On November 6, 2018 Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) reported its third quarter 2018 financial results and described upcoming clinical events (Press release, Synta Pharmaceuticals, NOV 6, 2018, View Source [SID1234530859]):

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"Madrigal made important progress thus far in 2018 to advance the development of MGL-3196, through successful completion of Phase 2 studies in NASH and dyslipidemia. We expect to begin a Phase 3 study in NASH in late 2018 or early 2019, subject to regulatory approval. We are evaluating the trial design and objectives of a Phase 3 study in dyslipidemia which could begin in 2019," stated Paul Friedman, M.D., Chief Executive Officer of Madrigal. "We are adding appropriate personnel resources as necessary to handle these development activities, and we believe we have significant financial resources to fund our currently planned Phase 3 programs.

Becky Taub, M.D., CMO and Executive VP, Research & Development of Madrigal added, "We are looking forward to presenting our Phase 2 NASH clinical data in a presidential plenary session on November 12, 2018, at The Liver Meeting 2018 at AASLD. We continue to believe in the potential of MGL-3196 to resolve NASH and improve multiple atherogenic lipids, and we are eager to move ahead with our Phase 3 clinical programs.

Financial Results for the Three Months and Nine Months Ended September 30, 2018

As of September 30, 2018, Madrigal had cash, cash equivalents and marketable securities of $488.5 million, compared to $191.5 million at December 31, 2017. The increase in cash and marketable securities resulted primarily from the net proceeds of $311.8 million from Madrigal’s public offering of common stock in June 2018, partially offset by cash used in operations of $19.2 million.

Operating expenses were $11.3 million and $26.2 million, respectively, for the three month and nine month periods ended September 30, 2018, compared to $8.6 million and $23.2 million in the comparable prior year periods.

Research and development expenses for the three month and nine month periods ended September 30, 2018 were $6.2 million and $16.5 million, respectively, compared to $6.7 million and $17.9 million in the comparable prior year periods. The decreases are primarily attributable to completion of treatment in our Phase 2 clinical studies in 2018.

General and administrative expenses for the three month and nine month periods ended September 30, 2018 were $5.1 million and $9.7 million, respectively, compared to $2.0 million and $5.3 million in the comparable prior year periods. The increases are due primarily to higher non-cash stock compensation expense from stock option awards.

Interest income for the three month and nine month periods ended September 30, 2018 was $2.8 million and $4.7 million, respectively, as compared to $174 thousand and $342 thousand in the comparable prior year periods. The change in interest income was due primarily to a higher average principal balance in our investment account in 2018, and increased interest rates.

Clinical Program Summaries for MGL-3196

NASH

Non-alcoholic Steatohepatitis (NASH) is a common liver disease in the United States and worldwide, unrelated to alcohol use, that is characterized by a build-up of fat in the liver, inflammation, damage (ballooning) of hepatocytes and increasing fibrosis. Although people with NASH may feel well and often do not know they have the disease, NASH can lead to permanent damage, including cirrhosis and impaired liver function in a high percentage of patients.

In October 2016, the first patient was treated in the ongoing Phase 2 trial of MGL-3196 for the treatment of NASH. The randomized, double-blind, placebo-controlled, multi-center Phase 2 study enrolled 125 patients 18 years of age and older with liver biopsy-confirmed NASH and included approximately 25 clinical sites in the United States. Patients were randomized to receive either MGL-3196 or placebo in a 2:1 ratio.

The primary endpoint of the study was the reduction of liver fat at 12 weeks compared with baseline (relative change), assessed by MRI-PDFF. Key secondary endpoints at 36 weeks included: reduction in liver fat compared with baseline (relative change), also assessed by MRI-PDFF; a two-point reduction in NAS (NALFD activity score) on biopsy; resolution of NASH on biopsy; and, safety and tolerability based on adverse events and changes in laboratory values.

The primary endpoint of the study at 12 weeks was achieved. Liver fat was reduced by 36.3% in all MGL-3196 treated patients (78) and 42.0% in a pre-specified group of high exposure MGL-3196 treated patients (44/78), as compared with 9.6% median reduction in liver fat in 38 placebo treated patients. These results were statistically significant (p<0.0001) for both MGL-3196 treatment groups. Further, 75% of the high-exposure MGL-3196 treated patients showed liver fat reductions of >30%.

At 36 weeks, MGL-3196 achieved multiple key secondary endpoints including a sustained highly significant (p<0.001) reduction in liver fat compared to placebo as

measured by MRI-PDFF; mean relative fat reduction for MGL-3196 was 37% versus 8.9% for placebo. MGL-3196 was associated with a greater percentage of subjects with a 2-point improvement in NAS (56% of 73 patients vs 32% of 34 placebo subjects, p=0.02). NASH resolution (NR) was seen in 27% of MGL-3196 compared with 6% of placebo subjects, p=0.02. MGL-3196 patients with > 30% fat reduction on Week 12 MRI-PDFF demonstrated a higher percentage of 2-point improvement in NAS (70%, p=0.001) and NR (39%, p=0.001) compared with placebo, demonstrating a strong relationship between early reduction in liver fat as demonstrated by week 12 MRI-PDFF and NASH improvement on liver biopsy at Week 36. In patients with NASH Resolution, 35% of the MGL-3196 treated patients and no placebo patients had more advanced NASH (baseline NAS >5).

At Week 36, MGL-3196 treated patients showed sustained reduction of fibrosis biomarkers. In MGL-3196 patients with NASH resolution, fibrosis also resolved in 50% of patients and was decreased statistically significantly relative to all placebo patients.

There were statistically significant reductions in liver enzymes in MGL-3196 treated patients compared to placebo treated patients; reductions of greater magnitude were achieved with longer duration of MGL-3196 treatment. Statistically significantly more MGL-3196 treated patients than placebo treated patients had normalization of ALT (alanine transaminase).

Similar to week 12, at week 36 there were sustained, statistically significant reductions in low-density lipoprotein cholesterol (LDL-C), triglycerides, ApoB and lipoprotein(a).

MGL-3196 was well tolerated in this trial with mostly mild and a few moderate AEs which were balanced between drug treated and placebo patients. There was an increase in incidence of mild transient diarrhea in MGL-3196-treated, often a single episode, at the start of treatment. Diarrhea incidence was not increased later in the study.

Based on liver enzyme inclusion criteria, some patients are receiving extended treatment beyond 36 weeks for up to 36 additional weeks. All patients in this extension study will receive MGL-3196 and only non-invasive assessments will be made, including serial MRI-PDFF, safety labs, and circulating biomarkers.

Additional information about the study [NCT02912260] can be obtained at www.ClinicalTrials.gov.

HeFH

Heterozygous familial hypercholesterolemia (HeFH), and a much rarer form called homozygous familial hypercholesterolemia (HoFH), are severe genetic dyslipidemias typically caused by inactivating mutations in the LDL receptor. Both forms of FH lead to early onset cardiovascular disease. HeFH, the most common dominantly inherited disease, is present in up to 1 in 200 people; the disease is found in higher frequencies

in certain more genetically homogenous populations. Treatments exist for both HeFH and HoFH but many patients (as many as 40 percent of HeFH patients) are not able to reach their cholesterol (LDL-C) reduction goals on these therapies, reflecting the lifetime burden of cholesterol buildup in their bodies. Based on evidence of impressive LDL cholesterol lowering in Phase 1, and data suggesting that MGL-3196 has a mechanism of action that is different from and complementary to statins, Madrigal initiated a Phase 2 proof-of-concept trial in HeFH in February 2017 and enrolled 116 patients.

In this Phase 2 HeFH trial, patients who were not at their LDL-C goal were randomized in a 2:1 ratio to receive either MGL-3196 or placebo, in addition to their current cholesterol lowering regimen, which included approximately 75% taking high intensity statins (20/40 mg rosuvastatin or 80 mg atorvastatin), and about 2/3 of patients also taking ezetimibe. MGL-3196 treated patients (placebo corrected) achieved highly significant (p< 0.0001) LDL-C lowering of 18.8%, and 21% LDL-C lowering in those on an optimal dose of MGL-3196. LDL-C lowering was 28.5% in MGL-3196 treated compared to placebo in a prespecified group of patients who did not tolerate high intensity statin doses. Highly significant reductions (p<0.0001) relative to placebo were also observed with ApoB, triglycerides (TG) (25-31%), apolipoprotein CIII (Apo CIII) and Lp(a) (25-40%) in all MGL-3196 treated patients and prespecified subgroups, irrespective of statin treatment.

MGL-3196 was well-tolerated with primarily mild and some moderate AEs, the numbers of which were balanced between placebo and drug-treatment groups.

About MGL-3196

Among its many functions in the human body, thyroid hormone, through activation of its beta receptor, plays a central role in controlling lipid metabolism, impacting a range of health parameters from levels of serum cholesterol and triglycerides to the pathological buildup of fat in the liver. Attempts to exploit this pathway for therapeutic purposes in cardio-metabolic and liver diseases have been hampered by the lack of selectivity of older compounds for the thyroid hormone receptor (THR)-β, chemically-related toxicities and undesirable distribution in the body.

Madrigal recognized that greater selectivity for thyroid hormone receptor (THR)-β and liver targeting might overcome these challenges and deliver the full therapeutic potential of THR-β agonism. Madrigal believes that MGL-3196 is the first orally administered, small-molecule, liver- directed, truly β-selective THR agonist. MGL- 3196 has now demonstrated in two Phase 2 double-blind, placebo-controlled trials in NASH and HeFH the potential for a broad array of therapeutically beneficial effects, improving components of both metabolic syndrome, such as insulin resistance and dyslipidemia, and fatty liver disease, including lipotoxicity and inflammation. Based on evidence of these pleiotropic actions, coupled with an excellent safety profile, Madrigal plans to initiate a Phase 3 clinical program in NASH.

On November 6, 2018 Athersys, Inc. (NASDAQ: ATHX) reported its financial results for the period ended September 30, 2018 (Press release, Athersys, NOV 6, 2018, View Source [SID1234530876]).

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Highlights of the third quarter of 2018 and recent events include:

Completed enrollment of our Phase 1/2 study evaluating MultiStem therapy in acute respiratory distress syndrome (ARDS) patients;

Commenced enrollment of patients in the MASTERS-2 Phase 3 registration study for ischemic stroke;

Continued to support Healios’ ongoing TREASURE study for ischemic stroke in Japan by providing clinical product;

Extended to December 6, 2018, Healios’ option and negotiation period for further expansion of the collaboration, including an exclusive option for a license to develop and commercialize MultiStem therapy in China for certain indications;

Recognized revenues of $2.3 million for the quarter ended September 30, 2018 and net loss of $9.7 million, or $0.07 net loss per share, for the quarter ended September 30, 2018; and

Cash and cash equivalents were $48.0 million at the end of the third quarter.

"We had another solid quarter in the third quarter of 2018 as we advanced key initiatives, reflected by the completion of enrollment in our exploratory clinical trial evaluating administration of MultiStem to patients suffering from ARDS and the initiation of enrollment in the Phase 3 MASTERS-2 study for treating ischemic stroke," commented Dr. Gil Van Bokkelen, Chairman & CEO at Athersys. "We are working collaboratively with Healios in multiple areas, and we further strengthened our core capabilities.

"In addition, we have maintained a solid balance sheet as we continue to implement our strategic plan, working toward the achievement of our key goals on behalf of our shareholders and the patients we are committed to help," concluded Dr. Van Bokkelen.

Third Quarter Results

Revenues increased to $2.3 million for the three months ended September 30, 2018 compared to $0.4 million for the three months ended September 30, 2017. Our revenues are generally derived from license fees, manufacturing-related activities for Healios, royalty and related contract revenue from our collaborations, and grant revenue.

Research and development expenses increased to $9.5 million for the three months ended September 30, 2018 from $5.4 million for the comparable period in 2017. The $4.1 million increase is primarily associated with increased clinical development costs of $3.0 million, increased personnel costs of $0.6 million, increased license fees of $0.2 million and increased internal research supplies and other of $0.3 million. The $3.0 million increase in our clinical costs during the period is primarily a result of increased clinical product manufacturing costs, covered in part by Healios, technology transfer services associated with planned Japan manufacturing for Healios, process development activities to support large-scale manufacturing, and costs related to our MASTERS-2 clinical trial that began enrolling patients in the third quarter of 2018.

General and administrative expenses increased to $2.6 million for the three months ended September 30, 2018 from $2.1 million in the comparable period in 2017. The $0.5 million increase was due primarily to increases in professional fees, consulting services, personnel costs and other administrative costs compared to the same period last year.

Net loss for the third quarter was $9.7 million in 2018 compared to a net loss of $7.2 million in 2017. The difference of $2.5 million reflects the above variances, as well as an increase of $0.2 million in other income.

In the nine months ended September 30, 2018, net cash used in operating activities was $8.8 million compared to $17.9 million in the nine months ended September 30, 2017. The difference reflects in part $15.0 million in license fees paid by Healios in connection with the collaboration expansion and an increase in clinical development activity in 2018. Healios is obligated to make two more license fee payments of $2.5 million each in December 2018 and March 2019. At September 30, 2018, we had $48.0 million in cash and cash equivalents, compared to $29.3 million at December 31, 2017.

Conference Call

William (B.J.) Lehmann, President and Chief Operating Officer, and Laura Campbell, Senior Vice President of Finance, will host a conference call today to review the results as follows:

Date Tuesday, November 6th, 2018
Time 4:30 p.m. (Eastern Time)
Telephone access: U.S. and Canada 800-273-1254
Telephone access: International 973-638-3440
Access code 7396506
Live webcast

www.athersys.com, under the Investors section
A replay will be available for on-demand listening shortly after the completion of the call until 11:59 PM Eastern Time on November 20, 2018 at the aforementioned URL, or by dialing (800) 585-8367 or (855) 859-2056 in the U.S. and Canada, or from abroad (404) 537-3406, and entering access code 7396506.

On November 6, 2018 Cancer Targeted Technology (CTT), a privately-held Seattle-based biotechnology company, reported that it filed an Investigational New Drug Application (IND) with the FDA to move forward a radiotherapeutic drug, CTT1403, into human clinical trials for prostate cancer (Press release, Cancer Targeted Technology, NOV 6, 2018, View Source [SID1234530938]). CTT1403 is a peptidomimetic drug that targets Prostate Specific Membrane Antigen (PSMA). PSMA is over-expressed on prostate cancer and this expression increases as the cancer metastasizes and becomes hormone-resistant. Unlike other drugs, CTT’s molecules bind irreversibly to PSMA. This distinctive mode of binding enhances uptake and results in rapid and extensive internalization of these drugs by tumor cells, leading to increased uptake within the tumor. CTT1403 is labeled with the radionuclide 177-Lutetium and, unlike other PSMA-targeted drugs in clinical development, contains a unique albumin binding component. The albumin binding moiety on CTT1403 acts to increase the circulation of the drug in the body and further substantially increases the dose of drug that accumulates at the tumor sites. Once targeted to the tumor, the radionuclide on CTT1403 leads to tumor cell destruction. CTT1403 has shown excellent safety results to date in animal studies and CTT1403 treatment results in prolonged survival of animals with prostate cancer tumors

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"We are very excited with the potential for CTT1403 to make a difference in men with advanced stage prostate cancer. This is a highly innovative molecule that combines excellent PSMA-targeting characteristics, already proven effective in prostate cancer, with the ability to enhance circulation time allowing for greater anti-tumor effects," stated Dr. Beatrice Langton-Webster, CTT’s CEO and Principal Investigator for the clinical program. The unique chemical structure for CTT1403 was designed by Dr. Cliff Berkman, Professor of Chemistry at Washington State University (WSU) and consultant to CTT as its Chief Scientific Officer. The work to discover and progress CTT1403 through preclinical development to IND was funded by a $2.3M Small Business Innovation Research contract from the NIH.

CTT recently completed clinical trials of CTT1057, the companion PET diagnostic to CTT1403, with excellent safety and imaging results. CTT1057 is undergoing further development and commercialization by CTT’s licensing partner AAA/Novartis. CTT1057 and CTT1403 can act as a theranostic pair to both diagnose and treat prostate cancer. Phase I clinical trials for CTT1403 are expected to start January, 2019.

On November 6, 2018 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported that Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in two upcoming investor conferences (Press release, Kura Oncology, NOV 6, 2018, View Source [SID1234530755]):

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A presentation at the Stifel Healthcare Conference in New York on November 13, 2018 at 8:45 a.m. ET / 5:45 a.m. PT; and

A fireside chat at the Evercore ISI HealthConX in Boston on November 27, 2018 at 4:15 p.m. ET / 1:15 p.m. PT.
A live audio webcast and replay of each presentation will be available in the Investors section of Kura Oncology’s website at www.kuraoncology.com.

On November 6, 2018 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported financial results for the third quarter ended September 30, 2018 and provided an update on recent corporate activities (Press release, Halozyme, NOV 6, 2018, View Source [SID1234530776]).

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"The expanded agreement we have signed with Roche, covering up to three new targets, speaks to the compelling and ongoing value proposition of our ENHANZE technology," said Dr. Helen Torley, president and chief executive officer. "The overall progress we made recently with the initiation of two Phase 1 trials combining ENHANZE with Alexion’s ALXN1210 and Bristol-Myers Squibb’s BMS-986179, an investigational anti-CD-73 antibody, reinforces our confidence in the potential for $1 billion in royalty revenue in 2027 and for up to $1 billion in cumulative lifetime milestone payments associated with our partners’ programs."

"Turning to our second potential growth engine, PEGPH20, we continue to make good progress with our pivotal HALO-301 pancreas cancer study and in our exploration of the pan tumor potential of PEGPH20. We are pleased to have moved into the randomization phase of our study in patients with cholangiocarcinoma and gall bladder cancer in August. Interest is high, with enrollment progressing very well in the randomization phase to date."

Third Quarter 2018 and Recent Highlights Include:

Halozyme licensed its ENHANZE drug-delivery technology to Roche for exclusive development of a new undisclosed clinical stage therapeutic target, with an option for Roche to select two additional targets within four years. Halozyme will receive an initial payment of $25 million, which will be recognized as revenue in the fourth quarter, with the potential to earn additional payments of up to $160 million to $165 million per target, subject to the achievement of specified development, regulatory and sales-based milestones. Halozyme will also receive mid-single digit royalties on sales of commercialized products.
Bristol-Myers Squibb has dosed the first subject in a Phase 1 clinical trial evaluating the safety, pharmacokinetics and pharmacodynamics of BMS-986179. This investigational anti-CD-73 antibody is being tested in combination with Halozyme’s proprietary ENHANZE drug delivery technology.
Alexion continuing to progress ALXN1210 with ENHANZE, which advanced into Phase 1 clinical testing in the third quarter of 2018.
Health Canada approves a subcutaneous (SC) formulation of trastuzumab (Herceptin SC) for the treatment of patients with HER2-positive breast cancer. Additionally, the U.S. Food and Drug Administration accepted a Biologics License Application from Genentech for a subcutaneous (SC) formulation of trastuzumab (Herceptin SC) in July 2018.
Data presentations from two clinical trials for PEGPH20 (pegvorhyaluronidase alfa) in patients with advanced pancreas and metastatic breast cancer at ESMO (Free ESMO Whitepaper) 2018. These data reinforce the potential for PEGPH20 in combination with chemotherapy and its ability to degrade tumor hyaluronan, which could allow for greater penetration of chemotherapy and improved access of the immune system to the tumor.
Janssen continuing in multiple ongoing trials of a subcutaneous formulation of DARZALEX (daratumumab) in support of plans for commercialization. Halozyme’s ENHANZE technology has the potential to enable a 15-ml injection to be delivered in five minutes or less. Ongoing trials in patients with multiple myeloma, amyloidosis and smoldering myeloma include four Phase 3 studies. Two additional Phase 3 trials, which are listed on clinicaltrials.gov, are planned and expected to begin shortly.
Progress continues in the HALO-301 trial in screening and enrolling patients. The company projects that an interim analysis of the first primary endpoint of progression free survival will be conducted upon achievement of the target number of events in the December 2018 to February 2019 time frame. The trial is investigating PEGPH20 in combination with ABRAXANE (nab-paclitaxel) and gemcitabine in first-line metastatic pancreas cancer patients with high levels of tumor hyaluronan (HA-High).
Strengthened management team and board of directors, with the appointment of Benjamin Hickey as Chief Commercial Officer and Bernadette Connaughton to the board of directors.
Third Quarter 2018 Financial Highlights

Revenue for the third quarter was $25.6 million compared to $63.7 million for the third quarter of 2017. The year-over-year decrease was driven by a one-time $30 million upfront license fee from Roche received in the prior year and an expected decrease in bulk rHuPH20 sales to partners and research and development reimbursements. The decrease was offset by a 9 percent growth in royalties on a reported basis from partner sales. Revenue for the third quarter included $18.7 million in royalties and $3.7 million in HYLENEX recombinant (hyaluronidase human injection) product sales.
Research and development expenses for the third quarter were $35.5 million, compared to $34 million for the third quarter of 2017.
Selling, general and administrative expenses for the third quarter were $14.9 million, compared to $13.3 million for the third quarter of 2017.
Net loss for the third quarter was $27.9 million, or $0.19 per share, compared to net income in the third quarter of 2017 of $2.7 million, or $0.02 per share.
Cash, cash equivalents and marketable securities were $364.4 million at September 30, 2018, compared to $469.2 million at December 31, 2017.
Financial Outlook for 2018

For the full year 2018, the company is updating its prior guidance ranges for net revenue, operating expenses, operating cash burn and year-end cash, and is now expecting:

Net revenue of $150 million to $160 million, an increase from the prior range of $125 million to $135 million, driven by the $25 million upfront payment from the recent Roche ENHANZE license agreement expected in the fourth quarter;
Operating expenses to $220 million to $230 million, a reduction from the prior range of $230 million to $240 million;
Operating cash burn of $50 million to $60 million compared to the prior range of $75 million to $85 million; and
Year-end cash balance of $340 million to $350 million, an increase from the prior range of $310 million to $320 million, driven by the $25 million upfront payment from the recent Roche ENHANZE agreement, and the reduction in operating expenses, partially offset by changes in our working capital.
Webcast and Conference Call

Halozyme will webcast its Quarterly Update Conference Call for the third quarter of 2018 today, Tuesday, November 6 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Torley will lead the call, which will be webcast live through the "Investors" section of Halozyme’s corporate website and a replay will be available following the close of the call. To access the webcast and additional documents related to the call, please visit halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The call may also be accessed by dialing (877) 410-5657 (domestic callers) or (334) 323-7224 (international callers) using passcode 387156. A telephone replay will be available after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay ID number 55575898.