On August 14, 2018 Aradigm Corporation (NASDAQ: ARDM) (the "Company") reported financial results for the second quarter and six months ended June 30, 2018 (Press release, Aradigm, AUG 14, 2018, View Source [SID1234529247]).

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Second Quarter 2018 Financial Results

The Company recorded $256,000 in revenue in the second quarter of 2018 compared with $7.7 million in revenue in the second quarter of 2017. The Company recognized $96,000 in contract revenue – related party, $95,000 in government contract revenue and $65,000 in government grant revenue for the second quarter of 2018, as compared to $7.5 million in contract revenue – related party, $196,000 in government contract revenue and $7,000 in government grant revenue for the second quarter of 2017.

Total operating expenses for the second quarter of 2018 were $3.0 million, compared with total operating expenses of $5.7 million for the second quarter of 2017. The decrease in research and development expenses of $2.1 million was due to a decrease in spend in support of the Linhaliq regulatory process towards US and EU approvals for market authorization and lower employee-related expenses due to a reduction in headcount. The decrease in general and administrative expenses of $0.5 million was primarily related to lower legal expenses, lower expenses for Board of Director fees and lower employee-related expenses due to a reduction in headcount.

Net loss for the second quarter of 2018 was $3.8 million or $(0.25) per share, compared with a net income of $1.0 million or $0.07 per share in the second quarter of 2017. For the quarter ended June 30, 2018, the shift to a net loss from net income resulted primarily from a decrease in revenue of $7.4 million and a decrease in operating expenses of $2.7 million.

Liquidity and Capital Resources and Related Matters

As of June 30, 2018, the Company reported cash and cash equivalents of $2.1 million.

In January, Aradigm received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for Linhaliq as a treatment for non-cystic fibrosis bronchiectasis NCFBE patients with chronic lung infections with Pseudomonas aeruginosa (P. aeruginosa).

The CRL states that the FDA has determined that it cannot approve the NDA in its present form and provides specific reasons for this action along with recommendations needed for resubmission; the areas of concern include clinical data, human factor validation study and product quality. We remain confident in the efficacy, safety and quality of Linhaliq (now named Apulmiq for the FDA) and are formally interacting with the FDA to discuss the topics covered in the CRL with the goal of developing plans to move towards resubmission of the Linhaliq NDA as soon as possible. We are committed to continuing to work on obtaining regulatory approval of Linhaliq in the US for NCFBE patients who suffer from this very severe disease which carries a burden of high morbidity and mortality with no treatment options.

The Aradigm Board of Directors approved temporary measures on February 9, 2018 intended to preserve the Company’s cash resources.

During the quarter ended June 30, 2018 Aradigm raised $4.0 million through the issuance of bridge notes and obtained commitments for additional monthly funding through September of 2018 totaling approximately $3.0 million. This $3.0 million along with the cash balance of $2.1 million will be sufficient to fund operations through the third quarter of 2018.

Aradigm is pursuing potential alternatives to resolve our cash position in the short term as well as developing strategic options that would provide for our long term viability. We feel it is very important to bring Linhaliq to commercialization in as many countries as possible to allow patients suffering from (NCFBE) to receive the benefits of Linhaliq. Patients, patient advocacy groups and key opinion leaders have expressed support for regulatory approval of Linhaliq as we work towards this goal. The MAA was filed on March 8, 2018 followed by the EMA validation of the MAA. The EMA review of the MAA for Linhaliq will be according to standard timelines, with an opinion of the Committee for Medicinal Products for Human Use (CHMP) expected within 210 days from the formal procedural start date of March 29, 2018. The time needed by us to respond to EMA questions during the MAA review will trigger formal clock-stops of the procedure and may add several months to the nominal 210 day duration, until the final CHMP opinion will be issued.

About Non-Cystic Fibrosis Bronchiectasis

NCFBE is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. It is often a consequence of a vicious cycle of inflammation, recurrent lung infections, and bronchial wall damage. NCFBE represents an unmet medical need with high morbidity and mortality that affects more than 150,000 people in the US. and over 200,000 people in Europe. There is currently no drug approved for the treatment of this condition.

On August 14, 2018 Mateon Therapeutics, Inc. (OTCQB:MATN), a biopharmaceutical company developing investigational drugs for the treatment of orphan oncology indications, reported second quarter 2018 financial results (Press release, Mateon Therapeutics, AUG 14, 2018, View Source [SID1234528884]).

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For the three months ended June 30, 2018, Mateon reported a net loss of $0.6 million, compared to a net loss of $3.9 million reported for the three months ended June 30, 2017. R&D expenses decreased to $0.3 million for the second quarter of 2018 compared to $3.0 million for the same period in 2017, while general and administrative expenses decreased to $0.6 million for the second quarter of 2018 compared to $0.9 million for the same period in 2017. In the second quarter of 2018, Mateon reported non-operating income of $0.3 million. As of June 30, 2018, Mateon had cash and cash equivalents of $2.0 million.

"Following the closing of our financing transaction in April, we re-initiated enrollment into our study of OXi4503 for relapsed/refractory acute myeloid leukemia and myelodysplastic syndromes. We continue to enroll patients into the trial’s sixth cohort, and are approximately halfway to our current ten patient target," said William D. Schwieterman, M.D., Chief Executive Officer of Mateon Therapeutics. "We also are close to finalizing our regulatory submission for a new clinical phase 2a study in patients with advanced melanoma, where we will be using CA4P as an immuno-oncology agent in combination with Opdivo. We have shown in animal studies that the necrotic tumor cell death induced by CA4P strongly stimulates an anti-tumor immune response when used in combination with checkpoint inhibitors, and are hopeful it will do the same in patients with metastatic melanoma who have failed currently approved treatments."

On August 14, 2018 CymaBay Therapeutics, Inc. (Nasdaq: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported that management will participate in upcoming investor conferences, including the Wedbush PacGrow Healthcare Conference, the H.C. Wainwright 20th Annual Global Investment Conference, and the Citi’s 13th Annual Biotech Conference (Press release, CymaBay Therapeutics, AUG 14, 2018, View Source [SID1234528922]).

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Wedbush PacGrow Healthcare Conference
Date: Wednesday, August 15
Time: 2:30pm Eastern Time
Location: Parker New York, New York, NY
Webcast: View Source

H.C. Wainwright 20th Annual Global Investment Conference
Date: Wednesday, September 5
Time: 9:10am Eastern Time
Location: St. Regis Hotel, New York, NY
Webcast: View Source

Citi’s 13th Annual Biotech Conference
Date: Thursday, September 6
Time: 1-on-1 meetings only
Location: Four Seasons Hotel, Boston, MA

On August 14, 2018 Prometic Life Sciences Inc. (TSX: PLI, OTCQX: PFSCF) (Prometic or the Corporation) reported today its unaudited financial results for the second quarter ended June 30, 2018 (Press release, ProMetic Life Sciences, AUG 14, 2018, View Source [SID1234528885]).

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"During the second quarter, the corporation made significant progress advancing its corporate action plan that was introduced during the annual shareholders meeting in May 2018," said Pierre Laurin, President and Chief Executive Officer of Prometic. "Notably, Prometic submitted its plan to the FDA regarding the design and implementation of the required additional in-process controls and assays related to its RyplazimTM (plasminogen) Biologics License Application (BLA). The FDA’s feedback following a review meeting in September will be used to confirm the remaining work to be completed and the associated timelines. We remain committed and focused to gaining the FDA’s approval of RyplazimTM (plasminogen). We continue our PBI-4050 and RyplazimTM (plasminogen) discussions with interested parties in order to conclude partnerships that will provide us with greater financial and operational flexibility. Finally, we met with the FDA today to discuss the regulatory pathway for our anti-fibrotic drug candidate, PBI-4050, for the treatment of Alström syndrome, for which we recently received a Rare Pediatric Disease Designation."

Commenting on the second quarter 2018 financial results, Bruce Pritchard, Prometic’s Chief Operating Officer and Chief Financial Officer, said, "During the second quarter of 2018, we generated $14.0 million of cash from the sale of plasma inventory. We used $44.9 million to fund operations through the first half of the year and remain comfortable with the full-year operating cash usage guidance that we provided at the annual shareholders meeting in May. Also, as previously mentioned, we are actively pursuing multiple initiatives to strengthen our balance sheet and extend our cash runway through value-creating milestones. In the meantime, we will continue to carefully manage our resources and control our costs."

Corporate Highlights

Appointed Mr. Bruce Wendel as Chief Business Development Officer

Small Molecule Therapeutics Highlights

PBI-4050 – Presented new clinical data at the International Liver Congress 2018 suggesting positive clinical activity observed in Alström patients with signs of improved liver function and reduced fibrosis in fat tissues
PBI-4050 – Presented new clinical data at the American Thoracic Society 2018 conference suggesting positive clinical activity was observed on blood biomarkers known to have anti-fibrotic activity
PBI-4547 – Presented new pre-clinical data at the American Diabetes Association scientific sessions suggesting the potential activity of PBI-4547 offers the potential to successfully address significant unmet medical needs in liver fibrosis, nonalcoholic steatohepatitis, nonalcoholic fatty liver disease, obesity and diabetes

Plasma-Derived Therapeutics Highlights

RyplazimTM (Plasminogen) – Submitted plan to FDA regarding the list of items outlined by the FDA, the design and implementation of required additional in-process controls and assays related to the Company’s RyplazimTM (plasminogen) BLA
IVIG – Achieved clinical primary and secondary endpoints in a pivotal phase 3 trial that also demonstrated safety and efficacy data comparable to existing commercial IVIG products, with no significant drug related safety issues.

2018 Second Quarter Financial Results

Revenues

Total revenues for the second quarter ended June 30, 2018 were $20.2 million compared to $3.6 million for the second quarter ended June 30, 2017. Total revenues for the six months ended June 30, 2018 were $24.4 million compared to $8.5 million for the comparable period in 2017. The increase was largely driven by $14.0 million from the sale of plasma inventory in the second quarter ended June 30, 2018. Due to the change in the production forecast resulting from the delay of the Ryplazim (plasminogen) BLA approval, the Corporation opted to sell this inventory and utilize the cash proceeds in its operations. Third party revenues from the sale of bioseparation products totaled $5.7 million for the second quarter ended June 30, 2018, compared to $2.9 million for the quarter ended June 30, 2017. Third party revenues from the sale of bioseparation products amounted to $9.4 million for the six months ended June 30, 2018, compared to $7.0 million for the six months ended June 30, 2017.

Cost of sales and other production expenses

Cost of sales and other production expenses were $16.4 million for the second quarter ended June 30, 2018 compared to $1.6 million for the corresponding period in 2017, representing an increase of $14.9 million. Cost of sales and other production expenses were $21.2 million during the six months ended June 30, 2018 compared to $3.9 million for the corresponding period in 2017, representing an increase of $17.2 million. The increase was due primarily to the cost of the plasma inventory sold of $15.5 million.

Research and Development (R&D)

Total R&D expenses were $24.0 million for the second quarter ended June 30, 2018 compared to $24.5 million for the second quarter ended June 30, 2017. Total R&D expenses were $46.4 million for the six months ended June 30, 2018 compared to $48.9 million for the corresponding period in 2017, representing a decrease of $2.5 million.

Administration, Sales & Marketing

Administration, selling and marketing expenses were $6.9 million for the second quarter ended June 30, 2018 compared to $8.1 million for the second quarter ended June 30, 2017. The $1.1 million decrease was due to a reduction in consulting fees and employee compensation expenses. Administration, selling and marketing expenses declined slightly to $14.6 million during the six months ended June 30, 2018 compared to $15.0 million for the corresponding period in 2017.

Finance Costs

Finance costs were $5.3 million for the second quarter ended June 30, 2018 compared to $1.9 million during the corresponding period of 2017, representing an increase of $3.5 million. Finance costs were $9.6 million for the six months ended June 30, 2018 compared to $3.2 million during the corresponding period of 2017, representing an increase of $6.3 million. This increase reflects higher debt levels during the six months ended June 30, 2018 compared to the same period of 2017 and the higher cost of borrowing on the non-revolving credit facility.

Net Loss

Prometic incurred a net loss of $33.1 million for the second quarter ended June 30, 2018 compared to a net loss of $31.5 million for the second quarter ended June 30, 2017. Prometic incurred a net loss of $67.7 million for the six months ended June 30, 2018 compared to a net loss of $60.6 million for the corresponding period of 2017. The net loss for the first six months of 2018 includes financing costs of $9.6 million as well as the write-down of $1.5 million of inventory. This increase in net loss was partially offset by a $2.5 million decrease in R&D during the first six months of 2018 as compared to the corresponding period in 2017.

Conference Call Information

Prometic will host a conference call at 11:00 am (ET) on Wednesday August 15, 2018. The telephone numbers to access the conference call are (647) 427-7450 and 1-888-231-8191 (toll-free). A replay of the call will be available as of Wednesday August 15, 2018 at 2:00 pm. The numbers to access the replay are 1-416-849-0833 and 1-855-859-2056 (passcode: 9986217). A live audio webcast of the conference call, with slides, will be available through the following: View Source

Additional Information in Respect to the Second Quarter Ended June 30, 2018

Prometic’s MD&A and condensed interim consolidated financial statements for the quarter ended June 30, 2018 will be filed on SEDAR (View Source) and will be available on the Company’s website at www.prometic.com.

On August 14, 2018 Sesen Bio, Inc. (NASDAQ: SESN), a late-stage clinical company developing next-generation antibody-drug conjugate (ADC) therapies for the treatment of cancer, reported pipeline updates and operating results for the second quarter ended June 30, 2018 (Press release, Eleven Biotherapeutics, AUG 14, 2018, View Source [SID1234528923]).

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"The first half of 2018 was full of successful milestones for Sesen Bio, and I am excited to have joined the company at such an important time in its evolution," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio, who was recently appointed on August 7, 2018. "The three-month data from the Phase 3 VISTA Trial demonstrate a strong complete response rate and favorable safety with Vicinium for high-grade non-muscle invasive bladder cancer, and we look forward to assessing twelve-month efficacy data in less than a year’s time. Now, with Fast Track designation for Vicinium, we are focused on advancing our engagement with the FDA, kicking off critical manufacturing readiness activities, initiating pre-commercial efforts and preparing for our very first BLA submission for Vicinium for this highly deserving patient population. I am very confident in what the future holds for Sesen Bio and look forward to delivering on the important milestones we have ahead."

Business Update

In June 2018, Sesen Bio completed an underwritten public offering of its common stock raising gross proceeds of approximately $46 million. The company believes this financing extends the company’s cash runway into 2020 based on its current operating plan.
Vicinium Program Updates

In August 2018, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to Vicinium for the treatment of BCG-unresponsive, high-grade non-muscle invasive bladder cancer (NMIBC). Fast Track designation is intended to expedite the development and review process of therapeutics that address unmet medical needs, including opportunities for more frequent interactions with the FDA.
In June 2018, the National Cancer Institute (NCI) initiated patient dosing in the Phase 1 trial of Vicinium in combination with AstraZeneca’s PD-L1 checkpoint inhibitor, Imfinzi (durvalumab). The NCI is evaluating the combination under a Cooperative Research and Development Agreement, which was executed in June 2017.
In May 2018, Sesen Bio presented positive, three-month data from its ongoing Phase 3 VISTA Trial of Vicinium for the treatment of patients with high-grade NMIBC who have been previously treated with bacillus Calmette-Guérin (BCG), during a plenary session at the American Urological Association Annual Meeting.
In the cohort of patients with carcinoma in situ (CIS) with or without papillary disease whose cancer recurred within six months of their last course of BCG treatment, treatment with Vicinium demonstrated a complete response rate of 39 percent. In evaluable patients in the cohort of patients with CIS with or without papillary disease whose cancer recurred after six months, but before 11 months, after their last course of BCG treatment, treatment with Vicinium demonstrated a complete response rate of 80 percent. This translates into a 42 percent complete response rate for the combined cohorts of CIS patients who were BCG-unresponsive within 12 months of their last BCG treatment.
In patients with papillary disease without CIS whose cancer recurred within six months of their last course of BCG treatment, treatment with Vicinium demonstrated a 68 percent recurrence-free rate at three months.
To date, Vicinium has been well-tolerated by patients in the VISTA Trial. Sesen Bio anticipates reporting twelve-month data from its Phase 3 VISTA Trial in mid-2019.
Second Quarter 2018 Financial Results

Cash Position: Cash and cash equivalents were $62.9 million as of June 30, 2018, compared to $15.8 for the same period in 2017.
R&D Expenses: Research and development expenses were $2.8 million for the quarter ended June 30, 2018, compared to $2.9 million for the same period in 2017. This decrease was due primarily to a reduction in Vicinium-related development expenses.
G&A Expenses: General and administrative expenses were $2.4 million for the quarter ended June 30, 2018, compared to $2.2 million for the same period in 2017. This increase was due primarily to an increase in professional fees.
Net Loss: Net loss was $9.0 million, or $0.16 per share, for the quarter ended June 30, 2018, compared to net loss of $7.3 million, or $0.30 per share, for the same period in 2017.
Financial Guidance: Following the company’s public offering in June 2018, Sesen Bio believes it will have capital sufficient to fund its current operating plans into 2020.
About the VISTA Clinical Trial
The VISTA Trial is an open-label, multicenter, single-arm Phase 3 clinical trial evaluating the efficacy and tolerability of Vicinium in patients with high-grade non-muscle invasive bladder cancer (NMIBC) that is carcinoma in situ (CIS), which is cancer found on the inner lining of the bladder that has not spread into muscle or other tissue) and/or papillary, which is cancer that has grown from the bladder lining out into the bladder but has not spread into muscle or other tissue, who have been previously treated with bacillus Calmette-Guérin (BCG). The primary endpoint of the trial is the complete response rate in patients with CIS with or without papillary disease. Patients in the trial receive locally administered Vicinium twice a week for six weeks, followed by once-weekly treatment for another six weeks, then treatment every other week for up to two years. Twelve-month data are anticipated in mid-2019. To learn more about the Phase 3 VISTA Trial, please visit www.clinicaltrials.gov and search the identifier NCT02449239.

About Vicinium
Vicinium, also known as VB4-845, is Sesen Bio’s lead product candidate and is a next-generation antibody-drug conjugate (ADC), developed using the company’s proprietary Targeted Protein Therapeutics platform, for the treatment of high-grade non-muscle invasive bladder cancer (NMIBC). Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A (ETA). Vicinium is constructed with a stable, genetically engineered peptide linker to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA Trial, designed to support the registration of Vicinium for the treatment of high-grade NMIBC in patients who have previously received two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Twelve-month data from the trial are anticipated in mid-2019. Additionally, Sesen Bio believes that Vicinium’s cancer cell-killing properties promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.