Acorda Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On May 9, 2018 Aileron Therapeutics (Nasdaq:ALRN), the clinical-stage leader in the field of stapled peptide therapeutics for cancers and other diseases, reported business highlights and financial results for the first quarter ended March 31, 2018 (Press release, Aileron Therapeutics, MAY 9, 2018, View Source;p=RssLanding&cat=news&id=2348220 [SID1234526343]).

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"In the first quarter, we continued to advance our clinical and non-clinical stapled peptide programs as we pursue our mission to provide transformational outcomes for patients with life-threatening diseases," said Joseph A. Yanchik III, President and Chief Executive Officer of Aileron. "The clinical activity and safety seen in our interim data from our ongoing Phase 2a clinical trial of ALRN-6924, in addition to our Phase 1 data, continue to support the clinical importance of p53 and the potential of ALRN-6924 in solid and liquid tumors where there is significant need for new treatment options. In addition, our research team continues to make progress in evaluating ALRN-6924 for development in combination studies, and to identify new targets and disease indications for clinical development."

ALRN-6924 Program Highlights

Enrollment Ongoing in Phase 2a Trial with ALRN-6924 in Peripheral T-Cell Lymphoma
ALRN-6924 is a first-in-class stapled peptide designed to reactivate wild-type p53 tumor suppression in solid and liquid tumors. Aileron is conducting a Phase 2a open-label, multi-center trial of ALRN-6924 as a monotherapy in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The Company believes that the preliminary overall response rate observed in the trial (as of February 26, 2018) is generally in line with the reported overall response rates for Romidepsin, the 2nd line PTCL market share leader. Given that ALRN-6924 continues to be well-tolerated, the Company is enrolling patients in an expansion cohort to determine if more frequent dosing can provide an increased benefit to certain patients. Aileron expects to report additional interim data from this trial in the second half of this year.

Company Continues to Advance Phase 1 and 1b Studies in AML and MDS
Aileron is conducting Phase 1 and 1b open-label, multi-center clinical trials of ALRN-6924 as a monotherapy and in combination with cytosine arabinoside (Ara-C) for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The dose escalation studies are designed to establish the recommended Phase 2 dose of ALRN-6924 in patients with AML or MDS, and to evaluate its safety and to provide a preliminary assessment of anti-leukemic activity. In an interim cut of the data (as of February 26, 2018), the Company has observed encouraging evidence of clinical activity and a safety profile consistent with earlier studies. Aileron expects to report interim data from these trials, its dosing strategy, and its plans for a Phase 2 trial in the second half of this year.

Company Expands Non-Clinical Studies of ALRN-6924 Combinations
Based on ALRN-6924’s unique mechanism of action and safety profile, Aileron has expanded its non-clinical research to test a variety of approved drugs in combination with ALRN-6924, including immuno-oncology agents, cyclin-dependent kinase inhibitors and traditional chemotherapeutic agents for solid and liquid tumors. Aileron expects to provide an update on its non-clinical data and development plans for its combination studies during the second half of 2018.
Interim Data Review of Phase 1 All Comers Trial Demonstrates ALRN-6924 Potential
In April, Aileron provided interim data (as of February 26, 2018) from the 63 evaluable patients in the Phase 1 dose escalation trial of ALRN-6924 in patients with advanced solid tumors and lymphomas. As of the February 26th cut-off date, five patients, including two patients who achieved complete responses (CR) and one patient who achieved a partial response (PR), remain on treatment for an average treatment period of 685 days. This trial tested nine dose levels and two dosing regimens of once and twice weekly. Of the 63 evaluable patients, 30 patients, or 48%, demonstrated disease control. This included two CRs, two PRs, and 26 with stable disease, with 42% of stable disease patients showing tumor shrinkage. In a subset of 41 patients whose cells did not contain mutated p53 and received a minimum dose of ALRN-6924, 24 patients (59%) demonstrated disease control, consisting of two CRs, two PRs, and 20 with stable disease.
ALRN-6924 Non-Clinical Results Published in Science Translational Medicine
In April, Science Translational Medicine published non-clinical results demonstrating the anti-cancer potential of ALRN-6924 in models of AML. Conducted by researchers at Albert Einstein College of Medicine, the studies showed that treatment with ALRN-6924 increased the median survival rate in an animal model of human AML (mice transplanted with human leukemia cells) from 50 to approximately 150 days. In addition, about 40% of the animals were cured, meaning they were tumor-free at one year.
Corporate Updates

Aileron Expands Scientific Advisory Board
In March, Aileron expanded its Scientific Advisory Board with the additions of preeminent scientists Dr. Brian Druker (Knight Cancer Institute, Oregon Health & Science University), Dr. Alan List (Moffitt Cancer Center), and Dr. Carol Prives (Columbia University), all of whom have made groundbreaking contributions to the development of novel cancer therapies.
Company to Present at Upcoming Conferences
The Company plans to participate at upcoming investor conferences, including the Bank of America Merrill Lynch 2018 Health Care Conference (May 15-17, Las Vegas), the Jefferies Global Healthcare Conference (June 5-8, NYC), and the Canaccord Genuity 38th Annual Growth Conference (Aug. 8-9, Boston).
First Quarter 2018 Financial Results

Cash Position and Guidance: Cash, cash equivalents and investments as of March 31, 2018 were $43.3 million, compared to $50.8 million as of December 31, 2017. The Company believes that its cash, cash equivalents and investments as of March 31, 2018 will enable the Company to fund its operating expenses and capital expenditure requirements into the second half of 2019.
R&D Expenses: Research and development (R&D) expenses were $4.8 million for Q1 2018, compared to $2.9 million for the same period in 2017. The increase in R&D expense was primarily driven by increased activity in the Company’s non-clinical research and increases in clinical and non-clinical personnel expense. Higher costs were attributable to research associated with expanded testing of a variety of approved drugs in combination with ALRN-6924 along with higher expenses as a result of hiring additional personnel to support ongoing clinical and non-clinical research programs. The Company expects R&D expenses to continue to increase as it continues to advance its ALRN-6924 program and hires additional R&D personnel.
G&A Expenses: General and administrative (G&A) expenses were $2.9 million in Q1 2018, compared to $1.6 million for the same period in 2017. The increase in G&A was primarily due to new hires, increases in non-cash stock compensation costs, and professional fees related to the increased cost of being a public company, consisting mostly of legal and accounting fees. The Company expects G&A expenses to continue to increase as it hires additional personnel to support the Company’s anticipated growth in its research and development activities and incurs increased expenses associated with being a public company.

Net Loss: The Company reported a net loss attributable to common stockholders of $7.6 million in Q1 2018 compared to $4.6 million for the same period in 2017. Based on the Company’s weighted average shares outstanding, the Company reported a net loss attributable to common stockholders of $0.52 per share in Q1 2018, compared to $10.58 per share for the same period in 2017.
Non-GAAP net loss attributable to common stockholders for Q1 2017 was $0.42 based on non-GAAP weighted-average common shares outstanding of 10.9 million shares. The non-GAAP weighted-average shares outstanding gives effect to the conversion of all outstanding shares of redeemable convertible preferred stock to common stock, as if such conversion had occurred at the beginning of the period.

A reconciliation of GAAP to non-GAAP financial measures has been provided in the table included below in this press release. An explanation of these measures is also included below under the heading "Non-GAAP Financial Measures."

Shares Outstanding: As of March 31, 2018, there were 14.7 million shares of common stock outstanding.

About ALRN-6924
ALRN-6924 is a first-in-class product candidate designed to reactivate wild type p53 tumor suppression by disrupting the interactions between the two primary p53 suppressor proteins, MDMX and MDM2. Aileron believes ALRN-6924 is the first and only product candidate in clinical development that can equipotently bind to and disrupt the interaction of MDMX and MDM2 with p53. Based on preclinical data and preliminary evidence of safety and anti-tumor activity in its ongoing clinical trials, there may be a significant opportunity to develop ALRN-6924 as a monotherapy or combination therapy for a wide variety of solid and liquid tumors. ALRN-6924 is currently being evaluated in multiple clinical trials for the treatment of acute myeloid leukemia (AML), advanced myelodysplastic syndrome (MDS) and peripheral T-cell lymphoma (PTCL). For information about its clinical trials, please visit www.clinicaltrials.gov.

On May 9, 2018 Inovio Pharmaceuticals, Inc. (NASDAQ:INO), a late-stage biotechnology company focused on the discovery, development, and commercialization of DNA immunotherapies targeted against cancers and infectious diseases, reported financial results for the first quarter ended March 31, 2018, along with a general business update (Press release, Inovio, MAY 9, 2018, View Source [SID1234526373]).

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Inovio Highlights

VGX-3100. A total of 60 sites globally are open and recruiting for REVEAL 1 (Phase 3 clinical trial for treating cervical dysplasia (CIN) caused by human papillomavirus (HPV)); recruiting patients in Phase 2 study for treating vulvar dysplasia (VIN) and associated diseases.
MEDI0457 in combination with durvalumab advanced to the Phase 2 efficacy stage of the trial, triggering a milestone payment to Inovio. MedImmune is evaluating MEDI0457 in combination with durvalumab, its PD-L1 checkpoint inhibitor, in patients with recurrent/metastatic HPV-associated HNSCC in a clinical trial with an estimated total enrollment of 50 patients.
INO-5401. Opening sites for Phase 1/2a study to evaluate the safety, immunogenicity and preliminary clinical efficacy of INO-5401 and INO-9012 in combination with Roche/Genentech’s atezolizumab in participants with locally advanced unresectable or metastatic/recurrent urothelial carcinoma (UCa); opening sites for Phase 1/2 study to evaluate safety, immunogenicity and preliminary efficacy of INO-5401 and INO-9012 in combination with Regeneron’s cemiplimab in participants with newly-diagnosed glioblastoma (GBM).
INO-1800. Inovio’s treatment for hepatitis B infection is being evaluated in a Phase 1 clinical study in which it has generated virus-specific T cells with a favorable safety profile to date. Inovio continues its partnering discussions and plans to report additional data from this trial at upcoming scientific conferences and in a publication in 2018.
Executed collaboration and partnering agreement with ApolloBio. Inovio received an upfront payment of $23 million (approximately $19.4 million after payment of required taxes) from ApolloBio, which gained the rights to develop, manufacture and commercialize VGX-3100 to treat precancers caused by HPV, within Greater China.
Entered into a clinical collaboration agreement with the Parker Institute for Cancer Immunotherapy. The agreement provides that Inovio and the Parker Institute will undertake clinical evaluation of novel combination regimens within the field of immuno-oncology. Under the agreement, the Parker Institute will have responsibility for funding and clinical study execution, working in collaboration with its established network. Inovio will provide financial contributions if Inovio’s product(s) studied under the collaboration reaches the initiation of a Phase 3 study.
Established partnership with CEPI (in April). Inovio will develop vaccine candidates against Lassa fever and Middle East Respiratory Syndrome (MERS). The Coalition for Epidemic Preparedness Innovations (CEPI) will directly fund up to $56 million to support Inovio’s pre-clinical and clinical advancement through Phase 2 of INO-4500, its Lassa fever vaccine, and INO-4700, its MERS vaccine, over a five-year period.
GENEOS Therapeutics, Inc. Our wholly-owned subsidiary, GENEOS Therapeutics, Inc., which is developing neoantigen-based personalized cancer therapies, plans to raise capital in 2018 to fund the development of its programs.
Cash Position. As of March 31, 2018, cash and cash equivalents and short-term investments were $112.8 million compared to $127.4 million as of December 31, 2017.
Dr. J. Joseph Kim, Inovio’s President & CEO said, "During the first quarter of 2018, Inovio has made significant progress in its clinical trials, while continuing to secure corporate partnerships and obtain significant non-dilutive funding. These accomplishments further validate our proprietary ASPIRE technology targeting cancer and emerging infectious diseases in addition to positioning us as a global leader for treating a wide spectrum of HPV-related diseases. We look forward to building on our treatment capabilities, while continuing to expand on our partnering successes from the first quarter."

First Quarter 2018 Financial Results

Total revenue was $1.5 million for the three months ended March 31, 2018, compared to $10.4 million for the same period in 2017. Total operating expenses were $34.3 million compared to $32.3 million for the same period in 2017.

As a result of the adoption of Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers, beginning on January 1, 2018, all contributions received from current grant agreements have been recorded as a contra-expense as opposed to revenue on the consolidated statement of operations. For the three months ended March 31, 2018, $2.2 million was recorded as contra-research and development expense which would have been classified as grant revenue in the prior year. Had this change in presentation not occurred, total revenue would have been $3.7 million for the three months ended March 31, 2018, compared to $10.4 million for the same period in 2017. Total operating expenses would have been $36.5 million compared to $32.3 million for the prior year period.

Inovio’s net loss for the quarter ended March 31, 2018 was $32.4 million, or $0.36 per basic and diluted share, compared to $23.1 million, or $0.31 per basic and diluted share, for the quarter ended March 31, 2017.

Revenue

The decrease in comparable revenue and grant agreement recognition for the first quarter 2018 compared to 2017 was primarily due to the prior year revenue recognized from the termination payment received from Roche during the first quarter of 2017 of $4.0 million. The decrease was also due to a decrease in grant funding recognized from our Defense Advanced Research Projects Agency (DARPA) Ebola grant of $4.7 million, partially offset by an increase in grant funding recognized from our Zika virus sub-grant of $1.2 million.

Operating Expenses

Research and development (R&D) expenses for the three months ended March 31, 2018 were $24.6 million compared to $24.5 million for the same period in 2017. The increase in R&D expenses was primarily related to our VGX-3100 clinical trials, activities under our collaboration with MedImmune and an increase in employee headcount to support our clinical trial activities and partnerships. These increases were offset by the $2.2 million contra-research and development expense recorded from grant agreements as discussed above, as well as a decrease in expenses related to the DARPA Ebola grant as it nears completion.

General and administrative (G&A) expenses were $9.7 million for the three months ended March 31, 2018 versus $7.8 million for the same period in 2017. The increase in G&A expenses was primarily related to the Chinese taxes and advisory fees incurred in connection with the ApolloBio upfront payment we received, offset by a decrease in non-cash stock based compensation.

Capital Resources

As of March 31, 2018, cash and cash equivalents and short-term investments were $112.8 million compared to $127.4 million as of December 31, 2017. As of March 31, 2018, the Company had 90.7 million common shares outstanding and 102.3 million common shares outstanding on a fully diluted basis, after giving effect to outstanding options, warrants, restricted stock units and convertible preferred stock.

Inovio’s balance sheet and statement of operations are provided below. Form 10-Q providing the complete 2018 first quarter financial report can be found at: View Source

Conference Call / Webcast Information

Inovio’s management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss Inovio’s financial results and provide a general business update.

The live webcast and a replay may be accessed by visiting the Company’s website at View Source Please connect to the Company’s website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Telephone replay will be available approximately two hours after the call at 877-481-4010 (domestic) or 919-882-2331 (international) using replay ID 29009.

On May 9, 2018 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the first quarter ended March 31, 2018 (Press release, Puma Biotechnology, MAY 9, 2018, View Source [SID1234526389]).

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Unless otherwise stated, all comparisons are for the first quarter 2018 compared to the first quarter 2017.

On July 17, 2017, Puma Biotechnology received approval from the U.S. Food and Drug Administration (FDA) for NERLYNX (neratinib) for the treatment of early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and the Company began shipment to wholesalers at the end of July 2017. Prior to the launch of NERLYNX the Company had no product revenue. Net product revenue from sales of NERLYNX in the first quarter of 2018 amounted to $36.0 million, compared to net product revenue of $6.1 million and $20.1 million in the third and fourth quarters of 2017, respectively.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss applicable to common stock of $24.3 million, or $0.65 per share, for the first quarter of 2018, compared to a net loss applicable to common stock of $72.9 million, or $1.97 per share, for the first quarter of 2017.

Non-GAAP adjusted net income was $1.1 million, or $0.03 per basic share and $0.02 per diluted share, for the first quarter of 2018, compared to non-GAAP adjusted net loss of $43.1 million, or $1.16 per basic and diluted share, for the first quarter of 2017. Non-GAAP adjusted net income (loss) excludes stock-based compensation expense, which represents a significant portion of overall expense and has no impact on the cash position of the Company. For a reconciliation of GAAP net loss to non-GAAP adjusted net income (loss) and GAAP net loss per share to non-GAAP adjusted net income (loss) per share, please see the financial tables at the end of this news release.

Net cash used in operating activities for the first quarter of 2018 was $6.3 million. At March 31, 2018, Puma had cash and cash equivalents of $78.6 million, compared to cash and cash equivalents of $81.7 million at December 31, 2017.

"We made substantial progress in the commercialization of our lead product, NERLYNX (neratinib), during the first quarter of 2018," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "We quickly built momentum in the U.S. market, with net sales steadily rising since our launch. Our exclusive licensing agreements to date, with Pint Pharma in Latin America, CANbridge in mainland China and Taiwan, Medison Pharma in Israel, and Specialised Therapeutics Asia in South East Asia, demonstrate our commitment to also make NERLYNX accessible to patients globally while we continue to grow the U.S. market.

"We are also pleased with the updated National Comprehensive Cancer Network (NCCN) guidelines, which designate NERLYNX as a recommended combination treatment option for breast cancer patients with brain metastases. In addition, data on neratinib were published in the journal Nature, which included initial results from Puma’s ongoing SUMMIT Phase II ‘basket’ clinical trial in patients with tumors harboring HER2 or HER3 mutations. SUMMIT is designed to evaluate the contributions of both genetic mutation and cancer type on individual patient response to neratinib. Information generated from the trial will help guide neratinib-based targeted therapy across a broad spectrum of tumor types with HER2 or HER3 mutations, including patients with rare tumors who may not otherwise have access to investigational therapies. We believe the publication of the initial SUMMIT data in this prestigious journal reflects the novelty and quality of this precision-medicine trial design, as well as the growing understanding that both tumor type and gene mutations play an important role in individual patients’ response to cancer therapies such as neratinib."

Mr. Auerbach added, "During 2018, we anticipate the following key milestones: (i) reporting updated Phase I/II data from neratinib plus Kadcyla (T-DM1) in the HER2-positive metastatic breast cancer trial in the second quarter of 2018; (ii) re-assessment of the Marketing Authorisation Application for neratinib by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in mid-2018; (iii) reporting data from the Phase III trial in third-line metastatic breast cancer patients in the second half of 2018; (iv) submitting for regulatory approval for the extended adjuvant HER2-positive early stage breast cancer indication in select countries in the second half of 2018; and (v) reporting additional data from the Phase II CONTROL trial in the fourth quarter of 2018."

Revenue

Total revenue consists of net product revenue from sales of NERLYNX, Puma’s first and only commercial product to date, and license revenue. The FDA approved NERLYNX for commercial sale in the United States in July 2017 and the Company commenced shipment to wholesalers in late July. For the first quarter of 2018, total revenue was $66.5 million, of which $36.0 million was net product revenue and $30.5 million was license revenue received from Puma’s sub-licensees.

Operating Expenses

Operating expenses were $89.9 million for the first quarter of 2018, compared to $73.2 million for the first quarter of 2017.

Cost of Sales:

Cost of sales was $6.4 million for the first quarter of 2018. The Company had no product sales prior to the third quarter of 2017.

Selling, General and Administrative Expenses:

Selling, general and administrative expenses were $36.6 million for the first quarter of 2018, compared to $18.4 million for the first quarter of 2017. The $18.2 million increase resulted primarily from increases of approximately $7.8 million in payroll and related costs, $6.6 million in marketing, market access, and legal expenses, $1.7 million in travel and related costs, and $1.7 million in stock-based compensation. These increases reflect the commercial launch of NERLYNX and overall corporate growth.

Research and Development Expenses:

Research and development (R&D) expenses were $46.9 million for the first quarter of 2018, compared to $54.8 million for the first quarter of 2017. The $7.9 million decrease resulted primarily from decreases of approximately $6.1 million for stock-based compensation and $4.0 million for clinical trial expenses, partially offset by an increase of $2.2 million for payroll and related costs in medical affairs and commercial quality assurance. For our existing clinical trials, we expect R&D expenses to decrease in subsequent quarters as clinical trials continue to wind down.

Conference Call

Puma Biotechnology will host a conference call to report its first quarter 2018 financial results and provide an update on the company’s business and outlook at 1:30 p.m. PDT/4:30 p.m. EDT on Wednesday, May 9, 2018. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international) at least 10 minutes prior to the start of the call and referencing the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on the company’s website for 90 days.

On May 9, 2018 Lodo Therapeutics Corporation, a drug discovery and development company focused on identifying and producing unique, bioactive natural products directly from the microbial DNA sequence information contained in soil, reported that it has formed a strategic drug discovery collaboration with Genentech, a member of the Roche Group (Press release, Lodo Therapeutics, MAY 9, 2018, View Source [SID1234526409]).

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Under the terms of the agreement, Genentech will utilize Lodo Therapeutics’ proprietary genome mining and biosynthetic cluster assembly platform to identify novel molecules with therapeutic potential against multiple disease-related targets of interest to Genentech. Lodo will receive an undisclosed upfront payment and is eligible to receive research, development and commercialization milestone payments up to $969 million based on achievement of certain predetermined milestones. In addition, Lodo is eligible to receive tiered-royalties on sales of certain products resulting from the collaboration.

"Lodo Therapeutics’ proprietary drug discovery platform is a powerful engine for identifying novel compounds with important therapeutic potential," said Thong Q. Le, chief executive officer at Lodo Therapeutics and Accelerator Life Science Partners. "We are incredibly excited to work with Genentech, and we look forward to demonstrating the power and utility of Lodo’s unique technology for the benefit of global human health."

Compounds derived from natural products comprise a significant proportion of the small molecule drugs used to treat cancer, infections and chronic illnesses such as Type 2 diabetes. Rather than relying on culturing known strains of bacteria, Lodo Therapeutics’ genome-based approach leverages the power of microbial evolution to identify novel, naturally occurring compounds that have therapeutic potential in the treatment of cancer and drug-resistant bacterial infections. This approach is expected to reduce the time and cost of drug discovery.

"Our ability to enter into a strategic collaboration with one of the leaders in innovating wholly new classes of drugs just two years after Lodo Therapeutics was founded reflects the potential of our proprietary platform to be a valuable resource to advance their drug discovery initiatives," said David Pompliano, Ph.D., co-founder and chief scientific officer of Lodo Therapeutics.

"We are excited to work with Genentech in their quest to discover novel, next-generation natural products derived from the microbiome of the soil using this innovative platform developed by Lodo," said Sean Brady, Ph.D., co-founder of Lodo Therapeutics and Associate Professor at The Rockefeller University. James Sabry, M.D., Ph.D., senior vice president and global head of Genentech Partnering, commented,

"Genentech is committed to accessing innovative technologies and we are excited to collaborate with Lodo Therapeutics to apply their Metagenomics Technology Platform to potentially discover therapeutics for difficult drug targets.