CYCLACEL PHARMACEUTICALS REPORTS FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE

On March 6, 2023 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported fourth quarter and full year 2022 financial results and provided a business update (Press release, Cyclacel, MAR 6, 2023, View Source [SID1234628186]).

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After a productive 2022, we anticipate that 2023 will be even more exciting for Cyclacel. We plan to advance oral fadraciclib, our CDK2/9 inhibitor, into Phase 2 proof-of-concept evaluating multiple cancer cohorts, and also further explore the anti-cancer potential of our oral PLK1 inhibitor plogosertib," said Spiro Rombotis, President and Chief Executive Officer. "We expect three key data readouts this year, including pharmacokinetic (PK), pharmacodynamic (PD), safety and activity data from the dose escalation part of our fadraciclib 065-101 Phase 1/2 study, initial clinical activity data from the Phase 2 proof of concept stage of the study and PK, PD, safety and activity data from the dose escalation part of our 140-101 Phase 1/2 study of plogosertib. These data have the potential to further demonstrate that fadraciclib and plogosertib are differentiated from other molecules in their respective classes

We are pleased with our pipeline’s progress in 2022 and believe that we have the opportunity to demonstrate promising results for our two drug candidates, fadraciclib and plogosertib, in the year ahead," said Mark Kirschbaum, M.D., Chief Medical Officer. "At the recent ENA 2022 Symposium we reported fadraciclib’s good tolerability profile and clear anti-cancer signals. We are currently recruiting patients at dose level 6a of 125mg administered orally twice daily for four out of four weeks. We plan to optimize the dosing schedule and move into Phase 2 testing of the tumor types that should be most sensitive to fadraciclib treatment. We are also advancing plogosertib through dose escalation and are now recruiting patients at dose level 4 in our Phase 1/2 solid tumor study. We have observed efficacy at lower dose levels with three patients on treatment for three to eight cycles. We expect to report additional data of our mechanistically differentiated PLK1 inhibitor from this trial later this year. We remain enthusiastic about Cyclacel’s advancing clinical-stage pipeline and look forward to presenting emerging data from these two programs during the year."

Key Business Objectives for 2023

· Report final data from dose escalation stage and RP2D determination from the 065-101 study of oral fadraciclib in patients with advanced solid tumors and lymphoma
· First patient dosed with oral fadraciclib in Phase 2 proof-of-concept stage of 065-101 study in patients with advanced solid tumors and lymphoma
· Report interim Phase 1 data from 140-101 study of oral plogosertib in patients with advanced solid tumors and lymphoma
· Report interim data from initial cohorts in Phase 2 proof-of-concept stage of 065-101 study with oral fadraciclib in patients with advanced solid tumors and lymphoma
· Report interim data from dose escalation stage of 065-102 study with oral fadraciclib in patients with advanced leukemia
· Report final data from dose escalation stage of 140-101 study with oral plogosertib in advanced solid tumors and lymphoma

Financial Highlights

As of December 31, 2022, cash and cash equivalents totaled $18.3 million, compared to $36.6 million as of December 31, 2021. Net cash used in operating activities was $20.8 million for the twelve months ended December 31, 2022 compared to $18.5 million for the same period of 2021. The Company estimates that its available cash, including the United Kingdom research & development tax credit receivable of $4.7 million, will fund currently planned programs into the fourth quarter of 2023

Research and development (R&D) expenses were $6.7 million and $20.3 million for the three months and year ended December 31, 2022, as compared to $4.6 million and $15.5 million for the same period in 2021. R&D expenses relating to fadraciclib were $5.3 million and $14.0 million for the three months and year ended December 31, 2022, as compared to $3.4 million and $11.1 million for the same period in 2021 due to increased costs associated with ongoing clinical trials evaluating fadraciclib in Phase 1/2 studies and an increase in non-clinical expenditures. R&D expenses related to plogosertib were $1.3 million and $5.5 million for the three months and year ended December 31, 2022, as compared to $1.1 million and $3.5 million for the same period in 2021 due to clinical trial costs associated with the plogosertib Phase 1/2 study.

General and administrative expenses for the three months and year ended December 31, 2022, were $2.1 million and $7.4 million, compared to $1.9 million and $7.5 million for the same period of the previous year due to an increase in employment and professional costs.

Total other income, net, for the three months and year ended December 31, 2022, were an expense of $0.2 million and income of $1.7 million, compared to an income of $43,000 and $0.2 million for the same period of the previous year. The increase of $1.5 million for the year ended December 31, 2022, is primarily related to royalty income.

United Kingdom research & development tax credits for the three months and year ended December 31, 2022 were $1.6 million and $4.7 million compared to $1.2 million and $3.8 million for the same period of the previous year and are directly correlated to qualifying research and development expenditure.

Net loss for the three months and year ended December 31, 2022, was $7.4 million and $21.2 million (including stock based compensation expense of $0.4 million and $1.5 million respectively), compared to $5.3 million and $18.9 million (including stock based compensation expense of $0.3 million and $1.2 million respectively) for the same period in 2021.

Conference call information:

US/Canada call: (800) 245-3047 / international call: (203) 518-9765

US/Canada archive: (800) 925-9627 / international archive: (402) 220-5390

Code for live and archived conference call is CYCCQ422. (Webcast link)

For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.

CTI BioPharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

On March 6, 2023 CTI BioPharma Corp. (Nasdaq: CTIC), a commercial biopharmaceutical company focused on the development and commercialization of novel targeted therapies for blood-related cancers, reported its financial results for the fourth quarter and full year ended December 31, 2022 (Press release, CTI BioPharma, MAR 6, 2023, View Source [SID1234628185]).

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"CTI is now established as a market leader in the treatment of cytopenic myelofibrosis following the accelerated approval and U.S. commercial launch of VONJO (pacritinib) over the past year," said Adam Craig, M.D., Ph.D., M.B.A., President, Chief Executive Officer and Interim Chief Medical Officer. "With the launch of VONJO in March 2022, we exceeded our year-end revenue goal by achieving $54 million in net sales in 2022 with strong quarter-over-quarter growth."

"As of year-end 2022, more than 1,000 patients were treated with VONJO, which is a significant milestone for this rare disease. Importantly, we have also achieved over 90% insurance coverage with both Medicare and Commercial plans. To further increase the market penetration of VONJO, our commercial team continues to reinforce the VONJO clinical value proposition for cytopenic myelofibrosis patients leveraging peer-to-peer interactions and education. New data presented at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting suggests the potential to strengthen the clinical differentiation for pacritinib through its potent Activin A receptor type 1 (ACVR1) inhibitor and anemia benefit. We look forward to continuing activities focused on market expansion in 2023, which are intended to drive quarter-over-quarter net sales increases," concluded, Dr. Craig.

2022 Key Accomplishments and Recent Highlights

•FDA approval of VONJO (pacritinib) for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L.
•$54 million in net sales in the first nine months following VONJO launch.
•Over 1,000 patients commercially treated with VONJO in 2022.

•Inclusion in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Myeloproliferative Neoplasms, with a recommendation for VONJO as a: First-line treatment option for higher-risk myelofibrosis patients with platelet counts <50 x 109/L who are not candidates for transplant; Second-line treatment option for: patients with higher-risk myelofibrosis who are not candidates for transplant with platelet counts ≥50 x 109/L with no response or loss of response to one prior JAK inhibitor and for patients with symptomatic lower-risk myelofibrosis with platelet counts <50 x 109/L with no response or loss of response to initial treatment.
•Oral presentation at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition highlighted pacritinib as a potent activin A receptor type 1 (ACVR1) inhibitor with significant anemia benefit in patients with myelofibrosis.
•On February 7, 2023, VONJO was granted seven years of orphan-drug exclusive approval by the FDA for treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 x109/L. The seven-year exclusive approval began on February 28, 2022.

Fourth Quarter and Full Year 2022 Financial Results

•Net Product Sales: Net product sales of $21.1 million and $53.9 million for the three months and year ended December 31, 2022, respectively, were entirely attributable to VONJO product sales in the United States. There were no product sales for the comparable periods in 2021.
•Operating Loss: Operating loss was $13.6 million and $35.4 million for the three months ended December 31, 2022 and 2021, respectively, and $79.8 million and $95.3 million for the years ended December 31, 2022 and 2021, respectively. The decrease in operating loss between the three-month periods ended December 31, 2022 and 2021 was primarily attributable to VONJO product sales. The decrease in operating loss between the years ended December 31, 2022 and 2021 resulted primarily from VONJO product sales, partially offset by an increase in selling, general and administrative activities related to the commercial launch of VONJO, as well as a $10.3 million milestone expense related to FDA approval of VONJO, which was included in other operating expenses.
•Net Loss: Net loss for the three months ended December 31, 2022 was $17.5 million, or $0.14 for basic and diluted loss per share, compared to net loss of $36.8 million, or $0.38 for basic and diluted loss per share, for the same period in 2021. Net loss for the year ended December 31, 2022 was $93.0 million, or $0.81 for basic and diluted loss per share, compared to net loss of $97.9 million, or $1.09 for basic and diluted loss per share, for the same period in 2021.
•Cash Position: As of December 31, 2022, cash, cash equivalents and short-term investments totaled $79.9 million, compared to $65.4 million as of December 31, 2021. Subsequent to the end of the quarter, the Company received $6.5 million in additional contractual funding from DRI Healthcare Trust in January 2023.

Conference Call and Webcast

CTI will host a webcast and conference call at 8:30 a.m. ET today to review its fourth quarter and full year 2022 financial results and provide a corporate update. The live and archived webcast may be accessed on the CTI BioPharma website under the Investors & Media section: Events and Presentations. To participate via telephone, please register in advance using the link provided in the event listing. The Company suggests participants log in 15 minutes in advance of the event.

About VONJO (pacritinib) capsules

VONJO (pacritinib) is an oral kinase inhibitor with activity against wild type Janus Associated Kinase 2 (JAK2), mutant JAK2V617F form, IRAK1, ACVR1 (ALK2) and FLT3, which contribute to signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. Myelofibrosis is often associated with dysregulated JAK2 signaling. At clinically relevant concentrations, pacritinib does not inhibit JAK1.

VONJO is indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. This indication is approved under accelerated approval based on spleen volume reduction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). CTI is conducting the Phase 3 PACIFICA study of VONJO in patients with myelofibrosis and severe thrombocytopenia as a post-marketing requirement.

Important VONJO Safety Information

•Hemorrhage: Serious (11%) and fatal (2%) hemorrhages have occurred in VONJO-treated patients with platelet counts <100 × 109/L. Serious (13%) and fatal (2%) hemorrhages have occurred in VONJO-treated patients with platelet counts <50 × 109/L. Grade ≥3 bleeding events (defined as requiring transfusion or invasive intervention) occurred in 15% of patients treated with VONJO compared to 7% of patients treated on the control arm. Due to hemorrhage, VONJO dose reductions, dose interruptions, or permanent discontinuations occurred in 3%, 3%, and 5% of patients, respectively. Avoid use of VONJO in patients with active bleeding and hold VONJO seven days prior to any planned surgical or invasive procedures. Assess platelet counts periodically, as clinically indicated. Manage hemorrhage using treatment interruption and medical intervention.

•Diarrhea: VONJO causes diarrhea in approximately 48% of patients compared to 15% of patients treated on the control arm. The median time to resolution in VONJO-treated patients was two weeks. The incidence of reported diarrhea decreased over time, with 41% of patients reporting diarrhea in the first eight weeks of treatment, 15% in weeks 8 through 16, and 8% in weeks 16 through 24. Diarrhea resulted in treatment interruption in 3% of VONJO-treated patients. None of the VONJO-treated patients reported diarrhea that resulted in treatment discontinuation. Serious diarrhea adverse reactions occurred in 2% of patients treated with VONJO compared to no such adverse reactions in patients in the control arm. Control pre-existing diarrhea before starting VONJO treatment. Manage diarrhea with antidiarrheal medications, fluid replacement, and dose modification. Treat diarrhea with antidiarrheal medications promptly at the first onset of symptoms. Interrupt or reduce VONJO dose in patients with significant diarrhea despite optimal supportive care.

•Thrombocytopenia: VONJO can cause worsening thrombocytopenia. VONJO dosing was reduced due to worsening thrombocytopenia in 2% of patients with pre-existing moderate to severe thrombocytopenia (platelet count <100 × 109/L). VONJO dosing was reduced due to worsening thrombocytopenia in 2% of patients with pre-existing severe thrombocytopenia (platelet count <50 × 109/L). Monitor platelet count prior to VONJO treatment and as clinically indicated during treatment. Interrupt VONJO in patients with clinically significant worsening of thrombocytopenia that lasts for more than seven days. Restart VONJO at 50% of the last given dose once the toxicity has resolved. If toxicity recurs hold VONJO. Restart VONJO at 50% of the last given dose once the toxicity has resolved.

•Prolonged QT interval: VONJO can cause prolongation of the QTc interval. QTc prolongation of >500 msec was higher in VONJO-treated patients than in patients in the control arm (1.4% vs 1%). QTc increase from baseline by 60 msec or higher was greater in VONJO-treated patients than in

control arm patients (1.9% vs 1%). Adverse reactions of QTc prolongation were reported for 3.8% of VONJO-treated patients and 2% of control arm patients. No cases of torsades de pointes were reported. Avoid use of VONJO in patients with a baseline QTc of >480 msec. Avoid use of drugs with significant potential for QTc prolongation in combination with VONJO. Correct hypokalemia prior to and during VONJO treatment. Manage QTc prolongation using VONJO interruption and electrolyte management.

•Major Adverse Cardiac Events (MACE): Another JAK-inhibitor has increased the risk of MACE, including cardiovascular death, myocardial infarction, and stroke (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which VONJO is not indicated. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with VONJO, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur.

•Thrombosis: Another JAK-inhibitor has increased the risk of thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which VONJO is not indicated. Patients with symptoms of thrombosis should be promptly evaluated and treated appropriately.

•Secondary Malignancies: Another JAK-inhibitor has increased the risk of lymphoma and other malignancies, excluding non-melanoma skin cancer (NMSC) (compared to those treated with TNF blockers), in patients with rheumatoid arthritis, a condition for which VONJO is not indicated. Patients who are current or past smokers are at additional increased risk. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with VONJO, particularly in patients with a known malignancy (other than a successfully-treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.

•Risk of Infection: Another JAK-inhibitor has increased the risk of serious infections compared to best available therapy (BAT) in patients with myeloproliferative neoplasms. Serious bacterial, mycobacterial, fungal and viral infections may occur in patients treated with VONJO. Delay starting therapy with VONJO until active serious infections have resolved. Observe patients receiving VONJO for signs and symptoms of infection and manage promptly. Use active surveillance and prophylactic antibiotics according to clinical guidelines.

•Interactions with CYP3A4 Inhibitors or Inducers: Co-administration of VONJO with strong CYP3A4 inhibitors or inducers is contraindicated. Avoid concomitant use of VONJO with moderate CYP3A4 inhibitors or inducers. Drug interruptions due to an adverse reaction occurred in 27% patients who received VONJO 200 mg twice daily compared to 10% of patients treated with BAT. Dosage reductions due to an adverse reaction occurred in 12% of patients who received VONJO 200 mg twice daily compared to 7% of patients treated with BAT. Permanent discontinuation due to an adverse reaction occurred in 15% of patients receiving VONJO 200 mg twice daily compared to 12% of patients treated with BAT.

Please click here for full Prescribing Information and the Medication Guide.

About Myelofibrosis

Myelofibrosis is bone marrow cancer that results in formation of fibrous scar tissue and can lead to thrombocytopenia and anemia, weakness, fatigue and an enlarged spleen and liver. Within the United States, there are approximately 21,000 patients with myelofibrosis, 7,000 of which have severe

thrombocytopenia (defined as blood platelet counts of less than 50 x109/L). Severe thrombocytopenia is associated with poor survival and high symptom burden and can occur as a result of disease progression or from drug toxicity with other JAK2 inhibitors.

Coherus BioSciences Reports Fourth Quarter and Full Year 2022 Results

On March 6, 2023 Coherus BioSciences, Inc. ("Coherus" or the "Company", Nasdaq: CHRS), reported financial results for its fiscal fourth quarter and full year ended December 31, 2022 and recent business highlights (Press release, Coherus Biosciences, MAR 6, 2023, View Sourcenews-releases/news-release-details/coherus-biosciences-reports-fourth-quarter-and-full-year-2022#:~:text=Net%20revenue%20was%20%2445.4%20million" target="_blank" title="View Sourcenews-releases/news-release-details/coherus-biosciences-reports-fourth-quarter-and-full-year-2022#:~:text=Net%20revenue%20was%20%2445.4%20million" rel="nofollow">View Source,was%20launched%20in%20October%202022%20. [SID1234628184])

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RECENT BUSINESS HIGHLIGHTS

The U.S. Food and Drug Administration (FDA) has notified the Company of the planned dates in the second quarter of 2023 for its required inspection of the toripalimab manufacturing facility in China. The inspection, previously hindered by COVID-related travel restrictions, is part of the FDA’s review of the biologics license application (BLA) for toripalimab, a PD-1 inhibitor for the treatment of nasopharyngeal carcinoma (NPC). Coherus plans to launch toripalimab in the U.S. directly upon potential approval by the FDA.
The FDA on March 3, 2023 approved a single-dose, prefilled autoinjector presentation of UDENYCA (pegfilgrastim-cbqv), which represents the first presentation innovation in the pegfilgrastim space in eight years and highlights Coherus’ commitment to developing innovative treatments that expand access and address the needs of patients undergoing cancer treatment. Coherus plans to launch UDENYCA AI in the second quarter.
The FDA review of the prior approval supplement for Coherus’ third pegfilgrastim presentation, the UDENYCA on-body injector (OBI), is ongoing, and Coherus plans to launch UDENYCA OBI directly upon potential approval later this year.
In February, the U.S. Centers for Medicare & Medicaid Services (CMS) assigned to CIMERLI (ranibizumab-eqrn) a permanent, product-specific Q-code, which will become active on April 1, 2023. The Q-code is expected to enable more efficient billing processes and speed time to reimbursement for providers.
On March 3, 2023, Coherus implemented a reduction in force impacting approximately 60 full-time and part-time employees in order to focus resources on strategic priorities including the commercialization of its diversified product portfolio and development of innovative immuno-oncology product candidates.
Coherus is introducing a guidance range of combined R&D and SG&A expenses for 2023 of $315 to $335 million. This guidance reflects nearly $100 million in expense reductions compared to prior 2023 guidance provided in April 2022.
"2023 will be a year of continued transformation for Coherus with significant value drivers including four anticipated product launches and multiple upcoming clinical catalysts," said Denny Lanfear, Coherus’ Chairman and Chief Executive Officer. "We are strengthening the UDENYCA franchise by offering unprecedented choice for patients and physicians with a prefilled syringe, autoinjector, and an on-body injector presentation of pegfilgrastim expected later this year. With onsite manufacturing inspections now being scheduled for toripalimab, we look forward to the approval and launch of toripalimab in NPC. We remain sharply focused on commercial execution as we accelerate near-term revenue growth with CIMERLI, our Lucentis biosimilar, further penetrate the pegfilgrastim market with new presentations for UDENYCA, prepare for the launch of our Humira biosimilar, YUSIMRY, and gain approval for and launch toripalimab in NPC."

Mr. Lanfear continued: "We expect significant topline revenue growth in 2023 and beyond as we execute commercially on our new product launches. We are also tightly focused on expense management throughout the Company and in coordination with our development and manufacturing partners, and the 2023 operating expense guidance we are providing today is nearly $100 million lower than we projected in April 2022. We expect revenue growth and expense control to enable a return to profitability in 2024."

FOURTH QUARTER and FULL YEAR 2022 FINANCIAL RESULTS

Net revenue was $45.4 million during the three months ended December 31, 2022 and included $38.3 million of net sales of UDENYCA and $6.9 million of net sales of CIMERLI, which was launched in October 2022. Net sales of UDENYCA for the fourth quarter of 2022 were reduced by a $4.7 million charge for a contingent liability related to resolving a dispute regarding certain sales from October 2020 through December 2021. Net revenue was $73.4 million during the three months ended December 31, 2021. For the twelve months ended December 31, 2022 and 2021, net revenue was $211.0 million and $326.6 million, respectively, and consisted primarily of net sales of UDENYCA. The decline for both the fourth quarter and the full year 2022 was primarily due to a decrease in the number of units of UDENYCA sold as well as a lower net realized price due to increased competition.

Cost of goods sold (COGS) was $14.2 million and $12.1 million during the three months ended December 31, 2022 and 2021, respectively, and $70.1 million and $57.6 million during the full year ended December 31, 2022 and 2021, respectively. COGS for the full year of 2022 included a $26.0 million write-down taken in the third quarter 2022 for inventory at risk of expiration, and 2021 included the write-down of $5.1 million of inventory that did not meet Coherus’ acceptance criteria. UDENYCA COGS also includes a mid-single digit royalty on net sales payable through the first half of 2024, and CIMERLI COGS includes a low to mid 50% royalty on gross profits.

Research and development (R&D) expense for the three months ended December 31, 2022 and 2021 was $29.0 million and $50.8 million, respectively, driven by lower development costs. For the full year ended December 31, 2022 and 2021, R&D expense was $199.4 million and $363.1 million, respectively. The decrease was primarily due to the $136.0 million upfront license fee paid to Junshi Biosciences in 2021, less spending in 2022 related to additional presentations of UDENYCA, and higher YUSIMRY development costs in 2021 for pre-approval inspections, all partially offset by the $35.0 million option exercise fee for CHS-006 in the first quarter of 2022.

Selling, general and administrative (SG&A) expense was $53.6 million and $50.1 million during the three months ended December 31, 2022 and 2021, respectively, and $198.5 million and $169.7 million during the full year ended December 31, 2022 and 2021, respectively. The increases were primarily driven by higher commercialization expenses in preparation for the commercial launch of CIMERLI in 2022 and for multiple new product launches anticipated in 2023, including, of toripalimab, YUSIMRY, the autoinjector and the on-body injector presentations of UDENYCA.

Net loss for the fourth quarter of 2022 was $58.9 million, or $(0.76) per share on a basic and diluted basis, compared to a net loss of $45.7 million, or $(0.60) per share on a basic and diluted basis for the same period in 2021. Net loss for the full year of 2022 was $291.8 million, or $(3.76) per share on a basic and diluted basis, compared to a net loss of $287.1 million, or $(3.81) per share on a basic and diluted basis for the full year of 2021.

Non-GAAP net loss for the fourth quarter of 2022 was $47.1 million, or $(0.60) per share on a basic and diluted basis, compared to non-GAAP net loss of $35.1 million, or $(0.46) per share on a basic and diluted basis for the same period in 2021. Non-GAAP net loss for the full year of 2022 was $234.8 million, or $(3.02) per share on a basic and diluted basis, compared to non-GAAP net loss of $224.5 million, or $(2.98) per share on a basic and diluted basis for the full year of 2021. Beginning in the first quarter of 2022, the Company no longer regularly excludes upfront and milestone-based license fee payments from its non-GAAP financial information. To conform to this change, the prior period non-GAAP financial information has been recast to include upfront and milestone-based license fee payments. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net loss and a reconciliation to the most directly comparable GAAP measures.

Cash, cash equivalents and investments in marketable securities were $191.7 million as of December 31, 2022, compared to $417.2 million at December 31, 2021.

2023 R&D and SG&A Expense Guidance

Coherus is introducing a guidance range of combined 2023 R&D and SG&A expenses from $315 to $335 million. This guidance includes approximately $50 million of stock-based compensation expense and excludes any collaboration upfront payments to Klinge Pharma for the in-license of their Eylea biosimilar program or milestones payments to Junshi Biosciences due upon U.S. approval of toripalimab. This financial guidance also excludes the effects of any potential future strategic acquisitions, collaborations or investments, the exercise of rights or options related to collaboration programs, and any other transactions or circumstances not yet identified or quantified. This guidance is subject to a number of risks and uncertainties. See Forward-Looking Statements described in the section below.

Conference Call Information
When: Monday, March 6th, 2023, starting at 5 p.m. ET

Please register through the following link for dial-in information and personal PIN:
View Source

Please register 15 minutes early to ensure a timely connection to the call.

A replay of the webcast will be archived at View Source

FDA Approves UDENYCA® Autoinjector

On March 6, 2023 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported that the U.S. Food and Drug Administration ("FDA") approved a single-dose, prefilled autoinjector presentation of UDENYCA (pegfilgrastim-cbqv), a biosimilar pegfilgrastim administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia (Press release, Coherus Biosciences, MAR 6, 2023, View Source [SID1234628183]). The UDENYCA autoinjector has a streamlined, easy-to-use design for use in both in-office and at-home settings of care.

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"The introduction of the autoinjector option for UDENYCA, with the ability to be administered at home or in the doctor’s office, will provide increased choice and control for patients and physicians, ultimately making treatment more accessible to patients," said Dr. Lee Schwartzberg, Chief of Medical Oncology and Hematology at the Renown Health William N. Pennington Cancer Institute, and Professor of Clinical Medicine, University of Nevada. "There are certain types of cancer patients, those who live far away, have an active lifestyle, or who are supporting the needs of a busy family, for whom this option eliminates the need to return to the clinic and enables them to choose the time and place for treatment without having to wear an on-body device."

"The UDENYCA autoinjector represents the first innovation in the pegfilgrastim space in eight years and highlights Coherus’ commitment to developing innovative solutions that expand access and address the needs of patients undergoing cancer treatment," said Denny Lanfear, CEO of Coherus.

The UDENYCA autoinjector (AI) is an intuitive design with administration triggered by push-on-skin activation, immediately and reliably delivering a complete pegfilgrastim dose. The approval of UDENYCA AI was supported by a comprehensive analytical data package, as well as a pharmacokinetic, pharmacodynamic and immunogenicity study.1

Commercial availability of UDENYCA AI is planned for the second quarter of 2023.

About UDENYCA

UDENYCA is the only pegfilgrastim brand offering two on-demand options—prefilled syringe (PFS) and AI providing more choice and flexibility customized to meet the needs of patients and practices. UDENYCA (pegfilgrastim-cbqv) administered via a proprietary on-body injector (OBI) device is under review by the FDA. If approved, UDENYCA OBI would offer providers a highly desired alternative to the originator’s on-body pegfilgrastim delivery system. Since its launch in 2019, over 263,000 patients have been treated with UDENYCA.

INDICATION
UDENYCA is a leukocyte growth factor indicated to

Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).
Limitations of Use: UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: Patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis.

WARNINGS AND PRECAUTIONS:

Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
Acute respiratory distress syndrome (ARDS):
Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCA in patients with ARDS.
Serious allergic reactions, including anaphylaxis: The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue UDENYCA in patients with serious allergic reactions.
Sickle cell crises: Severe and sometimes fatal crises have occurred. Discontinue UDENYCA if sickle cell crisis occurs.
Glomerulonephritis: The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events resolved after dose reduction or discontinuation. Evaluate and consider dose-reduction or interruption of UDENYCA if causality is likely.
Leukocytosis: White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of complete blood count (CBC) during UDENYCA therapy is recommended.
Thrombocytopenia: Thrombocytopenia has been reported in patients receiving pegfilgrastim. Monitor platelet counts.
Capillary Leak Syndrome: Has been reported after G-CSF administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. If symptoms develop, closely monitor and give standard symptomatic treatment, which may include a need for intensive care.
Potential for Tumor Growth Stimulatory Effects on Malignant Cells: The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer: MDS and AML have been associated with the use of pegfilgrastim in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for sign and symptoms of MDS/AML in these settings.
Aortitis: Has been reported in patients receiving pegfilgrastim products, occurring as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis when signs and symptoms develop without known etiology. Discontinue UDENYCA if aortitis is suspected.
Nuclear Imaging: Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. Consider when interpreting bone imaging results.
ADVERSE REACTIONS: Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.

To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences at 1-800-4-UDENYCA (1-800-483-3692) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full Prescribing Information available at www.UDENYCA.com

Calyxt, Inc. Reports its Fourth Quarter 2022 Financial Results and Provides Corporate Update

On March 6, 2023 Cellectis S.A. (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, reported that Calyxt, Inc. (Nasdaq: CLXT), a plant-based synthetic biology company for which Cellectis owns 49.1% (as of December 31, 2022) of its issued and outstanding common stock, reported operating and financial results for its fourth quarter ended December 31, 2022 (Press release, Cellectis, MAR 6, 2023, View Source [SID1234628182]). The contents of Calyxt’s announcement are included below:

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—Announced proposed merger with Cibus Global and filed initial registration statement on Form S-4—

—Current customer projects under development are on track—

—Signed agreement with Evologic Technologies to further develop and scale production of its Plant Cell Matrix and BioFactoryTM technologies—

Merger Agreement with Cibus

On January 17, 2023, Calyxt announced it had entered into a definitive merger agreement with Cibus Global, LLC (Cibus), a leader in precision gene editing in agriculture, under which Calyxt and Cibus will merge in an all-stock transaction. The merger will create a new industry-leading company that combines the two pioneers in agriculture-based gene editing and establishes one of the world’s most sophisticated facilities for trait development and next-generation plant breeding.

Under the terms of the merger agreement, Calyxt will issue shares of its common stock to Cibus shareholders in an exchange ratio such that upon completion of the merger, Calyxt shareholders will own approximately 5% of the combined company, subject to adjustments permitted by the merger agreement. The Boards of Directors of both companies have unanimously approved the transaction. Concurrent with the execution of the merger agreement, certain officers of Calyxt, all of Calyxt’s directors, and Cellectis S.A., Calyxt’s largest shareholder, executed support agreements in favor of the merger. These support agreements provide 49.8% approval from Calyxt shareholders. A majority of Cibus’ shareholders have also provided support agreements in favor of the transaction. The merger is expected to close in the second quarter of 2023, subject to customary closing conditions, including approval of the merger by the shareholders of Calyxt.

"Cibus is an excellent strategic fit for Calyxt given our complementary technology platforms, and the merger provides a great opportunity to leverage multiple synergies to drive innovation and shareholder value," said Michael A. Carr, President and Chief Executive Officer of Calyxt. "I am deeply proud of the significant accomplishments made by our team and their commitment to further the science of biotechnology and synthetic biology in significant ways."

Upon closing of the transaction, the combined company, renamed Cibus Inc., is expected to trade on the Nasdaq Capital Market under the proposed ticker symbol CBUS. The current Cibus management team will lead the new combined organization with Rory Riggs assuming the roles of Chair of the Board of Directors and Chief Executive Officer. Corporate headquarters for the combined company will be located in San Diego, California and Calyxt’s offices, laboratory, and breeding facilities in Roseville, Minnesota will remain operational as a key site for the combined company.

On February 14, 2023, Calyxt filed a registration statement on Form S-4 (the "Registration Statement") with the U.S. Securities and Exchange Commission. The Registration Statement contains a preliminary proxy statement / prospectus in connection with the transaction. Although the Registration Statement has not yet become effective and the information contained therein is subject to change, it provides important information about Calyxt and the proposed transactions.

Other key accomplishments in the fourth quarter of 2022, and through the date of this press release, include the following:

Current Customer Projects Under Development are on Track

Calyxt continued to progress the pilot project for a major consumer packaged goods company with delivery of initial quantities of a plant-based chemistry for customer evaluation expected in the second quarter of 2023.
Calyxt continued to progress the development of its soybean-based palm oil alternative plant trait and it achieved the first milestone payment in the fourth quarter of 2022, with the overall project scheduled for completion in the first quarter of 2024, at which time the second milestone payment would be due.
Signed Agreement with Global Infrastructure Partner to Enable Growth and Scale of Calyxt’s Proprietary Plant Cell Matrix and BioFactory Technologies

On October 6, 2022, Calyxt announced that it signed an agreement with a manufacturing partner, Evologic Technologies GmbH (Evologic), to further develop and scale Calyxt’s proprietary Plant Cell Matrix (PCMTM) and BioFactory technologies. Evologic’s contract development and manufacturing services, based on its proprietary bioprocessing platform and technology, supports companies delivering unique and sustainable bioproducts. Under the terms of the agreement, Evologic will work alongside Calyxt to grow and scale Calyxt’s proprietary PCM structures and is currently scaling one PCM for Calyxt.
Additional Updates

In early November 2022, Calyxt reached a settlement with one of its technology vendors regarding alleged intellectual property infringement. As a result of the settlement, Calyxt received $750 thousand in the fourth quarter of 2022 and received another $750 thousand earlier in the first quarter of 2023.
Financial Results for the Three Months Ended December 31, 2022

Cash, cash equivalents, and restricted cash totaled $3.5 million as of December 31, 2022.
Revenue was nominal in the fourth quarter of 2022 compared to $1.9 million in the fourth quarter of 2021. The decrease in revenue was driven by the late 2021 completion of the wind-down of the Company’s soybean product line. Revenue in the fourth quarter of 2022 was primarily associated with the Company’s agreement with a food ingredient manufacturer to develop a palm oil alternative.
Total operating expenses were $3.4 million in the fourth quarter of 2022 compared to $6.6 million in the fourth quarter of 2021. The decrease was driven by actions taken by management to lower Calyxt’s operating expenses.
Cash runway, considering interim funding to be provided by Cibus as described in the Merger Agreement, is sufficient to fund operations through the second quarter of 2023.