Leap Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Leap Therapeutics, 2017, NOV 13, 2017, View Source [SID1234522030]).

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On November 13, 2017 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported financial and clinical updates for the third quarter ended September 30, 2017 (Press release, Heat Biologics, NOV 13, 2017, View Source [SID1234521963]).

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"We had a very productive third quarter, as we achieved a number of important milestones," said Jeff Wolf, CEO of Heat. "We signed a critical manufacturing agreement to further advance our co-stimulatory programs, and we were also granted a Type C meeting with the FDA to review our Phase 2 clinical trial using our HS-110 for the treatment for non-small cell lung cancer."

Results for the third quarter of 2017 are summarized below.

Third Quarter 2017 Financial Highlights

Research and development expenses increased eight percent, to approximately $1.8 million, for the quarter ended September 30, 2017, compared to Q3 2016. The HS-110 program expense increased $0.4 million primarily due to Chemistry, Manufacturing and Control (CMC) activities, as well as continued patient enrollment for our HS-110 Phase 2, multi-arm trial for non-small cell lung cancer (NSCLC). R&D expenses related to the HS-410 Phase 2 trial decreased $0.4 million, as currently enrolled patients are now in long-term follow-up for recurrence-free survival. Additional R&D pre-clinical costs were associated with our Zika program, Pelican Therapeutics, Inc. ("Pelican") T-cell co-stimulatory programs, and laboratory supplies. Unallocated expenses included personnel-related expenses, professional and consulting fees, travel, and other costs. These costs increased approximately $0.1 million, primarily related to an increase in consultant fees and travel, offset by a decrease in personnel costs.

General and administrative expenses increased 45 percent, to $1.2 million, for the quarter ended September 30, 2017, compared to $0.8 million for the quarter ended September 30, 2016. The $0.4 million increase was primarily attributable to the increase in personnel costs as we establish Texas operations for our Pelican Therapeutics subsidiary.

Net loss attributable to Heat for the third quarter of 2017 was $2.3 million ($0.06) per basic and diluted share for the third quarter; compared to a net loss of $1.6 million, or ($0.08) per basic and diluted share for the quarter ended September 30, 2016.
Cash and cash equivalents totaled approximately $4.3 million, as of September 30, 2017. This amount does not include an additional $6.5 million of CPRIT funds received October 3, 2017.

Third Quarter 2017 Corporate Highlights

Heat’s subsidiary, Pelican Therapeutics, entered into a manufacturing agreement with KBI Biopharma, Inc. to advance its cancer-targeting immunotherapies. Under the agreement, KBI will offer comprehensive development and manufacturing services for cGMP production of Pelican’s PTX-35 antibody and PTX-15 fusion protein.

Heat was granted a Type C meeting with the FDA to discuss its registrational pathway and development plan for its NSCLC trial with HS-110 in combination with Bristol Myers-Squibb’s nivolumab (Opdivo).

Heat expanded its leadership team with two new hires: Lori McDermott, VP of Clinical Development; and Gary Vinson, VP of CMC.

On November 13, 2017 Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (Prometic) reported its unaudited financial results for the quarter and the nine month period ended September 30, 2017 (Press release, ProMetic Life Sciences, NOV 13, 2017, View Source [SID1234522008]).

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"Both our plasma-derived and small molecules lead clinical programs continue to progress as planned throughout advanced stages of the regulatory approval pathway. The PDUFA date has been set for plasminogen and PBI-4050 has been cleared to commence the pivotal phase 2/3 placebo controlled IPF clinical trial," said Pierre Laurin, President and Chief Executive Officer of Prometic. "Our focus is now centered on the completion of our commercial and marketing infrastructure in order to be ready to rapidly proceed with the launch of RyplazimTM, pending a positive final outcome of the regulatory approval process for our first plasma-derived drug".

"The third quarter 2017 financial results continue to be in line with our expectations, the previous quarters and guidance provided. The results demonstrate that the R&D and administration, selling and marketing expenses have stabilized at expected levels as we prepare to operate at a commercial scale," declared Mr. Bruce Pritchard, Prometic’s Chief Operating Officer and interim Chief Financial Officer. "As recently demonstrated, we will continue to put in place all the necessary elements to insure we can bridge the funding gap to value creation events and financial sustainability as efficiently as possible".

Third Quarter 2017 Therapeutic Highlights

Plasma-Derived Therapeutics:

Plasminogen:

The Corporation presented new long term clinical data from its pivotal Phase 2/3 trial of Ryplazim (Plasminogen IV) for the additional 36-week treatment period. The new data demonstrated no recurrence of lesions in the 10 patients treated with RyplazimTM for a total of 48 weeks. No safety or tolerability issues related to this longer-term dosing were observed.
The Corporation secured a Rare Pediatric Disease Designation by the FDA for RyplazimTM, a plasminogen replacement therapy for the treatment of patients with congenital plasminogen deficiency.
Small Molecule Therapeutics:

PBI-4050:

Idiopathic Pulmonary Fibrosis (IPF):

The Corporation received FDA acceptance of its PBI-4050 Investigational New Drug (IND) application to commence the pivotal Phase 2/3 clinical trial in patients suffering from IPF.
Alström Syndrome

The Corporation announced that longer-term data from its ongoing Phase 2 open labeclinical trial in subjects suffering from Alström Syndrome in the United Kingdom confirmed that the beneficial clinical effects previously observed are sustained during prolonged treatment.
Third Quarter 2017 Corporate and Operational Highlights

Corporate:

The Corporation executed definitive agreements in relation to the previously announced partnership with affiliates of Shenzhen Royal Asset Management Co., Ltd. (SRAM).
The Corporation closed the previously announced $53.1 million bought deal equity offering of common shares through a syndicate of underwriters led by Cantor Fitzgerald Canada Corporation as the lead underwriter and sole bookrunner. Pursuant to the offering, Prometic issued 31,250,000 common shares at a price of $1.70 per share for gross proceeds of $53,125,000.
Subsequent highlights to Third Quarter 2017:

The Corporation received confirmation from the FDA that its BLA for its plasminogen replacement therapy (RyplazimTM) had been accepted and granted priority review status with a Prescription Drug User Fee Act (PDUFA) action date for April 14, 2018;
The Corporation received priority review status for the New Drug Submission (NDS) the company plans to file with Health Canada for RyplazimTM for the treatment of patients with plasminogen deficiency;
The Corporation entered into a binding letter of intent to secure a USD $80 million (CAD $100 million) line of credit from Structured Alpha LP, an affiliate of Peter J. Thomson’s investment firm, Thomvest Asset Management Inc.
2017 Third Quarter Financial Results

The Corporation incurred a net loss of $17.8 million for the quarter ended September 30, 2017, compared to a net loss of $28.0 million for the quarter ended September 30, 2016. The Corporation incurred a net loss of $78.4 million during the nine months ended September 30, 2017 compared to $70.6 million during the nine months September 30, 2016. The decrease in net loss for the third quarter of 2017 as compared to the third quarter of 2016 was mainly attributable to the significantly higher revenues generated from milestone payments and licensing activities. The increase in net loss for the nine months ended September 30, 2017 as compared to the nine months ended September 30, 2016 is mainly attributable to the higher research and development ("R&D") and administrative, selling and marketing expenses related to the setting up of the extensive commercial and manufacturing infrastructure ahead of the planned commercialization Ryplazim.

Total revenues for the third quarter ended September 30, 2017 were $24.0 million compared to $3.7 million for the third quarter ended September 30, 2016. Revenues from the sale of goods amounted to $3.9 million for the third quarter ended September 30, 2017, compared to $2.4 million for the quarter ended September 30, 2016. Milestone payments and licensing revenues amounted to $19.7 million for the third quarter ended September 30, 2017 compared to nil for the third quarter of 2016. Total revenues for the nine months ended September 30, 2017 were $32.5 million compared to $12.3 million for the nine months ended September 30, 2016.

The Corporation incurred total R&D costs of $23.2 million for the quarter ended September 30, 2017 compared to $23.6 million for the third quarter of 2016. The Corporation incurred total R&D costs of $72.0 million during the nine months ended September 30, 2017 compared to $59.4 million during the nine months ended Jun 30, 2016. The overall R&D expense is primarily driven by the Plasma-derived therapeutics business, where the Corporation is operating as its own proprietary end-to-end source and supply, while the small molecule business is a much smaller contributor to the expense growth.

The plasma-derived therapeutics are produced by Prometic at its Laval plant and at the Winnipeg CMO while the small molecule therapeutics are manufactured by a third party for Prometic. The manufacturing cost of the therapeutics to be used in clinical trials and other R&D purposes represented approximately $22.9 million of the $72.0 million in R&D expenses reported during the nine months ended September 30, 2017 and $22.8 million of the $59.4 million in R&D expenses during the nine months ended September 30, 2016.

The increase in R&D expenses, excluding the manufacturing cost of therapeutics to be used in R&D activities discussed above (other R&D), as compared to the nine months of 2016 was primarily due to higher salary and benefit expenditures reflecting the increase in employees working on the clinical trials and at our research facilities. In addition, Contract Research Organizations ("CRO") and investigator expenses incurred in relation to the clinical trials and pre-clinical activities increased reflecting the increase in the number of trials in progress, the duration and higher patient enrolment of the trials.

Administrative, selling and marketing expenses amounted to $7.7 million during the third quarter of 2017, compared to $6.5 million for the quarter ended September 30, 2016. Administrative, selling and marketing expenses amounted to $22.7 million during the nine months ended September 30, 2017 compared to $16.5 million during the nine months ended September 30, 2016. The increase was mainly attributable to the higher salary and benefit expenses resulting from an increase in headcount mostly in marketing and commercial operations and overall salary increases.

Conference Call Information

Prometic will host a conference call at 11:00 am (ET) on Tuesday November 14, 2017. 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 from Tuesday November 14, 2017 at 2:00 pm until November 21, 2017. The numbers to access the replay are 1-416-849-0833 (passcode: 3866799) and 1-855-859-2056 (passcode: 3866799). A live audio webcast of the conference call, with slides, will be available through the following : View Source;s=1&k=99570B881A8129DE3DCA8DE3EBD93544

Additional Information in Respect to the Third Quarter 2017

Prometic’s MD&A and condensed interim consolidated financial statements for the quarter ended September 30, 2017 will be filed on SEDAR (View Source) and will be available on the Corporation’s website at www.prometic.com.

On November 13, 2017 Myovant Sciences (NYSE: MYOV), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for women’s health and endocrine diseases, reported corporate updates and financial results for the second fiscal quarter ended September 30, 2017 (Press release, Myovant Sciences, NOV 13, 2017, View Source [SID1234522028]).

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"We made significant clinical and corporate progress this quarter as we continue to build Myovant into a leading women’s health company. The positive results from Takeda’s two Phase 3 studies evaluating the efficacy and safety of relugolix for the treatment of uterine fibroids provide strong support for Myovant’s ongoing Phase 3 studies of relugolix for the treatment of heavy menstrual bleeding associated with uterine fibroids," stated Lynn Seely, M.D., President and Chief Executive Officer of Myovant Sciences. "In addition, we secured flexible financing commitments of up to $140 million, which puts us in a strong financial position to support the Phase 3 development of relugolix in uterine fibroids, endometriosis and advanced prostate cancer."

Recent Business Progress
Positive results in two Phase 3 clinical studies conducted by Takeda Pharmaceutical Company Limited ("Takeda") to evaluate the efficacy and safety of relugolix for the treatment of uterine fibroids.
•
On October 2, 2017, Myovant announced that Takeda reported positive top-line results from a Phase 3 study in Japan evaluating the efficacy and safety of relugolix compared with leuprorelin for the treatment of women with heavy menstrual bleeding associated with uterine fibroids. Relugolix met the study’s primary endpoint, achieving an 82.2% response rate, and was observed to be statistically non-inferior to leuprorelin (p = 0.0013) in meeting the study’s primary endpoint, the proportion of patients achieving a pre-defined reduction in menstrual bleeding. The incidence of adverse events in the study was generally similar between treatment groups and consistent with the mechanism of action of the study medications.
•
On November 9, 2017, Myovant announced that Takeda reported positive top-line results from a Phase 3 study in Japan evaluating the efficacy and safety of relugolix compared with placebo for the treatment of pain associated with uterine fibroids. Of the women treated with relugolix, 57.6% achieved a marked improvement in pain symptoms compared to 3.1% treated with placebo (p< 0.0001). Adverse events in the study were consistent with the mechanism of action of relugolix and adverse events observed in previous clinical studies.
•
Takeda plans to submit the data from both studies to regulatory authorities in Japan for marketing authorization of relugolix for the treatment of uterine fibroids. Myovant will be solely responsible for obtaining FDA approval for relugolix in the United States.
Secured flexible financing commitments of up to $140 million. On October 16, 2017, Myovant announced that it had secured up to $140 million in flexible financing commitments from NovaQuest Capital Management ("NovaQuest") and Hercules Capital, Inc. ("Hercules"). The NovaQuest financing is comprised of a note purchase commitment of up to $60 million and an equity purchase commitment of up to $40 million. An additional $40 million of debt financing capacity is committed in the form of a term loan facility from Hercules. Myovant plans to use the net proceeds from both financings to fund the ongoing Phase 3 development of relugolix in uterine fibroids, endometriosis and advanced prostate cancer. Pursuant to the agreements, upon closing, Myovant received net cash proceeds of approximately $32 million under the financing commitments.

Second Fiscal Quarter 2017 Financial Summary
Research and development (R&D) expenses for the quarter ended September 30, 2017 were $24.2 million, compared to $3.8 million for the comparable period in 2016. The increase over the prior year period is primarily due to costs associated with the five ongoing Phase 3 clinical trials of relugolix which were initiated in 2017. R&D expenses for the three months ended September 30, 2017 consisted primarily of clinical trial and clinical drug supply costs of $19.7 million, personnel expenses of $3.0 million, share-based compensation expense of $0.7 million, and costs billed to us under the services agreements with Roivant Sciences, Ltd. and Roivant Sciences, Inc. ("the Services Agreements") of $0.5 million, including personnel expenses and third-party costs associated with the preparation of our clinical and other research programs. R&D expenses were $3.8 million for the three months ended September 30, 2016, and consisted primarily of costs billed to us under the Services Agreements of $2.7 million, including personnel expenses and third-party costs associated with the preparation of our clinical and other research programs and share-based compensation expense.

General and administrative (G&A) expenses for the quarter ended September 30, 2017 were $6.1 million, compared to $3.0 million for the same period in 2016. G&A expenses for the three months ended September 30, 2017 consisted primarily of personnel-related and general overhead expenses of $2.3 million, share-based compensation expense of $2.1 million, legal and professional fees of $1.2 million and costs of $0.5 million billed to us under the Services Agreements, including personnel expenses, overhead allocations and third-party costs. G&A expenses were $3.0 million for the three months ended September 30, 2016, and consisted primarily of share-based compensation expense of $1.3 million, legal and professional fees of $1.0 million and costs of $0.3 million billed to us under the Services Agreements, including personnel expenses, overhead allocations and third-party costs.
Net loss for the quarter ended September 30, 2017 was $29.9 million, or $0.50 per share, compared to $34.7 million or $0.82 per share for the same period in 2016. The decrease in net loss was driven by the change in the fair market value of the previously outstanding Takeda warrant liability during the second quarter of 2016, which did not recur in the second quarter of 2017 due to its expiry on April 30, 2017. This was offset by an increase in costs associated with the ongoing LIBERTY 1 and LIBERTY 2, SPIRIT 1 and SPIRIT 2, and HERO Phase 3 clinical studies which were initiated in 2017 as well as increased personnel expenses to support Myovant’s growing operations.
Cash totaled $129.3 million on September 30, 2017.

About Relugolix
Relugolix is an oral, once-daily, small molecule gonadotropin-releasing hormone (GnRH) receptor antagonist that has been evaluated in over 1,600 study participants in Phase 1, Phase 2 and Phase 3 clinical trials. In these trials, relugolix has been shown to be generally well tolerated and to suppress estrogen and progesterone levels in women and testosterone levels in men. Common side effects are consistent with suppression of these hormones. In the ongoing Phase 3 SPIRIT clinical trials in women with endometriosis-associated pain and the ongoing Phase 3 LIBERTY clinical trials in women with heavy menstrual bleeding associated with uterine fibroids, relugolix will be evaluated with and without low-dose hormonal add-back therapy, the addition of which is expected to decrease potential side effects such as bone mineral density loss and hot flashes. The ongoing Phase 3 HERO study is evaluating relugolix in men with advanced prostate cancer.

On November 13, 2017 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration and fibrotic diseases, reported that positive results from a Phase 1 clinical trial of TRC102 (methoxyamine) and Fludara (fludarabine) in patients with advanced hematologic malignancies were published in the journal Oncotarget (Volume 8, Number 45, pages 79864-79875) (Press release, Tracon Pharmaceuticals, NOV 13, 2017, View Source;p=RssLanding&cat=news&id=2316621 [SID1234522013]).

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The Phase 1 trial enrolled a total of 20 patients, of whom 17 had measurable disease, with chronic lymphocytic leukemia (n=10), follicular lymphoma (n=3), diffuse large B cell lymphoma (n=3), plasma cell myeloma (n=2), mantle cell lymphoma (n=1), or anaplastic large cell lymphoma (n=1). Patients received one of five levels of TRC102 (15, 30, 60, 90, or 120 mg/m2) dosed intravenously on the initial day of recurring three week cycles in combination with Fludara dosed per label at 25 mg/m2 intravenously on days 1 through 5. Dose limiting toxicity was not observed. The most frequent toxicities were hematologic and were reversible when managed with supportive care. Four of the 17 patients (24%) experienced a partial response to treatment, and eight additional patients (8/17, 47%) had stable disease. The combination of TRC102 and Fludara produced evidence of tumor DNA damage that appeared to correlate with antitumor activity.

"We have now observed TRC102 to be well-tolerated in combination with three separate chemotherapeutics, Alimta, Temodar and Fludara, and we are encouraged by the responses seen to date," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We continue to make strong progress on the program and expect to report data from multiple National Cancer Institute-sponsored Phase 2 trials of TRC102 in 2018."

About TRC102

TRC102 (methoxyamine) is a novel, clinical-stage small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute or Case Comprehensive Cancer Center. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.