1stOncology™: Cancer Intelligence Service – Page 14404 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

ERYTECH Provides Business Update and

Reports Financial Results for Full Year 2017

On March 12, 2018 ERYTECH Pharma (Euronext: ERYP – Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported its financial results for the year ended December 31, 2017 (Press release, ERYtech Pharma, MAR 12, 2018, View Source [SID1234524674]).

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!

"2017 was a transformative year for ERYTECH with the achievement of a number of important clinical, regulatory and financial objectives," said Gil Beyen, Chairman and CEO of ERYTECH. "We are extremely pleased with the positive outcome of our Phase 2b trial of eryaspase in second-line metastatic pancreatic cancer and the success of our two financing operations, which generated gross proceeds of approximately $226 million, and our resulting dual listing on Nasdaq and Euronext Paris. With the proceeds of these transactions, we believe we are well capitalized to advance our pipeline programs, most notably the pivotal Phase 3 clinical trial of eryaspase for the treatment of second-line metastatic pancreatic cancer. We met with the FDA to discuss the proposed design of this trial and also obtained similar feedback from the CHMP. We are also exploring the launch of proof of concept studies in first-line pancreatic cancer, and other solid tumor indications, beginning with triple negative breast cancer. Lastly, we resubmitted our MAA for potential approval of eryaspase (GRASPA) for the treatment of relapsed and refractory ALL in Europe. We expect our momentum to continue as we progress towards potential approval in ALL, and anticipate significant advances from other clinical and preclinical research programs in our pipeline."

Full Year and Recent Business Highlights

• In September 2017, ERYTECH reported the full data set from its open-label, multi-center, randomized Phase 2b trial evaluating eryaspase in combination with chemotherapy for the treatment of second-line metastatic pancreatic cancer. In the trial, patients treated with eryaspase achieved significant improvement in both overall survival (OS) and progression-free survival (PFS).

• The company is now preparing for the launch of a pivotal Phase 3 clinical trial in this same indication in the United States and Europe. Feedback on the design of the trial was obtained from the U.S. Food and Drug Administration (FDA) and the Commission for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA). The proposed Phase 3 trial will evaluate eryaspase in combination with standard chemotherapy, compared to standard chemotherapy alone, in approximately 500 patients in the United States and Europe. The primary endpoint will be overall survival (OS). Enrollment of the first patient in this trial is expected in the third quarter of 2018.

• ERYTECH is also broadening the scope of eryaspase to first-line pancreatic cancer, as well as to other solid tumor indications. Recently, the company announced the selection of triple negative breast cancer (TNBC) as the next target indication for expanding the potential treatment scope of eryaspase. ERYTECH is preparing a Phase 2 proof-of-concept clinical trial for this indication and expects to enroll the first patient in this trial in the third quarter of 2018.

• In October 2017, ERYTECH resubmitted its MAA for eryaspase (GRASPA) for the treatment of relapsed and refractory (R/R) ALL. The MAA resubmission includes the Phase 2/3 clinical trial data from children and adults with R/R ALL as well as additional data to address the outstanding questions of the CHMP. CHMP feedback is expected by the end of 2018.

• In October 2017, the company also identified the recommended dosing from its open-label, dose escalation Phase 1 clinical trial evaluating the safety of eryaspase in combination with chemotherapy for first-line treatment of adult ALL patients, conducted at five clinical sites across the United States. The steering committee reviewed the safety data of the three treatment cohorts and approved further development at a dose level of 100 U/kg. Based on these data and the clinical results obtained in Europe, the company is preparing to discuss next steps for its development in ALL with the FDA in the second quarter of this year.

• In December 2017, the company announced topline results from the Phase 2b clinical trial evaluating eryaspase for the treatment of AML. The open-label, randomized, multi-center clinical trial enrolled a total of 123 patients at 30 European sites. The trial did not meet its primary endpoint of OS. Patient selection is likely the most important factor: the median age of patients in the trial was 78 years, and the median duration of treatment was 5-6 weeks in both treatment arms.

• Throughout 2017, the company also advanced its preclinical pipeline programs:

• In spring 2017, the company presented preclinical data on its erymethionase product candidate at the 2017 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Based on these preclinical studies, the company believes that erymethionase represents a promising new treatment approach against a broad range of cancers that rely on methionine metabolism.

• In September 2017, ERYTECH presented early preclinical data on its eryminase and erymethionase programs at the 13th International Congress of Inborn Errors of Metabolism (ICIEM). The findings from the research on eryminase, consisting of arginine deiminase encapsulated in red blood cells, showed a decrease in arginine levels in a disease model of arginase-1 deficiency, supporting a potential treatment approach for hyperargininemia. This study was conducted in collaboration with Queen’s University in Canada. The company’s preclinical data involving erymethionase, which is methionine- g-lyase encapsulated in red blood cells, showed lower homocysteine levels, supporting a potential treatment approach for homocystinuria. This study was conducted through a research collaboration with the Fox Chase Cancer Center (FCCC).

• ERYTECH also continues to explore its ERYMMUNE program, in which it intends to use its proprietary ERYCAPS platform to encapsulate tumor antigens within red blood cells as a potentially innovative approach to cancer immunotherapy. Preclinical proof-of-concept studies of ERYMMUNE are ongoing.
Full Year 2017 Financial Results

• ERYTECH’s key financial figures for the full year of 2017 compared with the same period of the previous year are summarized below:

In thousands of euros FY 2017 FY 2016
Revenues

— —
Other income

3,364 4,138

Total operating income

3,364 4,138

Research and development

(25,463 ) (19,720 )
General and administrative

(8,791 ) (6,808 )
Total operating expenses

(34,254 ) (26,528 )

Total operating loss

(30,889 ) (22,390 )

Financial income

539 558
Financial expenses

(3,183 ) (70 )
Financial income (loss)

(2,644 ) 488

Loss before tax

(33,533 ) (21,902 )

Income tax

3 (10 )

Net loss

(33,530 ) (21,913 )

Net loss for the full year 2017 was €33.5 million, compared to €21.9 million in 2016. The €11.6 million increase was primarily attributable to the increase in clinical and regulatory development expenses, related to the company’s ongoing clinical programs in ALL, AML and pancreatic cancer, the continuation of its regulatory initiatives in Europe and preparatory work related to additional clinical programs. R&D expenses also comprise pre-clinical developments on additional product candidates and the broadening of the ERYCAPS platform to include the potential development of immune therapies and enzyme-related therapies.

R&D expenses increased by €5.7 million. The increase included additional expenses in external provider services in relation with the company’s intensified clinical and regulatory activities, as well as the additional staffing for preclinical research and clinical development.

G&A expenses increased by €2.0 million, as a result of infrastructure developments to sustain the company’s growth.

Operating income decreased by €0.8 million, reflecting primarily a decrease in research tax credits.

The €2.6 million financial loss in 2017 was impacted by a €3.0 million currency exchange variation on the company’s cash position denominated in U.S. dollars and consolidated in euros.

•In April 2017, ERYTECH completed a €70.5 million ($82 million) private placement in which it issued 3,000,000 new ordinary shares.

•In November 2017, ERYTECH completed a global offering of its ordinary shares (including in the form of American Depositary Shares or ADSs) in the United States and Europe, with gross proceeds of approximately €124 million ($144 million). The offering resulted in the issuance of a total of 5,374,033 new ordinary shares, comprising 4,686,106 ADSs, at an offering price of $23.26 per ADS in the United States and 687,927 ordinary shares through a concurrent private placement in Europe and other countries outside of the United States and Canada at a price of €20.00 per ordinary share. Each ADS represents the right to receive one ordinary share. The underwriters exercised their overallotment option in full to purchase 702,915 additional ADSs and 103,189 additional ordinary shares in the global offering. Upon the consummation of the global offering, ERYTECH’s ADSs began trading on the Nasdaq Global Select Market on November 10, 2017.

•As of December 31, 2017, ERYTECH had cash and cash equivalents totaling €185.5 million (approximately $223 million), compared with €37.6 million on December 31, 2016. The net cash increase of €147.9 million was primarily the result of €177.4 million in net proceeds from the company’s financing activities in April and November 2017. Excluding the financing rounds, total cash utilization in 2017 was €26.4 million, comprised of a €24.7 million net cash utilization in operating activities and €1.7 million in capital expenditures.
Key News Flow and Milestones Expected over Next 12 Months

•Meeting with the FDA to discuss next steps in ALL

•Initiation of a pivotal Phase 3 clinical trial in second-line pancreatic cancer in Europe and the United States

•Initiation of a Phase 2 proof-of-concept clinical trial in first-line pancreatic cancer

•Initiation of a Phase 2 proof-of-concept clinical trial in TNBC

•Advance U.S. registration-directed activities for ALL

•CHMP feedback on MAA resubmission for GRASPA in R/R ALL

•Initiation of Phase 1 clinical trial with erymethionase

•Updates on preclinical pipeline programs

Full Year Results 2017 Conference Call Details

As a reminder, ERYTECH management will hold a conference call and webcast on Tuesday, March 13th, 2018 at 01:30pm CET / 08:30am EDT to business highlights and full year 2017 financials. Gil Beyen, Chairman and CEO, Eric Soyer, CFO and COO and Iman El-Hariry, CMO will deliver a brief presentation, followed by a Q&A session.

The call is accessible via the below teleconferencing numbers, followed by the Conference ID#: 7997444#:

USA: +1 8338186807 United-Kingdom: +44 02031070289
Switzerland: +080 0836508 Germany: +49 06922224728
France: +33 0176748988 Belgium: +32 024003547
Sweden: +46 0856619361 Finland: +358 0972519310
Netherlands: +31 0207075547 Spain: +34 914142503
The webcast can be followed live online via the link: View Source

An archived replay of the call will be available for 7 days by dialing (US & Canada): +1 833 818 6807, (UK): +44(0) 203 107 0289, (France): +33(0)1 726 74 89 88, (Spain): +34 91412503, Conference ID # 7997444#

An archive of the webcast will be available on ERYTECH’s website, under the "Investors" section at investors.erytech.com

2018 Financial Calendar:

General Assembly Meeting of Shareholders: Friday, June 22, 2018 at 10:00am CET in Paris

Quarterly financial updates:

Business Update and Financial Highlights for the 1st quarter of 2018: May 14, 2018 (after U.S. market close), followed by a conference call and webcast on May 15, 2018 (2:30pm CET/8:30am ET)

Business Update and Financial Highlights for the 2nd quarter and first-half of 2018: September 17, 2018 (after U.S. market close), followed by a conference call and webcast on September 18, 2018 (2:30pm CET/8:30am ET)

ENZO BIOCHEM REPORTS SECOND QUARTER AND FIRST HALF RESULTS

On March 12, 2018 Enzo Biochem Inc. (NYSE:ENZ) reported results for the fiscal quarter and six months ended January 31, 2018 (Press release, Enzo Biochem, MAR 12, 2018, View Source [SID1234524673]).

Quarter Highlights (Year over Year)

Total revenues for the second fiscal quarter increased to $27.0 million, or 3%, from $26.3 million in the prior year period.

Clinical Lab revenues for the quarter totaled $19.5 million, an increase of 4% over the prior year period, despite severe weather impacting operations. Enzo Life Sciences revenue was $7.4 million, unchanged over the year ago.
· Gross margins were 42% in the current year quarter, lower than 44% in the prior year period due to adverse weather noted above and lower genomic product sales.
· Heavier than usual increased legal expenses of $1.7 million resulted in an operating loss of ($3.1) million compared to ($1.0) million a year ago.
· GAAP net loss declined to ($0.9) million or ($0.02) per share, compared to ($1.0) million or ($0.02) per share a year ago, and for six months amounted to ($1.6) million or ($0.03) per share, compared to ($2.5) million or ($0.05) per share, a $0.9 million improvement.
· Total cash and cash equivalents at January 31, 2018 was $64.5 million, an increase of $0.3 million from July 31, 2017, and consolidated cash flow from operations was $0.8 million for the six months ended January 31, 2018, an increase of $3.7 million over the prior year period. Working capital stands at nearly $70 million as of January 31, 2018.
· During the quarter, the Company fully integrated and validated its AmpiProbe platform for use in its laboratory which is expected to result in significant savings in the cost of laboratory services in future periods.
· Interest in Enzo’s now completed 13-analyte women’s diagnostics health panel continues to mount, reinforcing build-up of physician servicing network in northeast service territory.
· In addition to continued emphasis on product development, the quarter’s activity was focused on increased marketing, including additions to and training of our sales staff, and appearances at major industry conferences and meetings to promote the Company’s highly efficient, higher margin molecular diagnostic test alternatives to profit-squeezed independent labs.

Barry Weiner, President, Comments

"The second fiscal quarter of 2018 has been an especially productive period. While we continued to gain ground with our AmpiProbe products and other New York State Department of Health approved diagnostics designed to allay cost pressures affecting the nation’s independent clinical laboratories, severe winter weather cut into our clinical laboratory operations revenues. In addition, in anticipation of a trial in New York’s Federal Southern District in litigation with Roche, following a favorable Markman patent-related decision by the court for Enzo, stepped-up depositions involving extensive expert testimony resulted in a substantial increase in litigation expenses. This case involves both patent and contract issues.

"Total revenues continue to grow, with Clinical Labs quarterly results improving year over year despite the harsh weather that affected operations of approximately two days resulting in lost revenues. Product revenues at Life Sciences also advanced, underscoring the benefits starting to derive from our strategic program to increase both services and product revenues. Our financial position and balance sheet remain strong providing the necessary capital from positive cash flow to grow organically and make long term capital investments.

"The expected new reduced PAMA Medicare reimbursements took effect in January further enforcing our strategy in helping laboratories to improve their margin utilizing our program of low cost products and services. Our focus remains on serving independent labs as an integrated, growth-oriented molecular diagnostics company, and a low-cost medically related assay provider and reference service organization. Put simply, with our current approved platforms and assays and those in our pipeline, we expect to be a lead supplier of affordable and reliable diagnostic testing either by product or service. Towards that end, we are diligently expanding and investing in our marketing program directed at independent labs and hospitals. The superior effectiveness and utility of our products that are compatible with existing in-house diagnostic systems has been demonstrated in various studies. We will adhere to those high standards of sensitivity and economy as we build our comprehensive testing line-up moving forward."

Second Quarter Results

The quarter’s total revenues amounted to approximately $27 million, compared to $26.3 million a year ago, an increase of 3%. Gross profit was $11.3 million or 42% of total revenue. Total operating expenses were $14.4 million and included selling and general and administrative expenses of $11.1 million, or 41% of revenue.

As noted, a favorable Markman decision in our New York litigation with Roche resulted in a significant increase in litigation expenditures to $1.7 million, compared with $370,000 a year ago. After slightly higher interest income, a foreign currency gain, and a $1.1 million tax benefit attributable to the Tax Cuts and Jobs Act of 2017, GAAP net loss amounted to $(0.9) million, or $(0.02) per share, compared to the year ago GAAP net loss of $(1.1) million or $(0.02) per share. Adjusted net loss amounted to $(2.0) million or $(0.04) per share compared to Adjusted net loss of $(1.1) million or $(0.02) per share a year ago. EBITDA (earnings before interest, taxes, depreciation and amortization) and Adjusted EBITDA were

both a loss of ($1.4) million, compared to ($0.2) million in the prior year period due largely to increased legal expenses.

As of January 31, 2018, cash and cash equivalents were $64.5 million with working capital of nearly $70 million. Cash flow from operations for the six months was $0.8 million, an increase of $3.7 million over the prior year period.

First Half Results

Total revenues were $54.6 million or 4% higher than prior year. Gross profit totaled $23.6 million, compared to $23.8 million a year ago, with gross margins of 43% and 45%, respectively. SG&A of $22.0 million increased $0.7 million, but as a percentage of sales declined to 40% from 43% a year ago. With legal expenses increasing to $2.1 million, from $0.7 million a year ago, the operating loss amounted to ($3.7) million, compared with ($2.2) million. The six month GAAP net loss totaled ($1.5) million, or ($0.03) per share, down from ($2.5) million, or ($0.05) per share, a 38% improvement.

Segment Results – Quarter

Enzo Clinical Labs revenues were $19.5 million, an increase of 4%, from $18.8 million in the prior year. The increase in revenue was offset in part by adverse winter weather and a severe Flu season in the Northeast that essentially curtailed patient visits to physicians and clinics by approximately two days during the quarter, consequently reducing the number of tests submitted and processed. As a result, gross margins were 40%, compared to 41% in the prior year period. SG&A increased approximately $210,000 due to headcount and costs in client and billing services, but as a percentage of revenues remained at 31%. Operating income was $0.9 million, versus $1.2 million in the prior year period. Enzo Life Sciences revenues were $7.4 million, unchanged over the year ago.

Gross profit equaled 48% compared to 53% a year ago due to lower genomic product sales and a decline in royalty income. SG&A remained flat at approximately $2.9 million, though as a percentage of revenues declined 10 basis points to 39%. Operating income amounted to $51,000, versus $381,000 a year ago due to lower margins on product sales.

Conference Call

The Company will conduct a conference call Tuesday, March 13, 2018 at 8:30 AM ET. The call can be accessed by dialing 1-888-459-5609. International callers can dial 1-973-321-1024. Please reference PIN number 9386236.

Interested parties may also listen over the Internet at: View Source

To listen to the live call on the Internet, please go to the web site at least fifteen minutes early to register, download and install any necessary audio software. For those who cannot listen to the live broadcast, a replay will be available approximately two hours after the end of the live call, through midnight (ET) on March 27, 2018. The replay of the conference call can be accessed by dialing 1-855-859-2056, and when prompted, use PIN number 9386236. International callers can dial 1-404-537-3406, using the same PIN number.
ADJUSTED Financial Measures

To comply with Regulation G promulgated pursuant to the Sarbanes-Oxley Act, Enzo Biochem attached to this news release and will post to the Company’s investor relations web site (www.enzo.com) any reconciliation of differences between GAAP and Adjusted financial information that may be required in connection with issuing the Company’s quarterly financial results.

The Company uses EBITDA as a measure of performance to demonstrate earnings exclusive of interest, taxes, depreciation and amortization. Adjustments to EBITDA are for items of a non-recurring nature and are reconciled on the table provided. The Company manages its business based on its operating cash flows. The Company, in its daily management of its business affairs and analysis of its monthly, quarterly and annual performance, makes its decisions based on cash flows, not on the amortization of assets obtained through historical activities. The Company, in managing its current and future affairs, cannot affect the amortization of the intangible assets to any material degree, and therefore uses EBITDA as its primary management guide. Since an outside investor may base its evaluation of the Company’s performance based on the Company’s net loss not its cash flows, there is a limitation to the EBITDA measurement. EBITDA is not, and should not be considered, an alternative to net loss, loss from operations, or any other measure for determining operating performance of liquidity, as determined under accounting principles generally accepted in the United States (GAAP). The most directly comparable GAAP reference in the Company’s case is the removal of interest, taxes, depreciation and amortization.

We refer you to the tables attached to this press release which includes reconciliation tables of GAAP to Adjusted net income (loss) and EBITDA to Adjusted EBITDA.

Delcath to Present at 30th Annual Roth Conference

On March 12, 2018 Delcath Systems, Inc. (OTCQB:DCTH), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, reported that Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath will present at the Roth Capital Partners 30th Annual Conference on Tuesday March 13, 2018 at 1:30pm Pacific Time. Dr. Simpson will highlight the recent corporate developments and provide an overview of the Company (Press release, Delcath Systems, MAR 12, 2018, View Source;p=RssLanding&cat=news&id=2337491 [SID1234524672]).

A live webcast of the presentation will be available at www.delcath.com/investors-events, and a replay will be available at the same address approximately one hour after the presentation for approximately 90 days.

The 30th Annual Roth Conference is being held at the Ritz Carlton Hotel, in Dana Point, California from March 11-14, 2018.

Cellectis Reports 4th Quarter and Full Year 2017 Financial Results

On March 12, 2018 Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported its results for the three-month period ended December 31, 2017 and for the year ended December 31, 2017 (Press release, Cellectis, MAR 12, 2018, View Source [SID1234524671]).

"I would like to highlight what remarkable progress we made in 2017, by transforming the off-the-shelf CAR T-cell concept into reality. I believe I can say without a doubt that we have only just scratched the surface of what a powerful treatment CAR T-cell therapy represents. 2018 will be a turning point for Cellectis, extending our lead in the allogeneic CAR T-cell field," said André Choulika, Chairman and Chief Executive Officer, Cellectis.

Earnings Call Details

Cellectis to hold a conference call for investors on Tuesday, March 13, 2018 at 8 a.m. EDT – 1 p.m. Paris Time. The call will include the company’s fourth quarter 2017 and year-end financial results.

The live dial-in information for the conference call is:

US & Canada only: 877-407-3104

International: 201-493-6792

In addition, a replay of the call will be available for 6 months following the conference by calling 877-660-6853 (Toll Free US & Canada); 201-612-7415 (Toll Free International).

The archived webcast of this event will be available archived for 6 months:

https://78449.themediaframe.com/dataconf/productusers/clls/mediaframe/23530/indexl.html

Avid Bioservices Reports Financial Results for Third Quarter of Fiscal Year 2018 and Recent Developments

On March 12, 2018 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported financial results for the third quarter of fiscal year (FY) 2018 ended January 31, 2018, and provided an update on its contract manufacturing operations, and other corporate highlights (Press release, Avid Bioservices, MAR 12, 2018, View Source [SID1234524669]).

Highlights Since October 31, 2017

"During and subsequent to our third quarter of fiscal year 2018, Avid completed two primary objectives. We successfully divested the company’s lead immuno-oncology assets to an organization with the financial resources and expertise to advance them, and we established a new operational structure that will allow our business to take full advantage of the substantial and growing demand for biologics manufacturing," said Roger Lias, Ph.D., president and chief executive officer of Avid Bioservices. "With the divestiture of our lead R&D assets, our transition to a dedicated CDMO business is complete, and our team is entirely focused on expanding and diversifying our customer base, as well as strengthening our process development capabilities. At present, we are in late-stage negotiations with several potential new customers and expect to announce the executed agreements before the end of the fiscal year. In recent weeks, we also completed a financing raising $23.2 million in gross proceeds. These funds are essential as they will support our operations, including upgrading our process development capabilities to ensure that we are fully capable of servicing our customers with the highest quality standards and equipment. We made rapid progress during the third quarter that we believe will allow us to build backlog and achieve sustainable growth in the future."

Recent CDMO Developments

Advanced eight current clients, some with multiple projects, through various stages of development.

Selected by Acumen Pharmaceuticals, Inc. to provide process development and clinical manufacturing services in support of ACU193, which is being developed for the treatment of Alzheimer’s disease.
° Avid and Acumen will immediately commence process development work with the goal of creating a robust, cost-effective and scalable process to support cGMP manufacture of ACU193.
Recent Corporate Developments and Financial Highlights

Changed company name from Peregrine Pharmaceuticals, Inc. to Avid Bioservices, Inc.
° As the Avid name is recognized in the industry for CDMO excellence and biologics manufacturing expertise, the brand is an important asset in the company’s transition to a dedicated CDMO business. The company also adopted the new NASDAQ ticker symbol, "CDMO" (NASDAQ:CDMO).

Reconstituted board of directors including six independent directors, all with significant CDMO experience.

Entered into an Asset Assignment and Purchase Agreement with Oncologie, Inc. for Avid’s phosphatidylserine (PS)-targeting program including bavituximab.
° Avid expects to receive an aggregate of $8.0 million in upfront payments over a period of six months and will be eligible to receive up to $95.0 million in development, regulatory and commercialization milestones.
° Oncologie, Inc. will be responsible for all future research, development and commercialization of bavituximab, and related intellectual property costs.
° Avid will receive royalties on net sales that are upward tiering into the mid-teens.
° Oncologie will enter into an agreement with Avid for future contract development and manufacturing activities in support of bavituximab.

Completed a public offering of 10,294,445 shares of common stock raising gross proceeds of approximately $23.2 million.
° Avid intends to use the net proceeds from the offering to support the growth of its contract manufacturing business and general corporate purposes.

The company maintains its manufacturing revenue guidance for the full FY 2018 of $50.0 million – $55.0 million.

The current manufacturing revenue backlog has increased to $39 million.

Contract manufacturing revenue from Avid’s clinical and commercial biomanufacturing services was $6.8 million for the third quarter of FY 2018 compared to $10.7 million for the third quarter of FY 2017. The decline was primarily due to lower demand from one of our largest customers.

Cost of contract manufacturing increased to $11.0 million in the third quarter of FY 2018 compared to $8.0 million for the third quarter of FY 2017. The current period increase in cost of manufacturing is primarily attributed to idle capacity costs of $5.3 million due to lower facility and personnel utilization compared to no idle capacity costs reported in the same prior year quarter.

Selling, general and administrative expenses for the third quarter of FY 2018 were $4.8 million, compared to $4.4 million for the third quarter of FY 2017. The current period increase in costs was primarily due to legal and other related fees associated with the settlement agreement with certain investors regarding the composition of the company’s board of directors and legal and advisory fees associated with the Asset Assignment and Purchase Agreement with Oncologie, Inc.

As of January 31, 2018, the company’s research and development segment met all the conditions to be classified as a discontinued operation. Accordingly, the operating results of our research and development segment are reported as a loss from discontinued operations for all periods presented.

Avid’s consolidated net loss attributable to common stockholders was $12.4 million or $0.28 per share, for the third quarter of FY 2018, compared to a net loss attributable to common stockholders of $9.2 million, or $0.25 per share, for the same prior year quarter.

Avid reported $17.9 million in cash and cash equivalents as of January 31, 2018, compared to $46.8 million at fiscal year ended April 30, 2017. Following the completion of a public offering during February 2018, the company had cash and cash equivalents of $41.7 million as of February 28, 2018.
More detailed financial information and analysis may be found in Avid’s Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.

Conference Call

Avid will host a conference call and webcast this afternoon, March 12, 2018, at 4:30 PM EDT (1:30 PM PDT).

To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices conference call. To listen to the live webcast, or access the archived webcast, please visit: View Source

About Avid Bioservices, Inc.
Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and cGMP manufacturing of biopharmaceutical products derived from mammalian cell culture. The company provides a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With nearly 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, Avid’s services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support. The company also provides a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. For more information, please visit www.avidbio.com.

Forward-Looking Statements
Statements in this press release which are not purely historical, including statements regarding Avid Bioservices’ intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk the company may experience delays in engaging new clients, the risk that the company may experience technical difficulties in processing customer orders which could delay delivery of products to customers, revenue recognition and receipt of payment or the loss of the customer, the risk that one or more existing customers terminates its contract prior to completion or reduces or delays its demand for development or manufacturing services, the risk that the company may need to use the majority of its cash to fund operations, thereby delaying the contemplated upgrade to its process development capabilities and expansion plans, and the risk that the company may not receive the full $8 million up front payment from Oncologie. Our business could be affected by a number of other factors, including the risk factors listed from time to time in our reports filed with the Securities and Exchange Commission including, but not limited to, our annual report on Form 10-K for the fiscal year ended April 30, 2017 and subsequent quarterly reports on Form 10-Q, as well as any updates to these risk factors filed from time to time in our other filings with the Securities and Exchange Commission. We caution investors not to place undue reliance on the forward-looking statements contained in this press release, and we disclaim any obligation, and do not undertake, to update or revise any forward-looking statements in this press release except as may be required by law.