On May 10, 2018 Diffusion Pharmaceuticals Inc. (Nasdaq:DFFN) ("Diffusion" or "the Company"), a clinical-stage biotechnology company focused on extending the life expectancy of cancer patients using the novel small molecule trans sodium crocetinate (TSC) in conjunction with standard radiation and chemotherapy, reported financial results for the three months ended March 31, 2018 and provides a business update (Press release, Diffusion Pharmaceuticals, MAY 10, 2018, View Source [SID1234526477]).

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"During the first quarter patients continued to be screened and enrolled into our lead clinical program, the INvestigation of TSC Against Cancerous Tumors (INTACT) trial for the treatment of inoperable glioblastoma multiforme, or GBM," said David Kalergis, Chairman and Chief Executive Officer of Diffusion Pharmaceuticals. "In January the first patients were dosed in this 236-patient Phase 3 study. The protocol calls for half of patients to be enrolled in the treatment arm, which is standard of care radiation and chemotherapy, plus TSC, and half to be enrolled in the control arm, which is standard of care alone. The design of INTACT is based on an almost four-fold increase in overall survival at two years demonstrated in inoperable GBM patients in the preceding Phase 2 study. We are hopeful that similar survival will be demonstrated in our pivotal Phase 3 study and that TSC will provide an effective treatment for these patients, for whom current options are limited."

The Company continues to prepare for a Phase 2, randomized, double-blind, placebo-controlled trial with TSC in acute stroke. The contemplated study, based on an abstract that was presented in January at the International Stroke Conference, calls for the administration of TSC by specially-trained Emergency Medical Technicians to ambulance-transported patients within two hours of the onset of a suspected acute stroke. The in-ambulance administration could potentially overcome the current severe timing delay in administering therapy to stroke patients. The trial, which has been named the Pre-Hospital Ambulance Stroke Trial – TSC (PHAST-T), is expected to commence in late 2018, subject to funding.

Diffusion is pleased to announce the granting of U.S. patent number 9,950,067, which expands the Company’s coverage of the use of TSC and related compounds in cancer therapy. The claims of the new U.S. patent relate to the treatment of a number of cancer types such as brain cancer (including glioblastoma) and pancreatic cancer, using TSC in conjunction with radiation therapy and chemotherapy. "This new U.S. patent further strengthens our IP portfolio in cancer treatment and is relevant to our technology in the Phase 3 study," stated General Counsel and IP Counsel Thomas Byrne.

"Intellectual property is an important component of our growth strategy, and we are pleased this patent has issued," Mr. Kalergis added. "We are expecting additional patent allowances in the near future that will further augment our IP."

Financial Results for the Three Months Ended March 31, 2018

We had cash and cash equivalents of $16.2 million as of March 31, 2018. We believe that our cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements through June 2019.

We recognized $1.8 million in research and development expenses during the three months ended March 31, 2018, compared with $1.0 million during the three months ended March 31, 2017. The increase was mainly attributable to a $1.1 million increase in expense related to our Phase 3 GBM trial, offset by a $0.3 million decrease in manufacturing costs.

General and administrative expenses for the three months ended March 31, 2018 were $1.5 million compared with $1.6 million for the three months ended March 31, 2017. Salaries and wages increased by $0.2 million due to the increase in headcount, which was offset by a decrease in professional fees of approximately $0.3 million.

In connection with the private placement of our Series A preferred stock and common stock warrants in March of 2017, we determined the warrants to be classified as liabilities and subject to remeasurement at each reporting period. As a result, we recognized $10.2 million in excess fair value of the common stock warrants over the gross proceeds from our private placement. We also recognized $2.9 million in placement agent commission and other offering costs. In total, for the three months ended March 31, 2017, we recorded a $12.9 million expense for the change in fair value of our common stock warrant liabilities, which was primarily attributable to the increase in the market price for our Common Stock. There were no such charges in 2018 as the warrants were reclassified into equity in November of 2017.

On May 10, 2018 Delcath Systems, Inc. (OTCQB:DCTHD), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, reported financial results for the quarter ended March 31, 2018 (Press release, Delcath Systems, MAY 10, 2018, View Source;p=RssLanding&cat=news&id=2348432 [SID1234526476]).

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Highlights from the first quarter of 2018 and recent weeks include:

Revenue from European sales for the quarter was $0.7 million;
Completed a $5.0 million capital raise in February 2018;
Announced that the independent Data Safety Monitoring Board (DSMB) of the Phase 3 FOCUS clinical trial has again recommended that the study continue without modification;
Announced the opening of the ALIGN registration trial for the treatment of Intrahepatic Cholangiocarcinoma (ICC);
Modified the Special Protocol Agreement (SPA) with the U.S. Food and Drug Administration (FDA) for the Company’s Phase 3 clinical trial of Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) to treat patients with hepatic dominant ocular melanoma (OM);
CHEMOSAT featured in main stage training presentation at European Conference on Interventional Oncology;
Reported the 500th CHEMOSAT treatment in Europe;
Announced results from a multi-center analysis of Delcath’s Percutaneous Hepatic Perfusion (PHP) therapy in the peer-reviewed Journal of Surgical Oncology; largest data set outside of clinical trial showed manageable toxicity and overall median overall survival of 15.3 months; and
Secured a commercial supply of melphalan hydrochloride for injection through an agreement with Tillomed Laboratories
Management Commentary

"Our focus continues to be on resolving the cash constraints and other restrictions related to our capital structure," said Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath. "These limitations have necessitated the series of transactions we completed in second half of 2017 and the early weeks of 2018, permitting us to exit our 2016 Convertible Note, raise additional capital, invest in our clinical development program, and advance our commercialization efforts for CHEMOSAT in Europe. We continue to work to resolve the remaining issues and secure new equity financing in order to execute our plan and create value for our shareholders."

"Despite cash constraints, revenues for the first quarter of 2018 were $0.7 million, consistent with the prior year quarter and reflecting steady adoption of CHEMOSAT in our core European markets. During the quarter, we announced a commercial supply agreement with Tillomed Laboratories for the supply of melphalan hydrochloride. This agreement provides us with firm control over our melphalan supply chain in Europe and, over time, will provide economies of scale. The supply agreement with Tillomed also gives Delcath access to the drug dossier for melphalan hydrochloride, an important asset that potentially provides a drug approval pathway with the European Medicines Agency (EMA) in Europe. As many of the cancers of the liver we are treating with CHEMOSAT are orphan indications in the United States, a Marketing Authorization Application (MAA) approval by the EMA for CHEMOSAT could potentially provide added market protection for these indications in Europe.

"Regarding our FOCUS Phase 3 Trial, we recently announced that the independent Data Safety Monitoring Board (DSMB) has completed another review of safety data for treated patients in the trial, and has again recommended that the study continue without modification. Enrollment in this trial remains slower than projected, and our ability to take proactive steps to support enrollment continues to be limited by the cash constraints we have been operating under. We continue to rollout the SPA protocol modification we announced in January to participating centers, and hope to accelerate enrollment in 2018 once cash constraints are alleviated. Any impact on enrollment from the SPA modification is not expected to be immediate, and it is unlikely that enrollment for this trial will be completed in time to submit an NDA to the FDA in 2019. We plan to update our enrollment projections in the second half of this year.

"On May 7, 2018 we announced the initiation our registration trial of Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) to treat patients with intrahepatic cholangiocarcinoma (ICC). Called The ALIGN Trial, this trial will seek to enroll approximately 295 ICC patients at approximately 40 clinical sites in the U.S. and Europe. The trial is being conducted under a Special Protocol Assessment (SPA) agreement reached with the U.S. Food and Drug Administration (FDA) in March 2017. The ALIGN Trial is based on a strong efficacy signal observed in the ICC tumor type through our commercial experience with CHEMOSAT in Europe. The sequential design of the therapies under investigation in the trial will allow us to minimize capital investment requirements in 2018. We are also leveraging our existing network of trial sites from our FOCUS Phase 3 trial to rollout the trial protocol as efficiently as possible. In this orphan population where there exists a huge unmet need, this trial provides us with a second pathway to commercial drug approval in the United States, and if successful we believe will be an important value driver for the Company.

"Though the recent months have been financially difficult, we remain committed to advancing our clinical and commercial programs. We are continuously working to improve our ability to operate so we can realize the potential of PHP therapy and return value to our shareholders," concluded Dr. Simpson.

First Quarter 2018 Financial Results

Revenue for the three months ended March 31, 2018 was $0.7 million, a slight decrease from $0.74 million for the prior year period. Selling, general and administrative expenses were approximately $2.4 million, unchanged from the prior year quarter. Research and development expenses for the current quarter increased to $5.7 million from $2.3 million in the prior year quarter. Total operating expenses for the current quarter were $8.1 million compared with $4.7 million in the prior year quarter.

The Company recorded net income for the three months ended March 31, 2018, of $7.2 million, an increase of $18.5 million, or 163.4%, compared to a net loss of $11.3 million for the same period in 2017. This increase in net income is primarily due to an $8.3 million decrease in interest expense primarily related to the amortization of debt discounts related to convertible notes that were fully satisfied in 2017, and a $13.5 million increase in the change in the fair value of the warrant liability, both non-cash items. Additionally, there was a $3.3 million increase in operating expenses primarily related to increased investment in our clinical trial initiatives.

Balance Sheet Highlights

As of March 31, 2018, Delcath had cash and cash equivalents of $2.0 million, compared with $4.0 million as of December 31, 2017. During the first quarter, the Company used $6.4 million of cash to fund operating activities.

In February 2018, the Company completed the sale of 424,000 shares of its common stock and the issuance of warrants to purchase 1.0 million common shares (the "February 2018 Warrants") pursuant to a placement agent agreement. The Company received net proceeds of $4.6 million, with cash proceeds after related expenses from this transaction of $4.3 million.

On April 9, 2018 the Company announced that shareholders approved the provisions of the Company’s Consent Solicitation filed with the Securities Exchange Commission (SEC) on February, 26, 2018. By a vote of 54.3%, shareholders as of the record date of February 9, 2018 approved the Company’s proposals to amend its certificate of incorporation to increase its authorized shares of common stock from 500,000,000 to 1,000,000,000 (the Authorized Share Increase), and, by a vote of 52.8%, to effect a reverse stock split of the Company’s common stock at a range of 1-for-100 to 1-for-500 (the Reverse Stock Split Authorization). We effected our increase in authorized shares on April 21, 2018 and our 1-for-500 reverse stock split on May 2, 2018.

Delcath believes it has sufficient capital and access to committed capital to fund its operating activities through May of 2018.

On May 10, 2018 Coherus BioSciences, Inc. (Nasdaq:CHRS),reported financial results for the quarter ended March 31, 2018 (Press release, Coherus Biosciences, MAY 10, 2018, View Source/phoenix.zhtml?c=253655&" target="_blank" title="View Source/phoenix.zhtml?c=253655&" rel="nofollow">View Source;p=RssLanding&cat=news&id=2348541 [SID1234526475]).

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First Quarter 2018 Corporate Highlights Include:

Oncology therapeutic franchise:

CHS-1701 (pegfilgrastim (Neulasta) biosimilar candidate)
Announced on March 26, 2018, that Judge Stark of the United States District Court for the District of Delaware adopted Magistrate Judge Burke’s Report and Recommendation to grant the motion of Coherus BioSciences, Inc. to dismiss with prejudice the patent infringement complaint alleging infringement of U.S. Patent No. 8,273,707 filed by Amgen Inc.
First Quarter 2018 Financial Results:

Research and development (R&D) expenses for the first quarter of 2018 were $25.5 million compared to $53.8 million for the same period in 2017. The decrease in R&D expenses in the first quarter over the same period in 2017 was mainly due to the completion of our clinical trials for the immunology biosimilar drug candidates, CHS-1420 (adalimumab (Humira) biosimilar) and CHS-0214 (etanercept (Enbrel) biosimilar), and the reprioritization of resources to advance CHS-1701. General and administrative (G&A) expenses for the first quarter of 2018 were $16.6 million, compared to $18.8 million for the same period in 2017. The decrease in G&A expenses in 2018 was mainly attributable to a decrease in personnel and in certain legal and consulting services as a result of cost control steps taken since June 2017. Net loss attributable to Coherus for the first quarter of 2018 was ($44.3) million, or ($0.74) per share, compared to a net loss of ($74.8) million, or ($1.54) per share, for the same period in 2017. Cash and cash equivalents and investments in marketable securities – totaled $95.2 million as of March 31, 2018, compared to $126.9 million as of December 31, 2017.
Guidance for 2018:

CHS-1701 (pegfilgrastim (Neulasta) biosimilar)

Anticipate acceptance of the biologics license application (BLA) on or before June 3, 2018 and a U.S. Food and Drug Administration (FDA) action date of November 3, 2018. Anticipate European approval opinion on or before June 28, 2018. Commercial partnering discussions are projected to continue for certain ex-U.S. territories. Anticipate U.S. commercial launch directly following the potential FDA action date, dependent on regulatory review and approval timing.
CHS-3351 (ranibizumab (Lucentis) biosimilar) and CHS-2020 (aflibercept (Eylea) biosimilar)

Initiate clinical development of CHS-3351. Continue preclinical development of CHS-2020.
CHS-1420 (adalimumab (Humira) biosimilar)

Pursue manufacturing objectives in support of a BLA. Continue to develop partnering options pursuant to a 2022 launch.
Cash flow

Anticipate cash use in operations of approximately $32 to $37 million for the second quarter of 2018.
Conference Call Information

When: Thursday, May 10, 2018 at 4:30 p.m. ET

Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)

Conference ID: 2767588

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 May 10, 2018 Eli Lilly and Company (NYSE: LLY) and ARMO BioSciences, Inc. (NASDAQ: ARMO) reported a definitive agreement for Lilly to acquire ARMO for $50 per share, or approximately $1.6 billion, in an all-cash transaction (Press release, ARMO BioSciences, MAY 10, 2018, View Source [SID1234526474]). ARMO BioSciences is a late-stage immuno-oncology company that is developing a pipeline of novel, proprietary product candidates designed to activate the immune system of cancer patients to recognize and eradicate tumors.

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The acquisition will bolster Lilly’s immuno-oncology program through the addition of ARMO’s lead product candidate, pegilodecakin, a PEGylated IL-10 which has demonstrated clinical benefit as a single agent, and in combination with both chemotherapy and checkpoint inhibitor therapy, across several tumor types. Pegilodecakin is currently being studied in a Phase 3 clinical trial in pancreatic cancer, as well as earlier-Phase trials in lung and renal cell cancer, melanoma and other solid tumor types. ARMO also has a number of other immuno-oncology product candidates in various stages of pre-clinical development.

"At Lilly Oncology, we are dedicated to developing cancer medicines that will make a meaningful difference for patients," said Sue Mahony, Ph.D., Lilly senior vice president and president of Lilly Oncology. "The acquisition of ARMO BioSciences adds a promising next generation clinical immunotherapy asset to Lilly’s portfolio of innovative oncology medicines."

"As we develop our immuno-oncology portfolio, Lilly will pursue medicines that use the body’s immune system in new ways to treat cancer," added Levi Garraway, M.D., Ph.D., senior vice president, global development and medical affairs, Lilly Oncology, "We believe that pegilodecakin has a unique immunologic mechanism of action that could eventually allow physicians to offer new hope for many cancer patients."

"ARMO is proud of the work we have done to advance the study of immunotherapies and of the development of pegilodecakin to-date," said Peter Van Vlasselaer, Ph.D., President and Chief Executive Officer of ARMO BioSciences. "Given the resources that Lilly, a leader in oncology R&D, can bring to bear to maximize the value of pegilodecakin and the rest of the ARMO pipeline, we believe it is in the best interest of ARMO, our stockholders and the patients we serve, to execute this transaction."

Under the terms of the agreement, Lilly will promptly commence a tender offer to acquire all shares of ARMO BioSciences for a purchase price of $50 per share in cash, or approximately $1.6 billion. The transaction is expected to close by the end of the second quarter of 2018, subject to customary closing conditions, including receipt of required regulatory approvals and the tender of a majority of the outstanding shares of ARMO’s common stock. Very shortly after the closing of the tender offer, Lilly will acquire any shares of ARMO that are not tendered into the tender offer through a second-step merger at the tender offer price.

This transaction will be reflected in Lilly’s reported results and financial guidance according to Generally Accepted Accounting Principles (GAAP), and is subject to customary closing conditions. There will be no change to Lilly’s 2018 non-GAAP earnings per share guidance as a result of this transaction.

Credit Suisse is acting as the exclusive financial advisor and Wachtell, Lipton, Rosen & Katz is acting as legal advisor to Lilly in this transaction. Centerview Partners LLC is acting as lead financial advisor to ARMO BioSciences and the Board, and Jefferies LLC is providing financial advice to ARMO, and Gunderson Dettmer is acting as legal advisor to ARMO.

About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and www.lilly.com/newsroom/social-channels.

On May 10,2018 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ:CKPT), a clinical-stage, immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, reported financial results and recent corporate highlights for the first quarter ended March 31, 2018 (Press release, Checkpoint Therapeutics, MAY 10, 2018, https://www.cnbc.com/2018/05/10/globe-newswire-checkpoint-therapeutics-reports-first-quarter-2018-financial-results-and-recent-corporate-highlights.html [SID1234526473]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "In the first quarter of 2018, Checkpoint continued to execute on milestones to advance the development of our lead immuno-oncology and targeted therapy clinical programs, while also strengthening our financial position. Notably, we completed an underwritten public offering in March, raising net proceeds of $20.8 million to continue to fund our development programs, and initiated the first dose expansion cohorts in the Phase 1 trials of CK-301, our fully human anti-PD-L1 antibody, and CK-101, our third-generation EGFR inhibitor. We look forward to reporting initial data from these expansion cohorts in the second half of 2018, and are targeting the initiation of our first registration trial for CK-301 in first-line non-small cell lung cancer in the first quarter of 2019."

Financial Results:

Cash Position: As of March 31, 2018, Checkpoint’s cash and cash equivalents totaled $34.9 million, compared to $19.2 million at December 31, 2017, an increase of $15.7 million.
R&D Expenses: Research and development expenses for the first quarter of 2018 were $6.9 million, compared to $3.7 million for the first quarter of 2017, an increase of $3.2 million.
G&A Expenses: General and administrative expenses for the first quarter of 2018 were $2.2 million, compared to $1.4 million for the first quarter of 2017, an increase of $0.8 million.
Net Loss: Net loss attributable to common stockholders for the first quarter of 2018 was $8.8 million, or $0.35 per share, compared to a net loss of $4.4 million, or $0.20 per share, for the first quarter of 2017.
Recent Corporate Highlights:

In March 2018, Checkpoint completed an underwritten public offering that raised net proceeds of $20.8 million.
Also in March 2018, Checkpoint completed the dose escalation portion of the ongoing Phase 1 clinical trial of CK-301, a fully human anti-PD-L1 antibody, in selected recurrent or metastatic cancers, and initiated the first dose expansion cohort, which is evaluating an 800 mg dose of CK-301 administered every two weeks.
In April 2018, Checkpoint presented preclinical data on BET inhibitor CK-103 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. CK-103 demonstrated combinatorial effects in an in vivo model with anti-PD-1 antibodies, which may support its development as an anti-cancer agent alone and in combination with Checkpoint’s anti-PD-L1 antibody CK-301.