NeuBase Therapeutics Reports Business Update and Financial Results for the First Quarter of Fiscal Year 2023

On February 14, 2023 NeuBase Therapeutics, Inc. (Nasdaq: NBSE) ("NeuBase" or the "Company"), a biotechnology platform company Drugging the Genome to address disease at the base level using a new class of precision genetic medicines, reported its financial results for the three-month period ended December 31, 2022, and other recent developments (Press release, NeuBase Therapeutics, FEB 14, 2023, View Source [SID1234627177]).

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"We plan on leveraging our PATrOL platform to perform ‘nuclease free’ in vivo gene editing to restore healthy gene function. This technology complements the field of CRISPR/Cas editors, base editors, and prime editors, with the potential to address the majority of disease-causing mutations. We believe the high fidelity and lack of immunogenicity of our editing approach offer the possibility to address tissue turnover by redosing. Throughout calendar year 2023, we anticipate sharing data on ex vivo and in vivo editing results against high-value genetic mutations, together with associated performance metrics, such as fidelity and efficiency. In addition to focusing on our internal programs, which we plan to announce in more detail over the coming months, we recently announced a research agreement with a global healthcare company to evaluate editing against three monogenic genetic disease-causing genes. Since announcing this initial agreement, we have held additional discussions with other leading healthcare companies on potential collaborations. This is truly an exciting time at NeuBase and we look forward to keeping you apprised of our progress," stated Dietrich A. Stephan, Ph.D., Founder and Chief Executive Officer of NeuBase.

"As previously announced, we are actively pursuing collaborative initiatives, including partnerships, for our gene silencing programs in myotonic dystrophy type 1 (DM1), Huntington’s disease (HD) and cancers driven by common KRAS gene mutations. We believe this is the best approach for these programs to keep building momentum as they move into the clinic and beyond," concluded Dr. Stephan.

First Quarter of Fiscal Year 2023 and Recent Operating Highlights

Gene Editing Program:
The Company is advancing development of the differentiated gene editing capabilities of its PATrOL platform, including identifying and evaluating multiple indications for possible future development.
Details of the gene editing pipeline expected to be provided during calendar year 2023.
Gene Editing Research Agreements:
Announced a research agreement with a global healthcare company to evaluate the PATrOL platform for three monogenic genetic diseases and collaborate with NeuBase on the evaluation of drug candidates for three undisclosed indications. The global healthcare company will have the exclusive opportunity, subject to certain terms and conditions, to license and develop the drug candidates created under this research evaluation agreement.
Engaged in discussions with other healthcare companies on potential for additional research agreements.
Gene Silencing Pipeline Collaborations:
Actively pursuing collaborative initiatives, including partnerships, for the Company’s DM1, HD, and KRAS (G12D and G12V) programs, which are expected to support future development of these programs.
Financial Results for the Fiscal Quarter Ended December 31, 2022

As of December 31, 2022, the Company had cash and cash equivalents of approximately $17.4 million, compared with approximately $23.2 million as of September 30, 2022.
NeuBase estimates its current cash and cash equivalents are sufficient to fund currently planned operating and capital expenditures into the second quarter of calendar year 2024.
For the fiscal quarter ended December 31, 2022, the Company reported a net loss of approximately $4.4 million, or a net loss of $0.13 per share, compared with a net loss of approximately $7.7 million, or a net loss of $0.24 per share, for the same period last year.
For the fiscal quarter ended December 31, 2022, total operating expenses were approximately $4.6 million, consisting of approximately $2.6 million in general and administrative expenses, $1.3 million in research and development expenses, and $0.7 million in restructuring costs. This compares with total operating expenses of approximately $7.3 million for the same period last year, consisting of approximately $2.9 million in general and administrative expenses and $4.4 million in research and development expenses.

Leidos Holdings, Inc. Reports Fourth Quarter and Fiscal Year 2022 Results

On February 14, 2023 Leidos Holdings, Inc. (NYSE: LDOS), a FORTUNE 500 technology, engineering, and science company, reported financial results for the fourth quarter and fiscal year 2022 (Press release, Leidos, FEB 14, 2023, View Source [SID1234627176]).

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Roger Krone, Leidos Chairman and Chief Executive Officer, commented: "The fourth quarter marked a strong finish to a banner year for Leidos, with record revenue and non-GAAP diluted EPS driving us to the top end of our revenue guidance range and beyond our EPS guidance range for the year. Our performance validated that our diversified and resilient portfolio and our investments in technology and innovation are positioning us for growth in key customer missions, including digital modernization, cyber, hypersonics, and force protection. Each and every day, our 45,000 people are helping our customers execute on important missions and meet the world’s most complex challenges."

Summary Operating Results

(in millions, except margin and per
share amounts)

Three Months Ended

Year Ended

December 30,
2022

December 31, 2021

December 30,
2022

December 31, 2021

Revenues

$ 3,697

$ 3,491

$ 14,396

$ 13,737

Net income

$ 180

$ 176

$ 693

$ 759

Net income margin

4.9 %

5.0 %

4.8 %

5.5 %

Diluted earnings per share (EPS)

$ 1.28

$ 1.23

$ 4.96

$ 5.27

Non-GAAP Measures*:

Adjusted EBITDA

$ 397

$ 359

$ 1,493

$ 1,510

Adjusted EBITDA margin

10.7 %

10.3 %

10.4 %

11.0 %

Non-GAAP diluted EPS

$ 1.83

$ 1.56

$ 6.60

$ 6.62

*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 $3.70 billion for the quarter and $14.40 billion for the year, up 6% and 5% over the comparable 2021 periods, respectively. For the quarter and the year, all segments grew, led by broad-based strength across the Civil segment.

Net income was $180 million, or $1.28 per diluted share, for the quarter, and $693 million, or $4.96 per diluted share, for the year. Net income margin for the quarter was 4.9%, down 10 basis points year-over-year. Net income in the quarter reflected impairment charges of $37 million incurred by exiting and consolidating underutilized leased spaces as part of an ongoing facility rationalization effort. Net income margin for the year decreased to 4.8% from 5.5% in fiscal year 2021, primarily as a result of the $26 million net benefit from an adjustment to legal reserves related to the Mission Support Alliance (MSA) joint venture recorded in the first quarter of fiscal year 2021 and the $19 million of expense related to an adverse arbitration ruling in the second quarter of fiscal year 2022. For the quarter net income was up 2%, and diluted EPS was up 4% compared to the fourth quarter of fiscal year 2021. For the year net income and diluted EPS were down 9% and 6%, respectively, compared to fiscal year 2021.

In addition, net interest expense in the quarter increased to $51 million from $46 million in the fourth quarter of 2021. The weighted average diluted share count for the quarter was 138 million, compared to 142 million in the prior year quarter, primarily as a result of the $500 million accelerated share repurchase agreement implemented in the first quarter of fiscal year 2022.

Adjusted EBITDA was $397 million for the fourth quarter (10.7% margin), up 11% over the fourth quarter of 2021. For the year adjusted EBITDA was $1.49 billion (10.4% margin), down 1% over fiscal year 2021. Non-GAAP net income was $255 million for the quarter and $919 million for the year, which generated non-GAAP diluted EPS of $1.83 for the quarter and $6.60 for the year. For the quarter, non-GAAP net income was up 14%, and non-GAAP diluted EPS was up 17% compared to the fourth quarter of fiscal year 2021. For the year non-GAAP net income was down 3%, and non-GAAP diluted EPS was essentially flat compared to fiscal year 2021.

Cash Flow Summary

Net cash provided by operating activities for the quarter was $105 million; after adjusting for payments for property, equipment and software, quarterly free cash flow was $52 million. For the year net cash provided by operating activities was $986 million (144% operating cash flow conversion ratio), and free cash flow was $857 million (94% free cash flow conversion ratio).

For the quarter Leidos used $258 million in investing activities and $135 million in financing activities. For the year Leidos used $313 million in investing activities and $865 million in financing activities. During the quarter Leidos completed the acquisition of Cobham Special Mission for a preliminary purchase consideration of approximately $190 million United States dollars, net of $6 million of cash acquired, which is subject to working capital adjustments. Cobham Special Mission provides airborne border surveillance and search and rescue services to the Australian Federal Government.

During the fiscal year 2022, Leidos returned $741 million to shareholders, including $199 million as part of its regular quarterly cash dividend program and $542 million in share repurchases. As of December 30, 2022, the Company had $516 million in cash and cash equivalents and $4.9 billion in debt.

On February 10, 2023, the Leidos Board of Directors declared that Leidos will pay a cash dividend of $0.36 per share on March 31, 2023, to stockholders of record at the close of business on March 15, 2023.

New Business Awards

Net bookings totaled $3.7 billion in the fourth quarter of fiscal year 2022 and $15.4 billion for fiscal year 2022, representing book-to-bill ratios of 1.0 and 1.1, respectively. As a result, backlog at the end of fiscal year 2022 was $35.8 billion, of which a record $8.4 billion was funded. Included in the quarterly bookings were several notable awards:

Expendable Hypersonic Multi-mission ISR and Strike (Mayhem) . Under a $334 million, 51-month contract, Leidos will assist the U.S. Air Force Research Laboratory (AFRL) in designing and developing a large-class air-breathing hypersonic system that surpasses current air-breathing systems in range and payload. The Mayhem system will use a scramjet engine to generate thrust, propelling the vehicle across long distances at speeds greater than Mach 5. Leidos will leverage its corporate depth in digital engineering (DE) and model based systems engineering (MBSE) to develop the concept from idea to an operational system.
Social Security Administration (SSA) IT Support Services Contract II (ITSSC2). The SSA awarded Leidos two new ITSSC2 task orders to provide systems and infrastructure support for the SSA’s Deputy Commissioner of Systems (DCS) and the Office of Systems Operations and Hardware Engineering (OSOHE). The indefinite delivery/indefinite quantity, time and material task orders have a combined estimated value of $1.5 billion over approximately 67 months if all options are exercised.
U.S. Space Development Agency (SDA) Tranche 1 Tracking Layer. Leidos received a subcontract with Northrop Grumman Strategic Space Systems to develop hypersonic defense sensors for the SDA. Through this award, the Leidos team will develop and build the sensor payload for a proliferated constellation of Low-Earth Orbit satellites for the Tranche 1 Tracking Layer. The Tracking Layer constellation will detect and track advanced hypersonic and ballistic missile threats as part of SDA’s missile defense architecture.
Forward Guidance

Leidos is initiating fiscal year 2023 guidance as specified in the table below.

Measure

FY23 Guidance

Revenues (billions)

$14.7 – $15.1

Adjusted EBITDA Margin

10.3% – 10.5%

Non-GAAP Diluted EPS

$6.40 – $6.80

Cash Flows Provided by Operating Activities (millions)

at or above $700

Fiscal year 2023 guidance for cash flows provided by operating activities reflects approximately $300 million of additional cash taxes compared to fiscal year 2022, primarily related to the Tax Cuts and Jobs Act of 2017 provision requiring the capitalization and amortization of research and development costs that went into effect on January 1, 2022. While awaiting potential Congressional action in 2022, Leidos accrued, but did not pay the incremental 2022 cash taxes and now expects to make payments in 2023 to cover both the 2022 and 2023 tax amounts. The actual impact on cash flows provided by operating activities will depend on the amount of research and development costs Leidos will incur, whether Congress modifies or repeals this provision and whether new guidance and interpretive rules are issued by the US Treasury, among other factors.

For information regarding adjusted EBITDA margin and non-GAAP diluted EPS, see the related explanations and reconciliations to GAAP measures included elsewhere in this release.

Leidos does not provide a reconciliation of forward-looking adjusted EBITDA margins or non-GAAP diluted EPS to net income margin or diluted EPS, due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation. Because certain deductions for non-GAAP exclusions used to calculate projected net income may vary significantly based on actual events, Leidos is not able to forecast on a GAAP basis with reasonable certainty all deductions needed in order to provide a GAAP calculation of projected net income margin, diluted EPS or net income attributable to Leidos shareholders at this time. The amounts of these deductions may be material and, therefore, could result in projected net income margin, net income attributable to Leidos shareholders and diluted EPS being materially less than projected adjusted EBITDA margins and non-GAAP diluted EPS.

Conference Call Information

Leidos management will discuss operations and financial results in an earnings conference call beginning at 8 A.M. eastern time on February 14, 2023. Analysts and institutional investors may participate by dialing +1 (877) 869-3847 (U.S. dial-in) or +1 (201) 689-8261 (international dial-in).

A live audio broadcast of the conference call along with a supplemental presentation will be available to the public through links on the Leidos Investor Relations website (View Source).

After the call concludes, an audio replay can be accessed on the Leidos Investor Relations website or by dialing +1 (877) 660-6853 (toll-free U.S.) or +1 (201) 612-7415 (international) and entering conference ID 13735521.

Kintara Therapeutics Announces Fiscal 2023 Second Quarter Financial Results and Provides Corporate Update

On February 14, 2023 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported financial results for its fiscal second quarter ended December 31, 2022 and provided a corporate update (Press release, Kintara Therapeutics, FEB 14, 2023, View Source [SID1234627174]).

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RECENT CORPORATE DEVELOPMENTS

Announced that Kintara had received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for VAL-083 for the treatment of diffuse intrinsic pontine glioma, a rare and highly aggressive childhood brain cancer (December).

Received formal notice from The Nasdaq Stock Market LLC stating that Kintara had regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market LLC ("Nasdaq") (November).

Announced that the FDA had granted Fast Track Designation for Kintara’s REM-001 therapy, which consists of three parts, the laser light source, the light delivery device, and the REM-001 drug product, for the treatment of patients with cutaneous metastatic breast cancer (CMBC) (November).

Completed a 1-for-50 reverse stock split of the Company’s outstanding and authorized common stock, which began trading on a reverse stock split-adjusted basis on Nasdaq on November 14, 2022 (November).

Announced that the REM-001 program in CMBC was paused to conserve cash which will be used to support the funding of the Company’s ongoing international registrational study for VAL-083 in glioblastoma (GBM). By pausing the REM-001 program, Kintara expects to save approximately $3.0 million through calendar 2023 (October).
"While we continue to look for ways to restart our REM-001 program in cutaneous metastatic breast cancer without reducing our cash runway, we are encouraged by the recent progress of our lead asset in brain cancer, VAL-083, and look forward to announcing top-line data in the international registrational GBM AGILE Study before the end of calendar 2023," commented Robert E. Hoffman, Kintara’s President and Chief Executive Officer. "There has been a significant lack of progress in the development of treatments for GBM in the last decades so we are devoted to advancing our novel brain-penetrant small molecule chemotherapy agent, VAL-083, closer to patients and physicians in dire need of new treatment options for this devastating disease."

SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR 2023 SECOND QUARTER ENDED DECEMBER 31, 2022

As of December 31, 2022, Kintara had cash and cash equivalents of approximately $4.9 million.

For the three months ended December 31, 2022, Kintara reported a net loss of approximately $3.5 million, or $2.10 per share, compared to a net loss of approximately $5.9 million, or $6.07 per share, for the three months ended December 31, 2021. For the six months ended December 31, 2022, Kintara reported a net loss of approximately $8.1 million, or $5.42 per share, compared

to a net loss of approximately $11.9 million, or $17.30 per share, for the six months ended December 31, 2021. The decreased net losses for the three and six months ended December 31, 2022 compared to the three and six months ended December 31, 2021 was largely due lower research and development expenses as well as lower general and administrative costs.

Kinnate Biopharma Inc. Receives Fast Track Designation from the U.S. Food and Drug Administration for KIN-3248, an Investigational Pan-FGFR Inhibitor

On February 14, 2023 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a clinical-stage precision oncology company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Kinnate’s investigational pan-FGFR inhibitor, KIN-3248, for the treatment of patients with unresectable, locally advanced or metastatic cholangiocarcinoma (CCA) harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other alterations, who have received at least one prior systemic therapy (Press release, Kinnate Biopharma, FEB 14, 2023, View Source [SID1234627173]).

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Cholangiocarcinoma, also known as bile duct cancer, is a rare condition, often diagnosed when it is advanced. Research has shown that FGFR is an actionable alteration in patients with CCA. FGFRs are tyrosine kinases that play a crucial role in cell proliferation, differentiation, migration and survival. FGFR2 gene fusions or other alterations are identified in approximately 16% of intrahepatic cholangiocarcinoma (ICC) tumors.

Fast Track is a process designed by the FDA to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need. A therapeutic candidate that receives Fast Track designation is eligible for more frequent interactions with the FDA to discuss the candidate’s development plan, and if relevant criteria are met, for Accelerated Approval and Priority Review.

About KIN-3248

KIN-3248 is an irreversible, small molecule pan-FGFR inhibitor designed to address primary FGFR2 and FGFR3 oncogenic alterations, including those predicted to drive acquired resistance to current FGFR-targeted therapies, such as gatekeeper, molecular brake, and activation loop mutations observed in cancers such as ICC and urothelial carcinoma (UC). In preclinical studies, KIN-3248 demonstrated inhibitory activity across a wide range of clinically relevant mutations that drive primary disease and acquired resistance to other FGFR inhibitors.

The KN-4802 clinical trial (NCT05242822) is an ongoing multi-center, open-label, two-part study of approximately 120 patients to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of KIN-3248 in adults with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations. In dose escalation (Part A), the trial will determine the recommended dose and schedule of KIN-3248 for further evaluation in patients with FGFR2 and/or FGFR3 gene alteration-driven cancers. Dose expansion (Part B) will assess the safety and efficacy of KIN-3248 at the recommended dose and schedule in FGFR inhibitor naïve and FGFR inhibitor pretreated patients with cancers driven by FGFR2 and/or FGFR3 gene alterations, including ICC, UC, and other advanced or metastatic solid tumors in adults.

This trial is currently enrolling across multiple sites in the U.S. and Taiwan, with additional sites expected globally. Initial dose escalation data is anticipated in the second half of 2023.

The company previously announced that a poster presentation of the design and rationale of the KN-4802 clinical trial will be presented at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium. Details are included below.

ASCO Genitourinary Cancers Symposium, February 16-18, 2023

Title: First-in-Human Phase 1/1b Study Evaluating KIN-3248, a Next‑Generation, Irreversible Pan-FGFR Inhibitor, in Patients With Advanced Urothelial Carcinoma and Other Solid Tumors Harboring FGFR2 and/or FGFR3 Gene Alterations
Author: Benjamin Garmezy, MD
Abstract Number: TPS593
Poster Board: P16
Session Type and Track: Trials in Progress Poster Session, Urothelial Carcinoma
Session Date: February 17, 2023, 12:30 p.m. PT / 3:30 p.m. ET

For additional information, visit the ASCO (Free ASCO Whitepaper) Meeting webpage: View Source

Invitae to Announce Fourth Quarter and Full Year 2022 Financial Results on Tuesday, February 28, 2023

On February 14, 2023 Invitae (NYSE: NVTA), a leading medical genetics company, reported that it will report its fourth quarter and full year 2022 financial results on Tuesday, February 28, 2023, and will host a conference call and webcast that day at 4:30 p.m. Eastern / 1:30 p.m (Press release, Invitae, FEB 14, 2023, View Source [SID1234627172]). Pacific to discuss its financial results and recent highlights.

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To access the conference call, please register at the link below:
View Source;confId=46549

Upon registering, each participant will be provided with call details and access codes.

The live webcast of the call and slide deck may be accessed here or by visiting the investors section of the company’s website at ir.invitae.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the company’s website.