On November 14, 2017 Molecular Templates, Inc. (Nasdaq:MTEM), a clinical-stage oncology company focused on the discovery and development of the company’s proprietary engineered toxin bodies (ETBs), which are differentiated, targeted, biologic therapeutics for cancer, reported financial results for the third quarter of 2017 (Press release, Molecular Templates, NOV 14, 2017, View Source [SID1234522067]). As of September 30, 2017, cash and cash equivalents totaled $68.2 million.

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"The completion of our merger with Threshold Pharmaceuticals as well as the $60M in financings in the third quarter mark a significant milestone for Molecular Templates," said Molecular Templates’ Chief Executive Officer and Chief Scientific Officer, Eric Poma, Ph.D. "The merger and financings put us in a strong position to continue to execute on the development of our lead program, MT-3724, in aggressive lymphomas as well as make strides toward the clinic in 2018 with our next generation of ETBs currently in preclinical development. Additionally, we are excited about our ongoing research collaboration with Takeda Pharmaceuticals as we look to expand the application of our ETB technology."

Company Highlights and Upcoming Milestones

Corporate
On August 1, 2017, we successfully completed the reverse merger with Threshold Pharmaceuticals, Inc. (previously Nasdaq ticker: THLD) and concurrently changed the Company’s name to Molecular Templates, Inc. (new Nasdaq ticker: MTEM).

On August 1, 2017, we closed an equity financing for $40 million; as well as a private placement of $20 million to Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Ltd.

MT-3724
On October 24, 2017, we announced the identification of the maximum tolerated dose (MTD) for MT-3724 and the initiation of and first patient dosed in an expansion cohort, as part of the second portion of the ongoing Phase I study focused on relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patients. The expansion cohort is expected to better define the overall response rate to MT-3724 in heavily pre-treated DLBCL patients. Initial results of this expansion cohort are expected to be announced in 1H18.

Molecular anticipates initiating a Phase II monotherapy study in relapsed and refractory DLBCL patients in 2018.
Takeda Collaboration

Expanded Takeda collaboration in June 2017 with Multi-Target Research and Licensing Collaboration Agreement to develop next-generation oncology therapies, including stock purchase.

MT-4019
Continued development of MT-4019, an ETB candidate that is designed to target CD38-expressing myeloma cancer cells.

Plan to submit an IND application to the FDA in mid-2018 to initiate a Phase I clinical trial in the United States.
Research

Several other ETB candidates in pre-clinical development targeting both solid and hematological cancers where the differentiated mechanism of action innate to ETBs, ribosome inactivation, could play a significant role in treating cancer.

Financial Results
The net loss attributable to common shareholders for the third quarter was $(11.1) million, or $(0.62) per basic and diluted share. This is compared to a net loss attributable to common shareholders for the same period in 2016, of $(3.6) million, or $(11.89) per basic and diluted share. As of September 30, 2017, cash and cash equivalents totaled $68.2 million, which includes $11.2 million received from the merger with Threshold Pharmaceuticals in August 2017 and the receipt of $60 million for two financings that closed on the same day.
Revenues for the third quarter of 2017 were $0.6 million, compared to no revenues during the same period in 2016. Revenues for the third quarter of 2017 related to research and development revenues from our collaboration with Takeda.

Total research and development (R&D) expenses for the third quarter of 2017 were $2.5 million, compared with $2.3 million for the same period in 2016. The $0.2 million increase in R&D expenses in the third quarter of 2017, compared with the same period in 2016, was primarily due to severance benefits related to the merger with Threshold.

Total general and administrative (G&A) expenses for the third quarter of 2017 were $4.0 million, compared with $0.8 million for the same period in 2016. The $3.2 million increase in G&A expenses in the third quarter of 2017, compared with the same period in 2016, was primarily due to costs associated with the Merger and being a publicly traded company.

Revenues for the nine months ended September 30, 2017 were $2.6 million, compared to $1.5 million for the same period in 2016. Revenues for the nine months ended September 30, 2017 were primarily comprised of research and development revenues from our collaboration with Takeda. Revenues for the same period in 2016 comprised of grant revenue from the Cancer Prevention & Research Institute of Texas ("CPRIT").

Total R&D expenses for the nine months ended September 30, 2017 were $4.8 million, compared to $7.2 million for the same period in 2016. The $2.4 million decrease in R&D expenses for the nine months ended September 30, 2017, compared the same period in 2016, was primarily due to decreased spending for outsourced preclinical costs.
Total G&A expenses for the nine months ended September 30, 2017 were $8.2 million, compared to $2.6 million for the same period in 2016. The $5.6 million increase in G&A spending for the nine months ended September 30, 2017, compared to the same period in 2016, was primarily due to costs associated with the Merger and being a publicly traded company.

The net loss attributable to common shareholders for the nine months ended September 30, 2017 was $(17.2) million, or $(2.75) per basic and diluted share, compared to a net loss attributable to common shareholders of $(9.6) million or $(32.01) per basic and diluted share, for the same period in 2016.

On November 14, 2017 Ligand Presents Analyst Day Presentation (Presentation, Ligand, NOV 14, 2017, View Source [SID1234522066]).

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On November 14, 2017 GTx, Inc. (Nasdaq:GTXI) reported financial results for the third quarter of 2017 and highlighted recent accomplishments and upcoming milestones (Press release, GTx, NOV 14, 2017, View Source;p=RssLanding&cat=news&id=2316925 [SID1234522065]).

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"During the quarter, we achieved a key milestone for the company when we reported positive results from our first clinical trial in stress urinary incontinence," said Robert J. Wills, Ph.D., Executive Chairman of GTx. "Remarkably, 18 out of 18 women who received enobosarm for 12 weeks responded. These responses also appear to be durable, lasting months after dosing. These exciting results provided the basis for our recently initiated, placebo-controlled clinical trial of enobosarm for the treatment of SUI."

"Recent data suggests 50 percent of women report SUI, for which there are no FDA-approved pharmaceutical therapies. An orally-available therapy would offer numerous advantages over existing treatments including surgery, and would provide a significant new option that many women would choose in order to address this medical condition," said Kenneth M. Peters, M.D., Chairman of Urology, Oakland University William Beaumont School of Medicine and the principal investigator in the trial.

Third Quarter 2017 Clinical Highlights and Anticipated Milestones

Stress Urinary Incontinence (SUI):

Enobosarm, a Selective Androgen Receptor Modulator (SARM), is being evaluated in Phase 2 clinical development for SUI, the Company’s lead indication. Recent important milestones are summarized as follows:

Reported positive results from the Phase 2 proof-of-concept (POC) clinical trial of enobosarm 3 mg administered orally in post-menopausal women with SUI. With the inclusion of the final patient completing treatment in the POC clinical trial, data from the 18 evaluable patients completing the required 12 weeks of daily treatment showed a clinically meaningful reduction (50 percent or greater) in stress leaks per day, compared to baseline. The mean decrease in stress leaks per day was 81 percent overall (5.17 mean leaks/day at baseline to 1.0 mean leaks/day at 12 weeks).
Patients are being followed for an additional 28 weeks post-treatment to assess the durability of treatment effect. Durability of response for patients who completed the 28-week observation phase has resulted in a 41 to 100 percent reduction in stress leaks/day from baseline (N=6). For those patients who have not completed the 28-week observation phase, the durability of response, measured beginning 4 weeks post dosing, continues to be sustained.
Highlighted the Phase 2 POC results at the International Continence Society (ICS) annual meeting in a poster entitled, "Kegels in a Bottle: Preliminary Results of a Selective Androgen Receptor Modulator (GTx-024) for the Treatment of Stress Urinary Incontinence in Post-Menopausal Women", which subsequently was voted best poster for the conference.

Initiated a second clinical trial, Assessing Enobosarm for Stress Urinary Incontinence Disorder (ASTRID): a randomized, double-blinded, placebo-controlled, Phase 2 trial to assess the efficacy and safety of two doses of enobosarm (1 mg and 3 mg) administered orally in post-menopausal woman with SUI compared to placebo. The primary endpoint of the trial is the percentage of patients with at least a 50 percent reduction in mean leaks/day, compared to baseline. This trial is expected to enroll approximately 400 patients across 70 clinical sites in the U.S. Top-line results are expected to be available by the end of 2018.
Breast Cancer:

Enobosarm is also being evaluated as a hormonal therapy for women with estrogen receptor positive (ER+) and androgen receptor positive (AR+) breast cancer in a Phase 2 clinical trial for this advanced breast cancer population. As reported earlier for the 9 mg cohort, the Phase 2 trial pre-specified threshold for success, clinical benefit response (CBR), was attained and therefore met the primary efficacy endpoint. In addition, the 18 mg cohort has also met the primary efficacy endpoint. The trial has now completed enrollment of the predefined number of evaluable patients in both dosage arms with at least 44 patients in each of two cohorts receiving 9 mg or 18 mg daily doses of enobosarm.

In the 9 mg cohort, following 24 weeks of treatment, a total of 14 patients achieved a CBR out of 49 evaluable patients confirmed as AR positive (28.6%), with two patients achieving a partial response and 12 reporting stable disease. Currently, four patients in this cohort remain on study. In the 18 mg cohort, with 48 evaluable patients, 12 patients achieved a CBR (25%) at 24 weeks with one patient demonstrating a partial response and 11 patients reporting stable disease. Three patients remain on study in the 18 mg cohort. Both doses of enobosarm appear to be safe and generally well tolerated. A complete summary of the study results will be submitted for presentation or publication in 2018.

Although both the 9 mg and 18 mg cohorts met the primary efficacy endpoint in the Phase 2 clinical trial, after evaluating the drug development environment for breast cancer, where treatment paradigms are shifting to immunotherapies and/or combination therapies, the Company has decided that the time and cost of conducting the necessary clinical trials for approval in this indication do not warrant further development of enobosarm in this indication at this time.

Duchenne Muscular Dystrophy (DMD):

SARMs have also been evaluated in preclinical models of DMD, in which GTx SARMs have increased lean muscle mass and physical function. The Company is pursuing a potential strategic collaboration with biopharma companies experienced in orphan drug development to continue the development of a SARM for the treatment of DMD.

Prostate Cancer:

The Company has a Selective Androgen Receptor Degrader (SARD) preclinical program to evaluate its novel SARD technology in castration-resistant prostate cancer (CRPC). The Company has ongoing mechanistic preclinical studies designed to select the most appropriate compound to advance into a first-in-human clinical trial.

Third Quarter 2017 Corporate Highlights and Financial Results

During the quarter, GTx raised net proceeds of $45.6 million in a private placement of its common stock and warrants to purchase its common stock. GTx sold 5,483,320 immediately separable units, comprised of an aggregate of 5,483,320 newly-issued shares of common stock and warrants to purchase up to 3,289,988 additional shares of common stock. Both the common stock and warrants have been registered for resale with the Securities and Exchange Commission.

As of September 30, 2017, cash and short-term investments were $53.6 million compared to $21.9 million at December 31, 2016.

Research and development expenses for the quarter ended September 30, 2017 were $5.9 million compared to $4.6 million for the same period of 2016.

General and administrative expenses for the quarter ended September 30, 2017 were $2.6 million compared to $2.3 million for the same period of 2016.

Net loss for the three months ended September 30, 2017 was $8.5 million compared to a net loss of $6.9 million for the same period in 2016.

Net loss for the nine months ended September 30, 2017 was $21.2 million compared to a net loss of $10.9 million for the same period in 2016. The nine months ended September 30, 2016 included a non-cash gain of $8.2 million due to the change in fair value of the Company’s warrant liability. During the first quarter of 2016, the Company modified its outstanding warrants with no further adjustment to the fair value of these warrants being required.
GTx had approximately 21.5 million shares of common stock outstanding as of September 30, 2017. Additionally, there are warrants outstanding to purchase approximately 6.4 million shares of GTx common stock at an exercise price of $8.50 per share and approximately 3.3 million shares of GTx common stock at an exercise price of $9.02.

On November 14, 2017 Genmab A/S (Nasdaq Copenhagen: GEN) reported that the first commercial sale of DARZALEX (daratumumab) in Japan has taken place, triggering USD 25 million in milestone payments from Janssen Biotech, Inc. (Janssen). The milestone was mentioned at the time of the September 2017 announcement of the approval of DARZALEX for the treatment of adults with relapsed or refractory multiple myeloma in Japan (Press release, Genmab, NOV 14, 2017, View Source [SID1234522064]). As a result of this milestone, Genmab is updating its 2017 financial guidance.

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"We’re pleased that DARZALEX is now commercially available for patients with relapsed or refractory multiple myeloma who are living in Japan," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

OUTLOOK
MDKK Revised Guidance Previous Guidance
Revenue 2,110 — 2,310 1,950 — 2,150
Operating expenses (1,000) — 1,100) (1,000) — (1,100)
Operating income 1,060 — 1,260 900 — 1,100
Cash position at end of year* >4,900 >4,500
*Cash, cash equivalents, and marketable securities

Genmab is improving its 2017 financial guidance last published on November 8, 2017 due to the inclusion of the DARZALEX milestones totaling USD 25 million associated with first commercial sale of DARZALEX in Japan.

Operating Result
We expect our 2017 revenue to be in the range of DKK 2,110 — 2,310 million, an increase of DKK 160 million compared to the previous guidance. We have increased our projected daratumumab milestones to DKK 960 million (previously DKK 800 million) due to inclusion of USD 25 million in milestone payments triggered by the first commercial sale of DARZALEX in Japan. We expect DARZALEX royalties to remain in the range of DKK 930 — 1,100 million, which are based on an estimated USD 1,100 — 1,300 million of DARZALEX sales in 2017. The remainder of the revenue mainly consists of Arzerra royalties, DuoBody milestones, and non-cash amortization of deferred revenue.
We anticipate that our 2017 operating expenses will remain in the range of DKK 1,000 —1,100 million.
As a result of the increased revenue, we now expect the operating income for 2017 to be approximately DKK 1,060 — 1,260 million, compared to DKK 900 — 1,100 million in the previous guidance.

Cash Position
As a result of the above and proceeds from the exercise of warrants during the year, we are now projecting a cash position at the end of 2017 of greater than DKK 4,900 million.

Outlook: Risks and Assumptions
In addition to factors already mentioned, the estimates above are subject to change due to numerous reasons, including but not limited to the achievement of certain milestones associated with our collaboration agreements; the timing and variation of development activities (including activities carried out by our collaboration partners) and related income and costs; DARZALEX and Arzerra sales and corresponding royalties to Genmab; fluctuations in the value of our marketable securities; and currency exchange rates. The financial guidance does not include any potential proceeds from future warrant exercises and also assumes that no significant agreements are entered into during 2017 that could materially affect the results.

On November 14, 2017 ERYTECH Pharma (Nasdaq and Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that Gil Beyen, Chairman and Chief Executive Officer, will present at the Jefferies Global Healthcare on November 15th, 2017 at the Waldorf Hilton Hotel (Aldwych) in London, UK (Press release, ERYtech Pharma, NOV 14, 2017, View Source;p=RssLanding&cat=news&id=2316895 [SID1234522063]).

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Conference Details:

Conference: Jefferies Global Healthcare Conference
Date: November 15, 2017
Presentation Time: 2:00 PM GMT/ 9:00 AM ET

A live webcast of the Jefferies Global Healthcare presentation will be available online from the investor relations page of the company’s corporate website at www.erytech.com/webcast.com. After the live webcast, an archive of the presentation will be available on the company website for 30 days.