On June 27, 2019 Bracco Imaging S.p.A., a global leader in diagnostic imaging, reported that it had signed a definitive agreement to acquire Blue Earth Diagnostics, a molecular imaging company based in Oxford, UK (Press release, Bracco, JUN 27, 2019, View Source [SID1234537282]). Subject to customary closing conditions, completion of the transaction is expected in Q3 of this calendar year.

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Bracco Imaging will acquire all outstanding shares of privately-held Blue Earth Diagnostics for the equity value of $ 450 million, plus closing adjustment estimated at $25 million, from leading healthcare company Syncona and Blue Earth Diagnostics’ management team. Upon closing of the transaction, Blue Earth Diagnostics will be a subsidiary of Bracco Imaging, led by its current leadership team and will retain the well-established Blue Earth Diagnostics name. Blue Earth Diagnostics employs approximately 100 people and is expected to generate revenues of $ 140M in the year to September 2019, primarily in the US.

The first novel PET molecular imaging agent developed by Blue Earth Diagnostics is Axumin (F18-fluciclovine) injection approved in the United States (US) and the European Union for PET imaging in men with suspected recurrent prostate cancer based on elevated prostate specific antigen (PSA) levels following prior treatment. The company’s pipeline includes innovative Prostate Specific Membrane Antigen (PSMA)-targeted radiohybrid ("rh") agents, which are a clinical-stage, investigational class of theranostic compounds, with potential applications in both the imaging and treatment of prostate cancer.[1]

Prostate cancer is the most common cancer in men, with an estimated number of more than 170 thousand new cases in 2019 in the US.[2] While most cases of primary prostate cancer can be treated successfully, the cancer will recur in up to one third of cases and in a third of those recurrences, patients develop distant metastases leading to a fatal outcome[3]. In two separate studies which evaluated the utility of Axumin (F18-fluciclovine) PET/CT in providing physicians with actionable information for the management of men with recurrent prostate cancer, the intended management plan was changed for approximately 60% of the study subjects, based on the results of the Axumin PET/CT scan.[4]

F18-fluciclovine has a broad range of other potential applications in cancer imaging and Blue Earth Diagnostics is investigating the molecule for other cancers including in neuro-oncology.

"Blue Earth Diagnostics’ innovative products and pipeline will significantly enhance Bracco Imaging’s portfolio in precision medicine and personalized diagnostics, while expanding our range of nuclear oncology imaging solutions in the Urology segment and other specialties," said Fulvio Renoldi Bracco, Chief Executive Officer, Bracco Imaging. "We are thrilled to welcome to Bracco this world class team with exceptional product development and commercialization expertise."

"The acquisition of Blue Earth Diagnostics by Bracco Imaging is a validation of the proven success of Axumin in prostate cancer, its potential uses beyond prostate cancer, and the PSMA pipeline under development," said Dr. Jonathan Allis, D.Phil., Chief Executive Officer, Blue Earth Diagnostics. "Bracco Imaging’s global footprint and clinical research and marketing support will enable us to further leverage our high-value platform for innovative radiopharmaceuticals to inform clinical management and guide care for cancer patients around the world."

J.P. Morgan is acting as Exclusive Financial Adviser to Bracco and as sole Underwriter of the financing for its [$450 million] acquisition of Blue Earth Diagnostics Ltd from Syncona Ltd. Santa Maria Law Firm and Greenberg Traurig acted as legal advisors.

On June 27, 2019 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported the completion of an in-depth operational review designed to extend the Company’s cash runway and deliver on its commitment to develop next-generation ADCs to bring more good days to patients and generate increased value for shareholders (Press release, ImmunoGen, JUN 27, 2019, View Source [SID1234537299]). Based on the outcomes of this review, the Company will prioritize continued development of mirvetuximab and a select portfolio of three earlier-stage product candidates targeting solid tumors and hematological malignancies. The Company will end the current quarter with approximately $240 million on its balance sheet and expects this cash, together with expense reductions resulting from the operational changes announced today and anticipated cash receipts from partners, will fund operations through the release of top-line results from the upcoming mirvetuximab Phase 3 study in platinum-resistant ovarian cancer, which are expected in the first half of 2022.

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The operational review commenced following the announcement that FORWARD I, ImmunoGen’s Phase 3 clinical trial evaluating mirvetuximab compared to chemotherapy in women with folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer, did not meet the primary endpoint. Data from FORWARD I did, however, demonstrate a consistent efficacy signal across a range of parameters in the pre-specified subset of patients with high FRα expression. Following consultation with the U.S. Food and Drug Administration (FDA), the Company will pursue a new Phase 3 study in this patient population.

In light of these developments and with the goal of extending the Company’s existing cash runway, ImmunoGen has established three strategic priorities for the business: execute a registration study for mirvetuximab in platinum-resistant ovarian cancer; advance a select portfolio of earlier-stage product candidates; and further strengthen its balance sheet through partnering. Consistent with these priorities, ImmunoGen will focus on the following core activities:

Initiate the registration study for mirvetuximab as a monotherapy for women with FRα-high, platinum-resistant ovarian cancer by the end of this year;

Complete enrollment and continue follow up in the ongoing FORWARD II mirvetuximab combination cohorts;

Continue IMGN632 development in patients with relapsed acute myeloid leukemia (AML), blastic plasmacytoid dendritic cell neoplasm (BPDCN), and other CD123-positive hematologic malignancies in collaboration with Jazz Pharmaceuticals;

Advance two additional assets that demonstrate ImmunoGen’s continued innovation in ADCs: IMGC936, which is in co-development with MacroGenics with an IND expected by the end of 2019; and the Company’s next generation anti-FRα ADC, which is expected to enter development in mid-2020; and

Monetize its remaining portfolio and platform technologies through out-licensing transactions or asset sales.

Correspondingly, the Company will reduce ongoing expenses through the following portfolio prioritization and restructuring initiatives:

Discontinue the development of IMGN779 in adults with relapsed/refractory CD33-positive AML;

Suspend all other research activities;

Reduce its workforce by approximately 220 employees, with a majority of these employees separating from the business by mid-July 2019; and

Seek to sub-lease excess office and lab space.

Following a transition period, the savings generated by the restructuring are expected to reduce ImmunoGen’s quarterly expenses by more than 50%. As a result of the workforce reduction, the Company expects to record a one-time charge totaling approximately $16.4 million related to termination benefits and other related expenses. This charge is expected to be recorded in the quarter ending June 30, 2019, and the related cash payments will be substantially paid out by June 30, 2020. In addition, an anticipated charge of $3.7 million is expected to be incurred for retention benefits in the same time period. Updated 2019 financial guidance will be provided when ImmunoGen announces it second quarter operating results on August 2, 2019.

"I thank the employees separating from the business for their significant contributions to ImmunoGen and to the advancement of the ADC field," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "Reorganizing the business is critical to the Company’s future, enabling us to extend our cash position and continue the development of mirvetuximab and our portfolio of promising ADCs in earlier stages of development. We look forward to continued progress with the business, including the start of the registration study for mirvetuximab by year-end and additional monotherapy and combination data at ESMO (Free ESMO Whitepaper) in September, identifying a recommended Phase 2 dose and initiating combination studies with IMGN632 in the second half of the year, and filing an IND for IMGC936 by the end of 2019."

"This was an extremely difficult decision for the Board, as we believe deeply in the therapeutic promise of ADCs, the Company’s science, and its people," said Steve McCluski, ImmunoGen’s Chairman of the Board. "These are, however, the right steps to take to bring mirvetuximab to patients and offer the best opportunity to capture long-term value for our shareholders, whom we thank for their support."

CONFERENCE CALL INFORMATION

ImmunoGen will hold a conference call today at 8 a.m. ET to discuss these results. To access the live call by phone, dial 1-786-789-4797; the conference ID is 6921368. The call may also be accessed through the Investors section of the Company’s website, www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through July 9, 2019.

ABOUT MIRVETUXIMAB SORAVTANSINE

Mirvetuximab soravtansine (IMGN853) is the first folate receptor alpha (FRα)-targeting ADC. It uses a humanized FRα-binding antibody to target the ADC specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.

ABOUT FORWARD I

FORWARD I is a Phase 3 trial in which 366 patients were randomized 2:1 to receive either mirvetuximab soravtansine or the physician’s choice of single-agent chemotherapy (pegylated liposomal doxorubicin, topotecan, or weekly paclitaxel). Eligible patients were diagnosed with platinum-resistant ovarian cancer that expresses medium or high levels of FRα and were treated with up to three prior regimens. The primary endpoint of this study was progression free survival (PFS), which was assessed in the entire study population and in the subset of patients with high FRα expression. ImmunoGen estimates that 12,000-14,000 patients per year in the U.S. meet these criteria, with a comparable number in the major markets in Europe.

ImmunoGen partnered with the GOG Foundation Inc., a leader in clinical research in gynecologic malignancies, on FORWARD I, which was conducted in North America and Europe.

ABOUT FORWARD II

FORWARD II is a Phase 1b/2 study of mirvetuximab in combination with Avastin (bevacizumab), carboplatin or Keytruda (pembrolizumab) in patients with FRα-positive platinum-resistant or platinum-agnostic ovarian

Picture 2

cancer, primary peritoneal, or fallopian tube tumors, as well as a triplet combination of mirvetuximab plus carboplatin and Avastin in patients with platinum-sensitive ovarian cancer.

On June 27, 2019 Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on advancing targeted therapeutics for the treatment of patients with significant unmet needs in hematology and oncology, reported plans to prioritize its existing resources on the development of momelotinib, its differentiated Phase 3 drug candidate for the treatment of patients with myelofibrosis (Press release, Sierra Oncology, JUN 27, 2019, View Source [SID1234537322]). Sierra also announced it has launched a campaign exploring non-dilutive strategic options to support the future continued development of its portfolio of potent and selective DDR (DNA Damage Response) assets, consisting of SRA737 (Chk1 inhibitor) and SRA141 (Cdc7 inhibitor).

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"We recently reported compelling proof-of-concept clinical efficacy data for SRA737 at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting, demonstrating that this drug candidate has notable anti-cancer activity in multiple indications and a defined clinical path forward towards potential initial registration for the treatment of anogenital cancer, an indication with considerable unmet need. For SRA141, we have demonstrated a potentially novel mechanism of cytotoxicity and successfully completed the IND process with the FDA enabling the commencement of clinical trials," said Dr. Nick Glover, President and CEO of Sierra Oncology. "While we continue to advance the assets in our DDR portfolio and view them as promising oncology drug candidates that warrant further development, we are prioritizing our resources on our lead drug, momelotinib. To support the continued development of SRA737 and SRA141 in the future, we intend to seek non-dilutive strategic options."

About Sierra’s DDR assets: SRA737 (targeting Chk1) and SRA141 (targeting Cdc7)
SRA737 is a potent, highly selective, orally bioavailable small molecule inhibitor of Checkpoint kinase 1 (Chk1), a key regulator of cell cycle progression and the DNA Damage Response (DDR). Tumors with high levels of replication stress become reliant on Chk1 to mitigate the potentially catastrophic consequences of excess genomic instability. Intrinsic sources of replication stress can include genetic alterations in tumor suppressors, oncogenes or DNA Damage Repair genes. SRA737+LDG is a novel drug combination, where non-cytotoxic low dose gemcitabine (LDG) acts as a potent extrinsic inducer of replication stress.

At the 2019 ASCO (Free ASCO Whitepaper) Annual meeting, Sierra reported preliminary efficacy data for SRA737 including a 30% Overall Response Rate in patients with anogenital cancer treated with SRA737+LDG , an indication for which the second line metastatic setting represents a significant unmet medical need with no approved therapies and very poor life expectancy. Additionally, subjects whose tumors harbored FA/BRCA gene network mutations displayed favorable outcomes across multiple indications, with an Overall Response Rate of 25% and Disease Control Rate of 81%.

Sierra has conducted preclinical research demonstrating SRA737 synergy in combination with other DDR-targeted agents including poly ADP-ribose polymerase (PARP) inhibitors, as well as with immuno-oncology therapeutics. Sierra has an agreement with Janssen Research & Development, LLC (Janssen), under which Janssen has agreed to supply the PARP inhibitor niraparib, facilitating the potential initiation of a combination trial with SRA737 that Sierra has designed for the treatment of prostate cancer. Sierra reported preclinical data in a late-breaking poster presented at the AACR (Free AACR Whitepaper) Annual Meeting 2019 demonstrating that SRA737+LDG activates innate immune signaling and establishes an anti-tumor immune microenvironment that profoundly synergizes with immune checkpoint inhibitors. Sierra has reported having management support from a major immuno-oncology company to potentially supply their leading immunotherapeutic agent to run a combination study with SRA737.

SRA141 is a potent, selective, orally bioavailable small molecule inhibitor of Cell division cycle 7 kinase (Cdc7). Sierra reported preclinical data in a late-breaking poster presented at the AACR (Free AACR Whitepaper) Annual Meeting 2019 highlighting a possible novel mechanism of cytotoxicity for SRA141 that is distinct from other agents, in which SRA141 alters DNA replication dynamics and delays cell cycle progression, leading to apoptotic tumor cell death. This differentiated mechanism of action may support a unique spectrum of clinical opportunities for SRA141 as both monotherapy and in combination with pro-apoptotic and mitotic disrupting agents. Sierra has successfully completed the IND process with the U.S. Food and Drug Administration (FDA) for SRA141 and has designed a potential Phase 1/2 trial with this drug candidate.

Sierra Oncology retains the global commercialization rights to SRA737 and SRA141.

About Sierra Oncology
Sierra Oncology is a clinical stage drug development company advancing targeted therapeutics for the treatment of patients with unmet medical needs in hematology and oncology.

Momelotinib, Sierra’s lead drug candidate, is a potent, selective and orally-bioavailable JAK1, JAK2 & ACVR1 inhibitor with a differentiated therapeutic profile in myelofibrosis encompassing robust constitutional symptom improvements, a range of meaningful anemia benefits, including eliminating or reducing the need for frequent blood transfusions, and comparable spleen control to ruxolitinib. More than 1,200 subjects have received momelotinib since clinical studies began in 2009, including more than 800 subjects treated for myelofibrosis.

Sierra plans to launch the MOMENTUM Phase 3 clinical trial in Q4 2019 to support potential registration of the momelotinib on a global basis. The randomized double-blind trial is designed to enroll 180 myelofibrosis patients who are symptomatic, anemic and have been treated previously with a JAK inhibitor. Dr. Srdan Verstovsek, MD, PhD, Chief, Section for Myeloproliferative Neoplasms, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, has been named Chief Investigator of the MOMENTUM trial.

Momelotinib is wholly owned by Sierra Oncology and is covered by patents anticipated to provide potential exclusivity to 2040 in the U.S. The FDA has granted Fast Track designation to momelotinib for the treatment of patients with intermediate/high-risk myelofibrosis who have previously received a JAK inhibitor.

On June 27, 2019 Innovent Biologics, Inc. (Innovent) (HKEX: 01801) and Eli Lilly and Company ("Lilly") jointly reported that the National Medical Products Administration (NMPA) has accepted its new drug application (NDA) for IBI301, a co-developed biosimilar product candidate of rituximab (MabThera/Rituxan) (Press release, Innovent Biologics, JUN 27, 2019, View Source [SID1234537283]). This NDA by Innovent is the fourth that has been accepted by the NMPA following Tyvyt (sintilimab injection), IBI303 (a biosimilar product candidate of adalimumab injection, granted priority review status) and IBI305 (a biosimilar product candidate of bevacizumab injection, granted priority review status).

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IBI301 is a recombinant human-mouse chimeric anti-cell surface protein (anti-CD20) monoclonal antibody for injection co-developed by Lilly and Innovent for the treatment of non-Hodgkin’s lymphoma (NHL) and other diseases. Rituximab was first approved by the U.S. Food and Drug Administration (FDA) for the treatment of NHL in November 1997, followed by approvals in chronic lymphocytic leukemia (CCL), rheumatoid arthritis (RA), and other disease indications. Branded rituximab has been well-recognized for its proven efficacy and safety profile. Despite the high unmet demand for effective cancer therapies in China, the adoption rate of rituximab is relatively low due to low affordability. The biosimilar product candidate of rituximab, IBI301, is expected to offer a high-quality and affordable alternative to patients in China.

The NDA is based on clinical data generated from two clinical studies, namely: a Phase 3 comparative study of efficacy and safety in patients with diffuse large B-cell lymphoma (DLBCL) and a pharmacokinetic (PK) study in patients with CD20-positive B-cell lymphoma. Both studies directly compare IBI301 to rituximab and have met their pre-defined primary endpoints.

"Two clinical studies have been conducted with rituximab injection as the control arm. Based on the high-quality clinical data, the NDA of IBI301 has been accepted by NMPA. We believe that the high-quality rituximab biosimilar will improve drug availability and benefit more patients and their families," said Professor Lugui Qiu from Blood Diseases Hospital, Chinese Academy of Medical Sciences.

"The Phase 3 study comparing IBI301 with rituximab when each is used in combination with standard chemotherapy (CHOP) in patients with DLBCL shows an objective response rate (ORR) and safety profile consistent with that of branded rituximab, which suggests biosimilarity between IBI301 and rituximab injection. We hope that the drug can be launched soon to benefit more lymphoma patients," said Professor Jun Zhu, Beijing Cancer Hospital.

Dr. Li Wang, Senior Vice-President of Lilly China and Head of Lilly China Drug Development and Medical Affairs, commented, "The NDA of IBI301 represents another millstone of strategic cooperation between Lilly and Innovent. We hope that IBI301 can be approved soon in order to offer an affordable treatment option for lymphoma patients in China."

"At present, we have fourteen assets in clinical research stage, four products in phase 3 clinical trials, and one, Tyvyt (sintilimab injection), is now successful approved and launched on the market. IBI301 is the fourth NDA filing Innovent has submitted to NMPA. We are excited about reaching this important milestone and hope to bring the high-quality drug to more patients. We’ll strive to deliver high-quality biopharmaceutical drugs from our rich pipeline to benefit more and more ordinary people," said Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent.

About non-Hodgkin’s lymphoma

Malignant lymphoma is one of the most common hematological malignancies in China. It is one of the top ten malignant tumors with high morbidity and mortality. In recent years, the incidence of malignant lymphoma has been rising. According to histopathology, lymphoma can be divided into Hodgkin’s lymphoma (HL) and non-Hodgkin’s lymphoma (NHL), of which NHL accounts for the majority. NHL is a general term for a series of related but different lymphoid malignant tumors. Most (80-85%) originates from B cells. The rest originates from T cells or an undetermined cell type. More than 95% of B-cell non-Hodgkin’s lymphoma cells express CD20. The incidence of NHL increases with age. The most common type of NHL in China is diffuse large B-cell lymphoma (DLBCL), accounting for 40-50% (about 30-40% in Western countries). DLBCL is a moderately malignant to highly malignant invasive lymphoma that progresses rapidly and leads to the death of patients within a few months without treatment. The clinical efficacy and safety of rituximab in CD20-positive non-Hodgkin’s lymphoma have been confirmed in several large-scale clinical trials.

About IBI301

IBI301 is a biosimilar of rituximab, a recombinant human-mouse chimeric anti-CD20 monoclonal antibody for injection co-developed by the Group and Eli Lilly and Company. Rituximab is a monoclonal antibody which binds to CD20 antigen on the surface of B lymphocytes and mediates complement-dependent cytotoxicity ("CDC") and antibody-dependent cellular cytotoxicity ("ADCC"). The normal and malignant B cells in the mediator dissolve, thereby achieving an anti-tumor therapeutic effect.

On June 27, 2019 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics 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 fourth quarter and full year of fiscal 2019 ended April 30, 2019 (Press release, Avid Bioservices, JUN 27, 2019, View Source [SID1234539009]).

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Highlights Since January 31, 2019

"Fiscal 2019 was a fundamentally transformative year for Avid, as the team successfully achieved a number of critical goals. Most notably, we converted the losses and negative margins in fiscal 2018 into a sustainable position of financial strength," stated Rick Hancock, interim president and chief executive officer. "Based on our current backlog as well as forecasts from our customers, we believe the company will achieve sustainable growth going forward. Avid is stronger today than it has been at any point in the past.

"With respect to business development, the five new clients signed in late fiscal 2018 contributed significantly to revenue diversification in fiscal 2019. These projects substantially increased capacity utilization, which drove a meaningful improvement in margins during the year.

"Of particular note is the new business we continue to win from existing customers. While some of this business results from the expansion of current projects, many of these projects are completely new, requiring development and/or manufacture of a new molecule. These ‘repeat business’ wins are particularly valuable to Avid as each offers the opportunity for later stage and commercial production, they generally onboard very efficiently and as a result are more profitable, and they provide strong testimonials as to the quality of our work and product."

"Avid finished the year with a strong fourth quarter, growing revenue to $17.1 million while increasing gross margins to 21 percent," said Dan Hart, chief financial officer. "During the fourth quarter we generated $5.6 million in operating cash flow increasing our net cash and cash equivalents by $4.6 million to $32.4 million. Looking ahead, we are encouraged by the forecasted increase in demand which we expect to strengthen the company’s overall financial standing and position us for profitability."

Financial Highlights and Guidance

The company is providing revenue guidance for the full fiscal year 2020 of $64 million – $67 million (ASC 606).

Revenue was $17.1 million for the fourth quarter of fiscal 2019, a 146% increase compared to $6.9 million for the fourth quarter of last fiscal year. This increase is primarily due to growing demand from a more diversified client base. Revenue for the full fiscal year 2019 met guidance at $53.6 million, and was flat compared to full fiscal year 2018.

As of April 30, 2019, revenue backlog was approximately $46 million, the majority of which is expected to be recognized in fiscal year 2020.

Gross margin for the fourth quarter of fiscal 2019 was 21%, and gross margin for full fiscal year 2019 was 13%, both representing significant improvements compared to gross margins of negative 28% during the fourth quarter of fiscal 2018 and negative 5% for full fiscal year 2018. The improvements in gross margins for both fiscal 2019 periods were primarily attributed to our product mix, increased capacity utilization and a reduction in direct manufacturing costs.

Selling, general and administrative expenses ("SG&A") for the fourth quarter of fiscal 2019 were $3.6 million, or 21% of revenue, compared to $4.2 million, or 60% of revenue, for the fourth quarter of last year. For full fiscal year 2019, total SG&A expenses were $12.8 million, or 24% of revenue compared to $16.5 million last fiscal year, or 31% of revenue. The decrease in SG&A was primarily due to a reduction in payroll and related costs, legal fees and other professional consulting fees, and facility costs, which were partially offset by increases in bonuses related to certain achievement levels of corporate goals and stock-based compensation.

During the fourth quarter of fiscal 2019 we generated income from continuing operations of $0.2 million compared to a net loss from continuing operations of $6.1 million for the fourth quarter of fiscal 2018. Fiscal year 2019 loss from continuing operations was $5.1 million compared to a prior year loss from continuing operations of $20.6 million. The decrease during the full fiscal year was primarily due to reductions in both cost of revenues and SG&A resulting in higher profitability margins.

For the fourth quarter of fiscal 2019, the company recorded consolidated net loss attributable to common stockholders of $1.1 million or $0.02 per share, compared to a consolidated net income attributable to common stockholders of $1.6 million or $0.03 per share, for the fourth quarter of fiscal 2018. For full fiscal year 2019, the company recorded a consolidated net loss attributable to common stockholders of $8.9 million or $0.16 per share, compared to a consolidated net loss attributable to common stockholders of $26.5 million or $0.56 per share, for full fiscal year 2018. For both the fourth quarter and full fiscal year 2018, net income and loss were favorably impacted by the sale of the company’s legacy R&D assets to Oncologie, Inc. for $8.0 million and the associated discontinued operations.

Avid reported $32.4 million in cash and cash equivalents as of April 30, 2019, compared to $42.3 million on April 30, 2018.
More detailed financial information and analysis may be found in Avid Bioservices’ Annual Report on Form 10-K, which will be filed with the Securities and Exchange Commission today.

Recent Developments

Signed project expansion orders and new manufacturing projects related to new molecules with current clients during the fourth quarter of fiscal 2019 representing future revenue in the amount of $19.7 million.

Completed a second process validation campaign during fiscal 2019. Completion of a process validation campaign is a critical step in the regulatory product approval process, and is likely to result in future commercial production at Avid.

The first process validation campaign of fiscal 2020 is in progress.
Conference Call

Avid will host a conference call and webcast this afternoon, June 27, 2019, 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