1stOncology™: Cancer Intelligence Service – Page 5548 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Processa Pharmaceuticals Provides Corporate Update and Announces Year End 2022 Financial Results

On March 31, 2023 Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) ("Processa" or the "Company"), a developer of Next Generation Chemotherapy drugs that provide a better safety-efficacy profile than their widely used
FDA-approved counterparts, reported an update on their clinical programs and announced financial results for the year ended December 31, 2022 (Press release, Processa Pharmaceuticals, MAR 31, 2023, View Source [SID1234629670]).

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!

Dr. David Young, President and CEO of Processa, commented, "We completed a successful Phase 2A trial of PCS12852 in patients with gastroparesis, positioning the asset well for potential out-licensing or business development opportunities. Today, we are focusing our energy and efforts on the Next Generation Chemotherapies (NGCs) that can reshape the landscape of chemotherapy.

Our first NGC to move into Phase 2B will be Next Generation Capecitabine (NGC-Cap). Since 50-70% of the patients on capecitabine typically have dose-limiting side effects, one major benefit of NGC-Cap is to significantly decrease or potentially eliminate these side effects, so patients do not need to reduce their dose or discontinue treatment entirely. As a safer and potentially more efficacious version of the presently used capecitabine, the target population for NGC-Cap includes patients with such cancers as colorectal, breast, pancreatic, and many other solid tumor cancers. These cancers have more than 200,000 newly diagnosed cases per year in the U.S. We look forward to meeting with the FDA in mid-April to discuss our NGC-Cap Phase 2B trial and hope to initiate the Phase 2B trial in colorectal cancer in the second half of 2023. Given we are working with an approved established cancer-killing molecule, and we will be following the principles of Project Optimus, we anticipate efficiencies in the development of NGC-Cap that we believe will confer better odds of success, while providing better and safer drugs to hundreds of thousands of patients in need of better treatment options."

Financial Results for the Year Ended December 31, 2022

Our cash balance on December 31, 2022, was $6.5 million. Subsequent to year-end, we raised net proceeds of $6.4 million from the sale of 8,432,192 shares of our common stock through a combination of financing vehicles, including a registered direct offering to accredited investors. Based on our current plans, we believe the cumulative $12.9 million will be adequate to fund our operations into the third quarter of 2024.

Our net loss for the year ended December 31, 2022 was $27.4 million, or $1.70 per share, compared to a net loss of $11.4 million, or $0.75 per share for the same period of 2021. The increase in our net loss was primarily due to a one-time non-cash impairment of an intangible asset for $7.3 million, along with increased stock-based compensation and clinical trial costs.

For the year ended December 31, 2022, we incurred $11.5 million in research and development costs, compared to $6.9 million for the same period in 2021. Our general and administrative expenses totaled $8.8 million for the year ended December 31, 2022 compared to $4.7 million for the same period in 2021. The increase was primarily due to stock-based and other compensation costs. During the year ended December 31, 2022, we allocated $8.8 million of total non-cash compensation costs between our R&D and G&A costs, with the majority being recorded as G&A.

We used cash of $9.6 million during the year ended December 31, 2022 to fund our three clinical trials and operations versus $8.8 million of cash we used in 2021. Our operating cash flow is significantly less than our net loss primarily due to non-cash expenses.

As of March 27, 2022, we had 24.6 million common shares outstanding.

Conference Call Information

To participate in this event, please log-on or dial-in approximately 5 to 10 minutes before the beginning of the call.

Date: March 30, 2023
Time: 4:30 p.m. ET
Toll Free: 888-506-0062
International: 973-528-0011
Entry Code: 382258
Live Webcast: View Source

ONCOCYTE REPORTS PRELIMINARY FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS AND PLANS TO FILE FORM 12B-25 TO EXTEND FILING DATE OF ITS FORM 10-K

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.

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.

NightHawk Biosciences Provides 2022 Year End Business Update

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]).

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.

Labcorp to Announce First Quarter Financial Results on April 25, 2023

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.

Labcorp Logo

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.

Kineta Reports Full Year 2022 Financial Results and Provides Corporate Update

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]).

"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.