On February 14, 2024 Adaptive Biotechnologies Corporation ("Adaptive Biotechnologies") (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, reported financial results for the fourth quarter and full year ended December 31, 2023 (Press release, Adaptive Biotechnologies, FEB 14, 2024, View Source [SID1234640079]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"2023 was a year of execution for MRD and strategic evolution for IM. The MRD business ended the year with 53% growth in clonoSEQ tests delivered and IM achieved key target and drug discovery milestones in cancer and autoimmune disorders," said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. "2024 is off to a strong start. As momentum continues to build in both MRD and IM, we look forward to maximizing the value of each of these distinct opportunities for our patients and shareholders."

Recent Highlights

•
Revenue for the fourth quarter and full year 2023 was $45.8 million and $170.3 million, respectively. The MRD business, which contributed over 60% of revenue, grew 9% and 18% over the corresponding periods. This growth was more than offset by an expected reduction in GNE amortization in the IM business.
•
clonoSEQ test volume increased 49% to 15,680 tests delivered in the fourth quarter of 2023, compared to the fourth quarter 2022 and ended the year with 56,496 tests delivered, up 53% versus 2022.
•
Signed partnership with Flatiron Health, a leading provider of EHR software and services for community oncology, to integrate the clonoSEQ Assay into Flatiron’s OncoEMR system.
•
IND secured for the first cell therapy product candidate; built regulated process workflow for the fully personalized cell therapy program.
•
Strategic review continues with the goal of maximizing the value of the MRD and Immune Medicine businesses.
Fourth Quarter 2023 Financial Results

Revenue was $45.8 million for the quarter ended December 31, 2023, representing a 17% decrease from the fourth quarter in the prior year. MRD revenue was $30.8 million for the quarter, representing a 9% increase from the fourth quarter in the prior year. Immune Medicine revenue was $15.0 million for the quarter, representing a 45% decrease from the fourth quarter in the prior year.

Operating expenses, which include a $25.4 million lease impairment charge, were $116.9 million for the fourth quarter of 2023, compared to $94.4 million in the fourth quarter of the prior year, representing an increase of 24%. Excluding the impact of the lease impairment charge, operating expenses for the fourth quarter of 2023 decreased 3% compared to the fourth quarter of the prior year. Interest and other income, net was $4.6 million for the fourth quarter of 2023, compared to $2.6 million in the fourth quarter of the prior year. Interest expense from our revenue interest purchase agreement was $3.0 million for the fourth quarter of 2023, compared to $3.6 million in the fourth quarter of the prior year.

Net loss was $69.5 million for the fourth quarter of 2023, compared to $40.2 million for the same period in 2022.

Adjusted EBITDA (non-GAAP) was a loss of $24.7 million for the fourth quarter of 2023, compared to a loss of $19.6 million for the fourth quarter of the prior year.

Full Year 2023 Financial Results

Revenue was $170.3 million for the year ended December 31, 2023, representing an 8% decrease from the prior year. MRD revenue was $102.7 million in 2023, representing an 18% increase from the prior year. Immune Medicine revenue was $67.5 million in 2023, representing a 31% decrease from 2022.

Operating expenses for 2023, which include a $25.4 million lease impairment charge, were $397.3 million, compared to $385.5 million for 2022, representing an increase of 3%. Excluding the impact of the lease impairment charge, operating expenses for 2023 decreased 4% compared to the prior year. Interest and other income, net was $15.5 million in 2023, compared to $4.1 million in 2022. Interest expense from our revenue interest purchase agreement was $13.8 million in 2023, compared to $4.2 million in 2022.

Net loss was $225.3 million in 2023, compared to $200.4 million in 2022.

Adjusted EBITDA (non-GAAP) was a loss of $116.4 million for 2023, compared to a loss of $121.6 million in the prior year.

Cash, cash equivalents and marketable securities was $346.4 million as of December 31, 2023.

2024 Financial Guidance

Adaptive Biotechnologies expects full year revenue for the MRD business to be between $130 million and $140 million. No revenue guidance is provided for the Immune Medicine business.

We expect full year operating expenses, including cost of revenue, to be between $360 million and $370 million.

Management will provide further details on the outlook during the conference call.

Webcast and Conference Call Information

Adaptive Biotechnologies will host a conference call to discuss its fourth quarter and full year 2023 financial results after market close on Wednesday, February 14, 2024 at 4:30 PM Eastern Time. The conference call can be accessed at View Source The webcast will be archived and available for replay at least 90 days after the event.

On February 13, 2024 Leidos Holdings, Inc. (NYSE: LDOS), a FORTUNE 500 innovation company, reported financial results for the fourth quarter and fiscal year 2023 (Press release, Leidos, FEB 13, 2024, View Source [SID1234643764]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Tom Bell, Leidos Chief Executive Officer, commented: "With a strong finish to the year, Leidos delivered on all of its financial commitments. Record top- and bottom-line performance enabled us to exceed the high end of the guidance ranges that we set last quarter for all metrics. Our financial performance over the last three quarters demonstrates how strongly the team has enhanced its focus on cost controls and cash generation and committed to a "promises made, promises kept" culture. 2024 is going to be another busy and exciting year for Leidos, as we capitalize on our leaner, more focused organizational structure and chart our path to our second decade of growth."

Summary Operating Results

(in millions, except margin and per
share data)

Three Months Ended

Year Ended

December 29, 2023

December 30, 2022

December 29, 2023

December 30, 2022

Revenues

$ 3,980

$ 3,697

$ 15,438

$ 14,396

Net income

$ 230

$ 180

$ 208

$ 693

Net income margin

5.8 %

4.9 %

1.3 %

4.8 %

Diluted earnings per share (EPS)

$ 1.66

$ 1.28

$ 1.44

$ 4.96

Non-GAAP Measures*:

Adjusted EBITDA

$ 452

$ 397

$ 1,669

$ 1,493

Adjusted EBITDA margin

11.4 %

10.7 %

10.8 %

10.4 %

Non-GAAP diluted EPS

$ 1.99

$ 1.83

$ 7.30

$ 6.60

*Non-GAAP financial measures should be considered in addition to, but not as a substitute for, the information provided in accordance with GAAP. Management believes that these non-GAAP measures provide another measure of Leidos’ results of operations and financial condition, including its ability to comply with financial covenants in our debt agreements. See Non-GAAP Financial Measures at the end of this press release for more information and a reconciliation of these non-GAAP measures to the most directly comparable GAAP measures.

Revenues were $3.98 billion for the quarter and $15.44 billion for the year, up 8% and 7% over the comparable 2022 periods, respectively. For the quarter and the year, revenues grew year-over-year due to increased demand across all customer segments, especially within the Health segment.

For the quarter, net income was $230 million, or $1.66 per diluted share, up 28% and 30%, respectively, compared to the fourth quarter of fiscal year 2022. Net income margin was 5.8%, up 90 basis points year-over-year. Adjusted EBITDA was $452 million (11.4% margin), up 14% over the fourth quarter of 2022. Non-GAAP net income was $276 million, which generated non-GAAP diluted EPS of $1.99. Non-GAAP net income was up 8%, and non-GAAP diluted EPS was up 9% compared to the fourth quarter of fiscal year 2022.

For the year, net income was $208 million, or $1.44 per diluted share. Net income and diluted EPS were down 70% and 71%, respectively, compared to fiscal year 2022. Net income margin for the year decreased to 1.3% from 4.8% in fiscal year 2022, primarily as a result of pre-tax impairment and restructuring charges of $699 million mainly associated with the Security Enterprise Solutions (SES) reporting unit recorded in the third quarter of fiscal year 2023. Adjusted EBITDA was $1.67 billion (10.8% margin), up 12% over fiscal year 2022. Non-GAAP net income was $1.02 billion, which generated non-GAAP diluted EPS of $7.30. Non-GAAP net income and non-GAAP diluted EPS were both up 11% compared to fiscal year 2022.

The primary drivers of increased earnings for the quarter and the year were improved program execution and reduced indirect spending across the company as well as increased volumes and higher incentive awards in the medical examination business.

Cash Flow Summary

In the fourth quarter, Leidos generated $304 million of net cash provided by operating activities and used $76 million in investing activities and $245 million in financing activities. Net cash provided by operating activities benefited from strong collections and working capital management, partially offset by higher cash tax payments. Days Sales Outstanding (DSO) for the quarter was 56, a 1-day improvement from the third quarter of 2023 and a 2-day improvement from the fourth quarter of fiscal year 2022.

Investing activities consisted primarily of $78 million in property, equipment and software payments, which resulted in quarterly free cash flow of $226 million. Financing activities were driven by $253 million returned to shareholders, including $202 million in share repurchases and $51 million as part of a regular quarterly cash dividend program.

For the year net cash provided by operating activities was $1.17 billion and free cash flow was $958 million. For the year Leidos used $211 million in investing activities and $715 million in financing activities. As of December 29, 2023, the Company had $777 million in cash and cash equivalents and $4.7 billion in debt.

On February 8, 2024, the Leidos Board of Directors declared that Leidos will pay a cash dividend of $0.38 per share on March 28, 2024, to stockholders of record at the close of business on March 15, 2024.

On February 13, 2024 CSL reported its Results Presentation for the Half-year ended 31 December 2023 (Presentation, CSL, FEB 13, 2024, View Source [SID1234642335]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On February 13, 2024, CRISPR Therapeutics AG (the "Company") reported to have entered into an investment agreement (the "Investment Agreement") with certain institutional investors relating to the issuance of 3,916,082 shares of the Company’s common shares, par value of CHF 0.03 per share (the "Common Shares"), to such investors (the "Offering") (Filing, CRISPR Therapeutics, FEB 13, 2024, View Source [SID1234641108]). The Common Shares will be issued to the investors at an issue price of $71.50 per share. The Investment Agreement contains customary representations and warranties, conditions to closing, termination provisions and indemnification obligations, including for liabilities under the Securities Act of 1933, as amended.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The gross proceeds from the Offering will be approximately $280 million, before paying estimated offering expenses. The Offering is being made pursuant to the automatically effective shelf registration statement on Form S-3 (File No. 333-258274) previously filed by the Company with the Securities and Exchange Commission on July 29, 2021.

The form of Investment Agreement is filed as Exhibit 10.1 to this Current Report on Form 8-K. The foregoing description of the respective terms of the Investment Agreement is not intended to be complete and is qualified in its entirety by reference to such exhibit. A copy of the opinion of Walder Wyss AG relating to the legality of the issuance and sale of the shares in the Offering is filed as Exhibit 5.1 to this Current Report on Form 8-K.

On February 13, 2024 Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications, reported the activation of four clinical trial sites in the United States (Press release, Pasithea Therapeutics, FEB 13, 2024, View Source [SID1234640978]). These U.S. clinical trial sites in Texas and Virginia are now open and actively enrolling patients.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This announcement follows the approval from the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for PAS-004, and FDA review of the protocol for the Company’s Phase 1 multicenter, open-label trial of PAS-004 in patients with MAPK pathway-driven advanced solid tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition.

The objective of the Phase 1 study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PAS-004 as well as to evaluate the preliminary anticancer activity (efficacy) of PAS-004 and to define the preliminary recommended Phase 2 dose.

The Company’s clinical development plan for PAS-004 following the Phase 1 study is to begin a Phase 2 clinical trial in NF1 pediatric and adult patients as soon as safety and PK are established.

Pasithea has selected Novotech as the clinical research organization (CRO) for the Phase 1 trial and will be collaborating in the U.S. with NEXT Oncology, led by Dr. Anthony Tolcher M.D., along with Dr. Ildefonso Rodriguez M.D., acting as principal investigator for the San Antonio, TX site. There are also three other clinical trial sites in Eastern Europe that are expected to open in the coming months.

"Activating our four clinical trial sites in the U.S. is a significant milestone in Pasithea’s mission towards developing PAS-004 as a potential best-in-class next-generation MEK inhibitor. We recognize the significant unmet needs and limited treatment options for patients with MAPK pathway-driven advanced solid tumors as well as NF1. We are ready to screen and enroll subjects in the coming month and look forward to gaining insight into the safety, tolerability and initial efficacy of PAS-004." said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea.

PAS-004 is the first macrocyclic MEK inhibitor to enter human clinical trials, with an expected extended half-life in humans which may provide better compliance rates as well as improved efficacy in NF1. Macrocycles are known to exhibit stronger binding, better solubility and longer half-life with more selectivity and less off target effect as compared to acyclic small molecules.

About PAS-004

PAS-004 is a small molecule allosteric inhibitor of MEK 1/2, which are dual-specificity protein kinases, in the MAPK signaling pathway. The MAPK pathway has been implicated in a variety of diseases, as it functions to drive cell proliferation, differentiation, survival and a variety of other cellular functions that, when abnormally activated, are critical for the formation and progression of tumors, fibrosis and other diseases. MEK inhibitors block phosphorylation (activation) of extracellular signal-regulated kinases (ERK), which can lead to cell death and inhibition of tumor growth. Existing FDA approved MEK inhibitors are marketed for a range of diseases, including certain cancers and neurofibromatosis type 1 (NF1). We believe these MEK inhibitors suffer from certain limitations, including known toxicities. Unlike current FDA approved MEK inhibitors, PAS-004 is macrocyclic, which we believe may lead to improved pharmacokinetic and safety (tolerability) profiles. Cyclization offers rigidity for stronger binding with drug target receptors. PAS-004 was designed to provide a longer half-life with what we believe is a better therapeutic window. Further, we believe the potency and safety profile that PAS-004 has demonstrated in preclinical studies may also lead to stronger and more durable response rates and efficacy, as well as better dosing schedules. PAS-004 has been tested in a range of mouse models of various diseases and has completed preclinical testing and animal toxicology studies. Additionally, PAS-004 has received orphan-drug designation from the FDA for the treatment of NF1, which may provide seven years of marketing exclusivity upon approval of an NDA.