On May 11, 2022 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported first quarter 2022 financial results and provided a business update (Press release, Cyclacel, MAY 11, 2022, View Source [SID1234614218]).

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"We are pleased to report another productive quarter for Cyclacel, which included continued expansion of our three, registration-directed, clinical trials and publication of research findings supporting our drug development strategy," said Spiro Rombotis, Chief Executive Officer of Cyclacel. "Oral fadraciclib, our CDK2/9 drug candidate, is proving to be well tolerated in 065-101, our Phase 1/2 solid tumor and lymphoma study, having reached dose level 5 in the dose escalation stage which provides for daily dosing over 4 out of 4 weeks. In our PLK1 program, we have dosed the first patients in the streamlined Phase 1/2 trial of CYC140 for the treatment of solid tumors and lymphomas. We have optimized the properties of CYC140 to fit its apoptosis-driven mechanism, including short half-life and differentiated structural and biological properties, compared to other PLK1 inhibitors in development. We therefore believe CYC140 has the potential to demonstrate activity across a wide range of solid tumors, as a single agent and in combinations."

"A growing body of preclinical research supports the clinical development plan of fadraciclib. In April, we announced publication of research from The University of Texas MD Anderson Cancer Center highlighting fadraciclib’s antileukemic activity in CLL. Fadraciclib treatment resulted in suppression of MCL1, a key target protein. In addition, synergy of fadraciclib in combination with venetoclax was observed against primary CLL cell lines, including those with 17p deletion. With funding estimated through mid-2023, we are continuing to execute on our clinical development plan. We look forward to presenting initial fadraciclib clinical data in solid tumors and lymphomas, in the coming weeks, determining the recommended Phase 2 dose and entering proof of concept stage in the second half of 2022."

Key Highlights

·Fadraciclib 065-101 Phase 1/2 study in advanced solid tumors: Phase 1 dose escalation has reached dose level 5 (100mg given twice a day for 5 days for 4 weeks in a 4-week cycle) with a favorable patient safety profile and appropriate pharmacokinetic data observed thus far. The study is enrolling at four sites with several additional sites planning to join the proof-of-concept stage of this registration-directed study in 2H 2022. The Phase 2 part includes seven histologically defined cohorts thought to be sensitive to the drug’s mechanism: breast, colorectal (including KRAS mutant), endometrial/uterine, hepatobiliary, ovarian cancers and lymphomas. The study also includes an eighth basket cohort which will enroll patients regardless of histology with biomarkers relevant to the drug’s mechanism, including MCL1, MYC and/or cyclin E amplified.

·Fadraciclib 065-102 Phase 1/2 study in patients with leukemias or myelodysplastic syndromes. This study is now enrolling at City of Hope and MD Anderson Cancer Center and is treating patients at dose level one. Once the recommended Phase 2 dose (RP2D) for single-agent, oral fadraciclib is determined, the study will enter into proof-of-concept, cohort stage, where fadraciclib will be administered, both as a single agent and in combinations, to patients in up to seven cohorts relevant to the drug’s mechanism of action and informed by the clinical activity of fadraciclib in previous studies. Single-agent cohorts will include patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) who have an inadequate response or have progressed on venetoclax combinations with hypomethylating agent (HMA) or low dose Ara C and relapsed/refractory AML or MDS patients with FLT3, KIT or MAPK pathways (including N and K RAS, BRAF, PTPN11, NF1). The trial will also include patients with CLL who have progressed after at least two lines of therapy including a BTK inhibitor and/or venetoclax.

Announced publication confirming fadraciclib suppresses MCL1 and synergizes with venetoclax in chronic lymphocytic leukemia. Results from the study confirmed that fadraciclib inhibited CDK9 mediated transcription, reduced levels of the short-lived, anti-apoptotic protein MCL1, and induced apoptosis in primary CLL cells. The data highlighted the importance of continuous treatment to prevent recovery of MCL1 protein levels. Furthermore, fadraciclib was shown to combine synergistically with the BCL2 antagonist, venetoclax, and demonstrated even greater synergy when targeted against 17p deleted CLL cells which were not sensitive to either agent alone.

·CYC140 140-101 Phase 1/2 study in solid tumors and lymphomas. This registration-directed study opened in April at City of Hope and MD Anderson Cancer Center and is enrolling patients in the Phase 1 dose escalation stage. The study uses a streamlined design and will initially determine RP2D for single-agent oral CYC140. Following RP2D, the trial will immediately enter into proof-of-concept, cohort stage, using a Simon 2-stage design. In this stage CYC140 will be administered to patients in up to seven mechanistically relevant cohorts including patients with bladder, breast, colorectal (including KRAS mutant), hepatocellular and biliary tract, and lung cancers (both small cell and non-small cell), as well as lymphomas plus an eighth basket cohort which will enroll patients with biomarkers relevant to the drug’s mechanism.

More information on our clinical trials can be found here.

Financial Highlights

As of March 31, 2022, cash and cash equivalents totaled $29.6 million, compared to $36.6 million as of December 31, 2021. Subsequent to the end of the first quarter, the Company received $3.6 million of United Kingdom research & development tax credits and $1.3 million in royalty receipts providing pro forma March 31, 2022, cash and cash equivalents of $34.5 million. The Company estimates that its available cash will fund currently planned programs through June 2023.

Research and development (R&D) expenses were $5.0 million for the three months ended March 31, 2022, as compared to $2.6 million for the same period in 2021. R&D expenses relating to fadraciclib were $3.6 million for the three months ended March 31, 2022, as compared to $1.7 million for the same period in 2021 due to increase in clinical trial costs associated with ongoing clinical trials evaluating fadraciclib in Phase 1/2 studies along with an increase in non-clinical expenditures. R&D expenses related to CYC140 were $1.1 million for the three months ended March 31, 2022, as compared to $0.7 million for the same period in 2021 due to clinical trial costs associated with the opening of clinical sites for CYC140 Phase 1/2 studies.

General and administrative expenses for the three months ended March 31, 2022, were $1.6 million, compared to $1.7 million for the same period of the previous year due to a decrease in professional and recruitment costs.

Total other income, net, for the three months ended March 31, 2022, was $1.3 million, compared to $0.1 million for the same period of the previous year. The increase of $1.2 million for the three months ended March 31, 2022, is primarily related to royalty income received from Thermo Fisher Scientific Corporation.

United Kingdom research & development tax credits were $1.1 million for the three months ended March 31, 2022, as compared to $0.7 million for the same period in 2021 as a direct consequence of increased qualifying research and development expenditure. Tax credit receipts of $3.6 million in respect of the financial year ended December 31, 2021, were received in May 2022.

Net loss for the three months ended March 31, 2022, was $4.1 million, compared to $3.5 million for the same period in 2021.

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.

On May 11, 2022 Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics company with the mission to improve patient outcomes by providing personalized insights that inform critical decisions throughout the patient care journey, reported that financial results for the first quarter 2022, ended March 31, 2022 (Press release, Oncocyte, MAY 11, 2022, View Source [SID1234614217]).

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First Quarter and Recent Highlights:

Reported total revenue of $1.4 million in the first quarter of 2022, compared with $1.1 million in the first quarter of 2021.
Launched our CLIA validated lab test for TheraSure Liver Transplant Monitoring, a donor-derived cell-free DNA (dd-cfDNA) test which has shown to successfully achieve an early indication of rejection episodes in organ transplant patients using a digital polymerase chain reaction (dPCR) technique.
Closed a platform partnership with Thermo Fisher to gain access to Ex-US channel for the Determa product line
Completed Irvine facility build out and installed Genexus instruments to begin DetermaIO IVD Kit process.
Completed an equity financing by raising $32.8 million in common stock to strengthen the balance sheet and further support our product portfolio.
"We continued to make solid progress in the first quarter, delivering 73% year over year growth in DetermaRx sample volumes and successfully onboarding new physicians and accounts. We also successfully completed an underwritten financing to strengthen our balance sheet and fuel our upcoming product launch efforts," said Ron Andrews, President and Chief Executive Officer of Oncocyte. "Looking ahead, we remain enthusiastic about our upcoming DetermaIO data releases at ASCO (Free ASCO Whitepaper) in early June and the continued rapid progress we have made to launch our transplant business as we announced last week. We also remain on track to submit three additional oncology tests, DetermaIO, DetermaTx and DetermaCNI, for reimbursement over the next 12-18 months. I appreciate the continued support of our shareholders and look forward to updating you as we execute on our strategic plans."

First Quarter 2022 Financial Results

Total revenue was $1.4 million for the first quarter of 2022, compared to $1.1 million for the prior quarter. First quarter revenues associated with DetermaRx were $1.0 million, up $0.2 million sequentially, and up $0.4 million year over year. Operating expenses for the first quarter 2022 were $9.4 million, compared to $11.4 million, a decrease of $2.0 million from the same period in the prior year. Research and Development expense for the first quarter 2022 was $5.1 million, an increase of $1.8 million from the same period a year ago. The increase in R&D expense was related to increased headcount in support of clinical trials in oncology and transplant. General and Administrative expense for the first quarter of 2022 was $5.7 million, an increase of $0.9 million for the same period in 2021, due primarily due to an increase in personnel and related expenses. Sales and Marketing expense in the quarter was $3.2 million, an increase of $1.0 million year over year, primarily attributable to an increase in headcount and continued ramp in sales and marketing activities related to the transplant business, as well as support the commercialization efforts within oncology.

Net loss was $10.3 million for the first quarter of 2022 and net loss per share was $0.11 on a weighted-average basic and diluted share count of 92.2 million, compared to a net loss of $3.9 million and a net loss per share of $0.05 on a weighted-average basic and diluted share count of 82.1 million in the same period of the prior year.

Cash, cash equivalents, restricted cash and marketable securities were $22.7 million as of March 31, 2022.

Webcast and Conference Call Information
Oncocyte will host a conference call to discuss the first quarter 2022 financial results after market close on Wednesday, May 11, 2022 at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time. The conference call can be accessed live over the phone (877) 407-9716 for U.S. callers or (201) 493-6779 for international callers, using conference ID: 13729461. The live webinar can be accessed at View Source

On May 11, 2022 GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver diseases, reported its cash position as of March 31, 2022 and revenues for the first three months of 2022 (Press release, Genfit, MAY 11, 2022, View Source [SID1234614216]).

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Cash position

As of March 31, 2022, the Company’s cash and cash equivalents amounted to €222.2 million compared with €108.9 million as of March 31, 2021 and €258.8 million as of December 31, 2021.

The increase in cash and cash equivalents between March 31, 2021 and March 31, 2022 takes into account the collaboration and license agreement signed with Ipsen in December 2021 which granted Ipsen an exclusive worldwide license to develop, manufacture and commercialize GENFIT’s investigational treatment elafibranor.1 As part of this licensing agreement, GENFIT received a non- refundable upfront payment of €120.0 million euros in December 2021, as well as €24.0 million in VAT collected on that amount. Furthermore, to underscore the long-term commitment represented by this partnership, Ipsen purchased newly issued GENFIT equity representing 8% post-issuance through a €28.0 million investment in GENFIT.

This increase also comprises three non-dilutive loans, which include two State-Guaranteed Loans from a pool of partner banks and Bpifrance respectively, as well as a subsidized loan from Bpifrance for an amount totaling €15.2 million euros.

The decrease in cash and cash equivalents between December 31, 2021 and March 31, 2022 notably includes the payment in January 2022 of the amount of €24.0 million representing the VAT collected on the initial upfront payment received from Ipsen in December 2021.

1 With the exception of China, Hong Kong, Taiwan, and Macau where Terns Pharmaceuticals holds the exclusive license to develop and commercialize elafibranor

Revenues

Revenues for the first three months of 2022 amounted to €3. 895 million compared to €1 thousand for the same period in 2021.

The initial upfront payment from Ipsen in December 2021 was partially recognized as deferred revenue, amounting to €40.0 million as at the end of 2021, to be gradually recognized as revenue following the completion of the ELATIVE double-blind study, in accordance with the IFRS 15 norms. Revenues for the first three months of 2022 mainly came from the partial recognition of this amount corresponding to this period.

On May 11, 2022 Onconova Therapeutics, Inc. (NASDAQ: ONTX), ("Onconova"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported financial results for the three months ended March 31, 2022, and provided a business update (Press release, Onconova, MAY 11, 2022, View Source [SID1234614215]).

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Highlights for the first quarter of 2022 and recent weeks include:

The ongoing Phase 1 solid tumor trials of narazaciclib in the United States and China continue to generate encouraging safety data with the maximum tolerated dose not yet reached in either trial. The trial in the United States is currently enrolling into its fourth dose cohort, which is evaluating a 160 mg dose administered orally each day (i.e. continuous daily dosing). The trial in China is enrolling into its fifth dose cohort, which is evaluating a 200 mg dose administered orally once a day on days 1-21 of 28-day cycles. A protocol amendment is being prepared to enable further dose escalation in the trial in China.
An abstract titled "Narazaciclib’s kinase inhibitory activity is differentiated from approved CDK4/6 inhibitors in preclinical models," has been accepted for publication at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Rigosertib’s investigator-sponsored program has seen progress across multiple ongoing and planned trials. The expansion cohort of the Phase 1/2a study of oral rigosertib plus nivolumab in patients with KRAS+ non-small cell lung cancer (NSCLC) continues to enroll patients, as does the Phase 2 trial of rigosertib monotherapy in advanced squamous cell carcinoma associated with recessive dystrophic epidermolysis bullosa (RDEB-associated SCC). A planned Phase 2 trial of rigosertib plus pembrolizumab in patients with metastatic melanoma was recently cleared to proceed by the United States Food and Drug Administration (FDA) following a review of its protocol.
Management Commentary

"We are pleased to be advancing two highly differentiated therapeutic candidates towards near-term milestones with cash runway expected to extend for at least eighteen months," said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. "We remain on track to identify narazaciclib’s recommended Phase 2 dose later this year, which will enable us to move forward into later-stage studies designed to evaluate its safety and efficacy in monotherapy and combination settings. As we finalize the specifics of these upcoming trials, we will continue to be informed by the results of our ongoing Phase 1 program and preclinical studies. The results of these studies to-date set narazaciclib apart from currently approved CDK4/6 inhibitors, and we look forward to building on these data in future trials."

Dr. Fruchtman continued, "Rigosertib’s investigator sponsored study program is also moving towards key catalysts. Later this quarter, our collaborators expect to initiate a Phase 2 study evaluating rigosertib plus anti-PD-1 therapy in metastatic melanoma patients refractory to checkpoint blockade. This trial is supported both by preclinical data that demonstrate rigosertib’s immunotherapeutic effects, and prior clinical results from the ongoing investigator sponsored study of the rigosertib-anti-PD-1 combination therapy in KRAS-mutated NSCLC. These initial results showed the studied doublet generating responses in refractory patients who previously failed therapy with a checkpoint inhibitor, a finding we hope to replicate in melanoma. We have continued to amass data in NSCLC since this initial readout, and look forward to providing updated results from the ongoing Phase 1/2a trial by the end of the year. The advancement of this and rigosertib’s other investigator-sponsored studies is expected to serve as a valuable complement to our narazaciclib program, which remains our core focus."

First Quarter Financial Results

Cash and cash equivalents as of March 31, 2022, were $50.8 million, compared with $55.1 million as of December 31, 2021. The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations for at least eighteen months.

Research and development expenses were $2.0 million for the first quarter of 2022, compared with $1.9 million for the first quarter of 2021.

General and administrative expenses were $2.2 million for the first quarter of 2022, compared with $2.2 million for the first quarter of 2021.

Net loss for the first quarter of 2022 was $4.1 million, or $0.20 per share on 20.9 million weighted average shares outstanding, compared with a net loss of $4.7 million, or $0.32 per share for the first quarter of 2021 on 14.6 million weighted average shares outstanding.

Conference Call and Webcast

Onconova will host an investment community conference call today beginning at 4:30 p.m. Eastern Time, during which management will discuss financial results for the first quarter of 2022, provide a business update, and answer questions. Interested parties can participate by dialing (855) 428-5741 (domestic callers) or (210) 229-8823 (international callers) and using conference ID 7369861.

A live webcast of the conference call will be available in the Investors & Media section of the Company’s website at www.onconova.com. A replay of the webcast will be available on the Onconova website for 90 days following the call.

On May 11, 2022 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported its financial results for the first quarter ended March 31, 2022 (Press release, Acorda Therapeutics, MAY 11, 2022, View Source [SID1234614214]).

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"Although Q1 over Q1 net sales decreased, we believe that this is not reflective of a trend for either Inbrija or Ampyra. We were pleased to see that as the Omicron wave waned, net sales of both products rebounded substantially. In particular, Inbrija sales, which were similar in January and February, increased by approximately 85% in March over February and continued to increase through April," said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer. "In addition, while we historically have seen Q4 to Q1 declines due to patient overstocking in Q4 and insurance resetting in January, the decline was exacerbated this year due in part to a significantly higher estimate for discounts and allowances, or D&A, in Q1 2022 compared to Q1 2021. We expect D&A charges to be lower over the remainder of the year, and we are reiterating our 2022 guidance of $68M-$78M in Ampyra net sales."

INBRIJA Ex-US
Today Acorda announced distribution and supply agreements with Biopas Laboratories to commercialize INBRIJA in nine countries within Latin America, including Brazil and Mexico. Under the terms of the agreements, Acorda will receive a significant, double-digit, tiered percentage of the selling price of INBRIJA in Latin America in exchange for supply of the product. Acorda will also receive sales-based milestones.

Esteve plans to launch INBRIJA in Germany in June 2022. Germany is the largest pharmaceutical market in Europe, and the fourth largest in the world.

First Quarter 2022 Financial Results
For the quarter ended March 31, 2022, the Company reported INBRIJA net revenue of $3.7 million, compared to $5.0 million for the same quarter in 2021.

The Company reported AMPYRA net revenue of $14.9 million, compared to $20.3 million for the same quarter in 2021. As previously disclosed, AMPYRA lost its exclusivity and generics entered the market in 2018, and the Company expects AMPYRA revenue to continue to decline.

Research and development (R&D) expenses for the quarter ended March 31, 2022 were $1.7 million, including negligible share-based compensation expenses, compared to $4.7 million, including $0.2 million of share-based compensation for the same quarter in 2021.

Sales, general and administrative (SG&A) expenses for the quarter ended March 31, 2022 were $26.9 million, including $0.5 million of share-based compensation, compared to $34.0 million, including $0.5 million of share-based compensation for the same quarter in 2021.

Change in fair value of derivative liability for the quarter ended March 31, 2022 was negligible, compared to $0.2 million for the same quarter in 2021.

Provision for income taxes for the quarter ended March 31, 2022 was $0.2 million, compared to a benefit from income taxes of $3.2 million for the same quarter in 2021.

The Company reported a GAAP net loss of $25.6 million for the quarter ended March 31, 2022, or $1.93 per diluted share. GAAP net loss in the same quarter of 2021 was $33.5 million, or $3.53 per diluted share.

Non-GAAP net loss for the quarter ended March 31, 2022 was $22.0 million, or $1.66 per diluted share. Non-GAAP net loss in the same quarter of 2021 was $23.3 million, or $2.46 per diluted share. This quarterly non-GAAP net loss measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, changes in the fair value of acquired contingent consideration, changes in the fair value of derivative liability related to our 2024 convertible senior secured notes, and expenses that pertain to non-routine corporate restructurings. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

At March 31, 2022, the Company had cash, cash equivalents, and restricted cash of $51.5 million, compared to $65.2 million at year end 2021. Restricted cash includes $18.6 million in escrow related to the 6% semi-annual interest portion, payable in cash or stock, of the convertible note exchange completed in December 2019. If the Company elects to pay interest due in stock, a corresponding amount of the restricted cash will be released from escrow.

Financial Guidance
For the full year 2022, Acorda continues to expect AMPYRA net revenue to be $68 – $78 million, and operating expenses to be $110 – $120 million. The operating expense guidance is a non-GAAP projection that excludes restructuring costs and share-based compensation as more fully described below under "Non-GAAP Financial Measures."

Webcast
To participate in the Webcast, please use the following pre-registration link:

View Source
If you register for the Webcast, you will have the opportunity to submit a written question for the Q&A portion of the presentation. Once you have registered, you will receive a confirmation email with Webcast details. You will receive an email 2 hours prior to the start of the webcast with the link to join. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 7:30 p.m. ET on May 11, 2022 until 11:59 p.m. ET on June 10, 2022. To access the replay, please dial 1 866 813 9403 (domestic) or +44 204 525 0658 (international); reference code 258745. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

Non-GAAP Financial Measures
This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP) and also certain historical and forward-looking non-GAAP financial measures. In particular, Acorda has provided non-GAAP net income (loss), adjusted to exclude the items below, and has provided 2022 operating expense guidance on a non-GAAP basis. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, the Company believes that the presentation of non-GAAP net income (loss), when viewed in conjunction with actual GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because this measure excludes (i) non-cash compensation charges and benefits that are substantially dependent on changes in the market price of our common stock, (ii) non-cash interest charges related to the accounting for our convertible debt which are in excess of the actual interest expense owing on such convertible debt, as well as non-cash interest related to the Fampyra royalty monetization and acquired Biotie debt, (iii) changes in the fair value of acquired contingent consideration which do not correlate to our actual cash payment obligations in the relevant periods, (iv) expenses that pertain to corporate restructurings which are not routine to the operation of the business, and (v) changes in the fair value of derivative liability relating to the 2024 convertible senior secured notes, which is a non-cash charge and not related to the operation of the business. The Company believes its non-GAAP net income (loss) measure helps indicate underlying trends in the Company’s business and is important in comparing current results with prior period results and understanding projected operating performance. Also, management uses this non-GAAP financial measure to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance.

In addition to non-GAAP net income (loss), we have provided 2022 operating expense guidance on a non-GAAP basis, as the guidance excludes restructuring costs and share-based compensation charges. Due to the forward looking nature of this information, the amount of compensation charges needed to reconcile this measure to the most directly comparable GAAP financial measure is dependent on future changes in the market price of our common stock and is not available at this time. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, the Company believes that the presentation of this non-GAAP financial measure, when viewed in conjunction with actual GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because it excludes (i) expenses that pertain to corporate restructurings not routine to the operation of our business, and (ii) non-cash charges that are substantially dependent on changes in the market price of our common stock. We believe this non-GAAP financial measure helps indicate underlying trends in the Company’s business and is important in comparing current results with prior period results and understanding expected operating performance. Also, management uses this non-GAAP financial measure to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance.