquisition by Pfizer in 2005.
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HST 003 and HST 004 – In December 2022, we announced the termination of our Phase 1/2 clinical study of HST 003 to evaluate the safety and efficacy of human extracellular matrix (hECM) to repair cartilage defects in the knee in combination with a microfracture procedure for futility related to patient recruitment. In the third quarter of 2022, we announced suspending all IND enabling activities on our HST 004 program focused on spinal disc repair due to pipeline reprioritization.

Full-Year 2022 Financial Highlights

Twelve Months Ended December 31, 2022 and 2021

Revenues

For the years ended December 31, 2022 and 2021, we recognized license revenues of $3.8 million and $27 thousand, respectively. The increase in the current period is due to a one-time payment of $3.75 million received in March 2022 as consideration for execution of the Allergan Letter Agreement.

For the years ended December 31, 2022 and 2021, we recognized product revenues of $0 and $0.9 million, respectively. The product revenue for the year ended December 31, 2021 was due to a one-time unanticipated sale of CCM to Allergan, unrelated to the Allergan Agreements. As of March 31, 2021, all obligations of the Company related to the additional supply of CCM to Allergan under the Allergan Agreements had been completed.

For the years ended December 31, 2022 and 2021, we recognized grant revenue of $0 and $0.1 million, respectively. The grant revenue for 2021 is associated with a research and development grant awarded to the Company from the NSF. As of March 31, 2021, all work required by the Company under the grant has been completed.

Cost of product revenues for the years ended December 31, 2022 and 2021, we recognized $0 and $0.2 million, respectively, for cost of product sold to Allergan under the Allergan Agreements.

Research and development expenses for the years ended December 31, 2022 and 2021 were $5.0 million and $8.5 million, respectively. The decrease of $3.5 million was primarily due to decreases in personnel related expenses, the number of clinical and preclinical candidates in development and corresponding reduction of costs, partially offset by facility rent increases.

General and administrative expenses for the years ended December 31, 2022 and 2021 were $9.4 million and $7.8 million, respectively. The increase of $1.6 million was primarily due to increases in royalty expenses, legal fees, outside services, rent expenses and personnel expenses, partially offset by reductions in insurance and other administrative expenses.

Cash and cash equivalents as of December 31, 2022 were $12.1 million. Histogen believes that its existing cash and cash equivalents and cash inflow from operations will be sufficient to meet Histogen’s anticipated cash needs into January of 2024.

Cellectar Reports Financial Results for Year Ended 2022 and Provides a Corporate Update

On March 9, 2023 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted treatments for cancer, reported financial results for the year ended December 31, 2022 and provided a corporate update (Press release, Cellectar Biosciences, MAR 9, 2023, View Source [SID1234628411]).

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Fourth Quarter and Recent Corporate Highlights

Presented preclinical data on the CLR 12120 series of targeted alpha therapies (TATs) at the 13th Annual World ADC Conference. The presentation, entitled: "Novel Conjugates – Radiotherapies," given by Cellectar’s Chief Operating Officer, Jarrod Longcor, highlighted data demonstrating the versatility of the phospholipid ether (PLE) targeting platform and the potential of the company’s alpha emitting precision medicines, supporting further development.

· Announced that Cellectar, the Wisconsin Alumni Research Foundation, and Drs. Jamey Weichert and Anatoly Pinchuk have resolved a lawsuit filed by Cellectar in October 2021 in the United States District Court for the Western District of Wisconsin concerning employee contracts and intellectual property rights in certain intellectual property pertaining to the diagnosis and treatment of cancer. The parties cannot further comment on that resolution, except to note that (i) all claims against Drs. Weichert and Pinchuk have been voluntarily dismissed, and (ii) Cellectar has secured an irrevocable, non-exclusive license to the patents at issue in the lawsuit.

· Announced Shane Lea as chief commercial officer, overseeing all marketing and commercialization efforts for Cellectar as it prepares for data from its pivotal trial in Waldenstrom’s macroglobulinemia.

· Appointed Dr. Andrei Shustov as senior vice president, medical to lead and provide oversight on all aspects of the Company’s clinical development program, medical affairs, and medical communications.

· Announced that a patient with primary central nervous system lymphoma enrolled in its Phase 2 CLOVER-1 Trial demonstrated a complete response according to the 2005 Response Criteria for CNS Lymphoma with total resolution of the tumor on imaging studies.

"2022 was highly productive for Cellectar. We currently have 43 global sites actively recruiting patients for our pivotal study in Waldenstrom’s macroglobulinemia (WM). In parallel, our technology demonstrated consistently positive outcomes across multiple indications. At the American Society of Hematology (ASH) (Free ASH Whitepaper) Conference, we presented a 50% response rate achieved by iopofosine in post BCMA multiple myeloma patients and successfully concluded our phase 1a pediatric study and will initiate a phase 1b for High Grade Gliomas supported by a $2 million NCI grant. We also reported the extraordinary complete response in a patient with relapsed/refractory CNS lymphoma further demonstrating iopofosine’s ability to cross the blood/brain barrier and target cancer," said James Caruso, president and CEO of Cellectar. "Importantly, we strengthened our commercial leadership with several key hires, including Shane Lea, who has launched six new hematology/oncology products, and Dr. Andrei Shustov, who provides a wealth of hematology/oncology clinical as well as study experience

Fourth Quarter 2022 Financial Highlights

• Cash and Cash Equivalents: As of December 31, 2022, the company had cash and cash equivalents of $19.9 million, compared to $35.7 million as of December 31, 2021. Net cash used in operating activities during the year ended December 31, 2022 was approximately $25.2 million. The company believes its cash on hand is adequate to fund budgeted operations into the fourth quarter of 2023.

• Research and Development Expense: R&D expense for the year ended December 31, 2022 was approximately $19.2 million, compared to approximately $17.6 million for the year ended December 31, 2021. The overall increase in research and development expense was primarily a result of an increase in manufacturing and costs related to production sourcing and pre-clinical costs.

• General and Administrative Expense: G&A expense for the year ended December 31, 2022 was $9.5 million, compared to $6.5 million for the same period in 2021. The increase in G&A costs was primarily a result of increased professional fees, a portion of which were non-recurring, as well as travel and personnel costs.

• Net Loss: The net loss attributable to common stockholders for the year ended December 31, 2022 was ($28.6) million, or ($4.05) per share, compared to ($24.1) million, or ($4.35) per share, in the year ended December 31, 2021.

BridgeBio Pharma Announces Proposed Public Offering of Common Stock

On March 9, 2023 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported that it has commenced an underwritten public offering of $150 million of shares of its common stock (Press release, BridgeBio, MAR 9, 2023, View Source [SID1234628410]). BridgeBio also intends to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of shares of its common stock. All of the shares in the proposed offering are to be sold by BridgeBio.

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Goldman Sachs & Co. LLC, Evercore, and Morgan Stanley are acting as book-running managers for the proposed offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the proposed offering.

The shares of common stock are being offered by BridgeBio pursuant to an effective shelf registration statement on Form S-3ASR that was previously filed with the U.S. Securities and Exchange Commission (SEC) on July 7, 2020 and automatically became effective upon filing. The offering is being made only by means of a prospectus supplement and the accompanying prospectus that will form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and may be obtained, when available, from Goldman Sachs & Co. LLC, by mail at 200 West Street, New York, New York 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at [email protected]; Morgan Stanley & Co. LLC, by mail at 1585 Broadway, New York, New York 10036, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, or by email at [email protected]; or by accessing the SEC’s website at www.sec.gov. The final terms of the proposed offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Black Diamond Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update

On March 9, 2023 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology medicine company developing MasterKey therapies designed to overcome limitations of existing therapies by targeting families of oncogenic driver mutations in patients with genetically defined cancers, reported financial results for the fourth quarter and full year ended December 31, 2022, and provided a corporate update (Press release, Black Diamond Therapeutics, MAR 9, 2023, View Source [SID1234628409]).

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"We expect 2023 to be a catalyst rich year for Black Diamond following tremendous progress for our two novel MasterKey inhibitors, with BDTX-1535 continuing to advance through our Phase 1 clinical trial and BDTX-4933 meeting critical milestones to further progress toward the clinic. The clearance of the Investigational New Drug (IND) application for BDTX-4933 by the U.S. Food and Drug Administration (FDA) earlier this year marks our third IND allowance in three years and demonstrates the strength of our MAP drug discovery engine along with the expertise of our research and clinical teams. We are driven by the clear unmet need for next-generation precision medicines to treat cancers by overcoming resistance, minimizing on-target and wild-type mediated toxicities, and addressing brain disease. We’ve designed a robust pipeline of products with brain penetration properties to address these key challenges," said David Epstein, Ph.D., President and Chief Executive Officer of Black Diamond. "We anticipate a clinical update for BDTX-1535 in the second half of 2023. We also expect to initiate the Phase 1 clinical trial of BDTX-4933 in the first half of this year and to progress our FGFR program and another undisclosed program toward development candidate nominations in 2023. As we continue to mature our pipeline, we are acutely focused on delivering meaningful benefit to patients and we believe that our approach has the potential to strengthen the treatment landscape for genetically defined cancers."

Recent Developments & Upcoming Milestones:

BDTX-1535:

BDTX-1535, an epidermal growth factor receptor (EGFR) MasterKey inhibitor, is being developed to treat genetically defined cancer in patients whose tumors are positive for EGFR MasterKey mutations in glioblastoma multiforme (GBM), as well as in non-small cell lung cancer (NSCLC). BDTX-1535 is fourth generation EGFR inhibitor designed to be irreversible (covalent) and brain-penetrant, and is unique in that it targets a family of driver mutations in addition to acquired resistance mutations arising from the use of third generation EGFR inhibitors to treat EGFR-positive NSCLC.
In April 2022, Black Diamond dosed the first patient in its Phase 1 global clinical trial of BDTX-1535 for the treatment of NSCLC, including in patients with brain metastases, and GBM. The dose-escalation portion of the Phase 1 clinical trial is actively recruiting and enrolling patients, and the Company remains on track to provide a clinical update on BDTX-1535 in the second half of 2023.
In October 2022, Black Diamond presented two posters at the 34th European Organisation for Research and Treatment of Cancer—National Cancer Institute—American Association for Cancer Research (EORTC-NCI-AACR) (Free EORTC-NCI-AACR Whitepaper) Symposium in Barcelona, Spain, with new preclinical data. The Company detailed anti-tumor activity of BDTX-1535 in preclinical models and highlighted that BDTX-1535 is designed using Black Diamond’s proprietary MAP drug discovery engine to target EGFR mutations of both NSCLC and GBM. Black Diamond also showcased BDTX-1535’s ability to achieve potent anti-tumor activity against EGFR alterations and amplification across preclinical models of NSCLC classical driver, intrinsic resistance and acquired resistance EGFR mutations and GBM, including intercranial patient derived xenograft models.
BDTX-4933:

BDTX-4933 is designed as a brain-penetrant, small molecule MasterKey reversible oral inhibitor of oncogenic BRAF Class I, II and III active RAF dimers promoted by upstream oncogenic alterations expressed by human cancers, while also avoiding paradoxical activation.
In the first quarter of 2023, Black Diamond received allowance of its IND application from the FDA. The Company expects to initiate a Phase 1 clinical trial of BDTX-4933 in patients with tumors harboring all-class BRAF or RAS mutations in the first half of 2023.
In October 2022, Black Diamond presented a poster at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium highlighting preclinical data showing BDTX-4933 to be a brain-penetrant RAF MasterKey inhibitor active against tumors that are driven by a Class I, II, or III BRAF mutation, as well as by other oncogenic RAS pathway alterations that promote constitutive RAF dimer activation. BDTX-4933 demonstrated potent, on-target inhibition of the RAF-MEK-ERK signaling pathway and anti-tumor activity in multiple preclinical models, including intracranial tumor models.
Discovery-Stage Pipeline and MAP Drug Discovery Engine:

Black Diamond continues to leverage its MAP drug discovery engine to advance its discovery-stage pipeline to bring therapies to underserved patients. Black Diamond anticipates progressing its fibroblast growth factor receptor (FGFR) program towards development candidate nomination and nomination of a development candidate against an undisclosed target in 2023.
Corporate:

In June 2022, Black Diamond appointed Sergey Yurasov, M.D., Ph.D., as its Chief Medical Officer, bringing over 25 years of oncology drug development experience and regulatory expertise.
In December 2022, Black Diamond announced that existing board member, Mark Velleca, M.D., Ph.D., was appointed to succeed Robert (Bob) A. Ingram as the Chairman of the Board of Directors.
In December 2022, Black Diamond announced the spinout of Launchpad Therapeutics, Inc. (Launchpad), an antibody-focused precision oncology company incorporating Black Diamond’s undisclosed early discovery stage antibody programs enabled by the MAP drug discovery engine. In conjunction with the transaction, a $30 million Series A financing was co-led by Versant Ventures and New Enterprise Associates (NEA) to fund discovery and development activities of the new company. Black Diamond retains a minority equity interest in Launchpad to enable further value creation.
Financial Highlights

Cash Position: Black Diamond ended 2022 with approximately $122.8 million in cash, cash equivalents, and investments compared to $209.8 million as of December 31, 2021. Net cash used in operations was $85.1 million for the year ended December 31, 2022 compared to $100.1 million for the year ended December 31, 2021.
Research and Development Expenses: Research and development (R&D) expenses were $14.6 million for the fourth quarter of 2022, compared to $19.7 million for the same period in 2021. Research and development expenses were $64.4 million for the year ended December 31, 2022, compared to $96.8 million for the year ended December 31, 2021. The decrease in R&D expenses was primarily due to reduced clinical trial activities stemming from the discontinuation of the development of BDTX-189 to focus on upcoming milestones for our pipeline programs, BDTX-1535 and BDTX-4933.
General and Administrative Expenses: General and administrative (G&A) expenses were $7.2 million for the fourth quarter of 2022, compared to $6.4 million for the same period in 2021, and $28.4 million for the year ended December 31, 2022, compared to $30.0 million for the year ended December 31, 2021. The decrease in G&A expenses was primarily due to a decrease in legal and other professional fees.
Net Loss: Net loss for the fourth quarter of 2022 was $21.1 million, as compared to $25.9 million for the same period in 2021. Net loss for the year ended December 31, 2022 was $91.2 million compared to $125.6 million for the year ended December 31, 2021.
Financial Guidance

Black Diamond ended 2022 with approximately $122.8 million in cash, cash equivalents and investments, which the Company believes is sufficient to fund its anticipated operating expenses and capital expenditure requirements into the third quarter of 2024.