On November 1, 2017 Pain Therapeutics, Inc. (Nasdaq:PTIE) reported financial results for the third quarter ended September 30, 2017 (Press release, Pain Therapeutics, NOV 1, 2017, View Source [SID1234521394]). Net loss for the third quarter of 2017 was $2.6 million, or $0.40 per share, respectively, compared to a net loss for the same period in 2016 of $3.5 million, or $0.54 per share. Net cash used during the third quarter was $2.2 million. Cash and investments were $11.9 million as of September 30, 2017, with no debt. The Company still expects net cash usage in the calendar year 2017 may be approximately $10 million. Following the resubmission of the REMOXY NDA in Q1 2018, the Company believes net cash usage in 2018 will decrease significantly compared to 2017.

“The White House recently declared the opioid epidemic a public health emergency,” said Remi Barbier, President & CEO. “We fully support this policy position, and have been a voice in support of such a policy for many years. Nearly 15 years ago, Pain Therapeutics pioneered abuse-deterrent technology for opioid drugs specifically to provide policy makers, regulators, physicians, pharmacists and patients an additional tool to help combat the opioid epidemic. In partnership with all constituents, we look forward to doing our part to address the issues of overdose and death from extended-release opioid drugs.”

Operating Highlights for Q3 2017

In September, the National Institutes of Health (NIH) awarded us a $1.8 million research grant to develop a blood-based diagnostic to detect Alzheimer’s disease.
In September, The National Institute on Drug Abuse (NIDA) awarded us a $2.2 million research grant to further develop FENROCK, an abuse-deterrent transdermal patch that contains the prescription drug fentanyl.
In October, we announced a successful Phase I clinical study for PTI-125, our drug candidate for the treatment of Alzheimer’s disease. As previously announced, our scientists plan to present full results of this study at the 10th Annual International Conference on Clinical Trials on Alzheimer’s Disease, in Boston, MA, on November 1-4th.
In October, we announced the FDA had agreed to a pre-NDA guidance meeting on November 14th to discuss the upcoming resubmission of an NDA for REMOXY ER. We will provide details of this FDA meeting after receipt of final meeting minutes.
Recently, we substantially completed a previously announced human nasal study with REMOXY ER. We plan to announce top-line results of this study by yearend 2017.
Financial Highlights for Q3 2017

At September 30, 2017, cash and investments were $11.9 million, compared to $14.1 million at June 30, 2017. The Company has no debt.
Net cash used during the three months ended September 30, 2017 was $2.2 million.
Research and development expenses for the three months ended September 30, 2017 decreased to $1.6 million, respectively, from $2.7 million for the same period in 2016, primarily due to decreases in REMOXY related expenses and the receipt of research grant funding from the National Institutes of Health for FENROCK and PTI-125, recorded as a reduction in research and development expenses activities. Research and development expenses included non-cash stock-related compensation of $0.3 million in both three months ended September 30, 2017 and 2016.
General and administrative expenses increased slightly to $1.0 million in the three months ended September 30, 2017 from $0.9 million for the same period in 2016. General and administrative expenses included non-cash stock-related compensation of $0.4 million in the three months ended September 30, 2017 compared to $0.5 million for same period in 2016.
About REMOXY ER (extended-release oxycodone capsules CII)
REMOXY ER is a proprietary, abuse-deterrent, extended-release oral formulation of oxycodone. The proposed indication for this drug candidate is for “the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.” We developed REMOXY to make oxycodone difficult to abuse yet provide 12 hours of steady pain relief when used appropriately by patients. In particular, REMOXY’s thick, sticky, high-viscosity gel-cap formulation may deter unapproved routes of drug administration, such as injection, snorting or smoking.

About Opioid Abuse
Opioid drugs such as oxycodone are an important treatment option for patients with severe chronic pain. However, oxycodone abuse and diversion remains a serious, persistent problem. Drug overdose deaths exceeded 64,000 in 2016, according to the CDC. For over a decade, Pain Therapeutics has pioneered Abuse-Deterrent Formulations (ADFs) to help in the fight against prescription drug abuse. ADFs attempt to raise the bar on prescription drug abuse by making it difficult, longer or aversive to tamper with long-acting opioid formulations, recognizing that no drug can be made abuse-proof.

About Pain Therapeutics, Inc.
We develop proprietary drugs that offer significant improvements to patients and physicians. Our expertise consists of developing new drugs and guiding these through various regulatory and development pathways in preparation for their eventual commercialization. We generally focus our drug development efforts around disorders of the nervous system. The FDA has not yet established the safety or efficacy of our drug candidates.

Our pipeline of drug assets includes:

REMOXY ER — (extended-release oxycodone capsules) Proprietary abuse-deterrence, twice-daily oxycodone targeted at severe chronic pain. NDA resubmission planned for Q1 2018.

PTI-125 Rx — Proprietary small molecule drug targeted at the treatment of Alzheimer’s disease. Phase I clinical-stage program, substantially funded by a research grant award from the NIH.

PTI-125 Dx — Blood-based diagnostic to detect Alzheimer’s disease. Early-stage program, substantially funded by a research grant award from the NIH.

FENROCK — (transdermal fentanyl patch system) Proprietary abuse-deterrent skin patch to treat severe pain. Early-stage program, substantially funded by a research grant award from National Institute on Drug Abuse.

NOTE: REMOXY ER and FENROCK are trademarks of Pain Therapeutics, Inc.

Important Note Regarding Forward-Looking Statements: This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Pain Therapeutics disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, statements regarding our projected cash usage in CY2017 and CY2018, statements regarding potential discussions with the FDA and the abuse-deterrent properties and potential benefits of REMOXY ER. Such statements are based on management’s current expectations but actual results may vary materially due to various factors, many of which are beyond the control of management. Drug development involves substantial risks and uncertainties, including but not limited to those risks and uncertainties relating to successfully completing the activities required to address the issues raised by the FDA in the September 2016 Complete Response Letter for REMOXY ER and the time required to do so, including the time required to reach resolution with the FDA on the scope of the appropriate actions to be undertaken and the possibility that the FDA may raise additional issues in the future that were not raised in the past. In addition, the development of abuse-deterrent drug products is a young and still emerging area of drug development, with regulatory guidance that may be inconsistent, unclear or still in development. Such statements are based on management’s current expectations, but actual results may differ materially due to various factors. For further information regarding these and other risks related to our business, investors should consult our filings with the U.S. Securities and Exchange Commission.

On November 1, 2017 Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) reported its financial results for the third quarter ended September 30, 2017 and provided a corporate update (Press release, Momenta Pharmaceuticals, NOV 1, 2017, View Source [SID1234521392]).

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“We continue to believe in the potential for the approval and launch of Glatopa 40 mg in late 2017 or early 2018 and that there remains a meaningful market opportunity for this product in the U.S.,” said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. “In the third quarter of 2017, we continued to advance our broad portfolio of biosimilar and novel drug candidates and more recently we were thrilled to announce the promotion of our co-founder, Ganesh Kaundinya, to Chief Operating Officer. We look forward to his continued contributions as we progress our robust portfolio of drug candidates.”

Third Quarter Highlights and Recent Events

Complex Generics:

Glatopa 20 mg: First FDA-approved, substitutable generic daily COPAXONE 20 mg (glatiramer acetate injection) for patients with relapsing forms of multiple sclerosis developed in collaboration with Sandoz

In the third quarter of 2017, Momenta recorded $10.9 million in product revenues from Sandoz’s Glatopa 20 mg sales.
In the third quarter of 2017, Momenta earned a $10 million milestone payment from Sandoz in connection with Glatopa 20 mg’s status at that time as the sole FDA-approved generic of COPAXONE 20 mg in the U.S. two years following its launch.
Glatopa 40 mg: Designed to be a generic version of three-times-a-week COPAXONE 40 mg for patients with relapsing forms of multiple sclerosis developed in collaboration with Sandoz

The Abbreviated New Drug Application (ANDA) submitted by Sandoz is under U.S. Food and Drug Administration (FDA) review. An approval of the application is dependent on the satisfactory resolution of the compliance observations stated in the FDA warning letter issued in February 2017 to Pfizer, the contracted fill/finish manufacturing partner for Glatopa. Pfizer has submitted a comprehensive response to the observations cited in the warning letter. The Company believes that marketing approval from the FDA continues to be possible in late 2017 or early 2018.
Biosimilars:

M923: a fully-owned proposed biosimilar to HUMIRA (adalimumab)

Momenta is working toward the first submission for marketing approval of M923 in late 2017. The Company expects first U.S. market formation for biosimilar versions of HUMIRA to begin in the 2022 – 2023 timeframe subject to marketing approval, patent considerations and litigation timelines.
M834: a proposed biosimilar to ORENCIA (abatacept) being developed in collaboration with Mylan

Momenta reported that M834 did not meet its primary pharmacokinetic endpoints in a Phase 1 study to compare the pharmacokinetics, safety and immunogenicity of M834 to US- and EU-sourced ORENCIA in normal healthy volunteers. Momenta and Mylan continue to gather and analyze these data to inform the next steps for the program.
M710: a biosimilar candidate being developed in collaboration with Mylan

Momenta and Mylan continue to progress M710 and are targeting a first regulatory submission for clinical development by early 2018.
Novel Drugs for Autoimmune Indications:

M281 (anti-FcRn): a fully human monoclonal antibody (mAb) targeting the neonatal Fc receptor (FcRn)

In August 2017, the Company completed the multiple ascending dose portion of the Phase 1 study in healthy volunteers. The Company plans to report the top-line data from the multiple ascending dose portion of the study in the fourth quarter of 2017.
M230 (SIF3): a Selective Immunomodulator of Fc receptors being developed in collaboration with CSL

In September 2017, Momenta announced that it opted into a 50% cost and profit sharing arrangement for all products developed under the CSL agreement, including M230. Under the agreement Momenta will fund 50% of global research and development and U.S. commercialization and manufacturing costs in exchange for 50% of U.S. profits. Royalties remain payable to Momenta for territories outside the U.S. and milestones are reduced.
Momenta and CSL have agreed upon a development plan for M230 and CSL is targeting a clinical trial in late 2017, subject to regulatory feedback.
M254 (hsIVIg): a robust, controlled sialylation process to generate tetra-Fc-sialylated immunoglobulins with consistent enhanced anti-inflammatory activity

The Company continues to progress the M254 program and expects to initiate an IND-enabling toxicology study in 2017 and is targeting a clinical trial in 2018.
Third Quarter 2017 Financial Results

Revenue: In the third quarter of 2017, the Company recorded $10.9 million in product revenues from Sandoz’s sales of Glatopa 20 mg compared to $23.3 million for the same period in 2016. The decrease in product revenues of $12.4 million, or 53%, was primarily due to higher sales deductions for Medicaid rebates, inventory price adjustments relating to Mylan’s entry into the COPAXONE market and a deduction of $0.2 million for reimbursement to Sandoz of the Company’s share of Glatopa-related legal expenses in the third quarter of 2017. In addition, under the terms of the collaboration agreement with Sandoz, the $10 million commercial milestone payment Momenta earned from Sandoz in the third quarter of 2017 was deducted from net profit prior to the calculation of Momenta’s 50% profit share.

Research and development revenue for the third quarter of 2017 was $13.2 million compared to $5.8 million recorded in the same quarter last year. The increase in research and development revenue of $7.4 million, or 128%, was primarily due to a $10 million commercial milestone payment earned by the Company on July 1, 2017 in connection with GLATOPA 20 mg/mL’s continuing to be the sole FDA-approved generic of COPAXONE at that time and achieving a certain level of contractually defined profits in the United States, partially offset by less revenue due to the termination of the Baxalta Collaboration Agreement, effective December 31, 2016, under which the Company was reimbursed for M923 employee expenses and external costs and for which Momenta recognized a portion of Baxalta’s initial upfront payment in the third quarter of 2016.

Total revenues for the third quarter of 2017 were $24.1 million compared to $29.1 million for the same period in 2016.

Operating Expenses: Total GAAP operating expenses were $58.6 million in the third quarter of 2017. Research and development expenses for the third quarter of 2017 were $37.9 million, compared to $31.6 million for the same period in 2016. The increase of $6.3 million, or 20%, was primarily due to $12.4 million in increased spending on M923, as the program was transitioned back to Momenta effective December 31, 2016 in connection with the termination of the Baxalta Collaboration Agreement, partially offset by a $3.4 million reduction in spend on the necuparanib program, which was discontinued in August 2016, and a $2.6 million lower spend on M230 as those costs are now shared with CSL.

General and administrative expenses for the third quarter of 2017 were $20.7 million, compared with $15.8 million for the same period in 2016. The increase of $4.9 million, or 31%, was primarily driven by approximately $3.3 million in legal fees relating to ongoing litigation and $0.8 million in personnel-related expenses driven by increased headcount and higher share-based compensation expense.

Third quarter non-GAAP operating expense was $51.6 million, at the lower end of previously provided guidance of $50 – $60 million for the fourth quarter of 2017. See “Non-GAAP Financial Information and Other Disclosures” and the table below entitled “Reconciliation of GAAP Results to Non-GAAP Financial Measures” for a reconciliation of GAAP operating expense to non-GAAP operating expense.

Net Loss: The Company reported a net loss of $33.2 million, or $0.44 per share for the third quarter of 2017 compared to a net loss of $17.5 million, or $0.26 per share for the same period in 2016.

Cash Position: At September 30, 2017, Momenta had $423.1 million in cash, cash equivalents and marketable securities compared to $456.8 million at June 30, 2017.

2017 Financial Guidance

Momenta provides non-GAAP operating expense guidance, which it believes can enhance an overall understanding of its financial performance when considered together with GAAP financial measures. Refer to the section of this press release below entitled “Non-GAAP Financial Information and Other Disclosures” for further discussion of this subject.

Non-GAAP operating expense is total operating expenses (which excludes collaboration expenses reimbursable by Mylan), less stock-based compensation expense and collaborative reimbursement revenues. Today, Momenta is providing updated non-GAAP operating expense guidance of approximately $200 – $210 million for 2017 and $43 – $53 million for the fourth quarter of 2017. The annual guidance includes approximately $50 million of spending on M923 that, as a result of Shire’s termination of the Baxalta collaboration agreement, will now be included in the Company’s 2017 operating expenses. The $50 million spend has been fully paid by Shire as part of the termination agreement.

The Company expects to recognize the $50 million upfront payment from CSL as revenue in the fourth quarter of 2017 and continues to expect to recognize revenue from Mylan’s $45 million upfront payment on a quarterly basis. The Company also estimates that collaborative reimbursement revenues will be approximately $0 – $2 million in the fourth quarter of 2017.

Non-GAAP Financial Information and Other Disclosures

Momenta uses a non-GAAP financial measure, non-GAAP operating expense, to provide operating expense guidance. Momenta believes this non-GAAP financial measure is useful to investors because it provides greater transparency regarding Momenta’s operating performance as it excludes non-cash stock compensation expense and collaborative reimbursement revenues. This non-GAAP financial measure should not be considered a substitute or an alternative to GAAP total operating expense and should not be considered a measure of Momenta’s liquidity. Instead, non-GAAP operating expense should only be used to supplement an understanding of Momenta’s operating results as reported under GAAP. Momenta has not provided GAAP reconciliation for its forward-looking non-GAAP annual or quarterly operating expense because Momenta cannot reliably predict without unreasonable efforts the timing or amount of the factors that substantially contribute to the projection of stock compensation expense, which is excluded from the forward-looking non-GAAP financial measure. The Company has provided the estimated reconciling information that is available without unreasonable effort in the section of this press release above entitled “2017 Financial Guidance.”

Conference Call Information

Management will host a conference call and webcast today at 10:00 am ET to discuss these results and provide an update on the Company. A live webcast of the conference call may be accessed on the “Investors” section of the Company’s website, www.momentapharma.com. Please go to the site at least 15 minutes prior to the call in order to register, download, and install any necessary software. An archived version of the webcast will be posted on the Momenta website approximately two hours after the call.

To access the call you may also dial (877) 224-9084 (domestic) or (720) 545-0022 (international) prior to the scheduled conference call time and provide the access code 6492819. A replay of the call will be available approximately two hours after the conclusion of the call and will be accessible through November 8, 2017. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide the access code 6492819.

On November 1, 2017 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) reported that the company will host its third quarter 2017 investor conference call and webcast at 8:30 am ET on Wednesday, November 8, 2017 (Press release, Merrimack, NOV 1, 2017, View Source [SID1234521390]).

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The call will cover an update on Merrimack’s recent progress as well as a summary of third quarter 2017 financial results. A press release detailing the information to be discussed on the call will be issued the morning of Wednesday, November 8, 2017. Investors and the general public are invited to listen to the call by dialing (877) 564-1301 (domestic) or (224) 357-2394 (international) five minutes prior to the start of the call and providing the passcode 6187659.

A listen-only webcast of the call will be available in the Investors section of Merrimack’s website, investors.merrimack.com, and a replay of the call will be archived there for six weeks.

On November 1, 2017 Intrexon Corporation (NYSE: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, reported it will release third quarter 2017 financial results after the market closes on Thursday, November 9th, 2017 (Press release, Intrexon, NOV 1, 2017, View Source [SID1234521389]). The Company will host a conference call that day at 5:30 PM ET to discuss the results and provide a general business update.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The conference call may be accessed by dialing 1-888-317-6003 (Domestic US), 1-866-284-3684 (Canada), and 1-412-317-6061 (International) and providing the number 7741944 to join the Intrexon Corporation Call. Participants may also access the live webcast through Intrexon’s website in the Investors section at View Source

Aeolus has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q/A [Amend], Aeolus, 2018, MAY 16, 2016, View Source [SID1234528062]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!