On March 27, 2024 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported a business update and announces full year 2023 financial results (Press release, Evaxion Biotech, MAR 27, 2024, View Source [SID1234641494]).

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Christian Kanstrup, Chief Executive Officer at Evaxion, commented: "We have made significant progress in our business and our financing strategies in recent months, notably the successful closing of our bridge financing round towards the end of 2023 and a subsequent public offering in early February 2024. We are very pleased with the MSD GHI participation in both financing rounds, following which we now have cash at hand into Q1 2025."

Christian continues: "With our refined strategy centered around AI-Immunology focusing on value realization via Targets, Pipeline and Responders based upon a muti-partner approach, we are enthusiastic about the prospects this brings for 2024. Further, we are executing to progress our ambition to fund our projected $14 million operational cash burn for 2024 through revenue generated from our business development activities."

Business Updates Since Last Quarterly Update

In January 2024, Evaxion announced it had commenced developing tailored novel cancer vaccines using the AI-Immunology platform. The initiative involves a new category of AI-identified tumor vaccine targets, ERVs, and aims to obtain preclinical Proof-of-Concept by the second half of 2024. With the AI-Immunology discovered novel cancer targets, designing personalized and precision vaccines may become feasible. This approach holds the potential to provide treatment solutions for cancer patients who typically do not respond to cancer immunotherapy.

In February 2024, the initial phases of an ongoing vaccine collaboration with MSD were successfully completed. The collaboration was initiated in September 2023, and in February 2024 MSD was revealed as the pharma partner for the EVX-B3 vaccine collaboration in connection with the collaboration update. The project aims to develop a vaccine against a bacterial pathogen responsible for a pressing global medical issue, lacking preventive or curative options.

Evaxion hosted an R&D Day on March 19, 2024, providing deeper insights into the validated and differentiated AI-Immunology platform. Key takeaway messages from the day were:

The proprietary AI-Immunology platform brings the potential for a new era in vaccine discovery, design and development using advanced AI and machine learning technologies.
AI-Immunology outcompetes standard vaccine target discovery approaches and holds the promise of addressing serious unmet needs.
With a unique modular architecture, AI-Immunology is scalable and adaptable towards partner needs.
The potential of AI-Immunology is validated by established partnerships, including the ongoing vaccine collaboration with MSD.
In the initial months of 2024, we showcased our differentiated AI-Immunology platform for vaccine target discovery, design and development, alongside our refined strategy for value generation, at the following conferences:

January 8-11: CEO Christian Kanstrup attended the 42nd annual J.P. Morgan Healthcare Conference.
February 27: Chief AI Officer, Andreas Holm Mattsson, participated in a panel discussion at the Sachs Associates 5th Annual European HealthTech CEO Forum.
February 28: CEO Christian Kanstrup presented the Sachs Associates 17th Annual European Life Sciences CEO Forum.
March 7: VP of AI & Innovation, Jens Kringelum, presented the 5th Biologics World Nordics 2024 Conference.
March 7: CEO Christian Kanstrup and CSO Birgitte Rønø participated in a fireside chat at the H.C. Wainwright 1st Annual Artificial Intelligence Based Drug Discovery & Development Virtual Conference.
March 7-8: Senior Project Manager, Immuno-oncology, Daniela Kleine-Kohlbrecher, presented at the 8th Annual MarketsandMarkets Next-Gen Immuno-Oncology Conference.

Anticipated 2024 Milestones
Milestones Target
EVX-B1 Conclusion of final MTA study with potential partner Q1 2024
AI-Immunology Launch of EDEN model version 5.0 Mid 2024
EVX-B2-mRNA EVX-B2-mRNA preclinical Proof-of-Concept obtained Q3 2024
EVX-01 Phase 2 one-year readout Q3 2024
EVX-B3 Conclusion of target discovery and validation work in collaboration with MSD (tradename of Merck & Co., Inc., Rahway, NJ, USA) H2 2024
Precision ERV cancer vaccines Preclinical Proof-of-Concept obtained H2 2024
Funding Ambition for full year 2024 is to generate business development income equal to 2024 cash burn (excluding financing activities) of $14 million*
* No assurances can be made that we will generate such business development income
Full Year 2023 Financial Results

Cash position: As of December 31, 2023, cash and cash equivalents were $5.6 million compared to $13.2 as of December 31, 2022. Cash position was strengthened by a private placement with gross proceeds of $5.3 million, which closed on December 21, 2023. The private placement included participation from existing and new shareholders, with the largest new shareholder being MSD Global Health Innovation Fund (MSD GHI), a corporate venture capital arm of Merck & Co., Inc., Rahway, NJ, USA, accounting for some 25% of the total aggregate offering amount. Further, the Private Placement included significant participation by all members of the Company’s management and the Company’s board of directors. After a public offering in February 2024, resulting in net proceeds of $12.7 million, we expect that our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements into February 2025. If all pre-funded warrants included in the public offering are exercised, we expect necessary funding will be in place into April 2025.
Research and Development expenses were $11.9 million for the year ended December 31, 2023, as compared to $17.1 million for the year ended December 31, 2022. The decrease was primarily due to a reduction in external costs.
General and Administrative expenses were $10.4 million for the year ended December 31, 2023, as compared to $8.2 million for the year ended December 31, 2022. The increase was primarily due to an increase in external costs in connection with funding activities.
Net loss was $22.1 million for the year ended December 31, 2023, or ($0.81) per basic and diluted share, as compared to a net loss of $23.2 million, or ($0.98) per basic and diluted share for the year ended December 31, 2022.
Based on the Company’s current cash position, with an estimated cash runway into February 2025 and the need for further funding, it is the assessment of management that there exists substantial doubt about the Company’s ability to continue as a going concern.

Webcast

Evaxion will host a Business Update and Full Year 2023 Financial Results webcast on Tuesday, April 2, at 15:00 CEST / 9:00 a.m. EDT. To join the conference call, listen to the presentation and ask verbal questions, please register in advance via this link to receive the dial-in telephone numbers and a unique pin code. The call can be accessed 15 minutes prior to the start of the live event. To join the webcast, please click on this link. The webcast recording will be available shortly after the event.

Evaxion Biotech A/S
Consolidated Statement of Financial Position Data (Audited)
(USD in thousands)
Dec 31,
2023 Dec 31,
2022

Cash and cash equivalents $ 5,583 $ 13,184
Total assets 12,889 22,025
Total liabilities 17,618 13,722
Share capital 5,899 3,886
Other reserves 97,342 90,262
Accumulated deficit (107,970) (85,845)
Total equity (4,729) 8,303
Total liabilities and equity $ 12,889 $ 22,025

Evaxion Biotech A/S
Consolidated Statement of Comprehensive Loss Data (Audited)
(USD in thousands, except per share data)

Three Months Ended
December 31,
Twelve Months Ended
December 31,
2023 2022 2023 2022


Revenue $ 73 $ — $ 73 $ —
Research and development (2,298) (4,073) (11,916) $ (17,056)
General and administrative (2,138) (2,452) (10,354) (8,208)

Operating loss (4,363) (6,525) (22,197) (25,264)
Finance income 559 70 963 2,831
Finance expenses (895) (590) (1,681) (1,508)

Net loss before tax $ (4,699) $ (7,045) $ (22,915) $ (23,941)

Income tax benefiT 177 173 790 772

Net loss for the period $ (4,522) $ (6,872) $ (22,125) $ (23,169)

Net loss attributable to shareholders of Evaxion Biotech A/S $ (4,522) $ (6,872) $ (22,125) $ (23,169)

Loss per share – basic and diluted $ (0.16) $ (0.29) $ (0.81) $ (0.98)
Number of shares used for calculation (basic and diluted) 29,061,036 24,082,247 27,335,829 23,638,685

On March 27, 2024 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported business updates and reported financial results for the fiscal quarter and full year ended December 31, 2023 (Press release, Erasca, MAR 27, 2024, View Source [SID1234641493]).

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"In 2023, our three clinical candidates reached important clinical and regulatory milestones, including gaining regulatory clarity to allow us to begin our global Phase 3 study for naporafenib, demonstrating encouraging therapeutic potential for ERAS-007, and achieving Fast Track Designation (FTD) for each of naporafenib in combination with trametinib, and ERAS-801," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "For ERAS-007, we presented promising preliminary clinical activity at ASCO (Free ASCO Whitepaper) 2023 in combination with encorafenib and cetuximab (EC) in EC-naïve patients with BRAF-mutant (BRAFm) colorectal cancer (CRC), and we expect to share additional data in the first half of 2024. We also advanced our central nervous system (CNS)-penetrant EGFR inhibitor ERAS-801 to further characterize activity in patients with EGFR-amplified recurrent glioblastoma (GBM), which represents approximately 85% of all patients with EGFR-altered GBM."

Dr. Lim continued, "In 2024, we have several key catalysts for naporafenib, which is currently being developed in two trials, SEACRAFT-1, which is ongoing in patients with RAS Q61X tissue agnostic solid tumors, and SEACRAFT-2, which is expected to initiate in the first half of 2024 in patients with NRAS-mutant (NRASm) melanoma. We are excited by our recent pooled analysis of the median overall survival (mOS) data from the Phase 1b and Phase 2 trials for naporafenib plus trametinib in patients with NRASm melanoma. These data showed an mOS of approximately 13-14 months, which nearly doubles the mOS observed for historical control observations for cytotoxic chemotherapy and single agent MEK inhibitors in patients similar to the SEACRAFT-2 patient population."

Research and Development (R&D) Highlights

•
Achieved Key Milestones for Naporafenib and ERAS-801 and Prioritized Pipeline: In November 2023, Erasca gained alignment with US and EU health authorities for the pivotal Phase 3 SEACRAFT-2 trial design that provided clarity on a registrational pathway for naporafenib plus trametinib in patients with NRASm melanoma. Erasca also completed dose escalation and identified a maximum tolerated dose (MTD) for ERAS-801, supporting the ongoing enrollment of efficacy signal-seeking expansion cohorts in patients with EGFR-altered GBM. In addition, a strategic pipeline prioritization
Exhibit 99.1

sharpened Erasca’s focus on existing programs that we believe have the highest probability of success for patients.

•
Analysis of mOS Data for Naporafenib: A pooled analysis of patients with NRASm melanoma dosed with the combination of naporafenib and trametinib at two different doses across two different trials (Phase 1b and Phase 2) showed an mOS of 13.0 and 14.1 months, respectively. The pooled dataset at each dose compares favorably relative to historical benchmarks.

Corporate Highlights

•
Granted Fast Track Designation for Naporafenib: In December 2023, the United States Food and Drug Administration (FDA) granted FTD to naporafenib in combination with trametinib (MEKINIST) for the treatment of adult patients with unresectable or metastatic melanoma who have progressed on, or are intolerant to, an anti‑programmed death-1 (ligand 1) (PD‑(L)1)-based regimen, and whose tumors contain an NRAS mutation.
•
Entered into two CTCSAs with Novartis for Naporafenib Combination in SEACRAFT-1 and SEACRAFT-2: In February 2024, Erasca announced two clinical trial collaboration and supply agreements (CTCSAs) with Novartis pursuant to which Novartis will provide its MEK inhibitor trametinib at no cost to Erasca in connection with two clinical trials evaluating naporafenib in combination with trametinib for the treatment of patients with RAS Q61X solid tumors as part of the ongoing Phase 1b SEACRAFT-1 trial, and for the treatment of patients with previously treated NRASm unresectable or metastatic melanoma as part of the planned randomized pivotal Phase 3 SEACRAFT-2 trial.

Key Upcoming Anticipated Milestones

•
SEACRAFT-1: Phase 1b trial for naporafenib (pan-RAF inhibitor) plus trametinib in patients with RAS Q61X tissue agnostic solid tumors
o
Initial Phase 1b combination data expected between the second and fourth quarters of 2024
•
SEACRAFT-2: Randomized pivotal Phase 3 trial for naporafenib plus trametinib in patients with NRASm melanoma
o
Phase 3 trial initiation expected in the first half of 2024
•
HERKULES-3: Phase 1b trial for ERAS-007 (ERK inhibitor) plus encorafenib (BRAFTOVI) + cetuximab (ERBITUX) (EC) in EC-naïve patients with BRAFm CRC
o
Phase 1b combination data expected in the first half of 2024
•
THUNDERBBOLT-1: Phase 1 trial for ERAS-801 (CNS-penetrant EGFR inhibitor) in patients with GBM
o
Initial Phase 1 monotherapy data expected in 2024

Fourth Quarter and Full Year 2023 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $322.0 million as of December 31, 2023, compared to $435.6 million as of December 31, 2022.

Research and Development (R&D) Expenses: R&D expenses were $24.8 million for the quarter ended December 31, 2023, compared to $29.4 million for the quarter ended December 31, 2022. The decrease was primarily driven by decreases in expenses incurred in connection with clinical trials, preclinical studies, discovery activities, and outsourced services and consulting fees, as a result of pipeline prioritization. R&D expenses were $103.8 million for the full year ended December 31, 2023, compared to $112.5 million for the full year ended December 31, 2022. The full year ended December 31, 2022 also included $102.0 million of in-process R&D expenses related to upfront and milestone payments and stock issuances under certain of our asset acquisition and license agreements.

General and Administrative (G&A) Expenses: G&A expenses were $9.1 million for the quarter ended December 31, 2023, compared to $8.7 million for the quarter ended December 31, 2022. The increase was primarily driven by personnel costs, including stock-based compensation, partially offset by decreases in insurance costs and legal fees. G&A expenses were $37.7 million for the full year ended December 31, 2023, compared to $33.0 million for the full year ended December 31, 2022.

Net Loss: Net loss was $29.7 million for the quarter ended December 31, 2023, compared to $135.3 million, inclusive of the $100.0 million of in-process R&D expenses recorded in connection with the Novartis license agreement, for the quarter ended December 31, 2022. For the full year ended December 31, 2023, Erasca reported a net loss of $125.0 million, or $(0.83) per basic and diluted share, compared to a net loss of $242.8 million, inclusive of the $100.0 million of in-process R&D expenses recorded in connection with the Novartis license agreement, or $(1.99) per basic and diluted share, for the full year ended December 31, 2022.

Conference Call and Webcast Information

Erasca will hold a conference call and webcast on Thursday, March 28, 2024 at 8:30 am ET. The webcast link for the conference call can be found here. The dial-in number is 1-877-407-0792 (U.S./Canada) or 1-201-689-8263 (international). The conference ID for all callers is 13745382. The live webcast and replay may be accessed by visiting Erasca’s website at Erasca.com/events.

On March 27, 2024 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases, reported that management will be participating in a fireside chat and investor meetings at the Needham 23rd Annual Healthcare Conference, being held virtually on April 8 – 11, 2024 (Press release, CorMedix, MAR 27, 2024, View Source [SID1234641492]).

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Needham 23rd Annual Healthcare Conference
Date: Monday, April 8, 2024
Time: 11:00 a.m. EDT
Format: Fireside Chat
Webcast: Click here

A replay of the fireside chat will also be available in the "Events and Presentations" page on the investor relations portion of the Company’s website at: www.cormedix.com

On March 27, 2024 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on February 20, 2024, for FoundationOneCDx Cancer Genomic Profile to be used as a companion diagnostic to identify patients eligible for AstraZeneca K.K.’s AKT inhibitor, Truqap tablets (generic name: capivasertib), in combination with Faslodex (generic name: fulvestrant) for patients with advanced unresectable or recurrent HR-positive, HER2-negative breast cancer with specific PIK3CA, AKT1 or PTEN alterations, which was approved by the MHLW on March 26, 2024 (Press release, Chugai, MAR 27, 2024, View Source [SID1234641491]).

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"We are very pleased that FoundationOne CDx Cancer Genomic Profile was approved as a companion diagnostic for capivasertib, a cancer agent for three alterations (PIK3CA, AKT1 and PTEN) in breast cancer. By using this test as a companion diagnostic, approximately half of patients1,2,3 with advanced HR-positive, HER2-negative breast cancer will be able to consider a more appropriate treatment option. We will continue to contribute to the advancement of personalized healthcare based on the patient’s genetic mutation status by expanding companion diagnostics," said Chugai’s President and CEO, Dr. Osamu Okuda.

This approval enables the detection of PIK3CA, AKT1 and PTEN alterations using the FoundationOne CDx Cancer Genomic Profile to guide the decision to use capivasertib in combination with faslodex for advanced HR-positive, HER2-negative breast cancer patients with tumors harbouring these alterations. The efficacy and safety of the combination therapy of capivasertib and fulvestrant* in this specific form of breast cancer was evaluated in the global phase III CAPItello-291 study4. AstraZeneca K.K. obtained approval from the MHLW on March 26, 2024.

As a leading company in the field of oncology, Chugai is committed to realizing advanced personalized healthcare in oncology and contributing to patients through the expansion of Comprehensive Genome Profile.

* Fulvestrant is the generic name of the breast cancer agent "FASLODEX" for which AstraZeneca K.K. has manufacturing and marketing approval.

Approval information The underlined and bolded part has been newly added.

Intended uses or indications

The Product is used for comprehensive genomic profiling of tumor tissues in patients with solid cancers.
The Product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.
Alterations Cancer type Relevant drugs
Activated EGFR alterations Non-small cell lung cancer (NSCLC) afatinib dimaleate, erlotinib hydrochloride, gefitinib, osimertinib mesylate, dacomitinib hydrate
EGFR exon 20 T790M alterations osimertinib mesylate
ALK fusion genes alectinib hydrochloride, crizotinib, ceritinib, brigatinib
ROS1 fusion genes entrectinib
MET exon 14 skipping alterations capmatinib hydrochloride hydrate
BRAF V600E and V600K alterations Malignant melanoma dabrafenib mesylate, trametinib dimethyl sulfoxide, vemurafenib, encorafenib, binimetinib
ERBB2 copy number alterations (HER2 gene amplification positive) Breast cancer trastuzumab (genetical recombination)
AKT1 alterations capivasertib
PIK3CA alterations
PTEN alterations
KRAS/NRAS wild-type Colorectal cancer cetuximab (genetical recombination), panitumumab (genetical recombination)
Microsatellite instability high nivolumab (genetical recombination)
Microsatellite instability high Solid tumors pembrolizumab (genetical recombination)
Tumor mutational burden high pembrolizumab (genetical recombination)
NTRK1/2/3 fusion gene entrectinib, larotrectinib sulfate
RET fusion genes selpercatinib
BRCA1/2 alterations Ovarian cancer olaparib
BRCA1/2 alterations Prostate cancer olaparib, talazoparib tosilate
FGFR2 fusion genes Biliary tract cancer pemigatinib
About FoundationOne CDx Cancer Genomic Profile
Developed by Foundation Medicine Inc., FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The program is available as a companion diagnostic for multiple molecular-targeted drugs approved in Japan.

Trademarks used or mentioned in this release are protected by laws.

On March 27, 2024 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, reported financial results for the year ended December 31, 2023, and provided a corporate update (Press release, Cellectar Biosciences, MAR 27, 2024, View Source [SID1234641490]).

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"2023 was a year of significant progress for Cellectar, culminating in the January announcement of the positive data from our pivotal study of iopofosine I 131 in Waldenstrom’s macroglobulinemia," said James Caruso, president, and CEO of Cellectar. "We continue to focus on the preparation of our NDA, which we plan to submit in the second half of 2024 and in parallel request accelerated approval, which if granted, would provide a six-month review period for the NDA. Our data in WM is truly impressive and we look forward to providing this meaningful new therapeutic for patients in a disease with limited treatment options."

Fourth Quarter and Recent Corporate Highlights

· Announced positive topline data achieving its primary endpoint in its CLOVER WaM pivotal study, evaluating iopofosine I 131, a potentially first-in-class, targeted radiotherapy candidate for the treatment of relapsed/refractory Waldenstrom’s macroglobulinemia (WM) patients that have received at least two prior lines of therapy, including Bruton tyrosine kinase inhibitors (BTKi). CLOVER WaM is the largest study to date in relapsed or refractory WM patients post-BTKi therapy and represents the most refractory population ever tested in clinical studies based upon a review of published literature. The CLOVER WaM study met its primary endpoint with a major response rate (MRR) of 61% (95% confidence interval [44.50%, 75.80%, two-sided p value < 0.0001]). The overall response rate (ORR) in evaluable patients was 75.6%, and 100% of patients experienced disease control. Responses were durable, with median duration of response not reached and 76% of patients remaining progression free at a median follow-up of eight months. Notably, iopofosine monotherapy achieved a 7.3% complete remission (CR) rate in this highly refractory WM population. A study data update is planned for Q2 of 2024.

· Reported a Complete Remission rate of 64% and Overall Response Rate of 73% in highly refractory patients in an Investigator Initiated Phase I Study of Iopofosine in Combination with External Beam Radiotherapy in Recurrent Head and Neck Cancer. In addition to the High Rate of Complete Remission Durability of clinical activity achieved a 67% Overall Survival and 42% Progression Free Survival at One Year.

· Announced that iopofosine I 131 demonstrated a pathological response with complete clonal clearance in a relapsed/refractory Waldenstrom’s macroglobulinemia (WM) patient with CNS involvement, also known as Bing-Neel Syndrome (BNS), enrolled in its Phase 2b CLOVER WaM pivotal trial.

· Enrolled the first patient in the company’s Phase 1b clinical study of iopofosine I 131 in pediatric high-grade gliomas (pHGG). The open-label study will evaluate efficacy, safety, and tolerability assessing two dosing regimens to identify the optimal recommended dose and schedule of iopofosine I 131 in pHGG patients for a Phase 2 study. The study is supported by a $2 million Fast Track SBIR grant from the National Institute of Health’s National Cancer Institute (NCI), which was awarded based in part on the promising Phase 1a trial data.

· Announced promising preclinical data for its proprietary novel alpha-emitting phospholipid radiotherapeutic conjugate, CLR 121255 (255Ac-CLR 121225) an actinium-labeled phospholipid ether (PLE), in pancreatic cancer models. The development of this compound expands the company’s clinical pipeline of PLE cancer targeting compounds to include targeted alpha therapies (TATs).

· Announced strategic partnerships with leading physician-led, community-based oncology networks Florida Cancer Specialists and American Oncology Network (AON) to advance the treatment of WM in the community setting.

· Announced a new licensing agreement with the Wisconsin Alumni Research Foundation (WARF) for intellectual property that was the result of collaborative research conducted at the University of Wisconsin-Madison (UW) with iopofosine I 131 in pediatric cancers. Under terms of the agreement, Cellectar has an exclusive license to develop and commercialize iopofosine in various pediatric solid cancers, such as high-grade glioma, neuroblastoma, and sarcoma.

· Expanded the Intellectual Property protection for its PDC Platform to deliver flavaglines as targeted anticancer payloads. The company received the Notice of Allowance for the patent entitled, "Phospholipid-flavagline conjugates and methods of using the same for targeted cancer therapy," from the Japanese, Chinese, Eurasian, Brazilian, and Mexican patent authorities. These patent allowances in key global regions follow prior allowances for the same patent in the U.S., Europe, Australia, and Canada.

· Announced the Tranche A warrants issued as part of the private placement announced in September 2023 were fully exercised. All participants in the previous financing, led by Rosalind Advisors, exercised their warrants with gross proceeds totaling approximately $44.1 million.

2023 Financial Highlights

· Cash and Cash Equivalents: As of December 31, 2023, the company had cash and cash equivalents of $9.6 million, compared to $19.9 million as of December 31, 2022. The decrease in cash was primarily a result of research and development expenses, and general and administrative expenses. Net cash used in operating activities during the twelve months ended December 31, 2023, was approximately $32.4 million. Net cash proceeds from the issuance of common stock, preferred stock, and warrants during 2023 was approximately $22.9 million. We believe our cash balance as of December 31, 2023, in combination with the funds generated by the warrants exercised by investors in January 2024 is adequate to fund our basic budgeted operations into the fourth quarter of 2024.

· Research and Development Expense: R&D expense for the year ended December 31, 2023, was approximately $28.2 million, compared to approximately $19.2 million for the year ended December 31, 2022. The overall increase in R&D expense was primarily a result of an increase in manufacturing and related costs related to greater production sourcing necessary to support clinical trials and establish commercial production capabilities.

· General and Administrative Expense: G&A expense for the year ended December 31, 2023, was $10.7 million, compared to $9.6 million for the year ended December 31, 2022. The increase in G&A costs was primarily a result of an increase in personnel costs partially offset by a reduction in professional fees.

· Net Loss: The net loss attributable to common stockholders for the year ended December 31, 2023, was ($38.0) million, or $(3.11) per share, compared to $(28.6) million, or ($4.05) per share in the year ended December 31, 2022.

Conference call & Webcast Details

Cellectar management will host a conference call for investors today, March 14, 2024, beginning at 8:30 am Eastern Time to discuss these results and answer questions. Stockholders and other interested parties may participate in the conference call by dialing 1-888-886-7786 (in the U.S.) or 1-416-764-8658 (outside the U.S.). The call will be available via webcast by clicking HERE or on the Events page of the company’s website.