On November 13, 2019, OncoCyte Corporation (the "Company") reported that it has entered into a series of Subscription Agreements (collectively, the "Subscription Agreement") with select institutional investors and other parties ("Investors"), whereby the Company agreed to issue and sell to the Investors, and the Investors agreed to purchase, an aggregate of 5,058,824 shares of the Company’s common stock (the "Common Stock") at a price per share of $1.70, for an aggregate cash purchase price of approximately $8.6 million (the "Financing") (Filing, 8-K, Oncocyte, NOV 13, 2019, View Source [SID1234551297]). The Subscription Agreement provides that the closing will occur no later than November 15, 2019. Broadwood Partners, L.P., which beneficially owns 22.9% of our common stock (pursuant to its Schedule 13D/A, as filed on September 13, 2019), has agreed to purchase 1,176,471 shares of our common stock in the Financing.

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The description of the terms and conditions of the Subscription Agreement and the rights and obligations of the Company and the Investors in connection therewith are qualified by reference in their entirety to the definitive terms and conditions of the Subscription Agreement, the form of which is attached hereto as Exhibit 10.1 hereto and incorporated herein by reference.

The Subscription Agreement is being filed in order to provide investors and the Company’s stockholders with information regarding its terms and in accordance with applicable rules and regulations of the Securities and Exchange Commission (the "Commission"). Pursuant to the Subscription Agreement, each of the Company and the Investors made customary representations, warranties and covenants to each other. The representations, warranties and covenants were made by the parties to and solely for the benefit of each other in the context of all of the terms and conditions of the Subscription Agreement, the Financing, and the specific relationship between the parties. Accordingly, investors and stockholders should not rely on the representations, warranties and covenants. Furthermore, investors and stockholders should not rely on the representations, warranties and covenants as characterizations of the actual state of facts or continuing intentions of the parties, since they were only made as of the date of the Subscription Agreement. Information concerning the subject matter of such representations, warranties and covenants may change after the date of the Subscription Agreement, which subsequent information may or may not be fully reflected in the Company’s reports or other filings with the Commission.

The Financing is being made pursuant to the registration statement on Form S-3, declared effective by the Commission on June 18, 2019 (Registration No. 333-231980), a base prospectus dated June 18, 2019 and a prospectus supplement to be filed prior to closing. A copy of the opinion of DLA Piper LLP (US) relating to the legality of the shares of common stock to be issued in the Financing is attached as Exhibit 5.1 to this Current Report on Form 8-K.

On November 13, 2019 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, whose product candidates are targeted, receptor-specific therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, reported results for its first quarter ended September 30, 2019 (Press release, Palatin Technologies, NOV 13, 2019, View Source [SID1234551127]).

Quarter End and Recent Highlights

Hypoactive Sexual Desire Disorder / Vyleesi (bremelanotide injection)
Vyleesi is the first as needed treatment for premenopausal women with acquired, generalized HSDD.

AMAG Pharmaceuticals, Palatin’s North American licensee, launched Vyleesi nationally in September with its established women’s health sales force of approximately 125 sales representatives. In the four weeks since the national launch, more than 1,300 healthcare providers have prescribed Vyleesi, which has resulted in more than 3,000 prescriptions received by AMAG’s specialty pharmacy partners.

Anti-Inflammatory / Autoimmune Programs
Melanocortin agonist products are under development for the treatment of inflammatory and autoimmune diseases such as dry eye, uveitis, diabetic retinopathy and inflammatory bowel diseases (ulcerative colitis). We announced positive results of a micro-dose study of radiolabeled PL8177, a selective melanocortin receptor 1 ("MC1r") peptide agonist, using an oral, delayed-release, polymer formulation. The study met all primary and secondary endpoints. PL8177 has potential application in treatment of ulcerative colitis and other inflammatory bowel diseases. The FDA has granted orphan drug designation for PL8177 for the treatment of non-infectious intermediate, posterior, pan and chronic anterior uveitis. Non-infectious uveitis (NIU) is a group of inflammatory diseases that produces swelling and destroys eye tissue and can result in vision loss. A Phase 2 proof-of-concept clinical study with a systemic formulation in NIU patients is anticipated to commence in the first quarter of calendar year 2020. A Phase 2 proof-of-concept clinical study with an oral formulation in ulcerative colitis patients is anticipated to commence in the second quarter of calendar year 2020.

An IND application for PL9643, a melanocortin peptide agonist, and commencement of a Phase 2 clinical study in dry eye disease, are currently anticipated in the first quarter of calendar year 2020.

Natriuretic Peptide Receptor ("NPR") System Program
The Company has designed and is developing potential drug candidates that are selective agonist for one or more different natriuretic peptide receptors, including natriuretic peptide receptor-A ("NPR-A"), natriuretic peptide receptor B ("NPR-B"), and natriuretic peptide receptor C ("NPR-C"). Active collaborations with several institutions are ongoing for PL3994, an NPR-A agonist that has potential utility in the treatment of a number of cardiovascular diseases, including genetic and orphan diseases resulting from a deficiency of endogenous active NPR-A, and PL5028, a dual NPR-A and NPR-C agonist in development for cardiovascular diseases, including reducing cardiac hypertrophy and fibrosis. A Phase 2A clinical trial evaluating PL3994 in heart failure patients with preserved left ventricular ejection fraction will begin enrollment in the latter half of calendar year 2019. This trial is supported by a grant from the American Heart Association.

Genetic Obesity Program
The Company’s melanocortin receptor 4 ("MC4r") peptide PL8905 and orally, active small molecule PL9610 are currently under investigation for the treatment of rare genetic metabolic and obesity disorders. These programs are under internal evaluation for orphan designation and potential development.

Corporate
Cash, cash equivalents and accounts receivable balances at September 30, 2019 total $96.8 million.

Debt and related liabilities were fully paid off in July 2019.

In September 2019, the Company’s Board of Directors approved a plan to offer to purchase and terminate certain outstanding common stock purchase warrants through privately negotiated transactions. The purchase and termination program has no time limit and may be suspended for periods or discontinued at any time.

To date, the Company entered into several warrant termination agreements to repurchase and cancel previously issued warrants. The Company repurchased and cancelled in the aggregate 6.5 million warrants at an aggregate buyback price of $2.5 million.

First Quarter Fiscal 2020 Financial Results
Palatin reported a net loss of $(4.5) million, or $(0.02) per basic and diluted share, for the quarter ended September 30, 2019, compared to a net loss of $(5.7) million, or $(0.03) per basic and diluted share, for the same period in 2018.

The difference in financial results between the three months ended September 30, 2019 and 2018 was due to reductions in operating and interest expenses combined with increases in reported license and contract revenue and investment income.

Revenue
For the quarter ended September 30, 2019, Palatin recognized as revenue $97,379 in reimbursement of shared Vyleesi costs compared to $34,505 for the quarter ended September 30, 2018.

Operating Expenses
Total operating expenses for the quarter ended September 30, 2019 were $5.0 million compared to $5.7 million for the comparable quarter of 2018. The decrease in operating expenses was mainly attributable to decreases in salaries and other employee related expenses.

Other Income/Expense
Total other income, net was $361,603 for the quarter ended September 30, 2019 compared to total other expense, net of $(53,288) for the quarter ended September 30, 2018. The difference is primarily related to an increase in investment income and secondarily to a decrease in interest expense.

Cash Position
Palatin’s cash, cash equivalents, and accounts receivable total $96.8 million as of September 30, 2019, compared to cash, cash equivalents and accounts receivable of $103.8 million at June 30, 2019. Current liabilities were $1.9 million as of September 30, 2019, compared to $4.2 million as of June 30, 2019.

Palatin Drug Discovery and Development Programs
During 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 receptor agonist peptides for treatment of inflammatory indications and natriuretic peptide receptor agonist compounds for treatment of cardiovascular and fibrotic diseases.

Conference Call / Webcast
Palatin will host a conference call and audio webcast on November 13, 2019 at 11:00 a.m. Eastern Time to discuss the quarter ended September 30, 2019 results of operations in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-888-599-8686 (US/Canada) or 1-323-794-2575 (international), conference ID 1609183. The audio webcast and replay can be accessed by logging on to the "Investor/Webcasts" section of Palatin’s website at View Source A telephone and audio 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 1609183. The webcast and telephone replay will be available through November 20, 2019.

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On November 13, 2019 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 2019 (Press release, Cyclacel, NOV 13, 2019, View Source [SID1234551143]). The Company’s net loss applicable to common shareholders for the three months ended September 30, 2019 was $2.0 million. As of September 30, 2019 cash and cash equivalents totaled $13.0 million.

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"The investigators evaluating CYC065, our CDK2/9 inhibitor, as a single agent have reported that a heavily pretreated patient with MCL1 amplified endometrial cancer achieved a partial response (PR) with tumor shrinkage of 48%," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "If this PR is confirmed with a follow up scan, it will provide further support that MCL1 dependent cancers may be sensitive to CYC065. We have previously reported that CYC065 durably suppresses MCL1 in cancer patients and believe that it is a leader amongst MCL1 suppressing medicines. In parallel, we have enrolled our first patient with an oral form of CYC065 and are continuing to recruit patients in Phase 1 studies evaluating CYC065 in combination with venetoclax in patients with relapsed or refractory AML, CLL or MDS. Altogether we are dosing patients in five clinical studies in pursuit of our strategy of overcoming cancer resistance through combinations of our candidates with approved drugs. With projected cash to the end of 2020 we look forward to delivering on multiple data outcomes from our ongoing studies."

Key Company Highlights

·Reported anticancer activity in part 2 of 065-01, the Phase 1 study of CYC065 as a single agent; a patient with MCL1 amplified endometrial cancer achieved partial response with 48% tumor shrinkage after 4 cycles of treatment at 213mg as reported by the investigators;
·Reached the second dose level in part 3 of 065-01 evaluating an oral form of CYC065 in patients with advanced cancers;
·Enrolled eight patients in the 065-03 Phase 1 study evaluating CYC065 in combination with venetoclax in patients with relapsed or refractory AML/MDS;
·Opened two new sites in the 065-02 study of CYC065 in combination with venetoclax in patients with relapsed/refractory CLL;
·Data from three ongoing studies have been selected for presentation at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. The presentations will provide updates for CYC065 in combination with venetoclax in patients with relapsed or refractory AML/MDS or CLL and sapacitabine in combination with venetoclax in patients with relapsed or refractory AML/MDS; and
·Continued enrollment in part 2 of the 682-11 Phase 1/2 study evaluating an oral regimen of sapacitabine in combination with venetoclax in patients with relapsed or refractory AML/MDS.

Key Upcoming Business Objectives

·Presentations at the 61stAmerican Society of Hematology Annual Meeting;
·Report updated safety, pharmacokinetics and efficacy of CYC065 Phase 1 data with frequent dosing schedule in patients with advanced solid cancers;
·Report initial safety and PK data from the Phase 1 study of an oral formulation of CYC065;
·Report initial safety and proof of concept data from the CYC065-venetoclax Phase 1 study in relapsed/refractory AML and MDS;
·Report initial safety and proof of concept data from the CYC065-venetoclax Phase 1 study in relapsed/refractory CLL;
·Report initial data from the sapacitabine-venetoclax Phase 1/2 study in patients with relapsed or refractory AML or MDS;
·Report initial data from the CYC140 Phase 1 First-in-Human study in relapsed or refractory leukemias;
·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; and
·Determine regulatory pathway and submissibility of sapacitabine in elderly AML patients.

Financial Highlights

As of September 30, 2019, cash and cash equivalents totaled $13.0 million compared to $17.5 million as of December 31, 2018. The decrease of $4.5 million was primarily due to net cash used in operating activities of $8.3 million, offset by net proceeds from a Common Stock Sales Agreement with H.C. Wainwright & Co., LLC of $4.1 million. In October 2019, we received $1.2 million in United Kingdom, research & development tax credits not included in the above amounts.

Research and development expenses were $1.1 million for the three months ended September 30, 2019 compared to $1.2 million for the same period in 2018.

General and administrative expenses were $1.3 million for each of the three months ended September 30, 2019 and 2018.

Other income, net for the three months ended September 30, 2019 was $0.2 million compared to $0.1 million for the same period of the previous year.

The accrued United Kingdom research and development tax credit was $0.3 million for each of the three months ended September 30, 2019 and 2018.

Net loss for the three months ended September 30, 2019 was $1.9 million compared to $2.1 million for the same period in 2018. With the projected cash-sparing benefits accruing from the alliance with The University of Texas MD Anderson Cancer Center, the Company believes that cash and marketable securities, which were approximately $13.0 million as of September 30, 2019, will be sufficient to finance operations 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 8636118

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 November 13, 2019 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases, reported financial results for the quarter ended September 30, 2019 (Press release, Gamida Cell, NOV 13, 2019, View Source [SID1234551177]). The company also highlighted continued progress in advancing its clinical development candidates: omidubicel, an advanced cell therapy in Phase 3 clinical development as a potential life-saving treatment option for patients in need of bone marrow transplant, and GDA-201, an investigational, natural killer (NK) cell-based cancer immunotherapy in Phase 1 development in patients with non-Hodgkin lymphoma and multiple myeloma.

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Gamida Cell provides a company update and reports financial results for the third quarter of 2019. Webcast at 4:30pm ET here: View Source

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"During the quarter, we made important progress toward our goal of developing next-generation cell therapies with the potential to redefine standards of care for patients with blood cancers and rare, serious hematologic diseases," stated Julian Adams, Ph.D., chief executive officer of Gamida Cell. "We are nearing completion of patient enrollment in our multi-center, randomized Phase 3 study of omidubicel and are on track to report topline data from the study in the first half of 2020. Positive data from the study would enable us to file our first biologics license application next year."

"Our second cell therapy program, GDA-201, is also advancing, and next month we will report additional data from the ongoing Phase 1 study at the Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper)," Dr. Adams continued. "During the meeting, we will also show new gene expression data that reinforce our understanding of the mechanism of action underlying our NAM technology platform which enabled the generation of both of our development candidates."

Program Highlights

Announced presentation of new data at the 61st Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper): Last week, Gamida Cell announced that additional data from the ongoing Phase 1 clinical study of GDA-201 will be presented during an oral session at the ASH (Free ASH Whitepaper) 2019 Annual Meeting, which is being held December 7 – 10 in Orlando, FL. The presentation, "Results of a Phase 1 Trial of GDA-201, Nicotinamide-Expanded Allogeneic Natural Killer Cells (NAM-NK) in Patients with Refractory Non-Hodgkin Lymphoma (NHL) and Multiple Myeloma (MM)" (Abstract #777), will take place on Monday, December 9, at 3:15 p.m. ET.

Additionally, new research on the mechanism of action of Gamida Cell’s NAM-based cell expansion platform, which is designed to enhance the number and functionality of allogeneic donor cells, will also be shared during the meeting. The poster presentation, "Nicotinamide (NAM) Modulates Transcriptional Signature of Ex Vivo Cultured UCB CD34+ Cells (Omidubicel) and Preserves Their Stemness and Engraftment Potential" (Abstract #3718), will take place on Monday, December 9, from 6:00 – 8:00 p.m. ET.
Advanced the Phase 3 clinical study of omidubicel: Patient enrollment continued to progress in the Gamida Cell’s Phase 3 study of omidubicel in patients with high-risk hematologic malignancies. The international, randomized, multi-center study is designed to evaluate the safety and efficacy of omidubicel compared to standard umbilical cord blood for allogeneic bone marrow transplant in approximately 120 patients with no available matched donor. The company anticipates completing patient enrollment by the end of this year with topline data anticipated in first half of 2020.
Initiated health outcomes research for omidubicel: In September, Gamida Cell and the CIBMTR (Center for International Blood and Marrow Transplant Research) announced a research agreement to evaluate outcomes of patients with hematological malignancies who undergo allogeneic hematopoietic stem cell transplant (bone marrow transplant) from various donor sources. The recently launched observational study includes both retrospective and prospective data contemporaneous to the Phase 3 study of omidubicel. The goal of this real-world, observational study is to better understand the variables that influence the health outcomes of patients receiving a transplant from a source other than a fully matched family donor.
Continued to focus on activities required to successfully bring omidubicel to patients: Gamida Cell is continuing to advance key activities required to bring omidubicel to patients in a commercial setting, including building out manufacturing infrastructure, assembling an experienced commercial team with expertise in cell therapy and transplant, establishing hospital services and patient assistance programs, and exploring coverage and reimbursement models to enable access.
Progressed enrollment in the Phase 1/2 study of omidubicel in patients with severe aplastic anemia: Enrollment is ongoing in a Phase 1/2 clinical study of omidubicel in patients with severe aplastic anemia, a rare, life-threatening bone marrow failure disease. Earlier this year, encouraging data from the first cohort of patients were reported at the 2019 Transplantation & Cellular Therapy (TCT) Meeting that demonstrated that all three patients in the cohort successfully underwent a bone marrow transplant consisting of omidubicel plus a haploidentical stem cell graft. The rapid engraftment, sustained hematopoiesis and accelerated immune recovery observed enabled the initiation of a second cohort, where patients will be treated with omidubicel as a stand-alone graft.
Continued to prepare for the next clinical study of GDA-201: The company is continuing its work to enable a Phase 1/2 multi-dose, multi-center study of GDA-201 in patients with non-Hodgkin lymphoma, which is expected to begin in 2020. The decision to focus the next clinical study on non-Hodgkin lymphoma is based on the encouraging clinical data reported at the 2019 TCT Meeting which demonstrated the GDA-201 was generally well tolerated and clinically active, with multiple complete responses observed.
Third Quarter 2019 Financial Results

Research and development (R&D) expenses in the third quarter of 2019 were $7.4 million compared to $5.1 million for the same period in 2018. R&D expenses were higher in the third quarter of 2019 compared to the same period in 2018 due to the advancement of omidubicel and GDA-201.
General and administrative expenses were $4.6 million for the third quarter of 2019, compared to $2.4 million for the same period in 2018. The difference was attributable mainly to a $1.2 million increase in activities related to commercial readiness, as well as $1.0 million increase in professional services and other expenses, including an increase in expenses associated with being a publicly-traded company.
Finance income, net, was $1.7 million for the third quarter of 2019, compared to finance expenses, net, of $2.2 million for the same period in 2018. The net increase was primarily due to non-cash income resulting from the re-valuation of warrants, offset by non-cash expenses from the re-valuation of the Israeli Innovation Authority royalty-bearing grant liability.
Net loss for the third quarter of 2019 was $10.1 million, compared to a net loss of $9.8 million for the same period in 2018.
As of September 30, 2019, Gamida Cell had total cash, cash equivalents and available-for-sale assets of $68.1 million, compared to $60.7 million as of December 31, 2018.
2019 Financial Guidance

Gamida Cell continues to expect cash used for ongoing operating activities in 2019 to range from $35 million to $40 million, reflecting anticipated expenditures to advance the company’s clinical programs.

Gamida Cell expects that its current cash, cash equivalents and available-for-sale securities will support the company’s ongoing operating activities into the fourth quarter of 2020. This cash runway guidance is based on the company’s current operational plans and excludes any additional funding that may be received or business development activities that may be undertaken.

Conference Call Information

Gamida Cell will host a conference call today, November 13, 2019, at 4:30 p.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors" section of Gamida Cell’s website at www.gamida-cell.com. To participate in the live call, please dial 866-930-5560 (domestic) or 409-216-0605 (international) and refer to conference ID number 8653335. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.

About Omidubicel

Omidubicel (formerly known as NiCord), the company’s lead clinical program, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers). Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU. In a Phase 1/2 clinical study, omidubicel demonstrated rapid and durable time to engraftment and was generally well-tolerated.1 A Phase 3 study evaluating omidubicel in patients with leukemia and lymphoma is ongoing in the U.S., Europe and Asia.2 Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia.3 The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov.

About GDA-201

Gamida Cell applied the capabilities of its NAM-based cell expansion technology to develop GDA-201 (formerly known as NAM-NK), an innate natural killer (NK) cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs of NK cells expanded in culture. GDA-201 is in Phase 1 development through an investigator-sponsored study in patients with refractory non-Hodgkin lymphoma and multiple myeloma.4

Omidubicel and GDA-201 are investigational therapies, and their safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On November 13, 2019 Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported that Jigar Raythatha, CEO, will present at three upcoming investor conferences (Press release, Constellation Pharmaceuticals, NOV 13, 2019, View Source [SID1234551128]):

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Jefferies London Healthcare Conference, 8:00 AM GMT/3:00 AM EST, November 20
Piper Jaffray Healthcare Conference in New York, 11:10 AM EST, December 3
Evercore ISI Healthcare Conference in Boston, 11:45 AM EST, December 4
A live audio webcast of these presentations and archives for replay will be available on the Investor Relations section of Constellation’s website at View Source The audio webcast replays will be available for 90 days following the live presentation.