On August 8, 2018 Sangamo Therapeutics, Inc. (NASDAQ: SGMO) reported second quarter 2018 financial results and recent accomplishments (Press release, Sangamo Therapeutics, AUG 8, 2018, View Source [SID1234528535]).

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"In the first half of 2018 we made strong progress on important initiatives including our clinical development programs and execution of a significant collaboration with Kite-Gilead for the use of ZFNs for engineered cell therapies in oncology," said Sandy Macrae, CEO of Sangamo. "More recently, with our proposed acquisition of TxCell, we have the opportunity to seize a leadership position in the development of gene-edited cell therapies for immunological diseases, one of our therapeutic areas of focus for our proprietary pipeline."

Macrae continued: "Today we announced positive preliminary data from the Alta clinical trial evaluating SB-525 gene therapy for hemophilia A. These are the first efficacy data from our clinical programs using AAV6. We are looking forward to the September 5th SSIEM presentation of preliminary data from the CHAMPIONS Study evaluating SB-913, our in vivo genome editing candidate for MPS II."

Recent Highlights
Corporate

Announced the proposed acquisition of TxCell, positioning Sangamo as a leader in CAR-Treg development
Appointed Karen Smith, M.D., Ph.D., to the Board of Directors, and Edward Rebar, Ph.D., as Senior Vice President and Chief Technology Officer
Clinical

Today announced positive preliminary data from the Phase 1/2 Alta Study evaluating SB-525 gene therapy for hemophilia A
Treated the fifth and sixth patients in the SB-913 Phase 1/2 CHAMPIONS Study for MPS II
Treated the first patient in the SB-318 Phase 1/2 EMPOWERS Study for MPS I
Received Clinical Trial Authorisation (CTA) in the U.K. for enrollment of subjects into ongoing Phase 1/2 clinical trials evaluating SB-318 and SB-913
Enrolled the first patient in the Phase 1/2 Thales Study evaluating ST-400 gene-edited cell therapy for the treatment of beta-thalassemia
Research

Delivered three oral and four poster presentations during the 21st Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) held in Chicago, IL from May 16-19, 2018
Second Quarter Ended June 30, 2018 Financial Results
For the second quarter ended June 30, 2018, Sangamo reported a consolidated net loss of $16.6 million, or $0.17 per share, compared to a net loss of $12.5 million, or $0.17 per share, for the same period in 2017. As of June 30, 2018, the Company had cash, cash equivalents, marketable securities and interest receivable of $574.2 million.

Revenues for the second quarter ended June 30, 2018 were $21.4 million, compared to $8.3 million for the same period in 2017. The increase in revenues was primarily related to the collaborations and licensing agreements with Pfizer, for hemophilia A, and Kite, a Gilead company, for gene-edited cell therapies for oncology. Second quarter 2018 revenues were primarily generated from Sangamo’s collaboration agreements with Kite, Pfizer and Bioverativ, a Sanofi company.

Total operating expenses for the second quarter ended June 30, 2018 were $40.6 million, compared to $21.0 million for the same period in 2017. Research and development expenses were $29.3 million for the second quarter ended June 30, 2018, compared to $15.0 million for the same period in 2017. The increase was primarily due to clinical and manufacturing expenses in support of current clinical studies and investment in dedicated manufacturing capacity. General and administrative expenses were $11.3 million for the second quarter ended June 30, 2018, compared to $6.0 million for the same period in 2017. The increase was primarily due to salaries and related costs and other professional fees in support of overall Company growth.

Financial Guidance for 2018
Sangamo will provide updated guidance on expected operating expenses in future quarterly reporting periods. The Company updates cash guidance as follows:

Cash and Investments: Sangamo expects a December 31, 2018 balance of cash, cash equivalents, marketable securities and interest receivable of at least $380 million. This anticipated cash balance is inclusive of research funding from existing collaborators and recent financings.
Conference Call
Sangamo will host a conference call today, August 8, 2018, at 5:00 p.m. ET, which will be open to the public. The call will also be webcast live and can be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations.

The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 7179826. For those unable to listen in at the designated time, a conference call replay will be available for one week following the conference call, from approximately 8:00 p.m. ET on August 8, 2018 to 11:59 p.m. ET on August 15, 2018. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 7179826.

On August 8, 2018 Stellar Biotechnologies, Inc. (Nasdaq: SBOT), a leading manufacturer of a key protein utilized in multiple immunotherapy development pipelines targeting Alzheimer’s, lupus and cancer, among other diseases, reported financial results for the three and nine months ended June 30, 2018 and provided an update on its business (Press release, Stellar Biotechnologies, AUG 8, 2018, View Source [SID1234528534]).

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During the third fiscal quarter, Stellar reported positive research results from viral clearance and glycosylation studies associated with its manufacturing scale-up initiatives. The company also completed equity financings and warrant exercises resulting in net cash proceeds of approximately $8.8 million.

Stellar’s President and Chief Executive Officer Frank R. Oakes said, "We are delivering on a number of initiatives. We achieved positive research results and a quality assurance milestone, advanced key operational programs designed to support our customers, and significantly strengthened our financial position. Additionally, with third-party clinical results now available, Stellar has the opportunity to support an anticipated pivotal Phase 3 clinical study of a KLH-conjugated vaccine candidate."

Stellar Chief Financial Officer Kathi Niffenegger said, "With a stronger balance sheet, which includes $11.2 million in working capital and no debt, we are well positioned to complete planned upgrades to our core aquaculture infrastructure, continue our optimization work, and advance our initiatives to develop additional market opportunities for our technology and products."

Financial Results

Three months ended June 30, 2018

Total revenues increased by $0.05 million to $0.07 million for the three months ended June 30, 2018 compared to $0.02 million for the same period last year due to an increase in product sales.

Total expenses decreased by $0.08 million to $1.23 million for the three months ended June 30, 2018 compared to $1.31 million for the same period last year:

Cost of sales and contract services decreased by $0.03 million to $0.05 million for the three months ended June 30, 2018 compared to $0.08 million for the same period last year. The decrease was primarily due to reduced expenses related to sales of KLH that was produced as a byproduct of the company’s research and development activities.
Research and development expenses decreased by $0.07 million to $0.47 million for the three months ended June 30, 2018 compared to $0.54 million for the same period last year. The decrease was primarily due to a reduction in KLH product inventory utilized for internal research and development activities.
General and administrative expenses increased by $0.02 million to $0.65 million for the three months ended June 30, 2018 compared to $0.64 million for the same period last year primarily due an increased noncash share-based compensation expenses, which were partially offset by reduced professional fees and travel expenses.
For the third quarter of fiscal year 2018, Stellar reported a net loss of $1.16 million, or $0.38 per basic share, compared to a net loss of $ 1.22 million, or $ 0.84 per basic share, for the third quarter of the prior year.

Nine months ended June 30, 2018

Total revenues decreased by $0.07 million to $0.16 million for the nine months ended June 30, 2018 compared to $0.23 million for the same period last year due to a decrease in product sales.

Total expenses decreased by $0.03 million to $4.05 million for the nine months ended June 30, 2018 compared to $4.08 million for the same period last year:

Cost of sales and contract services decreased by $0.12 million to $0.11 million for the nine months ended June 30, 2018 compared to $0.23 million for the same period last year primarily due to decreased product sales volume as well as reduced expenses related to sales of KLH that was produced as a byproduct of the company’s research and development activities.
Research and development expenses increased by $0.26 million to $1.59 million for the nine months ended June 30, 2018 compared to $1.33 million for the same period last year. The increase was primarily due to an increase in research and development activities intended to increase the scalability and throughput capacity of existing manufacturing systems, including engineering lots of KLH produced under the company’s optimization initiative.
General and administrative expenses decreased by $0.21 million to $2.10 million for the nine months ended June 30, 2018 compared to $2.31 million for the same period last year primarily due to reduced professional fees and travel expenses.
For the nine months ended June 30, 2018, Stellar reported a net loss of $3.91 million, or $1.93 per basic share, compared to a net loss of $3.81 million, or $2.63 per basic share, for the nine months ended June 30, 2017.

Working Capital

At June 30, 2018, the company had working capital of $11.2 million. Cash, cash equivalents and short-term investments totaled $11.3 million.

Stellar will file its Form 10-Q for the quarter ended June 30, 2018 with the Securities and Exchange Commission on or about August 8, 2018. To view the company’s filings with the Canadian Securities Administrators (CSA), visit the CSA’s SEDAR website.

On August 8, 2018 Apexigen, Inc., a clinical-stage biopharmaceutical company, reported the successful completion of its Series B and Series C financings in which it raised a total of $73 million (Press release, Apexigen, AUG 8, 2018, View Source [SID1234528533]).

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The $15 million Series B financing was led by Decheng Capital and the recent $58 million Series C financing was led by 3E Bioventures Capital, Virtus Inspire Ventures, and SV Tech Ventures. As a result of these financings, Apexigen’s Board of Directors was expanded to include Dan Zabrowski, Ph.D. of Decheng Capital, and Karen Liu, Ph.D. of 3E Bioventures Capital.

Apexigen intends to use these proceeds to advance the clinical development of its lead immuno-oncology (I-O) therapeutic APX005M, a monoclonal antibody targeting CD40. Currently, APX005M is in multiple Phase 2 clinical trials to treat different types of cancers. The proceeds will also be used to discover and develop Apexigen’s broader pipeline of therapies.

"Completing these financings puts Apexigen on a new trajectory for growth. We now have the resources to both execute our clinical development strategy for APX005M and accelerate building our pipeline of novel therapeutics based on our proprietary product discovery platform APXiMAB", said Xiaodong Yang, M.D., Ph.D., President and Chief Executive Officer of Apexigen. "For APX005M, we are conducting a robust clinical program with 8 ongoing clinical trials, as we believe CD40 activation by APX005M will become a key component in several new I-O therapeutic regimens for treating cancer patients. Looking ahead, we will use our powerful discovery research engine to accelerate generation of new I-O therapeutics."

About APX005M
APX005M is a novel, humanized monoclonal antibody that stimulates the anti-tumor immune response. APX005M targets CD40, a co-stimulatory receptor that is essential for activating both innate and adaptive immune systems. Binding of APX005M to CD40 on antigen presenting cells (i.e., dendritic cells, monocytes and B-cells) initiates a multi-faceted immune response bringing multiple components of the immune system (e.g., T cells, macrophages) to work in concert against cancer. APX005M is currently in Phase 2 clinical development for the treatment of cancers such as melanoma, non-small cell lung cancer, pancreatic cancer and renal cell carcinoma in various combinations with immunotherapy, chemotherapy or radiation therapy.

On August 8, 2018 Synthetic Biologics, Inc. (NYSE American: SYN), a late-stage clinical company developing therapeutics that preserve the microbiome to protect and restore the health of patients, reported financial results for the three months ended June 30, 2018 (Press release, Synthetic Biologics, AUG 8, 2018, View Source [SID1234528532]).

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"Following several productive meetings earlier this year, we are pleased to have reached preliminary agreement on key elements of our planned Phase 3 clinical trial for ribaxamase, our first-in-class therapeutic intervention designed to prevent the onset of primary C. difficile infection (CDI) by protecting the gut microbiome from antibiotic-mediated dysbiosis. We are in the process of optimizing a protocol synopsis for the Phase 3 clinical trial which we will discuss with the FDA at our end of Phase 2 meeting which is currently planned to take place towards the end of the third quarter," stated Steven A. Shallcross, Interim Chief Executive Officer and Chief Financial Officer.

"We will continue to work closely and collaboratively with the FDA to define a clear and achievable pathway toward gaining marketing approvals. In our ongoing interactions with FDA, what has become clear is their recognition of the unmet need for novel interventions to combat and prevent the proliferation of CDI. With more than 450,000 cases of CDI each year in the U.S., if approved, ribaxamase will be the first intervention specifically designed to prevent CDI associated with the most commonly used IV antibiotics," concluded Shallcross.

Clinical Development and Operational Update

Announced the Company reached preliminary agreement with the FDA on key elements of a proposed Phase 3 clinical program for SYN-004 (ribaxamase), which is expected to:
Comprise a global, event driven clinical trial with a fixed maximum number of patients for total enrollment,
Evaluate the potential efficacy and safety of ribaxamase in a broader patient population by the inclusion of additional IV β-lactam antibiotics in addition to ceftriaxone and by enrolling patients with a variety of underlying infections,
Evaluate the ability of ribaxamase to reduce the incidence of Clostridium difficile infection (CDI) in the ribaxamase treatment group compared to placebo as the primary efficacy endpoint,
Evaluate mortality risk as the co-primary safety endpoint which will be separate from the primary efficacy endpoint of reduction in the incidence of CDI,
Anticipate End-of-Phase 2 meeting with the FDA in 3Q 2018 to solidify the remaining elements of the planned SYN-004 (ribaxamase) Phase 3 clinical trial;
Plan to initiate SYN-004 (ribaxamase) Phase 3 clinical trial in 2H 2019;
Continue efforts to solidify clinical infrastructure, including exploring international regulatory and market access structures to support advancement of SYN-010, designed to treat an underlying cause of the symptoms associated with irritable bowel syndrome with constipation (IBS-C);
Reported supportive data from a second canine animal model demonstrating that when co-administered with oral amoxicillin and oral Augmentin, oral SYN-007 did not interfere with systemic absorption of the antibiotics but did diminish microbiome damage associated with these antibiotics in 2Q 2018.
Quarter Ended June 30, 2018 Financial Results

General and administrative expenses decreased by 13% to $1.4 million for the three months ended June 30, 2018, compared to $1.6 million for the same period in 2017. This decrease is primarily the result of lower salary expense, stock compensation, and related benefits costs incurred during the three months ended June 30, 2018 as compared to the three months ended June 30, 2017 due to the resignation of the Chief Executive Officer, along with the reduction of travel and consulting expense, offset by higher registration, investor relations and legal costs. The charge related to stock-based compensation expense was $264,000 for the three months ended June 30, 2018, compared to $539,000 for three months ended June 30, 2017.

Research and development expenses decreased by 25% to $3.6 million for the three months ended June 30, 2018, from $4.8 million for the three months ended June 30, 2017. This decrease is primarily the result of lower SYN-004 (ribaxamase) and SYN-010 program costs for 2018 since no clinical trials were ongoing during the quarter. The research and development costs incurred during the quarter were primarily related to planning for future Phase 3 (SYN-004) and Phase 2b/3 (SYN-010) clinical programs as we seek to secure the financial resources necessary for the completion of these clinical trials. The charge related to stock-based compensation expense was $293,000 for the three months ended June 30, 2018, compared to $331,000 for the same period in 2017.

Other income was $789,000 million for the three months ended June 30, 2018, compared to other income of $2.2 million for the same period in 2017. Other income for the three months ended June 30, 2018 is primarily comprised of non-cash income of $783,000 million from the change in fair value of warrants. The decrease in the fair value of the warrants was due to the decrease in our stock price from the prior quarter.

Cash and cash equivalents as of June 30, 2018 was $7.1 million, a decrease of $10.0 million from December 31, 2017.

Conference Call

Synthetic Biologics will hold a conference call today, Wednesday, August 8, 2018, at 4:30 p.m. (EDT). The dial-in information for the call is as follows, U.S. toll free: +1 888-347-5280 or International: +1 412-902-4280. Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at View Source." target="_blank" title="View Source." rel="nofollow">View Source An archive of the call will be available for replay at the same URL, View Source, for 90 days after the call.

On August 8, 2018 Clovis Oncology, Inc. (NASDAQ: CLVS) reported the randomization of the first patient in the Phase 3 ATHENA trial evaluating the combination of Clovis’ Rubraca(rucaparib), a poly (ADP ribose) polymerase inhibitor (PARP), and Bristol-Myers Squibb’s PD-1 inhibitor, OPDIVO (nivolumab), for the treatment of advanced ovarian cancer (Press release, Clovis Oncology, AUG 8, 2018, View Source [SID1234528526]). ATHENA, sponsored by Clovis, is part of a clinical collaboration with Bristol-Myers Squibb and is being conducted in association with the Gynecologic Oncology Group (GOG) and the European Network for Gynecological Oncological Trials (ENGOT). GOG and ENGOT are the two largest cooperative groups in the U.S. and Europe dedicated to the treatment of gynecological cancers.

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"I am pleased the GOG and ENGOT are conducting the first trial designed to investigate whether the combination of a PARP inhibitor and PD-1 blocking antibody can demonstrate not only an improvement in progression-free survival in the first-line maintenance setting for women with advanced ovarian cancer, but also whether the combination can change the natural course of the disease by delaying or reducing recurrence following front-line therapy," said Brad Monk, M.D., FACS, FACOG, Arizona Oncology (US Oncology Network), Professor, Gynecologic Oncology at University of Arizona and Creighton University, Medical Director of US Oncology Research Gynecology program in Phoenix, Arizona and Lead Investigator of the ATHENA trial.

"Rubraca combination trials such as ATHENA are encouraging to see, because the possible implications are particularly meaningful for women with advanced ovarian cancer, who need a wide range of treatment options," said Dr. Rebecca Kristeleit, Clinical Senior Lecturer and Consultant Medical Oncologist, University College London, U.K. and ATHENA ENGOT/Non-U.S. Lead Investigator. "The participation by the GOG and the ENGOT in the evaluation of a PARP inhibitor in combination with a PD-1 agent reflects the interest around this approach."

ATHENA is a Phase 3, randomized, multinational, double-blind, placebo-controlled, four-arm trial evaluating Rubraca and Opdivo as maintenance treatment following response to front-line treatment in newly-diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples. The primary endpoint is investigator assessed progression-free survival (PFS); secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), and safety.

"The initiation of the Phase 3 ATHENA trial is an important milestone for Clovis and a critical step towards helping women with advanced ovarian cancer, who are in need of new treatment options. We are particularly excited about the potential clinical utility of Rubraca in combination with Opdivo in this setting," said Patrick J. Mahaffy, President and Chief Executive Officer of Clovis Oncology. "The importance of this trial is also underscored by the participation of ENGOT and GOG, which we anticipate may facilitate enrollment."

The trial will enroll approximately 1,000 ovarian cancer patients at clinical trial centers in the United States and internationally. More information about the trial is available at www.clinicaltrials.gov, identifier NCT03522246.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian, metastatic castration-resistant prostate, and bladder cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for Rubraca. Rubraca is an unlicensed medical product outside of the U.S. and Europe.

Rubraca EU Authorized Use

Rubraca is licensed for adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy.

Click here to access the current Summary of Product Characteristics. Healthcare professionals should report any suspected adverse reactions via their national reporting systems.

Rubraca U.S. FDA Approved Indications and Important Safety Information

Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Rubraca is indicated as monotherapy for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.

Select Important Safety Information

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur uncommonly in patients treated with Rubraca, and are potentially fatal adverse reactions. In approximately 1,100 treated patients, MDS/AML occurred in 12 patients (1.1%), including those in long term follow-up. Of these, 5 occurred during treatment or during the 28-day safety follow-up (0.5%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 28 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents. Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1).

Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose (see Dosage and Administration (2.2) in full Prescribing Information) and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.

Based on its mechanism of action and findings from animal studies, Rubraca can cause fetal harm when administered to a pregnant woman. Apprise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca.

Most common adverse reactions in ARIEL3 (≥ 20%; Grade 1-4) were nausea (76%), fatigue/asthenia (73%), abdominal pain/distention (46%), rash (43%), dysgeusia (40%), anemia (39%), AST/ALT elevation (38%), constipation (37%), vomiting (37%), diarrhea (32%), thrombocytopenia (29%), nasopharyngitis/upper respiratory tract infection (29%), stomatitis (28%), decreased appetite (23%), and neutropenia (20%).

Most common laboratory abnormalities in ARIEL3 (≥ 25%; Grade 1-4) were increase in creatinine (98%), decrease in hemoglobin (88%), increase in cholesterol (84%), increase in alanine aminotransferase (ALT) (73%), increase in aspartate aminotransferase (AST) (61%), decrease in platelets (44%), decrease in leukocytes (44%), decrease in neutrophils (38%), increase in alkaline phosphatase (37%), and decrease in lymphocytes (29%).

Most common adverse reactions in Study 10 and ARIEL2 (≥ 20%; Grade 1-4) were nausea (77%), asthenia/fatigue (77%), vomiting (46%), anemia (44%), constipation (40%), dysgeusia (39%), decreased appetite (39%), diarrhea (34%), abdominal pain (32%), dyspnea (21%), and thrombocytopenia (21%).

Most common laboratory abnormalities in Study 10 and ARIEL2 (≥ 35%; Grade 1-4) were increase in creatinine (92%), increase in alanine aminotransferase (ALT) (74%), increase in aspartate aminotransferase (AST) (73%), decrease in hemoglobin (67%), decrease in lymphocytes (45%), increase in cholesterol (40%), decrease in platelets (39%), and decrease in absolute neutrophil count (35%).

Co-administration of Rubraca can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring. Because of the potential for serious adverse reactions in breast-fed children from Rubraca, advise lactating women not to breastfeed during treatment with Rubraca and for 2 weeks after the last dose. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Clovis Oncology, Inc. at 1-844-258-7662.