On March 13, 2018 Melinta Therapeutics, Inc. (NASDAQ:MLNT), a commercial-stage company discovering, developing and commercializing novel antibiotics to treat serious bacterial infections, reported financial results and an update on commercial and regulatory activities for the quarter ended December 31, 2017 (Press release, Cempra, MAR 13, 2018, View Source [SID1234524729]). During the quarter, the Company completed its reverse merger with Cempra, Inc. (Cempra) to become a publicly traded company. Fourth quarter and full year 2017 results include the addition of the Cempra business as of the merger date of November 3, 2017. Immediately following the quarter, the Company acquired the infectious disease business of The Medicines Company, including products Vabomere (meropenem and vaborbactam), Orbactiv (oritavancin) and Minocin (minocycline) for Injection. This press release includes highlights from The Medicines Company infectious disease business as of acquisition close on January 5, 2018.

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"Following Melinta becoming a public company on November 3, we swiftly acquired the infectious disease business from The Medicines Company, transforming Melinta into the largest global, pure-play antibiotics company. Today, we have a strong portfolio of products including Vabomere, Orbactiv and Minocin for Injection, together with our first drug Baxdela that we launched just this quarter," said Dan Wechsler, president and CEO of Melinta.

"We have a strong combined team, including the addition of over 150 seasoned professionals at the time of The Medicines Company transaction, and a leading pipeline of development and discovery assets including those from our own Nobel Prize-winning discovery platform. 2018 will be an exciting year for Melinta, and we look forward to launching our products, furthering our pipeline and telling our story focused on bringing life-saving anti-infective products to areas of unmet need and, in turn, building strong shareholder value over the long-term," Mr. Wechsler concluded.

Full Year 2017 and Recent Business Highlights

• March 2, 2017 – entered into commercial and co-development agreement with Menarini Group for delafloxacin in 68 countries outside of the United States

• >$100 million of upfront and potential milestone payments and double-digit royalties on sales in partnered territories

• Menarini pays 50% of future delafloxacin indication-expansion efforts

LOGO

• June 19, 2017 – the U.S. Food and Drug Administration (FDA) approved Baxdela indicated in adults for treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria

• A fluoroquinolone that exhibits activity against both Gram-positive and Gram-negative pathogens, including the distinction of being the only approved drug in its class that covers methicillin-resistant Staphylococcus aureus (MRSA)

• A fixed-dose therapy with limited disease or drug interactions and is available in interchangeable intravenous and oral formulations

• September 26, 2017 – announced the expansion of agreement with Eurofarma Laboratorios S.A. (Eurofarma) to include 19 countries in South and Central America and the Caribbean

• Eurofarma has submitted a marketing authorization for delafloxacin in Argentina

• November 3, 2017 – completed the reverse merger with Cempra to become a publicly traded company

• January 5, 2018 – acquired the infectious disease business of The Medicines Company, including approved products Vabomere, Orbactiv and Minocin for Injection

• Added a well-experienced commercial, medical affairs and commercial support organization

• Integration nearing completion

• Minimal disruption to product launches or performance, including Vabomere, which was recently launched

• February 6, 2018 – launched Baxdela in the United States

• March 8, 2018 – partner Menarini submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for delafloxacin for treatment of adults with ABSSSI

Q4 and Full Year 2017 Financial Results

Melinta reported a net loss available to shareholders of $20.9 million, or $1.48 per share, for the quarter ended December 31, 2017 compared to a net loss of $27.7 million for the same period in 2016. For the full year ended December 31, 2017, the Company reported net loss available to shareholders of $78.2 million.

Research and development expenses were $11.6 million for the quarter ended December 31, 2017, compared to $16.3 million for the same period in 2016. The decrease was driven primarily by fourth quarter 2016 New Drug Application (NDA)-related fees and milestone payments and lower manufacturing costs. For the full year ended December 31, 2017, the Company reported R&D expenses of $49.5 million.

LOGO

Selling, general and administrative expenses were $37.3 million for the quarter ended December 31, 2017, compared to $4.6 million for the same period in 2016. The increase was driven primarily by commercial launch preparation activities for Baxdela and transaction- and integration-related costs, including severance and stock-based compensation, due to the merger. For the full year ended December 31, 2017, the Company reported selling, general and administrative expenses of $63.3 million.

As of December 31, 2017, Melinta had cash and cash equivalents of $128.4 million. In addition, the Company has available debt capacity under the Deerfield agreement. It is anticipated that Melinta may strengthen its cash position through the completion of business development activities, similar to the transaction completed with Menarini. The Company also recently filed a universal shelf registration statement on Form S-3 with the SEC, which will allow the Company to provide more timely and efficient access to the capital markets should the Company decide to issue securities in the future, subject to market conditions.

2017 and Recent Pipeline and Publication Highlights

Includes highlights from The Medicines Company infectious disease business as of acquisition close on January 5, 2018.

• Publication of Baxdela Outcomes in ABSSSI Patients with Fluoroquinolone-resistant S. aureus Isolates

• Presented Outcomes of Baxdela Treatment of Gram-Positive and Gram-Negative Pathogens at IDWeek 2017

• Announced Topical Radezolid (partnered product) Well Tolerated in Phase 1 Study for Treatment of Acne, Initiation of Program in Patients with Bacterial Vaginosis, and Qualified Infectious Disease Product (QIDP) Designation for Bacterial Vaginosis

• Publication in Journal of Antimicrobial Chemotherapy of 1st Pivotal Phase 3 Baxdela Trial Data in ABSSSI

• Complete Results from the Phase 3 TANGO-1 Data for Vabomere Published in The Journal of the American Medical Association (JAMA)

• 2nd Pivotal Phase 3 Baxdela ABSSSI Trial Data Published in Clinical Infectious Diseases

• Discovery Platform Oral Presentations at European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) and American Society for Microbiology (ASM Microbe) Highlighting Progress Towards Leads for Drug-resistant Neisseria gonorrhoeae and Multidrug- and Extremely Drug-resistant ESKAPE Pathogens

2018 Upcoming Potential Catalysts

• Pivotal Phase 3 data for Baxdela in community-acquired bacterial pneumonia (CABP)

• Vabomere EMA regulatory approval decision

• TANGO-2 additional data and potential publications

• Additional ex-US approvals for Baxdela in Central and South America

• Ex-US partnership opportunities for Vabomere, Orbactiv and Minocin for Injection

• IND-enabling studies for lead ESKAPE compound

Conference Call and Webcast

Melinta’s earnings conference call for the quarter ended December 31, 2017 will be broadcast at 8:30am EDT on March 13, 2018. The live webcast can be accessed under "Events and Presentations" in the Investor Relations section of Melinta’s website at www.melinta.com.

Investors wishing to participate in the call should dial: 877-377-7553 and international investors should dial: 253-237-1151. The conference ID is 7787858. Investors can also access the call at View Source

A live webcast of the call will be available online from the investor relations section of the company website at www.melinta.com and will be archived there for 30 days. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 7787858.

AVEO has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, AVEO, 2018, MAR 13, 2018, View Source [SID1234524709]).

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On March 12, 2018 BUSINESS WIRE)–TARIS reported that CEO Purnanand Sarma is presenting, March 12th, at the Cowen and Company 38th Annual Health Care Conference from 8:30-8:55 a.m. ET in the Northeastern Room, 3rd floor at the Boston Marriott Copley Place (Press release, , DEC 12, 2018, View Source [SID1234524690]).

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On March 12, 2018 Crinetics Pharmaceuticals, Inc., a rare disease therapeutics company focused on endocrine disorders and endocrine-related cancers, reported an oral presentation and two poster presentations relating to the company’s drug development candidates (Press release, Crinetics Pharmaceuticals, MAR 12, 2018, View Source [SID1234525096]). These presentations will be made at the upcoming ENDO 2018, the Annual Meeting of the Endocrine Society, taking place from March 17-20, 2018 in McCormick Place West, Chicago, Illinois.

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Oral Presentation:

Title: Phase 1 Clinical Trial of CRN00808, an Orally Bioavailable sst2-Selective, Nonpeptide Somatostatin Biased Agonist for the Treatment of Acromegaly: Safety, Pharmacokinetics, and Inhibition of GHRH-Induced GH Secretion.
Session: OR06 – Pituitary Tumors: Acromegaly and Prolactinomas.
Poster: ORO6-3.
Date and Time: Saturday, March 17, 12-12:15 p.m. CDT
Location: W192.

Poster Presentations:

Title: Suppression of Growth Hormone and Insulin-Like Growth Factor 1 in Rats After Oral Administration of CRN00808, a Small Molecule, SST2 Selective Somatostatin Biased Agonist.
Session: P32 – Pituitary Transcription Factors and New Hormonal Signaling Pathways.
Poster: SUN-604.
Date and Time: Sunday, March 18, 1-3 p.m. CDT
Location: ENDOExpo, Hall F.

Title: Somatostatin Subtype 5 (sst5) Agonists for the Treatment of Hyperinsulinism: Orally-Bioavailable Small Molecules Suppress Insulin and Rescue Glyburide-Induced Hypoglycemia.
Session: P14-3 – Pediatric Endocrinology – Disorders of Sexual Differentiation, Transgender Medicine, Metabolic Disorders, and Growth.
Poster: MON-193.
Date and Time: Monday, March 19, 1-3 p.m. CDT
Location: ENDOExpo, Hall F.

On March 12, 2018 -Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that financial results for the three months ended January 31, 2018 and provides a business update (Press release, Advaxis, MAR 12, 2018, View Source [SID1234524666]).

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Recent Key Accomplishments Include:

Conditional Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA) for the company’s lead Lm Technology product candidate, axalimogene filolisbac, for the treatment of adult women who progress beyond first-line therapy of persistent, recurrent or metastatic carcinoma of the cervix (PRmCC);
Acceptance of data for publication from a Phase 2 clinical study of axalimogene filolisbac as a treatment for PRmCC in the peer-reviewed International Journal of Gynecological Cancer;
Three abstracts highlighting the company’s Listeria-based immunotherapy in combination with antibody-based immunotherapies have been accepted for poster presentation at the upcoming 2018 Keystone Symposia on Cancer Immunotherapies: Combinations (C5);
Publication of data from an investigator-initiated study of axalimogene filolisbac in combination with chemoradiation as a treatment for high-risk, locally advanced anal cancer in the International Journal of Radiation Oncology; and
$20.0 million in gross proceeds raised in a public offering of common stock.
Clinical Hold

In the evening of March 9, 2018, the company received notification from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) application for its Phase 1/2 combination study of axalimogene filolisbac with IMFINZI (durvalumab) for the treatment of patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer was placed on clinical hold. The clinical hold pertains to a recent submission of a safety report to the FDA regarding a Grade 5 Serious Adverse Event (patient death) on February 27, 2018 involving respiratory failure which occurred following the sixth combination cycle in the trial. Enrollment and further dosing are on hold in this trial while the company, its partner and the FDA work closely with the site investigator to review this event in detail and to resolve this clinical hold.

Enrollment and dosing in all other Advaxis clinical programs are unaffected at this time.

"We care deeply for our patients and for their safety as we work to research and develop new treatment options for advanced cancers. We believe in the potential of our Lm Technology to provide new advancements in the area of cancer care," stated Anthony Lombardo, interim Chief Executive Officer of Advaxis. "We are confident in the safety and efficacy profile of axalimogene filolisbac, to date, based on our experience in over 250 patients and over 700 doses across multiple trials in HPV-associated cancers."

Management Commentary

"We are pleased with the progress we made during the quarter across a number of important areas. In particular, we were delighted to file the MAA with the EMA for conditional approval of axalimogene filolisbac for the treatment of metastatic cervical cancer, a condition that causes approximately 24,000 deaths annually in Europe," stated Mr. Lombardo. "This is a significant milestone for Advaxis as it is our first marketing application for an Lm Technology product."

"Throughout the first quarter, we continued to advance our clinical programs and were pleased to announce the publication and presentation of data in support of the potential of our Lm-based antigen delivery platform to treat a variety of cancers in peer-reviewed journals and at premier medical and scientific meetings.

"Our goals for 2018 remain steadfast as we execute our plans to advance our robust clinical development programs across our four franchises: HPV-associated cancers, neoantigen therapy, hotspot/ cancer antigens and prostate cancer. Over the coming months, we expect to make meaningful progress with these programs and to achieve a number of important value-creating milestones," Mr. Lombardo concluded.

Balance Sheet Highlights

As of January 31, 2018, Advaxis had cash, cash equivalents and investments of $59.4 million, which included $4.5 million related to its previously announced participation in the New Jersey NOL program and the receipt of $2.7 million in connection with its controlled equity offering sales agreement. The company used approximately $12.7 million in cash to fund operations during the first quarter of fiscal year 2018, mainly attributed to funding strategic development programs and related personnel and infrastructure to support the company’s progress and growth.

Following the close of the first quarter, Advaxis completed an underwritten public offering of 10,000,000 shares of common stock at $2.00 per share for gross proceeds of $20.0 million before deducting the underwriting discounts and commissions and other estimated offering expenses.

Throughout fiscal year 2018, Advaxis plans to continue to invest in its core clinical programs and expects its current cash position will be sufficient to fund its business plan into the second calendar quarter of 2019.

Financial Highlights for First Quarter Fiscal Year 2018

The net loss for the first quarter ended January 31, 2018 was $20.5 million or $0.49 per share based on 41.4 million shares outstanding. This compares with a net loss for the first quarter of fiscal year 2017 of $17.1 million or $0.43 per share based on 40.1 million shares outstanding.

Research and development expenses for the first quarter of fiscal year 2018 were $17.1 million, compared with $13.6 million for the first quarter of fiscal year 2016. The increase was primarily due to continued investment in support of the company’s preclinical and clinical development programs, including support of the AIM2CERV Phase 3 clinical trial and costs associated with the MAA filing, which are now expected to wind down, post-submission. The increase also reflects higher headcount versus the first quarter of fiscal 2017, to support research and development initiatives primarily for the neoantigen franchises.

General and administrative expenses for the first quarter of fiscal year 2018 were $5.5 million, compared with $7.3 million for the fiscal year 2017 first quarter. The decrease was largely attributable to non-cash stock-based compensation expense in the prior-year quarter.

Conference Call and Webcast Information

Advaxis’ senior management will host a conference call to review financial results, provide a business update and answer questions. The conference call and live audio webcast will begin today at 4:30 p.m. Eastern time.

To access the conference call please dial (844) 348-6133 (domestic) or (631) 485-4564 (international) and refer to conference ID 2588455. A live and archived audio webcast of the call will be available on the company’s website at ir.advaxis.com/events-presentations.

For those unable to participate in the live conference call or webcast, a recording will be available beginning two hours after the call ends. To access the recording, dial (855) 859-2056 or (404) 537-3406 and provide conference ID 2588455.