On February 15, 2019 Nektar Therapeutics presented the corporate presentation (Presentation, Nektar Therapeutics, FEB 15, 2019, View Source [SID1234533358]).

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On February 15, 2019 Eli Lilly and Company (NYSE:LLY) reported the successful completion of its acquisition of Loxo Oncology, Inc. (NASDAQ:LOXO) (Press release, Eli Lilly, FEB 15, 2019, View Source [SID1234533343]). The acquisition broadens the scope of Lilly’s oncology portfolio into precision medicines through the addition of a pipeline of highly selective potential medicines for patients with genomically defined cancers.

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Lilly’s tender offer for all outstanding shares of common stock of Loxo Oncology, at a price of $235.00 per share in cash, expired as scheduled at one minute past 11:59 p.m., Eastern time, on Thursday, February 14, 2019. As of the expiration of the tender offer, 26,043,820 shares of Loxo Oncology common stock were validly tendered and not properly withdrawn, representing approximately 84.6 percent of the shares of Loxo Oncology common stock outstanding, and have been accepted for payment under the terms of the tender offer. Following completion of the tender offer, Lilly completed the acquisition of Loxo Oncology through the previously-planned second-step merger.

"We are pleased to announce the completion of our acquisition of Loxo Oncology, which will expand the breadth of our portfolio into precision medicines and target cancers that are caused by specific gene abnormalities," said Anne White, president of Lilly Oncology. "We look forward to working with the Loxo Oncology team and continuing to rapidly advance this pioneering scientific innovation and improve the lives of people with cancer."

"The Loxo Oncology team has always been relentless and unified around the common goal of bringing highly selective medicines to patients with genomically defined cancers," said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. "With the acquisition now complete, we look forward to realizing the full value of our pipeline with the ongoing support of our teams in Connecticut, Colorado and California."

The acquisition of Loxo Oncology provides Lilly with a promising pipeline of investigational medicines, including:

LOXO-292, a first-in-class oral RET inhibitor that has been granted Breakthrough Therapy designation by the FDA for three indications, with an initial potential launch in 2020. LOXO-292 targets cancers with alterations to the rearranged during transfection (RET) kinase. RET fusions and mutations occur across multiple tumor types, including certain lung and thyroid cancers as well as a subset of other cancers.
LOXO-305, an oral BTK inhibitor currently in Phase 1/2. LOXO-305 targets cancers with alterations to the Bruton’s tyrosine kinase (BTK), and is designed to address acquired resistance to currently available BTK inhibitors. BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas.
In November 2017, Loxo Oncology and Bayer Consumer Care AG entered into a global collaboration for the development and commercialization of the TRK inhibitors Vitrakvi (larotrectinib) and LOXO-195. The Bayer/Loxo agreement provides that Bayer may elect to convert the co-exclusive license to an exclusive license in the U.S. and Puerto Rico in the event of a change of control of Loxo Oncology. Bayer exercised its election under the Bayer/Loxo agreement to convert its co-exclusive license to an exclusive license in the U.S. and Puerto Rico, pending clearance under the Hart-Scott-Rodino Antitrust Improvements Act. When the new exclusive licensing arrangement takes effect, Lilly will receive royalties from Bayer on future sales of Vitrakvi and LOXO-195 both in the U.S. and in international markets.

Lilly has reaffirmed its current 2019 financial guidance. The expected financial impact of Lilly’s acquisition of Loxo Oncology has been previously communicated and is reflected in Lilly’s current 2019 financial guidance, as announced on February 6, 2019.

The Offer and the Merger
The tender offer for all of the outstanding shares of common stock of Loxo Oncology at a price of $235.00 per share, net to the seller in cash, without interest and less any required tax withholding (the "Offer"), expired as scheduled at one minute past 11:59 p.m., Eastern time, on Thursday, February 14, 2019. Computershare Trust Company, N.A., the depositary and paying agent for the Offer, has advised Lilly that 26,043,820 shares of Loxo Oncology common stock were validly tendered and not properly withdrawn in the Offer, representing approximately 84.6 percent of the shares of Loxo Oncology common stock outstanding. All of the conditions to the Offer have been satisfied and on February 15, 2019, Lilly and its wholly-owned subsidiary, Bowfin Acquisition Corporation, accepted for payment, and will promptly pay for, all shares validly tendered and not properly withdrawn in the Offer.

Following completion of the Offer, Lilly completed the acquisition of Loxo Oncology through the merger of Bowfin Acquisition Corporation with and into Loxo Oncology, without a vote of Loxo Oncology’s stockholders pursuant to Section 251(h) of the General Corporation Law of the State of Delaware, with Loxo Oncology surviving the merger as a wholly-owned subsidiary of Lilly. In connection with the merger, each share of common stock of Loxo Oncology not validly tendered into the Offer (other than (1) shares owned by Loxo Oncology immediately prior to the effective time of the merger, (2) shares owned by Lilly or Bowfin Acquisition Corporation at the commencement of the Offer and owned by Lilly or Purchaser immediately prior to the effective time of the merger or (3) shares held by any stockholder that was entitled to and has properly demanded statutory appraisal of its shares) has been converted into the right to receive the same $235.00 per share in cash, without interest and less applicable tax withholding, as will be paid for all shares that were validly tendered and not properly withdrawn in the Offer. Loxo Oncology’s common stock will be delisted from the NASDAQ Stock Market.

On February 15, 2020 Oncoceutics, Inc. reported the outlicense of the rights to the company’s lead compound, ONC201, for Japan to Ohara Pharmaceutical Co., Ltd (Press release, Oncoceutics, FEB 15, 2019, View Source [SID1234558361]). In addition, Ohara will receive a right of first refusal on the license of ONC201 for additional areas, including most of Asia and West Africa, and a right of first refusal for the company’s next generation compound, ONC206, in these territories.

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In return for the license and future rights, Ohara will make a multi-part payment to Oncoceutics including upfront payments, milestone payments, payment for purchase of the drug for re-sale, and royalties. In addition, Ohara will make a significant equity investment into Oncoceutics. Ohara will also be responsible for the execution of clinical trials required to obtain Marketing Authorization in Japan and the commercialization of ONC201 in the Japanese market.

ONC201 is a novel small molecule with a unique mechanism of action that has demonstrated anti-cancer activity and safety in preclinical models and in several ongoing clinical trials, including clinical trials in adult and pediatric patents with high-grade gliomas. The trials focus on gliomas that harbor a H3 K27M mutation that can be identified by immunohistochemistry or gene sequencing, including the FDA-approved companion diagnostic FoundationOne CDx. H3 K27M-mutant glioma is a molecularly-defined disease with a dismal prognosis.

Oncoceutics’ clinical trials are being carried out at numerous leading cancer centers across the United States, including: Massachusetts General Hospital, Dana Farber Cancer Institute, NYU Langone, MD Anderson Cancer Center, Levine Cancer Institute, Miami Cancer Institute, University of California San Francisco, and the University of Michigan. In addition, Emory University, University California Los Angeles, Columbia University and several other institutions are in the process of joining the program. Recently, the FDA granted Fast Track Designation to ONC201 for the Treatment of Adult Recurrent H3 K27M-mutant High-Grade Glioma.

"We are delighted to be partnering with Ohara Pharmaceutical Co., Ltd. whose mission and focus set them apart in the Japanese market and make them the ideal collaborators to bring ONC201 to Japanese patients with H3 K27M-mutant gliomas and other indications," said Wolfgang Oster, MD, PhD, Chief Executive Officer and Chairman of Oncoceutics. "This agreement sets the stage for developing ONC201 towards entry into global markets and providing a therapeutic option to patients in Japan who are affected by a serious disease. Oncoceutics will work closely with Ohara to expand the use of ONC201 into other cancers that are similarly responsive to the pathways engaged by ONC201. We are thrilled by the shared vision between the two companies to introduce a truly novel therapeutic paradigm to a broad selection of tumors that abuse dopamine signaling to promote their growth."

"We are excited to be working with the exceptional team at Oncoceutics to bring this novel medicine and medical concept to Japan for patients with cancer for whom there are no other options," said Seiji Ohara, President of Ohara Pharmaceuticals., Ltd. "The introduction of new treatment paradigms have often led to breakthroughs in diseases that have no therapeutic standards. The anticipated market entry for ONC201 in Japanese pediatric and adult oncology patients is consistent with Ohara’s strategy to challenge and address unmet medical needs. We are excited with the opportunity of the two companies to collaborate and develop ONC201 to address a broad selection of cancers responsive to ONC201."

On February 14, 2019 Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA; OTCQB: MDNAF), a clinical stage immuno-oncology company, reported financial results for the three and nine months ended December 31, 2018 (Press release, Medicenna Therapeutics, FEB 14, 2019, View Source [SID1234533326]).

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The following are the achievements and highlights for the quarter ending December 31, 2018 through to the date hereof:

Presented promising survival data from the ongoing MDNA55 Phase 2b clinical trial for the treatment of recurrent glioblastoma ("rGBM") the most common and uniformly fatal form of brain cancer showing a median overall survival of 15.2 months in the IL4 receptor positive patients who have a more aggressive form of rGBM. Whereas the current standard of care for all rGBM patients provide a median overall survival of only 8.0 months.
Strengthened the balance sheet with a $4.0 million financing in December 2018 and received an additional US$1.2 million in non-dilutive funding in the same month.
Provided an update on MDNA109 demonstrating that it has best-in-class potency toward cancer killing effector T cell and that it potently synergizes with anti-PD-1 or anti-CTLA-4 checkpoint inhibitors to eliminate tumors in the majority of tumor-bearing mice.
Upcoming milestones include:

Completion of patient enrolment in the MDNA55 Phase 2b rGBM is anticipated by the end of Q1 2019
Top line interim results announced in the MDNA55 Phase 2b clinical trial mid-2019
Initiation of Phase 2 clinical trial with MDNA55 for the treatment of newly diagnosed GBM in Q2 2019
Selection of lead MDNA109 candidate in Q1 2019
"2019 is off to an excellent start with compelling median overall survival data in the MDNA55 Phase 2b clinical trial for the treatment of recurrent glioblastoma reported in February as well as the impressive pre-clinical package we are assembling for MDNA109," said Dr. Fahar Merchant, President and CEO of Medicenna. He added that "the clinical and scientific progress we have made in addition to the capital raised and non-dilutive funds received in December has placed Medicenna on an excellent footing to hit key value inflection milestones for 2019."

MDNA55 update
On February 7, 2019 Dr. John H. Sampson, MD, PhD, (Robert H. and Gloria Wilkins Distinguished Professor and Chair of Neurosurgery at Duke University in Durham, NC) presented new clinical study results on MDNA55 for the treatment of rGBM at the 5th Annual Immuno-Oncology 360o Conference held in New York, NY. In a podium presentation entitled, "The IL4 Receptor as a Biomarker and Immunotherapeutic Target for Glioblastoma: Preliminary Evidence with MDNA55, a Locally Administered IL-4 Guided Toxin", Dr. Sampson outlined that following a single treatment with MDNA55 at the low dose, (a) the IL4R positive group showed a remarkable increase in median overall survival ("mOS") of 15.2 months when compared to 8.5 months in the IL4R negative group and (b) irrespective of IL4R expression, mOS was 11.8 months in all patients, substantially exceeding landmark mOS reported for approved drugs for rGBM (mOS is 8 months for Avastin and Lomustine).

On October 22, 2018, the Company presented results and participated in a poster discussion session at the European Society for Medical Oncology Congress held in Munich on October 20, 2018. Based on interim data from patients treated at low doses implemented during the first half of the Phase 2b study of MDNA55, the presentation highlighted the benefits of using of advanced imaging modalities in order to help tumor response evaluation and identify pseudo-progression in some patients which ultimately translates into tumor shrinkage, and potential treatment benefit.

On November 16, 2018, Medicenna presented an update on intratumoral delivery of MDNA55 using MRI-guided convective delivery at the 23rd Annual Meeting of the Society for Neuro-Oncology

MDNA109 update
On February 6, 2019 Dr. Moutih Rafei, PhD, (Associate Professor, Department of Pharmacology and Physiology, Université de Montreal) presented new results on MDNA109 and its long acting variants at the 5th Annual Immuno-Oncology 360o Meeting held in New York, NY. In a podium presentation entitled, "Putting Pedal to the Metal: Combining IL-2 Superkine (MDNA109) with Checkpoint Inhibitors." The presentation outlined that MDNA109, an engineered IL-2 superkine exhibited a 1000-fold enhanced affinity toward the CD122 receptor, has best-in-class potency toward cancer killing effector T cells, was not immunogenic in-vivo and potently synergized with anti-PD-1 or anti-CTLA-4 checkpoint inhibitors to eliminate tumors in the majority of tumor-bearing mice.

On November 9, 2018, Medicenna presented an update on preliminary pre-clinical results on MDNA109 at the 33rd Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) held in Washington, DC.

Operational update
On December 21, 2018, the Company completed a public offering and issued 4,000,000 units of the Company for gross proceeds of CDN$4,000,000.

On December 5, 2018, Medicenna received a US$1.2 million reimbursement of past expenses from the Cancer Prevention and Research Institute of Texas ("CPRIT").

Financial Results
For the three months ended December 31, 2018, Medicenna reported a net loss of $1,723,081 or $0.07 per share compared to a loss of $2,181,022 or $0.09 per share for the three months ended December 31, 2017. For the nine months ended December 31, 2018, Medicenna reported a net loss of $3,658,957 or $0.15 per share compared to a loss of $6,154,946 or $0.25 per share for the nine months ended December 31, 2017.

Research and Development Expenses
Research and development ("R&D") expenses of $2,356,683 were incurred during the nine months ended December 31, 2018, compared with $4,226,141 incurred in the nine months ended December 31, 2017 and were $1,275,896 during the three months ended December 31, 2018, compared with $1,351,703 incurred in the three months ended December 31, 2017. The decrease in the expenses in the current year periods can be primarily attributed to reduced discovery and pre-clinical expenses due to work ongoing and completed in the prior year related to the development of MDNA57as well as lower clinical trial costs due to reduced consulting costs, clinical supplies and CRO fees due to nearing the end of the clinical study and general cost containment. Finally, the variance in recoveries from CPRIT contributed to the changes in net loss of $905,585 in the three months and $3,824,293 in the nine months ended December 31, 2018 compared with $1,884,820 in the three months and $3,334,424 in the nine months ended December 31, 2017

General and Administrative Expenses
General and administrative ("G&A") expenses of $437,218 were incurred in the three months and $1,295,132 in the nine months ended December 31, 2018, compared with $824,007 in the three months and $1,894,230 in the nine months ended December 31, 2017. The decrease in G&A expenses period over period is attributed primarily to lower stock based compensation costs due to timing of grants as well as a lower number of option grants in the current year periods, reduced legal expenses in the current year periods due to expenses related to the graduation from the TSXV to TSX as well as the OTC listing incurred in the prior year periods and lower salary and benefit costs due to headcount reductions and a bonus accrual in the prior year and no comparable accrual in the current year periods

On February 14, 2019 Ohr Pharmaceutical, Inc. (Nasdaq: OHRP) (the "Company" or "Ohr") reported financial results for the three months ended December 31, 2018 (Press release, Ohr Pharmaceutical, FEB 14, 2019, View Source [SID1234533348]).

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"Since we announced the signing of a definitive agreement to merge with NeuBase Therapeutics, Inc., a privately-held biotechnology company, we have been working diligently to bring the proposed merger with NeuBase to our stockholders for a vote. We expect to hold a special stockholder meeting in the second calendar quarter of 2019," said Jason Slakter, M.D., chief executive officer of Ohr Pharmaceutical. "After reviewing various strategic alternatives for our business in 2018, we identified a merger with NeuBase as the best opportunity to generate value for our stockholders, based on their ongoing work to change the paradigm for treating rare genetic diseases with next generation, highly specific antisense oligonucleotide therapies. We look forward to working with NeuBase to create a successful company focused on bringing transformative new therapies to patients around the world suffering from rare genetic diseases."

Proposed NeuBase Merger and NASDAQ Listing Update:

On January 3, 2019, Ohr announced a definitive merger agreement with NeuBase Therapeutics, Inc. ("NeuBase")
The proposed merger has been approved by the board of directors of both Ohr and NeuBase
Ohr anticipates it will file the proxy materials for its proposed merger with NeuBase with the Securities and Exchange Commission (SEC) in the first calendar quarter of 2019
Ohr expects to hold a special meeting of stockholders in the second calendar quarter of 2019 to vote on the proposed merger with NeuBase
Ohr completed a 1-for-20 reverse stock split that was effective February 4, 2019, which Ohr believes will allow it to maintain its Nasdaq listing
Financial Results for the First Quarter of FY 2019 ended December 31, 2018:

For the three months ended December 31, 2018, the Company reported a net loss of approximately $0.9 million, or ($0.32) per share, compared to a net loss of approximately $4.2 million, or ($1.48) per share, in the three months ended December 31, 2017. Loss per share amounts have been retroactively adjusted for the reverse stock split effected on February 4, 2019.
For the three months ended December 31, 2018, total operating expenses were approximately $0.9 million, consisting of approximately $0.7 million in general and administrative expenses, approximately $0.1 million of research and development expenses, and approximately $0.2 million in depreciation and amortization. This compares to total operating expenses of $4.2 million in the three months ended December 31, 2017, comprised of approximately $1.5 million in general and administrative expenses, approximately $2.4 million in research and development expenses, and approximately $0.3 million in depreciation and amortization.
At December 31, 2018, the Company had cash and cash equivalents of approximately $3.1 million, compared to cash and equivalents of approximately $3.8 million at September 30, 2018.
Merger Agreement with NeuBase
On January 3, 2019, Ohr announced entering into a definitive merger agreement with NeuBase under which the stockholders of NeuBase would become the majority holders of the combined company. The proposed merger will create a public company focused on advancing NeuBase’s peptide-nucleic acid (PNA) antisense oligonucleotide (PATrOL) technology platform for the development of therapies to address severe and currently untreatable diseases caused by genetic mutations. The proposed merger has been approved by the board of directors of both companies.

On a pro forma basis and based upon the number of shares of Ohr common stock to be issued in the merger, current Ohr stockholders will own approximately 20% of the combined company and NeuBase stockholders will own approximately 80% of the combined company, after accounting for the additional NeuBase financing transaction. The actual allocation will be subject to adjustment based on Ohr’s and NeuBase’s cash balance at the time of closing and the amount of the additional financing consummated by NeuBase at or before the closing of the proposed merger. Certain members and affiliates of the board of directors and management of Ohr and NeuBase have indicated an intent to invest in the additional NeuBase financing.

The proposed merger is subject to the approval of Ohr’s stockholders and the satisfaction or waiver of other customary conditions.