On March 27, 2019 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported the pricing of an underwritten public offering of an aggregate of 5,250,000 units at a public offering price of $1.00 per unit (Press release, Moleculin, MAR 27, 2019, View Source [SID1234534675]). Each unit is comprised of one share of common stock and 0.5 of a warrant to purchase one share of common stock for a total of 5,250,000 shares of common stock and warrants to purchase 2,625,000 shares of common stock.

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Moleculin Biotech, Inc. is a clinical-stage pharmaceutical company focused on the treatment of highly resistant cancers. (PRNewsfoto/Moleculin Biotech, Inc.)

Each warrant will have an exercise price of $1.10 per share and is exercisable immediately. The warrants will expire five years from the date of issuance. The shares of common stock and the accompanying warrants included in the units can only be purchased together in this offering but will be issued separately and will be immediately separable upon issuance. The offering is expected to close on or about March 29, 2019, subject to customary closing conditions.

The gross proceeds of the offering are expected to be $5.25 million, prior to deducting the underwriting discount and other estimated offering expenses.

Oppenheimer & Co. Inc. is acting as the sole underwriter for the offering. Roth Capital Partners, LLC and Maxim Group LLC are acting as financial advisors to the Company.

The Company intends to use the net proceeds of the offering to fund its planned clinical trials, preclinical programs, for other research and development activities and for general corporate purposes.

The securities described above are being offered pursuant to a prospectus supplement and an accompanying prospectus forming part of a shelf registration statement on Form S-3 (No. 333-219434) previously filed with and declared effective by the Securities and Exchange Commission (SEC). A final prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, by telephone at (212) 667-8055, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On March 27, 2019 OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, reported that the Company will host a Key Opinion Leader (KOL) Symposium focused on the potential of TAVO (tavokinogene telseplasmid), its lead immunotherapy investigational product candidate, on Friday, April 5, 2019 at 8:00 a.m. ET in New York City (Press release, OncoSec Medical, MAR 27, 2019, View Source [SID1234534659]).

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The KOL Symposium will feature a keynote presentation from Adil Daud, M.D., the Lead U.S. Investigator for KEYNOTE-695 and Clinical Professor of Medicine and Dermatology at University of California, San Francisco (UCSF), and Director of Melanoma Clinical Research at the UCSF Helen Diller Family Comprehensive Cancer Center.

Among other important topics, Dr. Daud’s presentation will:

Outline the significance of the emerging data from the KEYNOTE-695 trial where patients with anti-PD-1 checkpoint refractory metastatic melanoma are being treating with the combination of TAVO + KEYTRUDA
Provide insights of how TAVO is differentiated from other therapeutic approaches for patients with checkpoint refractory metastatic melanoma
Following Dr. Daud’s presentation, OncoSec’s management team will:

Outline the U.S. and EU accelerated approval pathway and timelines for the approval of TAVO to treat metastatic melanoma patients who are refractory to anti-PD-1 checkpoint therapy
Showcase OncoSec’s newly-developed proprietary visceral lesions applicator or VLA, which is designed to treat a variety of deep visceral tumors including gastrointestinal (GI) tumors, pancreatic tumors and hepatocellular carcinomas (HCC)
Provide an overview of data presented at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, highlighting OncoSec’s novel anti-tumor therapeutic product candidate
The FDA designated Fast Track Development Program status to OncoSec’s TAVO in combination with KEYTRUDA to stop or cause the regression of the tumor of patients with Stage III/IV melanoma who are progressing on either KEYTRUDA or OPDIVO. A drug that receives Fast Track designation is eligible for Accelerated Approval, if relevant criteria are met.

A live webcast of the event will be available. To access the live webcast, please visit the Investor Relations section of OncoSec’s website at ir.oncosec.com. An archived replay of the webcast will also be available at the same location.

On March 27, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson reported the submission of a Type II variation application to the European Medicines Agency (EMA) for DARZALEX▼ (daratumumab) in combination with bortezomib, thalidomide and dexamethasone (VTd) for newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant (ASCT) (Press release, Johnson & Johnson, MAR 27, 2019, View Source [SID1234534676]).

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The submission is supported by data from the Phase 3 CASSIOPEIA (MMY3006) study. Additional information about this study can be found at www.ClinicalTrials.gov (NCT02541383).

"With this regulatory submission, Janssen could help redefine treatment for transplant eligible patients by providing the opportunity to be treated with a daratumumab regimen for the very first time," said José Antonio Burón Vidal, Vice President, Medical Affairs, Europe, Middle East and Africa (EMEA), Janssen-Cilag, S.A. "We continue to deliver advances in multiple myeloma, and if approved, this could offer a broader range of frontline patients a new treatment option and improved outcomes."

Janssen has also submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval of daratumumab-VTd for newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant (ASCT).

In Europe, daratumumab is indicated:1

in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant
as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy
in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
About the CASSIOPEIA Trial2

The randomised, open-label, two-arm, multicentre, Phase 3 study is sponsored by the French Intergroupe Francophone du Myelome (IFM) in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen R&D, LLC. The study includes participants with previously untreated multiple myeloma eligible for high dose chemotherapy and ASCT. In the first part of the study, on which the filing is based, participants were randomised to receive either induction (before transplantation) and consolidation (after transplantation) treatment with daratumumab combined with bortezomib, thalidomide and dexamethasone or bortezomib, thalidomide and dexamethasone alone. The primary endpoint is the proportion of patients that achieve a stringent Complete Response (sCR) rate after consolidation therapy. In the second part of the study, patients that achieved a response will undergo a second randomisation to either receive maintenance treatment of daratumumab or no further treatment (observation). The primary endpoint of this part of the study is progression free survival (PFS). The total duration for each participant in the study will be approximately 138 weeks. The end of the study will occur approximately five years after the last participant is randomised in the second phase of the study. Disease assessments will be performed every four weeks in the first phase of the study and then every eight weeks in the second phase of the study.

About daratumumab

Daratumumab is a first-in-class3 biologic targeting CD38, a surface protein that is highly expressed across multiple myeloma cells, regardless of disease stage.4 Daratumumab is believed to induce tumour cell death through multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), as well as through apoptosis, in which a series of molecular steps in a cell lead to its death.1 A subset of myeloid derived suppressor cells (CD38+ MDSCs), CD38+ regulatory T cells (Tregs) and CD38+ B cells (Bregs) were decreased by daratumumab.1 Daratumumab is being evaluated in a comprehensive clinical development programme across a range of treatment settings in multiple myeloma, such as in frontline and relapsed settings.2,5,6,7,8,9,10,11 Additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant haematologic diseases in which CD38 is expressed, such as smouldering myeloma.12,13 For more information, please see www.clinicaltrials.gov.

For further information on daratumumab, please see the Summary of Product Characteristics at View Source

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive licence to develop, manufacture and commercialise daratumumab.14

About Multiple Myeloma

Multiple myeloma (MM) is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells.15 In Europe, more than 48,200 people were diagnosed with MM in 2018, and more than 30,800 patients died.16 Almost 40 percent of patients with MM do not reach five-year survival.17

Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure.18 Refractory MM is when a patient’s disease progresses within 60 days of their last therapy.19,20 Relapsed cancer is when the disease has returned after a period of initial, partial or complete remission.21 While some patients with MM have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.22 Patients who relapse after treatment with standard therapies, including proteasome inhibitors and immunomodulatory agents, have poor prognoses and few treatment options available.23

On March 27, 2019 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company") a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported its financial results and business highlights for the fourth quarter and full year ended December 31, 2018 (Press release, Cyclacel, MAR 27, 2019, View Source [SID1234534660]). The Company’s net loss applicable to common shareholders for the three months and year ended December 31, 2018 was $2.1 million and $7.5 million, respectively. As of December 31, 2018, cash and cash equivalents totaled $17.5 million, not including net proceeds of approximately $4.1 million from a Common Stock Sales Agreement.

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"We are executing on our targeted oncology strategy with the objective of delivering data readouts from multiple clinical programs," said Spiro Rombotis, President and Chief Executive Officer. "At the heart of our business strategy is targeting patients with overexpression of cancer resistance proteins, including Mcl-1, MYC, cyclin E, and inherited mutations in DNA damage pathways, such as BRCA. We believe CYC065 is the first investigational drug to have consistently demonstrated durable suppression of Mcl-1 at tolerable dosing in patients. We have treated patients in two out of four studies under our MD Anderson collaboration, the Phase 1 study of a combination of CYC065 and venetoclax in relapsed/refractory CLL and the first-in-human, Phase 1 study of CYC140 in advanced leukemias. Protocols for the other two studies have been finalized and will be submitted to institutional review boards. The first two patients with BRCA mutant breast cancer were treated in the sapacitabine and olaparib IST. With estimated capital on hand until the end of 2020 we look forward to reporting data from our ongoing clinical studies and realizing shareholder value from our targeted drug pipeline."

Fourth Quarter and Full-Year Highlights

Drug Development

CYC065 CDK Inhibitor

Initiated a Phase 1 clinical trial evaluating CYC065, a CDK2/9 inhibitor, in combination with venetoclax in patients with relapsed/refractory CLL. The first patient has been treated with this dose regimen without dose-limiting toxicity. The strong biological rationale of dual Mcl-1 and Bcl-2 suppression was presented at the 2018 AACR (Free AACR Whitepaper) in a poster titled "Strategic combination of the cyclin-dependent kinase inhibitor CYC065 with venetoclax to target anti-apoptotic proteins in chronic lymphocytic leukemia." The data showed an enhanced effect of the combination of CYC065 and venetoclax in CLL tumor samples, including demonstrating activity in 17p deleted samples which were resistant to either agent alone.

Data from the Phase 1 part 1 clinical study of CYC065 monotherapy administered intravenously over 4 hours every 3 weeks in patients with advanced solid tumors were reported at an oral presentation at the 2018 AACR (Free AACR Whitepaper). Prolonged reduction of Mcl-1 expression was observed in 11 out of 13 patients treated at the recommended Phase 2 dose (RP2D) following a single dose of CYC065. Cyclacel continues to enroll patients in part 2 of the study evaluating CYC065 in a more intensive schedule for 2 days per week over 2 weeks of a three-week cycle. Part 3 of the study is planned to evaluate an oral CYC065 formulation.

Discussions with principal investigators and/or cooperative groups progressed with the objective of evaluating CYC065 in patients with certain hematological malignancies and solid tumors.

x 200 Connell Drive, Suite 1500, Berkeley Heights, NJ 07922, USA Tel +1 908 517 7330 Fax +1 866 271 3466

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www.cyclacel.com – [email protected]

DNA Damage Response (DDR) Program

The first two patients have been dosed in the Phase 1b/2 investigator-sponsored study of sapacitabine in combination with olaparib, an approved PARP inhibitor, in patients with BRCA mutant breast cancer. According to the investigators both patients achieved tumor shrinkage. Dual targeting of the DNA damage response pathway with the addition of sapacitabine to olaparib may enhance the efficacy of the current standard of care for such patients.

Patient enrolment has continued in part 3 of a Phase 1 study evaluating a revised dosing schedule of sequential sapacitabine and seliciclib, Cyclacel’s first-generation CDK inhibitor, in BRCA mutation positive patients with advanced breast, ovarian and pancreatic cancer. New data on an expanded cohort from part 1 of this study will be the subject of a poster titled "Expansion cohort of Phase I study of oral sapacitabine and oral seliciclib in patients with metastatic breast cancer and BRCA1/2 mutations" at the 2019 AACR (Free AACR Whitepaper).

CYC140 PLK1 Inhibitor

The first patient has been dosed in a Phase 1 first-in-human study evaluating CYC140 in patients with advanced leukemias. CYC140 is a small molecule, selective polo-like-kinase 1 (PLK1) inhibitor that has demonstrated potent and selective target inhibition and high activity in xenograft models of human cancers.

SEAMLESS Phase 3 Study

Stratified and exploratory subgroup analyses have defined a subgroup of patients for whom the sapacitabine regimen may represent an improvement over low intensity treatment by decitabine alone. Following consultation with three European regulatory authorities regarding a potential approval pathway for sapacitabine the Company intends to submit a request for scientific advice to the Scientific Advice Working Party (SAWP) of the European Medicines Agency.

Corporate Developments

Entered into a collaboration with The University of Texas MD Anderson Cancer Center to evaluate three Cyclacel medicines in patients with hematological malignancies. MD Anderson will evaluate CYC065, CYC140 and sapacitabine either as single agents or in combination with approved drugs, in up to 170 enrolled patients across four clinical trials.

Added Robert J. Spiegel, M.D. to the Company’s 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.

2019 Key Upcoming Business Objectives

·Report expansion cohort, Phase 1 clinical data with an oral sequential regimen of sapacitabine and seliciclib in patients with BRCA mutant metastatic breast cancer at the 2019 AACR (Free AACR Whitepaper)
·Initiate CYC065-venetoclax Phase 1 study in patients with relapsed or refractory AML or MDS
·Initiate sapacitabine-venetoclax Phase 1 study in patients with relapsed or refractory AML or MDS
·Report initial data from the CYC065-venetoclax Phase 1 studies in leukemias

·Report initial data from the CYC140 Phase 1 First-in-Human study
·Report initial data and bioavailability from the Phase 1 study of an oral formulation of CYC065
·Report updated CYC065 Phase 1 data in patients with advanced solid cancers
·Report data from the IST Phase 1b/2 trial of sapacitabine-olaparib combination in patients with BRCA mutant metastatic breast cancer when reported by the investigators
·Determine regulatory pathway and submissibility of sapacitabine in elderly AML

Financial Highlights

As of December 31, 2018, cash and cash equivalents totaled $17.5 million, compared to $23.9 million as of December 31, 2017. The decrease of $6.4 million was primarily due to net cash used in operating activities of $6.7 million, net cash used in investing activities of $0.1 million, offset by $0.4 million of net cash provided by financing activities.

Revenues for the three months and year ended December 31, 2018 amounted to $0.2 million compared to nil revenue for the same periods in 2017. The revenue is related to a June 2015 collaboration, licensing and supply agreement with ManRos Therapeutics SA.

Research and development expenses were $1.1 million and $4.3 million for the three months and year ended December 31, 2018 as compared to $0.7 million and $4.2 million for the same periods in 2017. Research and development expenses relating to transcriptional regulation increased by $1.5 million from $1.1 million for the year ended December 31, 2017 to $2.5 million for the year ended December 31, 2018, as the clinical evaluation of CYC065 progresses. Research and development expenses relating to sapacitabine decreased by $1.7 million from $2.5 million for the year ended December 31, 2017 to $0.8 million for the year ended December 31, 2018, primarily as a result of a reduction in expenditures associated with the SEAMLESS Phase 3 trial and related costs.

General and administrative expenses for the three months and year ended December 31, 2018 were $1.5 million and $5.3 million, respectively compared to $1.5 million and $5.3 million for the same period of the previous year.

Total other income, net for the three months and year ended December 31, 2018 were $0.1 million and $0.9 million, compared to $0.1 million and $1.0 million for the same period of the previous year. The decrease of $0.1 million for the year ended December 31, 2018 is primarily related to a reduction in income received under an Asset Purchase Agreement with ThermoFisher Scientific Company and offset by a $0.2 million increase in interest income.

United Kingdom research & development tax credits were $0.4 million and $1.3 million for the three months and year ended December 31, 2018 as compared to $0.2 million and $1.0 million for the same periods in 2017.

Net loss for the three months and year ended December 31, 2018 were $2.0 million and $7.3 million compared to $1.9 million and $7.5 million for the same periods in 2017.

The Company raised net proceeds of approximately $4.7 million, of which $4.1 million was received in 2019, from its Common Stock Sales Agreement with H.C. Wainwright. This agreement is now complete. Together with cash resources of $17.5 million as of December 31, 2018 the Company estimates cash resources will fund currently planned programs through the end 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 9719419.

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 March 27, 2019 Eureka Therapeutics, Inc., a clinical stage biotechnology company developing novel T-cell therapies that harness the evolutionary power of the immune system, reported the publication of a proof-of-concept study in Science Translational Medicine entitled "GPRC5D is a target for the immunotherapy of multiple myeloma with rationally designed CAR-T cells (Press release, Eureka Therapeutics, MAR 27, 2019, View Source [SID1234534677])." The study was led by researchers from Eureka, Memorial Sloan Kettering Cancer Center (MSK) and Juno Therapeutics (Juno).

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Antibody-based therapies, including bi-specific antibodies and chimeric antigen receptor (CAR) T-cell therapies targeting B cell maturation antigen (BCMA) for multiple myeloma, have shown promising clinical results, but relapses associated with low-to-negative expression of BCMA have been reported, necessitating additional targets for multiple myeloma.

The orphan G protein-coupled receptor GPRC5D has been previously identified in bone marrow cells in patients with multiple myeloma. However, the protein expression profile of GPRC5D remained elusive. Through immunohistochemical analyses, the study demonstrated that GPRC5D is expressed on malignant bone marrow plasma cells, while normal tissue expression is limited to the hair follicle, an immune-privileged site.

In 83 evaluated primary myeloma marrow samples, 65% of samples have GPRC5D expression above a 50% antigen expression cutoff on CD138+ cells. More importantly, GPRC5D expression on CD138 multiple myeloma cells was independent of BCMA expression, suggesting GPRC5D as an ideal clinical target.

In collaboration with MSK, Eureka developed antibodies targeting GPRC5D using Eureka’s proprietary E-ALPHA discovery platform. These antibodies, together with antibodies targeting BCMA and another undisclosed multiple myeloma target, were licensed by Eureka and MSK to Juno (now Celgene) in 2016 for use in CARs.

In a head-to-head comparison with BCMA-targeted CARs with an identical backbone, GPRC5-targeted CAR-T cells demonstrated efficient antigen-specific cytotoxicity in vitro, as well as comparable effect in inducing tumor regression and extending survival at different dose levels in vivo. The study further showed that tumor escape can be rescued by GPRC5D-targeted CAR T-cells in a model of BCMA-antigen loss mediated relapse.

"The study confirms GPRC5D as a viable target in multiple myeloma," said Eric Smith, M.D., Ph.D., a medical oncologist and the Director of Clinical Translation within the Cellular Therapeutics Center at MSK. "We look forward to moving this study into the clinic, including in relapsed patients after BCMA-targeted therapy."

"Targeting GPRC5D has the potential to improve the durability of response from current bi-specific and T-cell therapies that target only BCMA," said Dr. Cheng Liu, President and Chief Executive Officer at Eureka Therapeutics. "This study reflects our commitment to increasing the long-term clinical benefit for patients with multiple myeloma and other cancers, and we look forward to leveraging our E-ALPHA and ARTEMIS platforms to develop transformational new T-cell therapies that are potentially safer and more effective."