On May 9, 2018 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer and wet age‐related macular degeneration, reported financial results for the first quarter ended March 31, 2018 (Press release, Tracon Pharmaceuticals, MAY 9, 2018, View Source [SID1234526400]).

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First Quarter 2018 and Recent Corporate Highlights

In April 2018, TRACON closed a private placement of its common stock and warrants providing aggregate gross proceeds of approximately $38.7 million. In conjunction with the financing, the Company appointed Ted Wang, Ph.D., Chief Investment Officer of Puissance Capital Management, to its Board of Directors.

Enrollment continues in the Phase 3 TAPPAS trial of TRC105 for the treatment of angiosarcoma that is accruing at 25 sites in the United States and multiple sites in the United Kingdom and France. At the initial meeting in May 2018, the Independent Data Monitoring Committee recommended that the trial continue as planned. We expect to conduct the interim analysis to determine the final sample size and eligible population for the trial in the second half of 2018.

Enrollment continues in the Phase 1/2 trial of TRC253, TRACON’s product candidate for the treatment of prostate cancer that was in-licensed from Janssen. The Phase 1/2 trial is designed to assess safety, determine the recommended Phase 2 dose and assess response by prostate-specific antigen (PSA) levels. If Janssen opts to reacquire TRC253 prior to or following completion of the Phase 1/2 trial, TRACON is entitled to receive a $45.0 million opt-in payment, up to $137.5 million in potential milestone payments and a low-single digit royalty.
"Our clinical programs continue to advance as planned, and we expect multiple potentially value-creating data readouts over the remainder of 2018, all delivered through our cost-efficient product development platform," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "Most importantly, our global pivotal Phase 3 TAPPAS trial of TRC105 in angiosarcoma continues to enroll well, with the key interim analysis expected in the second half of the year."

Expected Upcoming 2018 Milestones

Presentation of data from preclinical studies of TRC105 in combination with PD-1 checkpoint inhibition at International Microenvironment Cancer Society meeting in June 2018 in Lisbon.

Completion of the dose escalation portion of the Phase 1/2 trial of TRC253 in patients with prostate cancer in mid-2018.

Announcement of top-line data from the randomized Phase 2 TRAXAR trial of TRC105 in combination with Inlyta for patients with advanced or metastatic renal cell carcinoma is expected in the second half of 2018.

Announcement of the results of the interim analysis from the Phase 3 pivotal TAPPAS trial of TRC105 in angiosarcoma is expected in the second half of 2018.

Presentation of data from the Phase 1b trial of TRC105 in combination with Opdivo in patients with non-small cell lung cancer is expected in the second half of 2018.
First Quarter 2018 Financial Results

Cash, cash equivalents and short-term investments were $62.5 million at March 31, 2018, compared to $34.5 million at December 31, 2017.

Collaboration revenue was $3.0 million for the first quarter of 2018 compared to $0.6 million for the first quarter of 2017. The increase was due to the $3.0 million non-refundable upfront payment received in connection with the Ambrx agreement recorded as revenue in the first quarter of 2018.

Research and development expenses for the first quarter of 2018 were $9.4 million compared to $5.6 million for the first quarter of 2017. The increase was primarily attributable to increased TRC105 drug manufacturing activities in the first quarter of 2018 as compared to the 2017 period.

General and administrative expenses for the first quarter of 2018 were $1.8 million compared to $2.0 million for the first quarter of 2017.

Net loss for the first quarter of 2018 was $8.4 million compared to $7.1 million for the first quarter of 2017.
Investor Conference Call

The Company will hold a conference call today at 4:30 p.m. EST / 1:30 p.m. PST to provide an update on corporate activities and to discuss the financial results of its first quarter of 2018. The dial-in numbers are (855) 779‑9066 for domestic callers and (631) 485-4859 for international callers. Please use passcode 3189378. A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About Carotuximab (TRC105)

TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in a pivotal Phase 3 trial in angiosarcoma and multiple Phase 2 clinical trials, in combination with VEGF inhibitors. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU. The ophthalmic formulation of TRC105, DE-122, is currently in a randomized Phase 2 trial for patients with wet AMD. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.

About TRC253

TRC253 is a novel, orally bioavailable small molecule that is a potent, high affinity competitive inhibitor of the androgen receptor (AR) and AR mutations, including the F876L (also known as F877L) mutation. The AR F876L mutation results in an alteration in the AR ligand binding domain that confers resistance to therapies for prostate cancer. Activation of the AR is crucial for the growth of prostate cancer at all stages of the disease. Therapies targeting the AR have demonstrated clinical efficacy by extending time to disease progression, and in some cases, the survival of patients with metastatic castration-resistant prostate cancer. However, resistance to these agents is often observed and several molecular mechanisms of resistance have been identified, including gene amplification, overexpression, alternative splicing, and point mutation of the AR.

On May 9, 2018 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that Marc N. Casper, president and chief executive officer, will present at the Bank of America Merrill Lynch 2018 Health Care Conference on Wednesday, May 16, 2018, at 8:00 a.m. (PT) at the Encore at the Wynn Las Vegas, Las Vegas, Nev (Press release, Thermo Fisher Scientific, MAY 9, 2018, View Source [SID1234526399]).

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You can access the live webcast of the presentation via the Investors section of our website, www.thermofisher.com.

On May 9, 2018 Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage biopharmaceutical company developing novel oncology therapeutics, reported financial results for the quarter ended March 31, 2018 (Press release, Stemline Therapeutics, MAY 9, 2018, View Source [SID1234526393]). The Company also reviewed recent clinical and regulatory events, and outlined key upcoming milestones:

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SL-401 in Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

In April, we announced initiation of a rolling Biologics License Application (BLA) submission for SL-401, and expect to complete the rolling submission in 2Q18.
If our BLA is successful, we anticipate possible U.S. approval of SL-401 in the 4Q18/1Q19 timeframe.
In preparation for possible approval, we continue to build out our pre-launch and commercial activities.
At the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, we are sponsoring a BPDCN disease awareness booth designed to continue to build awareness around BPDCN and CD123.
We anticipate feedback from the European Medicines Agency (EMA) regarding a potential regulatory filing in Europe, later this year.
Additional Clinical Trials

SL-401 is also being evaluated in clinical trials in additional indications including myeloproliferative neoplasms (MPN) [focused on chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF)], acute myeloid leukemia (AML), and multiple myeloma.
We are evaluating possible registration-directed trial designs in CMML and MF given the results observed to date. Updates relating to these programs are expected later this year.
SL-801: the Phase 1 trial in patients with advanced solid tumors is ongoing, and dose escalation continues. Data from the SL-801 trial were selected for presentation at the upcoming ASCO (Free ASCO Whitepaper) meeting in June.
SL-701: the Phase 2 trial in patients with second-line glioblastoma has completed. Data from the SL-701 trial were selected for presentation at the upcoming ASCO (Free ASCO Whitepaper) meeting in June.
Ivan Bergstein, MD, CEO of Stemline, commented "The initiation of our rolling BLA submission advances us ever closer to potential approval and commercialization of SL-401. We continue to build out our commercial infrastructure, including accelerating efforts to raise awareness around BPDCN and CD123. In parallel, we continue to pursue SL-401 in other CD123 positive malignancies and look forward to forging additional registrational opportunities. We expect clinical updates from each of our pipeline candidates this year – all with an eye towards achieving our goal of improving the lives of patients with cancer and building a leading biopharmaceutical company."

First Quarter 2018 Financial Results Review
Stemline ended the first quarter of 2018 with $106.2 million in cash, cash equivalents and investments, as compared to $66.2 million as of December 31, 2017, which reflects a cash increase of $40.0 million for the quarter. The $40.0 million increase in cash represents the $55.7 million in net cash proceeds received from the Company’s follow-on public offering during January 2018 offset by $15.7 million of net cash expenditures during the first quarter 2018. The Company ended the first quarter of 2018 with 30.2 million shares outstanding.

For the first quarter of 2018, Stemline had a net loss of $18.4 million, or $0.69 per share, compared with a net loss of $14.6 million, or $0.67 per share, for the same period in 2017.

Research and development expense was $12.7 million for the quarter ended March 31, 2018, compared with $9.6 million for the quarter ended March 31, 2017, representing an increase of $3.1 million. The higher costs are primarily driven by an increase in regulatory and manufacturing expenses in support of our BLA filing and potential commercialization of SL-401.

General and administrative expense was $5.9 million for the quarter ended March 31, 2018, compared with $5.4 million for the quarter ended March 31, 2017, representing an increase of $0.5 million. The increase in expense was due to $0.9 million in higher pre-launch expenses in support of preparing for a potential commercialization of SL-401 in BPDCN, if marketing approval from the FDA is received. Additionally, the higher costs also resulted from a $0.9 million increase in non-cash stock-based compensation expense and increased headcount. Partially offsetting the higher costs was a decrease in legal expenses of $1.3 million.

About BPDCN
Please visit the BPDCN disease awareness booth (#4125) at ASCO (Free ASCO Whitepaper) 2018 and www.bpdcninfo.com.

On May 9, 2018 SELLAS Life Sciences Group Inc. (Nasdaq:SLS) ("SELLAS"), a clinical-stage biopharmaceutical company focused on novel cancer immunotherapies for a broad range of cancer indications, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its novel drug candidate, galinpepimut-S (GPS), for the treatment of multiple myeloma (MM) (Press release, Sellas Life Sciences, MAY 9, 2018, View Source [SID1234526392]). GPS is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms Tumor 1 (WT1) protein, which is present in an array of tumor types.

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"We are delighted to receive this orphan drug designation as it underscores the great need for innovative, effective treatments for this rare cancer, and recognizes the potential benefits that GPS may provide for patients with MM," said Angelos Stergiou, MD, ScD h.c., President & Chief Executive Officer of SELLAS. "Receiving orphan drug designation for the treatment of MM is a significant regulatory milestone in the development of GPS. We have reported median progression-free survival (PFS) of 23.6 months in the high-risk MM disease setting, compared to historically inferior outcomes in such a patient cohort of around 12 months, and GPS stimulated time-dependent and robust CD4+ T cell or CD8+ T cell immune responses as well as multifunctional cross-epitope T cell reactivity."

GPS has also received orphan drug designation for the treatment of acute myeloid leukemia (AML) and malignant plural mesothelioma (MPM). SELLAS has Phase 3 clinical trials planned for GPS in both AML and MPM and is developing GPS as a potential treatment for a broad range of other cancer indications, including multiple myeloma.

The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. Orphan drug designation may provide certain benefits, including a seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA application fees.

On May 9, 2018 Selecta Biosciences, Inc. (NASDAQ:SELB), a clinical-stage biopharmaceutical company focused on unlocking the full potential of biologic therapies by mitigating unwanted immune responses, reported financial results for the first quarter ended March 31, 2018 and provided a corporate update (Press release, Selecta Biosciences, MAY 9, 2018, View Source [SID1234526391]).

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"We are very pleased by the clinical activity seen in the SEL-212 phase 2 data presented recently at PANLAR, not only in SEL-212’s ability to control serum uric acid levels with convenient monthly doses, but also in the reduced incidence of gout flares compared to the current FDA-approved uricase. We have two more anticipated data readouts from this trial at EULAR and a medical conference in the third quarter and we are also planning to initiate the Phase 3 program later this year," said Werner Cautreels, Ph.D., President and CEO of Selecta. "And now that our next program, SEL-403, has entered the clinic for the treatment of patients with mesothelioma at the National Cancer Institute, we have demonstrated the versatility of our tolerance SVP platform in an additional therapeutic area of high unmet need. SEL-403 is the first non-immunogenic immunotoxin that targets mesothelin on cancer cells providing the possibility of improving efficacy and safety for a broad group of cancer patients."

Recent Business Highlights and Activities

Presented Positive New Data from Ongoing Phase 2 Trial of SEL-212 at PANLAR 2018 Congress in April: In April 2018, Selecta presented new data from patients receiving SEL-212 for the treatment of chronic severe gout at the Pan American League of Associations for Rheumatology (PANLAR) 2018 Congress in Buenos Aires, Argentina. The data was generated from patients that received three monthly doses of SEL-212, up to 0.15 mg/kg of SVP-Rapamycin in combination with 0.2 or 0.4 mg/kg of pegsiticase, followed by two monthly doses of pegsiticase alone. Approximately 75% of evaluable patients maintained serum uric acid level control below 6 mg/dl during the initial three months of therapy with concurrent mitigation of anti-drug antibodies (ADAs) against the pegsiticase enzyme. Furthermore, 91% of patients dosed with pegsiticase alone in month four after the initial three monthly doses of SEL-212 maintained serum uric acid control. The company plans to present an expanded data set of the PANLAR cohorts at the EULAR conference on June 15th and will host a conference call to discuss the data on June 15th at 8.30 am.

Data from Cohorts Receiving Five Combination Doses in Phase 2 Trial of SEL-212 to be Presented in the Third Quarter at a Medical Meeting: In February 2018, Selecta began enrolling new cohorts of patients in the current Phase 2 trial who are expected to receive five monthly doses of SVP-Rapamycin in combination with pegsiticase. These patients are receiving SVP-Rapamycin doses ranging from 0.1mg/kg-0.15mg/kg in combination with 0.2 mg/kg of pegsiticase. The company expects to present data from these patients at an upcoming medical meeting in the third quarter of 2018.

SEL-212 to Enter Phase 3 in 2018 Following Comprehensive Dose Selection Trial:Selecta is actively engaged in preparations for an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), which will define the company’s design for the Phase 3 program. The company plans to initiate its Phase 3 program in 2018.

Patient Enrollment Ongoing for SEL-403 Phase 1 Trial for Mesothelioma: In March 2018, the first patient was dosed in a Phase 1 clinical trial of SEL-403, Selecta’s combination product candidate consisting of SVP-Rapamycin and LMB-100, for the treatment of patients with malignant pleural or peritoneal mesothelioma who have undergone at least one regimen of chemotherapy. LMB-100, which was in-licensed by Selecta in 2017, is a recombinant immunotoxin that targets mesothelin, a protein expressed in nearly all mesotheliomas and pancreatic adenocarcinomas, and a high percentage of other malignancies, including lung, breast and ovarian cancers. This open-label dose-escalation Phase 1 trial is being conducted under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health, and is expected to enroll at least 18 patients. The trial will evaluate the safety and tolerability of this treatment and provide data on pharmacokinetics, ADA levels, as well as an objective response rate assessment.
First Quarter Financial Results:

Revenue: For the first quarter of 2018, the company recognized no revenue, which compares with $0.1 million for the first quarter of 2017. The decline is the result of reduced revenue recognized from the company’s grants and collaborations.

Research and Development Expenses: Research and development expenses for the first quarter of 2018 were $11.1 million, relatively unchanged from the $11.0 million for the first quarter of 2017.

General and Administrative Expenses: General and administrative expenses for the first quarter of 2018 were $4.7 million, which compares with $3.9 million for the first quarter of 2017. The increase is primarily the result of greater headcount and related salaries needed to support a maturing clinical-stage public company.

Net Loss: For the first quarter of 2018, Selecta reported a net loss attributable to common stockholders of $(15.9) million, or $(0.71) per share, compared to a net loss of $(15.1) million, or $(0.82) per share, for the same period in 2017.

Cash Position: Selecta had $83.5 million in cash, cash equivalents, short-term deposits, investments and restricted cash as of March 31, 2018, which compares with a balance of $97.0 million at December 31, 2017. Selecta continues to expect that its cash, cash equivalents, short-term deposits, investments and restricted cash will be sufficient to fund the company’s operating expenses and capital expenditure requirements into mid-2019.
Conference Call Reminder
Selecta management will host a conference call at 8:30 a.m. ET today to announce the company’s first quarter financial results and provide a corporate update. Investors and the public can access a live and archived webcast of this call via the Investors & Media section of the company’s website, View Source Individuals may also participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10118841.