On August 10, 2022 Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for genetically defined cancers with alterations in mTOR pathway genes, reported that financial results for the second quarter of 2022 (Press release, Aadi Bioscience, AUG 10, 2022, View Source [SID1234618873]).

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"We continue to progress in key areas after our first full quarter following FYARRO’s launch. We are excited to see FYARRO reaching more patients through continued account adoption and steady growth in overall sales," said Neil Desai, Ph.D., Founder, President and Chief Executive Officer of Aadi. "We are also encouraged by the progress on our tumor agnostic PRECISION 1 trial targeting TSC1 and TSC2 inactivating alterations which continues to ramp up, with activation of additional clinical trial sites and patient enrollment. We anticipate providing preliminary data on a meaningful number of patients in this trial during the first half of 2023. In addition, we continue to evaluate strategies for new clinical indications of nab-sirolimus either as single agent or in combination with other targeted therapies with the potential for new programs as early as 2023."

Corporate Updates for the Second Quarter 2022

FYARRO net product sales for the three months ended June 30, 2022 were $3.4 million, the first full quarter of sales following the product launch late in the first quarter.
A product-specific permanent J-code (J9331) for FYARRO from Centers for Medicare and Medicaid Services (CMS) became effective on July 1, 2022. This code is expected to further facilitate reimbursement for FYARRO.
The Company announced its addition to both the U.S. small cap Russell 2000 Index and broad-market Russell 3000 Index at the conclusion of the 2022 Russell indexes annual reconstitution, which captures the 4,000 largest U.S. stocks, ranking them by total market capitalization.
Partnerships with prominent next generation sequencing (NGS) providers and leaders in genomic testing and profiling was announced during the quarter, which included Foundation Medicine, Tempus and others. The Company is leveraging these partnerships to expedite patient identification and recruitment for the ongoing PRECISION 1 trial of nab-sirolimus in patients harboring tumors with inactivating alterations in TSC1 or TSC2 genes, and is making significant progress toward opening the trial in at least 20 major cancer centers and upward of 120 treatment sites in the U.S. by the end of 2022.
A poster presentation entitled, "nab-Sirolimus for patients with advanced malignant PEComa with or without prior mTOR inhibitors: Biomarker results from AMPECT and an expanded access program" was presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The data included exploratory biomarker results reported from the final analysis of mTOR inhibitor-naïve advanced malignant PEComa patients treated with nab-sirolimus in the Advanced Malignant PEComa Trial (AMPECT) trial as well as an analysis of prior mTOR inhibitor exposed advanced malignant PEComa patients treated with nab-sirolimus in the Expanded Access Program (EAP) through June 2021. Findings from both the AMPECT study and the EAP showed greater clinical benefit in patients with TSC1 or TSC2 inactivating alterations who received nab-sirolimus compared to all evaluable patients, regardless of prior mTOR inhibitor exposure.
The Company sponsored a poster at the Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) which indicated the incidence of advanced cancer patients carrying TSC1 or TSC2 inactivating gene alterations numbered approximately 12,000 annually in the US, thus potentially rendering these patients eligible for nab-sirolimus therapy.
Second Quarter 2022 Financial Results

Cash and cash equivalents on June 30, 2022 were $118.7 million, compared to $149.0 million as of December 31, 2021. Based on current plans, the Company expects cash and cash equivalents to fund operations into 2024.
Total revenue for the quarter ended June 30, 2022 was $3.4 million resulting from sales of FYARRO.
In the second quarter of 2022, the Company recorded a non-cash impairment charge of $3.7 million to write-off the value of an intangible asset related to the Gossamer license agreement with the Company’s predecessor, Aerpio.
Net loss for the three months ended June 30, 2022 was $18.3 million compared to $1.5 million for the three months ended June 30, 2021.
Conference Call Information

The Aadi management team is hosting a conference call and webcast today at 8:30 am ET (5:30 am PT) to provide a corporate update and discuss results for the second quarter of 2022.

Participants may access a live webcast of the call on the "Investors & News" page of the Aadi Biosciences website at aadibio.com. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

About FYARRO

FYARRO is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

About the PRECISION 1 Trial

The PRECISION 1 trial is a multi-center, open-label, tumor-agnostic pivotal study, of nab-sirolimus designed as a basket trial that will evaluate approximately 120 adult and adolescent patients with solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes. The trial will have two independent arms of 60 patients each to separately evaluate patients with either TSC1 or TSC2 inactivating alterations. Aadi has received Fast Track designation to evaluate nab-sirolimus in this indication from the FDA. The first patient in the PRECISION 1 trial was dosed in March 2022.

On August 10, 2022 Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the "Company") reported financial results (IFRS, unaudited) for the second quarter and first half of 2022 (Press release, Epigenomics, AUG 10, 2022, View Source [SID1234618423]).

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Key figures

Total revenue increased slightly from EUR 223 thousand to EUR 241 thousand in the first half of 2022 compared with the same period of the previous year.
Research and development costs increased from EUR 1,545 thousand in the first six months of 2021 to EUR 3,140 thousand in reporting period. The increase is due to investment in the "Next-Gen" product and increased enrollment of the post approval study compared to the reduced Covid-19 impacted enrollment of 2021.
Sales, General and Administrative expenses increased from EUR 3,021 thousand to EUR 3,582 thousand.
EBITDA (before share-based payment expenses) amounted to EUR -3,677 thousand in the reporting period, compared with EUR -3,165 thousand in the same period of the previous year.
The net loss for the period was EUR -3,957 thousand (H1 2021: EUR -3,528 thousand); the loss per share decreased from EUR 0.41 to EUR 0.24 compared to the prior-year period.
Cash consumption increased to EUR 6,283 thousand in the first half of 2022, compared with EUR 4,214 thousand in the same period of the previous year.
As of June 30, 2022, the Company had cash and cash equivalents of EUR 18,043 thousand (December 31, 2021: EUR 23,049 thousand).
Epigenomics AG assumes that given the planned financial development, a cumulative loss of more than half of the nominal share capital will occur in the near future. The Company will, upon occurrence of the loss, make a corresponding publication and call a shareholders meeting pursuant to Section 92 par. 1 German Stock Corporation Act ("Aktiengesetz") to which the loss will be notified.
Operational developments

Epigenomics’ Executive Board remains confident that Epi proColon "Next-Gen" will meet the Centers for Medicare and Medicaid Services’ (CMS) reimbursement criteria (74% sensitivity and 90% specificity) and therefore filled a pre-submission with FDA for the clinical trial this spring. Patient enrollment is on-track to begin this summer.
The Company is also continuing its efforts to achieve CMS reimbursement for the current Epi proColon test via legislation. Sponsorship of the bill has increased to a bipartisan representation of 68 members of Congress. However, evaluating the prospects for success remains difficult.
In order to achieve the goal of FDA approval and reimbursement for "Next-Gen", the Company will need to raise additional capital to complete the trial and supporting activities required for subsequent FDA approval. The Company is actively exploring all methods to attract the necessary capital to achieve its goals, including a potential listing on an alternative exchange.
Greg Hamilton, CEO of Epigenomics AG: " We are on track to accomplish our "Next-Gen" goals for 2022, specifically, initiation on the clinical trial and presentation of preliminary data. In order to deliver and commercialize "Next-Gen" the Company must raise the necessary capital. We believe that with the release of the preliminary data and the initiation of the study, we will be able to realize the significant market opportunity with "Next-Gen"."

Outlook 2022

Revenue

The Company confirms its outlook for fiscal year 2022 and continues to expect revenue within the range of EUR 0.3 million to EUR 0.8 million.
EBITDA / cash consumption

For EBITDA (before share-based payment expenses), Epigenomics forecasts a range of EUR
-15.0 million to EUR -17.0 million for the current full year 2022. Based on the Company’s 2022 business plan, cash consumption is expected to be in line with the EBITDA forecast (before share-based compensation expenses).
Further information

The interim statement for the first six months 2022 (unaudited) can be found on Epigenomics’ website at: View Source

Conference call for analysts and investors

Epigenomics AG will host a conference call for analysts and investors today at 4.00 pm (CET) / 10.00 am (EDT). The webcast can be accessed at the following link: View Source

Participants are asked to dial in 10 minutes prior to the start of the conference call and to register using the link above.

An audio replay of the conference call will be provided on the Epigenomics’ website subsequently.

On August 10, 2022 TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported financial results for the second quarter ended June 30, 2022 (Press release, Tracon Pharmaceuticals, AUG 10, 2022, View Source [SID1234618158]). The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

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"We continue to have robust accrual in the ENVASARC pivotal trial as we have enrolled more than 36 patients and look forward to reporting the interim efficacy analysis on the initial 36 patients in the fourth quarter, after each patient has had two on-study scans." said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "Additionally, we await the outcome of the binding arbitration relating to I-Mab’s alleged breaches of the TJ4309 and bispecific antibody agreements, and anticipate completing the TJ4309 Phase 1 trial that permits I-Mab the opportunity to terminate the license for a $9M payment to TRACON. We expect both the arbitration decision and the termination of the TJ4309 license to occur this year."

Recent Corporate Highlights

In June, we announced a registered direct financing of approximately $4.0 million in the aggregate with an accredited institutional healthcare-focused fund, which was completed at market price.

In July, we announced the enrollment of the 36th patient in the ENVASARC Phase 2 pivotal trial at the 600 mg dose of envafolimab.

In August, we announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1/2 clinical study of YH001 in combination with envafolimab and doxorubicin for the treatment of sarcoma patients, including patients who have not received prior therapy.

In August, the Independent Data Monitoring Committee (IDMC) recommended the ENVASARC trial proceed as planned following the review of more than three weeks of safety data from more than 20 patients who received the 600 mg dose of envafolimab as a single agent or with Yervoy.
Expected Key 2022 Milestones

Report the interim safety analysis by the IDMC following the review of more than twelve weeks of safety data from more than 20 patients who received the 600 mg dose of envafolimab as a single agent or with Yervoy.

Report the interim efficacy analysis by the IDMC following the review of more than twelve weeks of efficacy data from 36 patients who received the 600 mg dose of envafolimab as a single agent or with Yervoy.

Initiate dosing in the Phase 1/2 clinical trial of envafolimab with our potential best in class CTLA-4 antibody YH001 as well as with doxorubicin chemotherapy.

Report the International Chamber of Commerce (ICC) Arbitration Panel’s (the Tribunal) binding decision in the ongoing arbitration involving the TJ4309 and bispecific antibody agreements with I-Mab Biopharma where we are seeking to recover over $200 million in damages.

Complete the TJ4309 Phase 1 clinical trial permitting I-Mab the opportunity to terminate the TJ4309 license for a $9.0 million payment to TRACON.
Second Quarter 2022 Financial Results

Cash and cash equivalents were $13.6 million at June 30, 2022, compared to $24.1 million at December 31, 2021 and is expected to fund the company into 2023.

Research and development expenses for the second quarter of 2022 were $2.9 million, compared to $3.1 million for the second quarter of 2021.

General and administrative expenses for the second quarter of 2022 were $3.3 million, compared to $6.1 million for the second quarter of 2021. The decrease was primarily attributable to legal expenses incurred in the second quarter of 2021 due to the now stayed lawsuit filed by I-Mab in the Delaware Court of Chancery involving the TJ4309 agreement.

Net loss for the second quarter of 2022 was $6.2 million, compared to $8.9 million for the second quarter of 2021.
Conference Call Details

To access the call by phone, please register using this link and you will be provided with dial in details.

A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the pivotal ENVASARC Phase 2 trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. TRACON expects the trial to enroll more than 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into a cohort of treatment with single agent envafolimab at 600 mg every three weeks and 80 patients enrolled into a cohort of treatment with envafolimab at 600 mg every three weeks with Yervoy. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.

About YH001

YH001 is an IgG1 antibody against CTLA-4 that has shown enhanced antibody dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) in vitro. In preclinical studies YH001 demonstrated superior T cell activation and superior tumor growth inhibition activity compared to ipilimumab. YH001 also demonstrated superior activity compared to ipilimumab in human transgenic mouse tumor models when combined with a PD-(L)1 antibody. In these models, single agent YH001 depleted regulatory T cells and increased CD8+ T cells in tumor tissue. YH001 is being dosed as a single agent in a Phase 1 trial in China (NCT04699929) and in combination with the PD-1 antibody toripalimab in a Phase 1 trial in Australia (NCT04357756).

About TRC102

TRC102 (methoxyamine) is a novel small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA) and has orphan drug designation from the FDA in malignant glioma, including glioblastoma.

About TJ004309

TJ004309 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TJ004309 is currently being studied in an ongoing Phase 1 trial to assess safety and preliminary efficacy as a single agent and when combined with the PD-L1 checkpoint inhibitor Tecentriq in patients with advanced solid tumors.

On August 10, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported its financial results for the first half-year of 2022 (Press release, Evotec, AUG 10, 2022, View Source [SID1234618079]).

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HIGHLIGHTSEVOTEC CONTINUES ITS STRONG ORGANIC REVENUE GROWTH IN ALL BUSINESS AREAS

Group revenues increased by 24% to € 336.9 m (H1 2021: € 271.3 m) driven by strong demand for its base business; like-for-like revenue growth (excluding fx-effects) 19%
Continued strong revenue growth momentum: Total EVT Execute revenues (incl. intersegment revenues) up 26% to € 351.0 m (H1 2021: € 279.5 m); EVT Innovate revenues due to a strong growth in Q2 up 36% to € 78.0 m (H1 2021: € 57.3 m)
Reported adjusted Group EBITDA totalled € 33.6 m (H1 2021: € 36.2 m); excellent Group gross margin increasing by 270 bps to 27.3% excluding Just – Evotec Biologics, which is in its build up phase; lower contribution from milestones, upfronts and licenses as well as continued expenses for capacity expansion; higher energy costs, higher costs along the supply chain and costs related to the acquisition of Rigenerand Srl; negative effects partially offset by positive fx-effects
Other non-operating result of € (89.8) m (H1 2021: € 106.1 m) explained by the non-cash fair value adjustments of the equity investment in publicly listed Exscientia plc.

NEW AND EXTENDED ALLIANCES REFLECT SUCCESS OF GROWTH STRATEGY

Significant operational and scientific step-up of targeted protein degradation alliance with Bristol Myers Squibb ("BMS")
Several new integrated drug discovery collaborations signed, including INDiGO, CMC and DMPK agreements
New collaborations signed, based on unique, data-driven platforms with Almirall (dermatology), Boehringer Ingelheim (iPSC), Eli Lilly (E.MPD), Janssen (TargetAlloMod) and Sernova (iPSC)
Just – Evotec Biologics: Just –Evotec Biologics is currently in its initial build up phase. Strategic investments into disruptive technology platform show good progress – foundation laid for accelerated revenue growth; multiple new development and manufacturing agreements, e.g., among others with Alpine Immune Sciences (after period-end)
Co-owned pipeline projects progressing well, e.g. Phase II start of BAY 2395840 (diabetic neuropathic pain), expansion with JingXin for EVT201, submission for approval in China
Successful expansion of the EVOequity portfolio with new strategic equity stakes in several promising companies such as Centauri, IMIDomics, Sernova and Tubulis
Launch of Aurobac Therapeutics, a joint venture with Boehringer Ingelheim and bioMérieux, to create the next generation of antimicrobials along with actionable diagnostics to fight Antimicrobial Resistance ("AMR")

CORPORATE

Effective May 2022, Dr Matthias Evers joins Management Board as Chief Business Officer ("CBO"), responsible for business development, digital technology and strategy
Signing of definitive agreement to acquire the cell technology company Rigenerand Srl, a leader in the field of cGMP manufacturing of cell therapies, which will operate as Evotec (Modena) Srl
Annual General Meeting 2022: Approval of all proposed agenda items; Camilla Macapili Languille elected to the Supervisory Board

BUSINESS OUTLOOK FOR FULL-YEAR 2022 REFINED AND MID-TERM TARGETS 2025 CONFIRMED

Group revenues now expected to be in a range of € 715 – 735 m versus € 700 – 720 m previously (unchanged at € 690 – 710 m at constant exchange rates) (2021: € 618 m)
Adjusted Group EBITDA expected to be unchanged in the range of € 105 – 120 m (new guidance range at constant exchange rates of € 85 – 100 m versus € 95 – 110 m previously) (2021: € 107 m)
Unpartnered research and development expenses expected to be in a range of € 70 – 80 m (2021: € 58 m)
Mid-term goals target revenue growth to more than € 1,000 m, adjusted EBITDA of at least € 300 m and unpartnered research and development expenses of more than € 100 m
The forecast takes in account – as far as possible – the current increased global uncertainties related to e.g. the COVID-19 pandemic and the war in Ukraine, resulting in uncertainty around the global price and supply situation for energy, other raw materials and supplies as well as logistics relevant to the business.

More detailed information and financial tables are available in our half-year report published on the Evotec website under the following link: View Source

Webcast/Conference Call
The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. The conference call will be held in English.

On August 10, 2022 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported second quarter 2022 financial results and provided a business update (Press release, Cyclacel, AUG 10, 2022, View Source [SID1234618078]).

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"In the first half of 2022 we have established that oral fadraciclib, our CDK2 and CDK9 inhibitor, is well-tolerated and demonstrated single-agent, anticancer activity across multiple solid tumor and lymphoma patients in our 065-101 study," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "In the second half of 2022 we are optimizing the dosing schedule to maximize target coverage and determine recommended Phase 2 dose (RP2D). We then anticipate advancing into Phase 2 proof of concept stage of 065-101. We believe that daily dosing of oral fadraciclib targeting both CDK2 and CDK9 at efficacious doses without dose limiting toxicities may represent best-in-class properties. We look forward to reporting additional clinical and preclinical data at our upcoming R&D Day for both fadraciclib and CYC140, our differentiated PLK1 inhibitor, also in a Phase 1/2 study."

"We are excited with the progress of oral fadraciclib in our Phase 1/2 solid tumor and lymphoma study because of the promising safety and early efficacy results we are seeing in a challenging Phase 1 population," said Mark Kirschbaum, M.D., Chief Medical Officer of Cyclacel. "As fadraciclib has been relatively well tolerated, 065-101 principal investigators agreed to continue dose escalation with the current 4-week schedule. Following Food and Drug Administration (FDA) clearance of a protocol amendment, we are recruiting patients at the sixth dose level of 065-101. We have previously observed partial response and anticancer activity including tumor shrinkage in endometrial, lymphoma and pancreatic cancer patients. In parallel we are determining which tumor types to prioritize for the Phase 2 stage of 065-101 informed by preclinical modeling and data from our clinical collaborators. The 065-102 study of fadraciclib in advanced leukemias continues to enroll at the 100mg twice a day dose level after clearance of a protocol amendment that allowed us to skip two dose levels. We are also encouraged that the 140-101 dose escalation study of CYC140 is now recruiting patients with solid tumors and lymphomas for the second dose level."

Key Highlights

Oral fadraciclib 065-101 Phase 1/2 study in advanced solid tumors: The study has enrolled seventeen patients with advanced solid tumors and lymphomas treated with oral fadraciclib up to dose level five (100mg dosed twice daily, 4 weeks out of 4) with no-dose limiting toxicities observed thus far. Following recent FDA clearance to escalate, two additional, higher dose levels will be evaluated before determining recommended Phase 2 dose. Dose level six is now recruiting.
Summary of key efficacy, safety and PK findings to date:

A cutaneous T cell lymphoma (CTCL) patient achieved partial response (PR) in the first oral treatment cycle.
A patient with a very aggressive form of peripheral T cell lymphoma (PTCL) achieved 38% reduction in target lesions by PET scan in the first oral treatment cycle.
An endometrial cancer patient achieved stable disease with 15% reduction of target lesions after the first oral treatment cycle. In an earlier study of intravenous fadraciclib as monotherapy, a patient with MCL1 amplified endometrial cancer achieved confirmed complete response (CR) and remains on study after two and a half years of treatment.
A pancreatic cancer patient achieved stable disease by confirmatory scan for five oral treatment cycles.
No dose limiting toxicities have been observed at any of the five dose levels evaluated thus far. The FDA has cleared a protocol amendment to escalate to two additional dose levels; dose level six at 150mg and dose level 7 at 200mg twice daily.
Demonstrated evidence of target engagement for CDK2 and CDK9 in cell assay systems; patient PK data suggested that these targets are potentially inhibited at 100mg twice daily levels.
The 065-101 study is enrolling at four sites. Several additional sites are in start-up preparations to join the Phase 2 proof-of-concept stage of this registration-directed study. The Phase 2 part of 065-101 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.

Oral fadraciclib 065-102 Phase 1/2 study in leukemias or myelodysplastic syndromes: Based on good tolerability in the 065-101 study, FDA clearance of a protocol amendment in the 065-102 study has accelerated dose progression by omitting dose levels two and three and now enrolling at dose level four.

In April, the Company announced a publication in the journal, Leukemia, 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.
Oral CYC140 140-101 Phase 1/2 study in solid tumors and lymphomas: The registration-directed, Phase 1 dose escalation stage of this study is enrolling patients at dose level two.
Summary of key efficacy, safety and PK findings to date:

No dose limiting toxicities observed to date.
An ovarian cancer patient in 140-101 achieved stable disease with tumor shrinkage after the first treatment cycle and is continuing treatment on cycle three.
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.

Financial Highlights

As of June 30, 2022, cash and cash equivalents totaled $29.1 million, compared to $36.6 million as of December 31, 2021. Net cash used in operating activities was $8.7 million for the six months ended June 30, 2022 compared to $7.8 million for the same period of 2021. The Company estimates that its available cash will fund currently planned programs into the second half of 2023.

Research and development (R&D) expenses were $4.2 million for the three months ended June 30, 2022, as compared to $4.1 million for the same period in 2021. R&D expenses relating to fadraciclib were $2.6 million for the three months ended June 30, 2022, as compared to $2.8 million for the same period in 2021 due to increased clinical trial costs of $0.5 million associated with ongoing clinical trials evaluating fadraciclib in Phase 1/2 studies offset by a reduction of $0.7 million in non-clinical expenditures. R&D expenses related to CYC140 were $1.5 million for the three months ended June 30, 2022, as compared to $1.1 million for the same period in 2021 due to clinical trial costs associated with the start of the CYC140 Phase 1/2 study.

General and administrative expenses for the three months ended June 30, 2022, were $1.6 million, compared to $2.0 million for the same period of the previous year due to a decrease in facilities, professional and recruitment costs

Total other income, net, for the three months ended June 30, 2022, was $0.2 million, compared to $9,000 for the same period of the previous year. The increase of $0.2 million for the three months ended June 30, 2022, is primarily related to foreign exchange gains.

United Kingdom research & development tax credits were $1.0 million for each of the three months ended June 30, 2022 and June 30, 2021 and are directly correlated to qualifying research and development expenditure. Tax credit receipts of $3.3 million in respect of the financial year ended December 31, 2021, were received in April 2022.

Net loss for the three months ended June 30, 2022, was $4.6 million, compared to $5.1 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.