On March 31, 2023 Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics company, reported plans to file a Form 12b-25 with the U.S. Securities and Exchange Commission regarding its Annual Report on Form 10-K and reports preliminary financial results for the full year ended December 31, 2022 (Press release, Oncocyte, MAR 31, 2023, View Source [SID1234629669]). The Company is completing its final review of the information required to be presented for the relevant period. The Form 12b-25 provides the Company with an additional 15 calendar days to complete its assessment and allows its independent registered public accounting firm extra time to complete its audit of the Company’s financial statements before filing its Form 10-K reports.

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The Company currently anticipates filing the 2022 Form 10-K as soon as practicable and expects that, in compliance with Rule 12b-25, it will be filed no later than April 17, 2023.

"The Company continues to work diligently to submit the filing. Turning to our recent performance, we have committed to a strategic shift from a service lab model to a product-driven revenue model with low-cost infrastructure and scalable high-margin distributable content" said Joshua Riggs, CEO. "With a reduced cash burn, we believe this puts us in a better position to support the future of our core products and rapidly deliver on our major milestones ahead. We are confident that a kitted product approach puts our unique technology in the hands of researchers at every level, from pharma to academia, encouraging research on the role of the tumor microenvironment in oncology and transplant graft health and viability."

Recent Highlights:

● Appointed Joshua Riggs to President, CEO, and to its Board of Directors
● Appointed seasoned healthcare executive Lou Silverman to its Board of Directors as Lead Independent Director
● Announced the divestiture of DetermaRx, resulting in expected savings of approximately $30 million in operating cost and development obligations over the next two years
● Implemented cost reduction plans to drive expected quarterly average 2H 2023 cash burn below $6 million, down from $10.5 million in 2H 2022
● Focused development of VitaGraft and DetermaIO in 2023 with DetermaCNI in development pipeline for 2024
● Entered into an amendment to the Chronix Merger Agreement in February 2022 to reduce contingent liabilities and open a kitting opportunity for VitaGraft
● Completed VitaGraft RUO feasibility, anticipated to enter pre-manufacturing optimization in 2Q 2023
● Initiated DetermaIO multicenter SWOG study for Triple Negative Breast Cancer and had Metastatic Colorectal Cancer data accepted for publication in Clinical Cancer Research
● Submitted DetermaIO reimbursement dossier to MolDx in December 2022

2022 Preliminary Financial Results

Consolidated revenues for the three and twelve months ended December 31, 2022, were approximately $1.1 million and $5.6 million, respectively, a decrease of 69% compared to fourth quarter 2021 and 27% compared to the full year 2021. Excluding DetermaRx revenue, the continuing operations revenue was $1.0 million for the year ended December 31, 2022.

Consolidated DetermaRx revenues for the three months ended December 31, 2022 were $0.8 million, a 3% increase from the same period in 2021. Consolidated DetermaRx revenues for the year ended December 31, 2022, were approximately $3.6 million, a 47% percent increase from the previous year.

Consolidated cost of revenues for the three months ended December 31, 2022 were approximately $2.4 million, including $1.6 million from the cost of diagnostic tests and testing services we performed for our pharma customers, and approximately $0.8 million in noncash amortization expense.

Consolidated cost of revenues for the year ended December 31, 2022 were approximately $8.9 million, including $5.2 million from the cost of diagnostic tests and testing services we performed for our pharma customers, and $3.7 million in noncash amortization expense. Cost of revenues for continuing operations were approximately $1.0 million.

Consolidated operating expenses for the year ended December 31, 2022 were approximately $69.0 million, including $22.4 million from general and administrative, $19.4 million from research and development, $13.6 million from sales and marketing, $31.0 million gain from change in fair value of contingent consideration, $44.6 million from impairment loss. Operating expenses from continuing operations for the year ended December 31, 2022 were approximately $18.0 million.

Conference Call Information

The Company will host a conference call on April 3rd at 8:30 am EDT / 5:30 am PDT to discuss the results along with recent corporate developments. The dial-in number in the U.S./Canada is 1-877-407-9716; for international participants, the number is 1-201-493-6779. To access the live webcast, go to the investor relations section on the Company’s website, or by clicking here: View Source;tp_key=b228274c7e. A webcast replay will be available on the Oncocyte website for 90 days following the completion of the call.

On March 31. 2023 NightHawk Biosciences (NYSE American: NHWK), a fully-integrated biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported strategic, financial, and operational updates for the year ended December 31, 2022 (Press release, NightHawk Biosciences, MAR 31, 2023, View Source [SID1234629668]).

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Jeff Wolf, Chief Executive Officer of NightHawk, commented, "We are making progress on our transition towards biodefense and biomanufacturing through our Elusys and Scorpion subsidiaries as we wind down our HS-110 and PTX-35 oncology programs. Pursuant to this, we are investing in our biomanufacturing technologies and capabilities, including our San Antonio and Manhattan, Kansas biologics manufacturing facilities, which we believe will position us well in the future. The manufacturing capabilities associated with these facilities are designed to streamline the development and delivery of life-saving medical countermeasures, while enabling us to offer excess capacity to third parties on a fee-for-service model."

2022 Financial Results

For the year ended December 31, 2022, the Company recognized revenue of $6.4 million, which included $6.0 million of product sales revenue, $0.1 million of contract revenue, and $0.3 million of CPRIT grant revenue. For the year ended December 31, 2021, the Company recognized revenue of $2.1 million for qualified expenditures under the CPRIT grant. The increase in product sales revenue was due to the sale of ANTHIM (obiltoxaximab) to the Canadian government. The decrease in grant revenue was due to the fact that the Company recognized all $15.2 million of CPRIT grant revenue. For the year ended December 31, 2022, the Company had a grants receivable balance of $1.5 million for CPRIT proceeds not yet received, but for which the costs had been incurred or the conditions of the award had been met.
For the year ended December 31, 2022, the Company recognized $6.4 million of cost of sales. No product sales were recognized for the year ended December 31, 2021, and thus no cost of sales was recorded. The increase was due to the cost of sales related to the ANTHIM (obiltoxaximab) sale to the Canadian government. Cost of sales includes $5.9 million of inventory, $0.3 million of pre-acquisition backlog, and $0.2 million of shipping and fulfillment expenses.
Selling, general and administrative ("SGA") expenses for the years ended December 31, 2022 and 2021 were $21.1 million and $16.8 million, respectively. The increase of $4.3 million was primarily due to an increase in consulting and other professional expenses to manage the business of $3.2 million, an increase in facilities expense of $1.2 million primarily due to the opening of the Company’s San Antonio facility, an increase in personnel expense of $0.8 million due to an increase in headcount, an increase in rent expense of $0.5 million, an increase in insurance expense of $0.3 million, an increase in depreciation of $0.3 million, an increase in marketing expenses of $0.2 million, an increase in software expense of $0.2 million offset by a decrease in stock-based compensation of $2.4 million.
Research and development expenses increased to $23.5 million from $16.5 million for the years ended December 31, 2022 and 2021, respectively. HS-110 R&D expense decreased by $1.2 million, HS-130 expense decreased by $0.2 million, and PTX-35 expense decreased by $0.3 million, all due to a decrease in site and investigator fees as a result of the closing of the clinical trials. ANTHIM (obiltoxaximab) expenses increased due to the Company’s acquisition of Elusys in April 2022. Other program expenses decreased by $0.7 million, including preclinical costs associated with the RapidVax program, T-cell costimulatory programs, and laboratory supplies. Unallocated research expenses increased by $8.2 million primarily from license fees, sponsored research agreements for preclinical research, as well as increased clinical and CMC consulting expenses and Skunkworx lab and personnel costs.
Net loss attributable to NightHawk Biosciences was approximately $43.4 million, or ($1.70) per basic and diluted share, for the year ended December 31, 2022, compared to approximately $35.1 million, or ($1.41) per basic and diluted share, for the year ended December 31, 2021.
As of December 31, 2022, the Company had approximately $44.3 million in cash, cash equivalents, and short-term investments.
Pursuant to the disclosure requirements of the NYSE American Company Guidelines Sections 401(h) and 610(b), NightHawk reports that its audited financial statements for the year ended December 31, 2022, included in the 2022 Form 10-K, contain an audit opinion from its independent registered public accounting firm that includes an explanatory paragraph related to the Company’s ability to continue as a going concern due to the fact that the Company has suffered recurring losses from operations and has not generated significant revenue or positive cash flows from operations.

About ANTHIM

Anthrax is a life-threatening infectious disease caused by Bacillus anthracis. Cases of inhalational anthrax in humans can occur through intentional spread of B. anthracis spores as a biowarfare or bioterrorism agent. B. anthracis spores introduced through the lungs lead to inhalational anthrax, which is deadly in humans.

ANTHIM is a monoclonal antibody that binds to the protective antigen (PA) component of anthrax toxin. ANTHIM’s toxin neutralizing activity prevents entry of anthrax toxin into susceptible cells, avoiding further spread of the toxin throughout the body and the ensuing tissue damage that leads to death. ANTHIM is supplied as single-dose vials for IV infusion.

Indications and Usage

ANTHIM is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. ANTHIM should only be used for prophylaxis when its benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis. The effectiveness of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax. There have been no studies of the safety or pharmacokinetics (PK) of ANTHIM in the pediatric population. Dosing in pediatric patients was derived using a population PK approach. ANTHIM does not have direct antibacterial activity. ANTHIM should be used in combination with appropriate antibacterial drugs. ANTHIM is not expected to cross the blood-brain barrier and does not prevent or treat meningitis.

IMPORTANT SAFETY INFORMATION Including BOXED WARNING

WARNING: HYPERSENSITIVITY and ANAPHYLAXIS
Hypersensitivity reactions, including anaphylaxis, have been reported during ANTHIM infusion. ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs.

WARNINGS AND PRECAUTIONS

Hypersensitivity and anaphylaxis have been reported during the IV infusion of ANTHIM. Due to the risk of hypersensitivity and anaphylaxis, ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Monitor individuals who receive ANTHIM closely for signs and symptoms of hypersensitivity reactions throughout the infusion and for a period of time after administration. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs. Pre-medication with diphenhydramine is recommended prior to administration of ANTHIM. Diphenhydramine pre-medication does not prevent anaphylaxis and may mask or delay onset of symptoms of hypersensitivity.

ADVERSE REACTIONS

The safety of ANTHIM has been studied only in healthy volunteers. It has not been studied in patients with inhalational anthrax. The most frequently reported adverse reactions were headache, pruritus, infections of the upper respiratory tract, cough, vessel puncture site bruise, infusion site swelling, urticaria, nasal congestion, infusion site pain, and pain in extremity.

USE IN SPECIFIC POPULATIONS

Pediatric Use: There have been no studies of the safety or PK of ANTHIM in the pediatric population.
To see the complete prescribing information for ANTHIM, click here.

On March 31, 2023 Labcorp (NYSE: LH), a leading global life sciences company, will report its financial results for the first quarter of 2023 before the market opens on Tuesday, April 25, 2023 (Press release, LabCorp, MAR 31, 2023, View Source [SID1234629666]). The company will host a conference call and webcast beginning at 9 a.m. ET that day to discuss the results. The earnings press release and accompanying financial information will be posted on the Labcorp Investor Relations website.

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The call will be webcast live on the Labcorp Investor Relations website. Participants may also register for the call by clicking on this link, to receive the dial-in numbers and unique PIN to access the call. The webcast and dial-in are listen-only. It is recommended that participants join 10 minutes prior to the start, although participants may register and join at any time during the call.

A replay of the webcast will be available approximately two hours after the conclusion of the live event, and will be available until April 11, 2024. To access the webcast recording, visit the Labcorp Investor Relations website.

On March 31, 2023 Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported financial results for the full-year ended December 31, 2022 and provided a corporate update (Press release, Kineta, MAR 31, 2023, View Source;utm_medium=rss&utm_campaign=kineta-reports-full-year-2022-financial-results-and-provides-corporate-update [SID1234629665]).

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"2022 was transformational for Kineta, culminating with the successful completion of our reverse merger with Nasdaq-listed Yumanity Therapeutics," said Shawn Iadonato, Ph.D., Chief Executive Officer of Kineta. "We enter this year with tremendous progress advancing KVA12123 into clinical development, receiving IND clearance from the FDA, and initiating a first-in-human clinical trial of our VISTA blocking immunotherapy that addresses immune resistance in the tumor microenvironment. We look forward to sharing initial clinical data by the end of 2023 from this Phase 1/2 trial of KVA12123 in patients with advanced solid tumors."

RECENT CORPORATE HIGHLIGHTS

Completed the reverse merger with Yumanity Therapeutics and commenced trading on Nasdaq under new ticker symbol "KA" on December 19, 2022.
Opened a Phase 1/2 clinical study evaluating KVA12123, Kineta’s novel anti-VISTA monoclonal antibody, in advanced solid tumors, anticipating 10 U.S. sites to participate in this clinical study.
Received U.S. Food and Drug Administration (FDA) acceptance of Kineta’s Investigational New Drug application (IND) to evaluate its VISTA blocking immunotherapy KVA12123 as a potential treatment for patients with advanced solid tumors.
Entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside the U.S. and Canada). Under this collaboration, Kineta will evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KVA12123, its novel anti-VISTA monoclonal antibody, alone and in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with advanced solid tumors. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Presented preclinical data on KVA12123 and Kineta’s anti-CD27 agonist antibody pre-clinical program at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting.
Presented preclinical data on Kineta’s anti-CD27 agonist antibody pre-clinical program at the AACR (Free AACR Whitepaper) Conference on Tumor Immunology and Immunotherapy.
Strengthened Kineta management team with addition of Keith Baker as Chief Financial Officer.
Initiated an "at-the-market" (ATM) equity offering program relating to sales of common stock with Jeffries, LLC.
ANTICIPATED FUTURE MILESTONES

Dose first patient in the combination arm (Part B) of the ongoing KVA12123 Phase 1/2 clinical study.
Report initial clinical data of KVA12123 by end of 2023.
2022 FINANCIAL HIGHLIGHTS

Cash position: As of December 31, 2022, cash was $13.1 million, compared to $11.1 million as of December 31, 2021. The increase was primarily due to net cash of $7.8 million received from Yumanity and $7.4 million net proceeds received from the private placement in connection with the reverse merger. The Company believes its cash and the committed proceeds pursuant to the second closing of the private placement expected on May 31, 2023 will be sufficient to fund operating expenses and capital expenditure requirements for a period of at least 12 months.
Research and development expense (R&D): Research and development expense was $15.9 million compared to $15.6 million for the prior year. The increase in R&D expense was primarily due to lower research activities related to KCP-506 as the Phase 1 clinical trial approached study completion during 2022, partially offset by higher KVA12123 activities in anticipation of initiating Phase 1 clinical trials in December 2022.
General and administrative expense: General and administrative expense was $8.7 million compared to $4.6 million for the prior year. The increase was primarily due to higher personnel-related costs from non-cash stock-based compensation with performance conditions contingent upon the closing of the reverse merger and increased professional services fees in preparation of the reverse merger and becoming a public company.
In-process research and development: In-process research and development expense was $18.9 million in connection with the reverse merger.

Other non-operating expenses: Other expenses were $21.9 million compared to $0.7 million for the prior year. The Company incurred a non-cash fair value charge of $15.3 million in connection with converting debt into equity, $3.7 million in interest expense and a $3.3 million non-cash warrant expense in connection with fundraising.
Net loss: The Company reported a net loss of $63.4 million, or $12.87 per basic and diluted share, compared to a net loss of $11.8 million, or $2.71 per basic and diluted share for the prior year. The increase was due to lower revenue due to research studies concluded in 2022, higher operating expenses as discussed above, change in fair value in converting debt into shares of common stock and interest expense on the convertible notes.

On March 31, 2023 Instil Bio, Inc. ("Instil") (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported its fourth quarter and full-year 2022 financial results and provided a corporate update (Press release, Instil Bio, MAR 31, 2023, View Source [SID1234629664]).

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Fourth Quarter 2022 Highlights and Anticipated Milestones:

Instil confirms cash runway beyond 2026 with consolidation of R&D operations to the UK: In January 2023, the Company announced the consolidation of the Phase 1 clinical trial and related manufacturing of CoStAR-TIL to its active operations in Manchester, UK leading to an extension of the expected cash runway to beyond 2026. Instil’s Manchester, U.K. operations have extensive experience and success in the manufacture and development of TIL and other cell therapy products since 2011. Instil continues to pursue a potential lease or sale of its commercial manufacturing facility in Tarzana, California. Under the current operating plan, starting in the second half of 2023, we expect quarterly cash burn of less than $10 million through the end of 2024.

ITIL-306 phase 1 study in UK anticipated to initiate in 2H’2023: Instil anticipates initiating a phase 1 study of ITIL-306 in the United Kingdom in the second half of 2023 following anticipated Clinical Trial Application, or CTA, clearance from the Medicines and Healthcare products Regulatory Agency, or MHRA. Instil anticipates initial clinical data from the ITIL-306 program in 2024.

Prioritization of ITIL-306 after discontinuation of ITIL-168 and subsequent consolidation to the UK for manufacturing: After a voluntary pause of the DELTA-1 trial for ITIL-168 in October 2022 due to a decreased rate of successful manufacturing of ITIL-168, the Company discontinued the program in December 2022 and announced a reduction in U.S. headcount and prioritization of CoStAR-TIL programs, including ITIL-306.
Fourth Quarter 2022 Financial and Operating Results:

As of December 31, 2022, Instil had $260.9 million in total cash and cash equivalents and marketable securities, comprised of $43.7 million in cash and cash equivalents and $217.2 million in marketable securities, compared to $454.1 million in total cash and cash equivalent and marketable securities, comprised of $37.6 million in cash and cash equivalents and $416.5 million in marketable securities, as of December 31, 2021. Instil expects that its cash, cash equivalents and marketable securities as of December 31, 2022 will enable it to fund its operating plan beyond 2026.

Research and development expenses were $20.7 million and $141.1 million for the fourth quarter and full year ended December 31, 2022, respectively, compared to $42.6 million and $107.3 million for the fourth quarter and full year ended December 31, 2021, respectively.

General and administrative expenses were $12.9 million and $62.2 million for the fourth quarter and full year ended December 31, 2022, respectively, compared to $11.2 million and $48.3 million for the fourth quarter and full year ended December 31, 2021, respectively.

Restructuring and impairment charges were $23.2 million for the fourth quarter and full year ended December 31, 2022.

INSTIL BIO, INC.
SELECTED FINANCIAL DATA
(Unaudited; in thousands, except share and per share amounts)

Statements of Operations

Three Months Ended
December 31, Year Ended December 31,
2022 2021 2022 2021
Operating expenses:
Research and development $ 20,722 $ 42,577 $ 141,056 $ 107,251
General and administrative 12,910 11,175 62,235 48,309
Restructuring and impairment charges 23,167 — 23,167 —
Total operating expenses 56,799 53,752 226,458 155,560
Loss from operations (56,799) (53,752) (226,458) (155,560)
Interest income 1,796 35 3,655 80
Interest expense (745) — (1,883) —
Other income (expense), net 1,299 (573) (564) (1,275)
Loss before income tax expense (54,449) (54,290) (225,250) (156,755)
Income tax benefit (expense) 605 (1,060) 2,073 (39)
Net loss $ (53,844) $ (55,350) $ (223,177) $ (156,794)
Net loss per share, basic and diluted $ (0.41) $ (0.43) $ (1.72) $ (1.48)
Weighted-average shares used in computing net loss per share, basic and diluted 129,872,810 128,952,362 129,512,610 105,993,230

Selected Balance Sheet Data

December 31,
2022 December 31,
2021
Cash, cash equivalents and marketable securities $ 260,920 $ 454,099
Total assets $ 482,128 $ 609,983
Total liabilities $ 118,523 $ 54,784
Convertible preferred stock and stockholders’ equity $ 363,605 $ 555,199

Note Regarding Use of Non-GAAP Financial Measures

In this press release, Instil Bio has presented certain financial information that has not been prepared in accordance with U.S. generally accepted accounting principles ("GAAP"). These non-GAAP financial measures include non-GAAP net loss and non-GAAP net loss per share, which are defined as net loss and net loss per share, respectively, excluding non-cash stock-based compensation expense. Instil Bio believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Instil Bio’s financial performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of Instil Bio’s operating results. In addition, these non-GAAP financial measures are among the indicators Instil Bio’s management uses for planning purposes and to measure Instil Bio’s performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by Instil Bio may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies. Please refer to the below reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures.

Three Months Ended
December 31, Year Ended December 31,
2022 2021 2022 2021
Net loss $ (53,844) $ (55,350) $ (223,177) $ (156,794)
Adjustments:
Non-cash stock-based compensation expense 6,643 8,904 30,441 26,197
Non-GAAP net loss $ (47,201) $ (46,446) $ (192,736) $ (130,597)
Non-GAAP net loss per share, basic and diluted $ (0.41) $ (0.43) $ (1.72) $ (1.48)
Adjustments
Non-cash stock-based compensation expense per share 0.05 0.07 0.24 0.25
Non-GAAP net loss per share, basic and diluted*. $ (0.36) $ (0.36) $ (1.48) $ (1.23)
Weighted-average shares used in computing net loss per share, basic and diluted 129,872,810 128,952,362 129,512,610 105,993,230
* Non-GAAP net loss per share, basic and diluted may not total due to rounding.