On November 13, 2018 Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, reported preclinical data on SY-1365, its first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor, showing synergistic anti-tumor activity in combination with carboplatin, a standard-of-care therapy, in models of ovarian cancer and providing a mechanistic rationale for the ongoing investigation of the combination in the Phase 1 clinical trial of SY-1365 (Press release, Syros Pharmaceuticals, NOV 13, 2018, View Source [SID1234531258]). The Company also announced the first preclinical data on its class of highly selective oral CDK7 inhibitors, which showed significant anti-proliferative activity in preclinical models of breast and ovarian cancers. These data were presented at the 30th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium in Dublin.

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"Selective CDK7 inhibition represents a potentially transformative approach for treating a range of cancers that have eluded effective treatment," said Eric R. Olson, Ph.D., Syros’ Chief Scientific Officer. "Our presentations at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) meeting highlight our leadership in the field and support the ongoing clinical development of SY-1365 as well as the selection of SY-5609, a highly selective oral CDK7 inhibitor, as our next development candidate. Given the broad potential of CDK7 inhibitors as a new class of medicines, we believe physicians and patients will seek options across multiple modalities and believe an oral molecule could serve as an important complement to SY-1365. We are committed to maximizing the potential of CDK7 inhibition for patients, as we work to achieve our vision of developing new medicines that provide profound benefit for patients."

SY-1365 Preclinical Combination Data
The preclinical data presented at EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) provide a strong mechanistic rationale for the ongoing clinical investigation of SY-1365 in combination with carboplatin in ovarian cancer patients. Homologous recombination deficiency (HRD), a cellular defect caused by the disruption of normal DNA damage repair processes, sensitizes cells to treatment with DNA repair inhibitors, including PARP inhibitors and DNA-damaging agents such as carboplatin. In preclinical models of ovarian cancer, SY-1365 was shown to inhibit DNA repair and decrease the expression of homologous recombination repair (HRR) genes, which are important for repairing harmful breaks in DNA. These data suggest that SY-1365 induces an HRD-like state, which may result in enhanced sensitivity to DNA-damaging agents and DNA repair inhibitors.

Consistent with the proposed mechanism-of-action, SY-1365 demonstrated synergy with carboplatin in ovarian cancer cell lines and demonstrated greater anti-tumor activity in combination with carboplatin in xenograft models of ovarian cancer than either agent alone.

Syros is currently conducting a Phase 1 clinical trial assessing the safety and efficacy of SY-1365 as a single agent and in combination with standard-of-care therapies in multiple ovarian and breast cancer patient populations. The ongoing trial includes a study cohort evaluating SY-1365 in combination with carboplatin in ovarian cancer patients who have relapsed after one or more prior therapies. Additional details about the trial can be found using the identifier NCT03134638 at www.clinicaltrials.gov.

Preclinical Data from Oral CDK7 Inhibitor Program
Syros created a suite of highly selective and potent orally available CDK7 inhibitors. The preclinical data at EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) detail for the first time the selectivity, potency and anti-tumor activity of these inhibitors. Using a representative member of Syros’ suite of oral CDK7 inhibitors, these data show:

200- to 1,200-fold greater selectivity for CDK7 over other members of the CDK family, including CDK2, CDK9 and CDK12.
Robust anti-proliferative activity in triple negative breast cancer and ovarian cancer cell lines, which was associated with the induction of apoptosis and cell cycle arrest.
Strong correlation between biochemical potency, CDK7 target engagement and tumor growth inhibition.
Substantial anti-tumor effects in multiple cell-line and patient-derived xenograft models of triple negative breast and ovarian cancers.
These data helped support the selection of SY-5609 as the Company’s next development candidate. Syros is currently advancing SY-5609 into Investigational New Drug (IND) application-enabling preclinical studies.

The poster presentations on the SY-1365 preclinical combination data and on the oral CDK7 inhibitor program are now available on the Publications and Abstracts section of the Syros website at www.syros.com.

On November 13, 2018 Rubius Therapeutics, Inc. (Nasdaq: RUBY), a biotechnology company developing an entirely new class of allogeneic cellular therapies, reported third quarter 2018 financial results and operational progress (Press release, Rubius Therapeutics, NOV 13, 2018, View Source [SID1234531334]).

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"During the third quarter, we remained focused on advancing our first program, RTX-134, for the treatment of phenylketonuria. We are on track to file an Investigational New Drug application during the first quarter of 2019," said Pablo J. Cagnoni, M.D., chief executive officer of Rubius Therapeutics. "We are also continuing to advance our earlier pipeline, which we believe holds broad therapeutic potential across cancer, autoimmune disease and additional enzyme deficiencies. In order to successfully bring our medicines to patients, we are ensuring that we will have state-of-the-art manufacturing capabilities in place, as shown through the purchase, in July, of our 135,000-square foot manufacturing facility in Smithfield, RI."

Third quarter highlights include:

· On track to submit first IND for lead program, RTX-134, during the first quarter of 2019, and an additional three to four INDs during 2019 and 2020

· Closed initial public offering (IPO) in July 2018, raising $254.3 million in net proceeds

· Acquired and initiated renovations on manufacturing facility in Smithfield, RI; facility is expected to be operational by the end of 2020

· Continued to generate promising preclinical data in support of additional pipeline programs; data expected to be published during 2019

· Strengthened internal capabilities in discovery, platform development and manufacturing and grew the organization to 110 employees to predominantly support research and development (R&D) activities

Third Quarter Financial Results

Net loss for the third quarter of 2018 was $26.4 million or $0.42 per common share, compared to $11.9 million or $1.48 per common share in the third quarter of 2017.

In the third quarter of 2018, Rubius invested $14.4 million in R&D related to its novel RED PLATFORM and towards expanding and advancing its product pipeline, compared to $6.1 million in the third quarter of 2017. The year-over-year increase was due to an additional $2.9 million of costs incurred in preparation for the Phase 1/2a clinical trial for RTX-134, and $3.6 million was associated with personnel costs and stock-based compensation driven by increases in R&D headcount to support Rubius’ goal of delivering four to five IND’s during 2019 and 2020.

G&A expenses were $13.2 million during the third quarter of 2018, as compared to $5.8 million for the third quarter of 2017. The higher costs were primarily driven by a $4.6 million increase in stock-based compensation and a $1.9 million increase in personnel costs and professional fees to support the Company’s growth and to operate as a public company.

Nine Month Financial Results

Net loss for the first nine months of 2018 was $62.0 million or $2.33 per common share, compared to $27.0 million or $3.42 per common share in the first nine months of 2017.

In the nine months ended September 30, 2018, Rubius invested $35.2 million in R&D related to its novel RED PLATFORM and towards expanding and advancing its product pipeline, compared to $14.6 million in the first nine months of 2017. The year-over-year increase was due to an increase of $5.8 million of costs incurred in preparation for the Phase 1/2a clinical trial for RTX-134, and $6.6 million in personnel costs and stock-based compensation driven by increases in R&D headcount to support Rubius’ goal of delivering four to five IND’s during 2019 and 2020.

G&A expenses were $27.3 million during the first nine months of 2018, as compared to $11.2 million for the same period in 2017. The higher costs were primarily driven by a $8.7 million increase in stock-based compensation and a $6.0 million increase in personnel costs and professional fees to support the Company’s growth and to operate as a public company.

During the third quarter of 2018, the Company adopted new guidance for the accounting for stock-based payments to nonemployees, effective as of January 1, 2018. As a result of this adoption, previously reported amounts for the six months ended June 30, 2018 for R&D expenses and G&A expenses were reduced by $0.7 million and $8.0 million, respectively.

Cash Position

As of September 30, 2018, cash, cash equivalents and investments grew significantly to $408.9 million as compared to $104.3 million as of December 31, 2017, providing Rubius with a cash runway into 2021. The increase in cash reflects $254.3 million of net proceeds from the company’s IPO during the third quarter of 2018 and $101.0 million of net proceeds received from its Series C preferred stock financing during the first quarter of 2018. The proceeds received from the financings were offset by $38.6 million used in operations during the nine-month period and $11.7 million of capital purchases, including $8.0 million to acquire the manufacturing facility in Smithfield, Rhode Island.

About Phenylketonuria and RTX-134

Phenylketonuria (PKU) is an inherited, rare enzymatic disorder characterized by the body’s inability to effectively metabolize the amino acid phenylalanine. The accumulation of phenylalanine in the blood causes damage to the central nervous system and a range of symptoms, including intellectual disability, delayed development and impaired cognitive function. RTX-134 is an allogeneic cellular therapy for the treatment of PKU, which expresses the enzyme phenylalanine ammonia lyase (PAL) inside the cell. In preclinical studies, phenylalanine was shown to diffuse into RTX-134, where PAL converted phenylalanine into ammonia and trans-cinnamic acid, metabolites that are cleared by the body. Compared to current therapeutic interventions, RCT product candidates may have a longer and more sustained treatment duration given the 120-day half-life of red blood cells and may avoid immune-driven adverse events and reduction in efficacy, which result from antibody formation.

On November 13, 2018 Tempest Therapeutics Inc. reported a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting in Washington, D.C., describing lead compound TPST-1120’s two-pronged mechanism of directly targeting tumor cells dependent on fatty acid metabolism and driving a metabolic shift in the tumor microenvironment to glycolysis from fatty acid oxidation (Press release, Tempest Therapeutics, NOV 13, 2018, View Source [SID1234531259]). The resulting significant reductions in tumor growth and stimulation of durable anti-tumor immunity support Tempest’s rationale to advance the first-in-class oral small molecule inhibitor of PPAR alpha into clinical studies in patients with advanced solid tumors in early 2019.

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The poster titled "Antagonism of Peroxisome Proliferator Activated Receptor Alpha (PPARα) by TPST-1120 Suppresses Tumor Growth and Stimulates Anti-Tumor Immunity" describes studies that demonstrate significant anti-tumor efficacy of TPST-1120. As monotherapy, TPST-1120 prevented fatty acid oxidation and directly inhibited primary human tumor cells in culture and in human tumor xenografts in immune-deficient mice. In tumor-bearing immune-competent animals, TPST-1120 inhibited tumor growth as a single agent and in combination with chemotherapy or with anti-PD-1 antibodies.

For example, TPST-1120 plus gemcitabine significantly increased the long-term survival of mice with pancreatic tumors. TPST-1120 in combination with anti-PD-1 antibodies in mouse models of ovarian and colon cancer showed suppression of tumor growth and complete remissions in some animals. Importantly, cured mice were completely protected against autologous tumor re-challenge in the ovarian model, strongly suggesting immunological T cell memory against the primary tumor.

TPST-1120 elicits its potent anti-tumor effects through direct binding of the PPAR alpha transcription factor, inhibiting the expression of its regulated genes that are critical for fatty acid oxidation. Several malignancies such as hepatocellular carcinoma and renal cell cancer are reliant on fatty acid oxidation. In addition, suppressive immune cells in the tumor microenvironment such as a particular subset of macrophages, regulatory T cells and myeloid-derived suppressor cells all favor fatty acid oxidation. The utilization of fatty oxidation by tumor cells and suppressive immune cells underlines the tumor-intrinsic and tumor-extrinsic anti-tumor properties of TPST-1120.

"Immuno-metabolism is a rapidly evolving field, and it is increasingly recognized that regulating particular metabolic checkpoints that are essential to promote bio-energetic pathways necessary for sustaining tumor growth are important new targets in oncology. Our poster provides the rationale for advancing TPST-1120 into patients with advanced cancers and also provides insights into the clinical development of this first-in-human molecule," said Tom Dubensky, Ph.D., president and CEO of Tempest.

On November 13, 2018 Palatin Technologies, Inc. (NYSE American: PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems for the treatment of diseases with significant unmet medical need and commercial potential, reported results for its first fiscal quarter ended September 30, 2018 (Press release, Palatin Technologies, NOV 13, 2018, View Source [SID1234531294]).

Recent Highlights and Program Updates

Female Sexual Dysfunction / Vyleesi (bremelanotide)

●Vyleesi, the trade name for bremelanotide – Under development for Hypoactive Sexual Desire Disorder ("HSDD"):

¯FDA (U.S. Food and Drug Administration) set the PDUFA (Prescription Drug User Fee Act) action goal date of March 23, 2019 for completion of the review of the New Drug Application (NDA) for Vyleesi.

oSee 8-K filing today regarding the FDA’s review of the NDA submission for Vyleesi and the request for additional data.

¯AMAG Pharmaceuticals is the exclusive licensee for North America.

¯Palatin is in discussions with potential collaboration partners for certain regions outside of the licensed territories of North America, China and South Korea.

Anti-Inflammatory / Autoimmune Programs

●Melanocortin receptor 1 and 1/5 (MC1r, MC1/5r) agonists under development for the treatment of inflammatory and autoimmune diseases such as dry eye, uveitis, diabetic retinopathy and inflammatory bowel diseases:

¯PL-8177:

oAnnounced positive pharmacokinetics and pharmacodynamic results with no reported safety or tolerability concerns from a first-in-human Phase 1 safety study of subcutaneous dosing of PL-8177 in single and multiple ascending doses.

oData from a separate clinical study investigating an oral formulation of PL-8177 is currently expected by the end of calendar year 2018.

oProgram is under internal evaluation for orphan designations.

¯PL-8331 for ocular indications:

oPreclinical IND enabling activities commenced.

oProgram is under internal evaluation for orphan designations.

Natriuretic Peptide Program

¯PL-3994: Phase 2a, open label study in heart failure patients with preserved ejection fraction, targeted to commence in the first half of 2019.

¯PL-5028: Preclinical studies evaluating potential use in fibrotic disease ongoing.

Genetic Obesity Program

¯MC4r selective peptide and oral small molecule agonists: Commenced preclinical IND activities.

¯Program is under internal evaluation for orphan designations.

Corporate

¯Decreased debt from $7.2 million at June 30, 2018 to $5.3 million at September 30, 2018.

First Quarter Fiscal 2019 Financial Results

For the first fiscal quarter ended September 30, 2018, the Company reported a net loss of $(5.7) million, or $(0.03) per basic and diluted share, compared to net income of $10.6 million, or $0.05 per basic and diluted share, in the same period in 2017. The difference was primarily attributable to the recognition of $26.9 million in license and contract revenue during the 2017 period pursuant to our license agreements with AMAG and Fosun and secondarily attributable to the decrease in research and development expenses pursuant to the completion of our Vyleesi Phase 3 clinical trial program.

Revenue
The Company recognized $34,505 of revenue for the first fiscal quarter ended September 30, 2018, compared to $21.9 million in license and contract revenue related to our license agreement with AMAG and $5.0 million in license revenue related to the license agreement with Fosun for the quarter ended September 30, 2017.

Operating Expenses
Total operating expenses were $5.7 million for the first fiscal quarter ended September 30, 2018, compared to $15.7 million in the same period of 2017. The decrease in operating expenses was mainly attributable to the completion of the Vyleesi Phase 3 clinical trial program and ancillary studies necessary to file the NDA in HSDD in March 2018.

Other Income/Expense
Total other expense, net was $53,288 for the first fiscal quarter ended September 30, 2018 compared to $0.4 million for the same period of 2017. Total other expense, net for both periods consisted primarily of interest expense related to the Company’s venture debt offset by investment income.

Income Tax
Pursuant to the license agreement with Fosun, $500,000 was withheld in accordance with tax withholding requirements in China and was recorded as an expense during the fiscal year ended June 30, 2018. For the quarter ended September 30, 2017, Palatin incurred $225,255 in income tax expense utilizing an estimated effective annual income tax rate applied to income for the quarter and the remaining balance of $274,745 was included in prepaid expenses and other current assets at September 30, 2017. Any potential credit to be received by Palatin on its United States tax returns is currently offset by Palatin’s valuation allowance.

There was no income tax expense recorded in the quarter ended September 30, 2018.

Cash Position
At September 30, 2018, the Company had cash, cash equivalents, and accounts receivable aggregating $32.7, compared to cash and cash equivalents and accounts receivable of $38.0 million at June 30, 2018. Current liabilities were $8.5 million as of September 30, 2018, compared to $10.8 million as of June 30, 2018.

The Company believes that existing capital resources will be sufficient to fund its planned operations through at least the 2019 calendar year.

Palatin Drug Discovery Programs
In the conference call and webcast, management will update and discuss next steps in Palatin’s portfolio of drug development programs. These include Palatin’s melanocortin receptor­1 and receptor-1/5 agonist peptides for treatment of anti-inflammatory and autoimmune indications, receptor-4 peptide and small molecule agonists for the treatment of genetic obesity indications and natriuretic peptide receptor agonist compounds for treatment of cardiovascular and pulmonary indications.

Conference Call / Webcast
Palatin will host a conference call and webcast on November 13, 2018 at 11:00 a.m. Eastern Time to discuss the quarter ended September 30, 2018 results of operations and also provide an update on its programs under development. Individuals interested in listening to the conference call live can dial 1-877-260-1479 (US/Canada) or 1-334-323-0522 (international), conference ID 5988704. The webcast and replay can be accessed by logging on to the "Investor/Webcasts" section of Palatin’s website at View Source A telephone and webcast replay will be available approximately one hour after the completion of the call. To access the telephone replay, dial 1-888-203-1112 (US/Canada) or 1-719-457-0820 (international), passcode 5988704. The webcast and telephone replay will be available through November 20, 2018.

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On November 13, 2018 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported financial results and business highlights for the third quarter 2018 (Press release, Cyclacel, NOV 13, 2018, View Source [SID1234531427]). The Company’s net loss applicable to common shareholders for the three months ended September 30, 2018 was $2.1 million. As of September 30, 2018, cash and cash equivalents totaled $19.0 million.

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"We continue to execute on our strategy to rapidly develop CYC065 and CYC140 in hematological malignancies and CYC065 in advanced solid tumors," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "The Phase 1 study evaluating CYC065 in combination with venetoclax in patients with relapsed/refractory CLL and the CYC140 first-in-human study are open for enrollment. Two further protocols evaluating combinations of CYC065 and sapacitabine are in development. Our alliance with MD Anderson allows us to parallel track the development of our drugs in a cash-sparing manner while utilizing MD Anderson’s expertise to recruit patients across four studies. We estimate that our cash resources will be sufficient to fund operations until the second quarter of 2020. We are also pleased to report that the IST evaluating sapacitabine and olaparib in BRCA positive patients with breast cancer has started to enroll."

Key Company Highlights

·Announced a three-year strategic alliance agreement with The University of Texas MD Anderson Cancer Center enabling clinical evaluation of three Cyclacel medicines in patients with hematological malignancies. MD Anderson will conduct four clinical studies, with a total projected enrollment ofpatients, investigating CYC065, CYC140 and sapacitabine either as single agents or in combination with approved drugs.

·Opened for enrollment the Phase 1 clinical trial evaluating CYC065 in combination with venetoclax, a Bcl-2 inhibitor, in patients with relapsed/refractory CLL. Preclinical data presented at AACR (Free AACR Whitepaper) 2018 showed enhanced activity of CYC065 and venetoclax combination in CLL tumor samples, including those with 17p deletions. The combination also demonstrated activity in two CLL samples resistant to either agent alone, suggesting that dual targeting of Mcl-1 and Bcl-2 dependent mechanisms could induce synergistic cell death.

·First patient dosed in the Phase 1b/2 investigator-sponsored trial (IST) of sapacitabine with olaparib, an approved PARP inhibitor, in BRCA positive patients with breast cancer. Preclinical data support the hypothesis that dual targeting of the DNA damage response pathway by combining olaparib with sapacitabine may enhance the efficacy of standard of care treatment for BRCA positive patients with breast cancer.

·Activated the CYC140 first-in-human study in advanced leukemias. CYC140 is a novel, small molecule, selective polo-like-kinase 1 (PLK1) inhibitor. CYC140 is differentiated from other PLK1 inhibitors, demonstrating potent and selective target inhibition and high activity in xenograft models of human cancers when dosed orally at non-toxic doses.

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¨ 1 James Lindsay Place, Dundee, DD1 5JJ, UK Tel +44 1382 206 062 Fax +44 1382 206 067

www.cyclacel.com – [email protected]

·Progressed patient enrollment in part 2 of the Phase 1 study evaluating CYC065 monotherapy in patients with advanced solid tumors including those with Mcl-1, MYC or cyclin E amplified cancers relevant to CYC065’s mechanism of action. Part 2 is evaluating increased dosing frequency of two days per week for two weeks of a three-week cycle.

·Completed meetings with three European regulatory authorities with the objective of determining a potential regulatory pathway for sapacitabine in elderly AML. The regulators provided consistent guidance on next steps and Cyclacel is evaluating a potential request for a meeting with the Scientific Advice Working Party of the European Medicines Agency.

·Appointed Robert J. Spiegel, M.D. to the Board of Directors. Dr. Spiegel brings over 30 years of R&D and operational experience in the biopharmaceutical industry as well as advisory experience to venture capital and private equity funds.

·Entered into a Common Stock Sales Agreement with H.C. Wainwright & Co., LLC as sales agent, pursuant to which the agent may sell shares of common stock having an aggregate offering price of up to $5.0 million by any method that is deemed to be an "at the market offering" as defined in Rule 415 under the Securities Act of 1933 as amended.

Financial Highlights

As of September 30, 2018, cash and cash equivalents totaled $19.0 million compared to $23.9 million as of December 31, 2017. The decrease of $4.9 million in the nine-months was primarily due to net cash used in operating activities, including $1.2 million of R&D tax credit received from the United Kingdom government.

Research and development expenses were $1.2 million for the three months ended September 30, 2018 compared to $1.0 million for the same period in 2017.

General and administrative expenses were $1.3 million for the three months ended September 30, 2018 compared to $1.2 million for the same period in 2017.

Other income, net for the three months ended September 30, 2018 was $0.1 million compared to $36,000 for the same period of the previous year.

The United Kingdom R&D and tax credits were $0.3 million for the three months ended September 30, 2018 compared to $0.2 million for the same period in 2017.

Net loss for the three months ended September 30, 2018 was $2.1 million compared to $1.9 million for the same period in 2017. With the cash-sparing benefits accruing from the MD Anderson alliance the Company believes that cash and marketable securities, which were approximately $19.0 million as of September 30, 2018, will be sufficient to finance operations until the second quarter of 2020.

Conference call information:

US/Canada call: (877) 493-9121 / international call: (973) 582-2750

US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406

Code for live and archived conference call is 3775807

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.