MRTX Braces For Busy Year, ADXS Stays Focused, OPHT Inks Gene Therapy Deals

(RTTNews) - The following are some of today's top gainers in the pharma/biotech sector.

1. Mirati Therapeutics Inc. (MRTX)

Gained 18.40% to close Thursday's (June 7) trading at $46.00.

News: The Company has offered to sell 2.75 million shares of its common stock to the public at a price of $38.85 per share.

In addition, Mirati is offering to certain investors pre-funded warrants to purchase up to an aggregate of 421,650 shares of common stock at a purchase price of $38.849 per warrant, which represents the per share public offering price for the common stock less the $0.001 per share exercise price for each such pre-funded warrant.

The aggregate gross proceeds from this offering are expected to be approximately $123.2 million. The offering is expected to close on or about June 11, 2018.

The underwriters have a 30-day option to purchase up to an additional 412,500 shares of common stock in connection with the public offering.

Pipeline:

The Company's lead product candidate is Sitravatinib, which is being evaluated as a single agent and in combination with Opdivo in non-small cell lung cancer. Also in the pipeline are MRTX849 and Mocetinostat, both of which are also being developed for non-small cell lung cancer.

Clinical Trials & Near-term Catalysts:

-- A phase II study of Sitravatinib in combination with Opdivo in non-small cell lung cancer is underway, with an update expected in the fall of 2018. -- A phase II study of Sitravatinib in bladder cancer is expected to be initiated in Q3, 2018. -- A phase Ib study of Sitravatinib as a single agent in non-small cell lung cancer is ongoing, with an update expected in the fall of 2018. -- IND filing for MRTX849 in non-small cell lung cancer is expected in Q4, 2018. -- A phase II study of Mocetinostat in non-small cell lung cancer is underway, with an update expected in the fall of 2018.

2. Advaxis Inc. (ADXS)

Gained 11.10% to close Thursday's trading at $1.90.

News: The Company announced a new prioritization of its product portfolio.

Plan details:

Advaxis has decided to reduce internal investment in axalimogene filolisbac (AXAL) and will seek partnership opportunities for AXAL in most human papillomavirus (HPV)-associated cancers, including cervical cancer.

If the company is unable to secure a partner within a limited period of time, Advaxis will wind down the ongoing phase III study of axalimogene filolisbac, dubbed AIM2CERV trial, in high-risk locally advanced cervical cancer, and will not conduct the ADVANCE PD-1 combination trial in metastatic cervical cancer, which has not yet been initiated.

Advaxis has determined to focus future development efforts for AXAL on HPV-positive head-and-neck cancer through cost-effective clinical studies that are currently being explored.

The Company will be increasing internal investment in the ADXS-NEO program, which is expected to enter phase I testing in the first half of this year, and in the ADXS-HOT program, for which IND is expected to be filed this year.

ADXS-NEO and ADXS-HOT are being developed for multiple cancers.

On March 12, 2018, the Company announced that the FDA placed a clinical hold on its phase 1/2 combination study of Axalimogene filolisbac with AstraZeneca's IMFINZI for the treatment of patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer. The clinical hold was implemented following a patient death, involving respiratory failure, in the trial.

Advaxis plans to submit a response to the FDA shortly, and expects to receive a response from the Agency within 30 days after the submission.

The Company also announced that its annual cash burn will be reduced to approximately $50 million from approximately $80 million through a combination of portfolio rationalization and headcount reduction.

3. Pacific Biosciences of California Inc. (PACB)

Gained 11.03% to close Thursday's trading at $3.02.

News: The Company has launched microbial multiplexing kit and new SMRT grant program.

The new tools enable microbiologists to do more, and see more than ever before, according to the Company.

Recent event:

On May 2, 2018, the Company reported financial results for its first quarter ended March 31, 2018.

Net loss for the first quarter of 2018 was $24.2 million or $0.20 per share compared to $23.9 million or $0.26 per share for the first quarter of 2017. Total revenue for the recent first quarter dropped to $19.4 million from $24.9 million in the year-ago comparable quarter.

The Company ended March 31, 2018 with cash of $79.3 million.

4. Daré Bioscience Inc. (DARE)

Gained 10.92% to close Thursday's trading at $1.32.

News: The Company announced the appointment of David Friend to the newly created role of Chief Scientific Officer (CSO).

Clinical Trials & Near-term Catalysts:

The lead product candidate is Ovaprene, a non-hormonal contraceptive ring intended to provide protection over multiple weeks of use.

A post-coital test (PCT) clinical trial for Ovaprene was initiated as recently as last month. The study is enrolling 50 couples, with the woman to be evaluated over the course of five menstrual cycles, with a target of having at least 25 women complete a total of 21 visits.

Data from the study is expected to be available in the second half of 2019. If all goes well as planned, the Company intends to prepare and file an Investigational Device Exemption (IDE) with the FDA to commence a pivotal clinical trial to support marketing approvals of Ovaprene in the United States, Europe and other countries worldwide.

5. Ophthotech Corporation (OPHT)

Gained 10.36% to close Thursday's trading at $3.09.

News: The Company has entered into an exclusive global license agreement with the University of Florida Research Foundation and the University of Pennsylvania (Penn) to develop and commercialize a novel adeno-associated virus (AAV) gene therapy product for the treatment of rhodopsin-mediated autosomal dominant retinitis pigmentosa, an eye disease.

Ophthotech expects to initiate a Phase 1/2 clinical trial in early 2020.

Near-term Catalyst:

-- Top-line data from a phase 2a clinical trial of Zimura in patients with wet age-related macular degeneration is expected to become available before the end of 2018.