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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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.

On Februuary 14, 2019 Coherus BioSciences, Inc. (Nasdaq: CHRS), reported that its fourth quarter and full year 2018 financial results will be released after market close on Thursday, February 28, 2019 (Press release, Coherus Biosciences, FEB 14, 2019, View Source/news-releases/news-release-details/coherus-biosciences-report-fourth-quarter-and-full-year-2018" target="_blank" title="View Source/news-releases/news-release-details/coherus-biosciences-report-fourth-quarter-and-full-year-2018" rel="nofollow">View Source [SID1234533347]). Starting at 4:30 p.m. ET, Coherus’ management team will host a conference call to discuss the financial results and provide a general business update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

After releasing fourth quarter and full year 2018 financial results, the company will post them on the Coherus website at View Source." target="_blank" title="View Source." rel="nofollow">View Source

Conference Call Information

When: Thursday, February 28, 2019 starting at 4:30 p.m. ET
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 3398069
Webcast: View Source
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

On February 14, 2019 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported financial results for its third fiscal quarter ended December 31, 2018, and provided an update on its business (Press release, Replimune, FEB 14, 2019, View Source [SID1234533346]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Replimune continues to make significant progress with all of our development programs," said Robert Coffin, Ph.D., co-founder, President and CEO of Replimune. "We anticipate a number of key events in the first half of 2019, including the initiation of the Phase 2 portion of the Phase 1/2 clinical trial of RP1 in combination with nivolumab in four solid tumor types, initiation of a Phase 1 clinical trial of RP2 alone and in combination with anti-PD1 therapy and, of particular note, the initiation of enrollment of our potentially pivotal randomized controlled Phase 2 clinical trial of RP1 in combination with cemiplimab in cutaneous squamous cell carcinoma."

Recent Business Highlights and Upcoming Events

RP1 – Completed enrollment of RP1 as single agent and opened enrollment of patients to be treated with RP1 in combination with nivolumab in the Phase 1 portion of the Phase 1/2 clinical trial. RP1 is Replimune’s first product candidate to enter the clinic and is based on a proprietary strain of herpes simplex virus armed with a gene encoding a potent fusogenic protein, intended to enhance tumor killing potency, immunogenic cell death and the activation of systemic anti-tumor immune responses, and with a gene encoding the cytokine GM-CSF. Replimune is currently testing RP1 in a two-part Phase 1/2 clinical trial of RP1 alone and in combination with nivolumab in approximately 150 patients. In the Phase 1 portion of the Phase 1/2 clinical trial, Replimune is assessing the safety and tolerability of RP1 administered alone in patients with advanced solid tumors followed by dosing in combination with nivolumab anti-PD1 therapy. In part 2 of the Phase 1/2 clinical trial, Replimune intends to study the safety and efficacy of RP1 in combination with nivolumab in four cohorts of patients with melanoma, bladder cancer, microsatellite instability high cancers, and non-melanoma skin cancers. The Phase 2 portion of the clinical trial is on track to initiate in the first half of 2019. Data from the Phase 1 portion of the clinical trial (RP1 alone and RP1 combined with nivolumab) is expected to be presented at a medical conference in the second half of 2019.

RP1 – Phase 2 clinical trial of RP1 in combination with cemiplimab remains on-track to initiate in the first half of 2019. The registration directed randomized controlled Phase 2 clinical trial is intended to enroll approximately 240 patients with cutaneous squamous cell carcinoma (CSCC) comparing treatment with cemiplimab alone to treatment in combination with RP1, under the Company’s collaboration with Regeneron. Cemiplimab is Regeneron’s anti-PD1 drug which was approved by the U.S. Food and Drug Administration (FDA) for the treatment of locally recurrent and metastatic CSCC in 2018.

RP2 – Phase 1 clinical trial of RP2 as single agent and in combination with anti-PD1 therapy remains on-track to initiate in first half of 2019. RP2 is a version of RP1 that, in addition to expressing GALV-GP-R- and GM-CSF, also expresses a genetically encoded anti-CTLA-4 antibody intended to block the inhibition of the initiation of immune response caused by CTLA-4. RP2 is intended to be used primarily in combination with anti-PD1 or anti-PD-L1 therapy.

RP3 – Phase 1 clinical trial of RP3 as single agent and in combination with anti-PD1 therapy remains on-track to initiate in the first half of 2020. RP3 is a further armed oncolytic immuno-gene therapy which expresses two immune co-stimulatory activating ligands. Following the assessment of a number of co-stimulatory pathways, which like anti-CTLA-4 are expected to be primarily active at the site and time of anti-tumor immune response initiation, the selected RP3 product candidate expresses CD40L and 4-1BBL, together with anti-CTLA-4 and GALV-GP-R-. CD40L activates CD40, resulting in the broad activation of both innate and adaptive immunity, and 4-1BBL activates 4-1BB (CD137) to promote the expansion of cellular and memory immune responses.

Poster to be presented at AACR (Free AACR Whitepaper). A poster describing pre-clinical data relating to Replimune’s Immulytic platform and entitled "Development & characterization of a new oncolytic immunotherapy platform based on herpes simplex virus type 1" is to be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in Atlanta, Georgia, March 29th-April 1st 2019 (Abstract # 3136). The poster will be made available on the Company’s website at the time of presentation.

Build out of Replimune’s manufacturing facility to support late-stage development and commercialization is on track and expected to be operational in the first half of 2020. In July 2018, Replimune signed a lease for a 63,000-square-foot facility in Framingham, MA where the Company intends to establish world-class multi-product manufacturing capabilities for its Immulytic product candidates. The capacity of this facility is expected to be sufficient to support full commercialization of the Company’s product candidates. The facility is expected to be operational in the first half of 2020.

Financial Highlights

Replimune reported a net loss of $7.7 million for the quarter ended December 31, 2018 compared with $4.4 million for the same period in the prior year. The increase in the net loss was primarily due to an increase in research and development expenses and administrative costs associated with our operations.

Research and development expenses for the quarter ended December 31, 2018 were $7.9 million compared with $3.6 million for the same period in the prior year. The increase in research and development expenses was primarily driven by additional costs related to Replimune’s preclinical and clinical development activities for its pipeline, as well as increased salary and related benefits

costs due to the increase in employee headcount from 33 on December 31, 2017 to 48 on December 31, 2018.

General and administrative expenses were $2.3 million for the quarter ended December 31, 2018 compared with $1.2 million for the same period in the prior year. The increase in general and administrative expenses was primarily due to the increase in employee headcount and the impact of stock-based compensation in 2018.

Replimune ended the quarter with $141.8 million in cash and cash equivalents and short-term investments, compared with $61.6 million as of March 31, 2018. The increase reflects net proceeds received of $103.3 million in connection with its IPO.

Based on its current operating plan, Replimune expects that its current cash and cash equivalents and short-term investments will enable it to fund its operating expenses and capital expenditure requirements into the second half of 2021.

On February 14, 2019 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported financial results for the fourth quarter and full year ended December 31, 2018 (Press release, Quest Diagnostics, FEB 14, 2019, View Source [SID1234533345]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In 2018 we grew revenues, adjusted earnings and cash from operations despite some challenges in the marketplace. Quest is well positioned once again in 2019 to deliver on our commitment to grow revenues and earnings, as our in-network status now extends to approximately 90% of commercially insured lives in the U.S.," said Steve Rusckowski, Chairman, CEO and President. "Our guidance for 2019 reflects significant reimbursement pressure offset by strong volume growth and continued execution of our Invigorate program. I am pleased to report our volumes for the year are off to a good start."

Net revenues and selling, general and administrative expenses for the three and twelve months ended December 31, 2017 have been restated to reflect the impact of new revenue recognition rules that became effective January 1, 2018 and were adopted on a full retrospective basis. Under the new rules, the company reports uncollectible balances associated with patient responsibility as a reduction in net revenues; historically these amounts were classified as bad debt expense within selling, general and administrative expenses.

For further details impacting the year-over-year comparisons related to operating income, operating income as a percentage of net revenues, net income attributable to Quest Diagnostics, and diluted EPS, see note 2 of the financial tables attached below.

As discussed in the company’s periodic reports filed with the Securities and Exchange Commission, recording revenues and accounts receivable involves judgment and estimation. The company follows a standard process, which considers historical denial and collection experience and other factors, to estimate contractual allowances and implicit patient price concessions, and regularly updates its estimates, recording adjustments in the current period as changes in estimates. Based on this process, during the fourth quarter the company increased its reserves for revenues and accounts receivable.

Guidance for Full Year 2019

Note on Non-GAAP Financial Measures

As used in this press release the term "reported" refers to measures under the accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP measures as follows: (i) for the purpose of income measures the term "adjusted" refers to operating performance measures that exclude special items such as the effect of changes in tax law on our deferred tax assets (liabilities) and reserves, restructuring and integration charges, excess tax benefit ("ETB") associated with stock-based compensation and other items; and (ii) the term "adjusted diluted EPS excluding amortization expense" represents the company’s diluted EPS before the impact of special items (described above) and amortization expense.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional tables attached below include reconciliations of adjusted measures to GAAP measures.

Conference Call Information

Quest Diagnostics will hold its quarterly conference call to discuss financial results beginning at 8:30 a.m. Eastern Time today. The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "Investor." The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 866-424-7881 for domestic callers or 203-369-0869 for international callers; no passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on February 14, 2019 until midnight Eastern Time on February 28, 2019. Anyone listening to the call is encouraged to read the company’s periodic reports, on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On February 14, 2019 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the Leerink Partners Global Healthcare Conference on Wednesday, February 27, 2019 (Press release, Eli Lilly, FEB 14, 2019, View Source [SID1234533344]). Christi Shaw, president of Lilly Bio-Medicines, will participate in a fireside chat at 1:00 p.m., Eastern Time.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s investor website at View Source A replay of the fireside chat will be available for approximately 90 days