Recently Presented Preclinical Data Show Potential for ADXS-NEO as Anti-Cancer Immunotherapy Agent

On May 11, 2018 Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported on recently presented preclinical data demonstrating the anti-cancer potential of their Lm vector that presents tumor neoantigens, and is being evaluated in the ADXS-NEO program (Press release, Advaxis, MAY 11, 2018, View Source [SID1234526525]). ADXS-NEO is derived from the Company’s proprietary Lm Technology and is being developed in partnership with Amgen.

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These preclinical findings were discussed in poster presentations at the recent American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Additionally, portions of these data were presented by Amgen at a podium presentation during the European Neoantigen Summit 2018.

The first study, as discussed in a poster presentation at AACR (Free AACR Whitepaper) entitled "Neoantigens that fail to elicit measurable T cell responses following peptide immunization can control tumor growth when delivered using a Listeria-based immunotherapy platform," showed that ADXS-NEO generates T cell responses against neoantigen peptides that control tumor growth, even when they were identified as "non-immunogenic" using a conventional peptide-adjuvant immunization. The poster is available here: View Source

In the second study, discussed in a poster presentation at AACR (Free AACR Whitepaper) entitled "Targeting frameshift mutations with a Listeria monocytogenes immunotherapy drives neoantigen-specific antitumor immunity in MC38 and CT26 mouse tumor models," Advaxis’ Lm platform was shown to target frameshift mutations and generate T cells to multiple neoantigens per frameshift in MC38 and CT26 mouse tumor models. The poster is available here: View Source

"The results of these studies highlight the therapeutic potential of targeting neoantigens and suggest that ADXS-NEO could impact the way we approach treatment across a range of cancers," said Ken Berlin, President and CEO of Advaxis. "We look forward to our continued collaboration with Amgen, and to moving into the clinic with this product candidate."

"These preclinical findings provide foundational rationale suggesting that ADXS-NEO has the potential to generate immune responses against multiple neoantigens with the ability to control tumor growth. This is a personalized approach that uses a patient’s own immune system to recognize and eliminate cancer cells harboring multiple mutations that caused their malignancy," said Robert G. Petit, Ph.D., Chief Scientific Officer and Executive Vice President of Advaxis. "We also saw potent immune responses targeting frameshift mutations and control of tumor growth via multiple complementary mechanisms. This is important because frameshift mutations are observed to generate up to nine times more neoantigens per mutation than in-frame mutations" according to Turajlic, et al.

About ADXS-NEO

ADXS-NEO is a personalized Listeria monocytogenes (Lm)-based immunotherapy designed to generate immune response against mutation-derived tumor-specific neoantigens. The program focuses on creating a customized treatment with neoantigens specifically selected based on a biopsy of the patient’s tumor. The approach enables the development of tailored immune-therapies. ADXS-NEO is being evaluated in collaboration with Amgen.

The AngloNordic Life science conference

On May 10, 2018 MonTa Biosciences reported that attend the AngloNordic Life science conference in London on Mya 24th to meet investors and network with other European biotechs and investors (Press release, MonTa Biosciences, MAY 10, 2018, View Source [SID1234618633])

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STORM Therapeutics to present at Bio€quity Europe 20

On May 10, 2018 STORM Therapeutics, the drug discovery company focused on the discovery of small molecule therapies modulating RNA epigenetics, reported that it will be giving a company presentation at Bio€quity Europe 2018, Ghent, Belgium, 14 – 16 May 2018 (Press release, STORM Therapeutics, MAY 10, 2018, View Source [SID1234561044]).

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Keith Blundy, CEO of STORM Therapeutics will be presenting on Wednesday, 16 May 2016 at 9:10am CEST in Rector Gillis Suit, Level 1, Het Pand, Onderbergen 1, Ghent, Belgium.

Now celebrating its 19th meeting, Bio€quity Europe is the seminal industry event for financial dealmakers looking for investor-validated life science companies positioning themselves to attract capital, and for pharmaceutical licensing professionals to assess top prospects. Bio€quity Europe has showcased more than 700 leading European companies to thousands of investment and pharma business development professionals.

10-Q – Quarterly report [Sections 13 or 15(d)]

Osiris 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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La Jolla Pharmaceutical Company Announces Financial Results for the Three Months Ended March 31, 2018 and Recent Corporate Progress

On May 10, 2018 La Jolla Pharmaceutical Company (Nasdaq: LJPC), a leader in the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, reported financial results for the three months ended March 31, 2018 and highlighted recent corporate progress (Press release, La Jolla Pharmaceutical, MAY 10, 2018, View Source [SID1234526585]).

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Recent Corporate Progress

In May 2018, La Jolla closed a $125 million royalty financing agreement with HealthCare Royalty Partners (HCR). Under the terms of the agreement, La Jolla will receive $125 million in exchange for tiered royalty payments on worldwide net sales of GIAPREZA. Payments under the agreement start annually at a maximum royalty rate, with step-downs based on the achievement of annual net sales thresholds. Through December 31, 2021, the royalty rate will be a maximum of 10%. Starting January 1, 2022, the maximum royalty rate may increase by 4% if an agreed-upon, cumulative sales threshold has not been met, and, starting January 1, 2024, the maximum royalty rate may increase by an additional 4% if a different agreed-upon, cumulative sales threshold has not been met. The agreement is subject to maximum aggregate royalty payments to HCR of 180% of the $125 million to be received by La Jolla, at which time the payment obligations under the agreement would expire. The agreement was entered into by La Jolla’s wholly owned subsidiary, La Jolla Pharma, LLC, and HCR has no recourse under the agreement against La Jolla or any assets other than GIAPREZA.

In March 2018, La Jolla announced the commercial availability of GIAPREZATM (angiotensin II) injection for intravenous infusion (formerly known as LJPC-501). In December 2017, GIAPREZA was approved by the U.S. Food and Drug Administration (FDA) to increase blood pressure in adults with septic or other distributive shock. GIAPREZA mimics the body’s endogenous regulatory peptide that is central to the renin-angiotensin-aldosterone system to increase blood pressure. Prescribing information for GIAPREZA is available at www.giapreza.com.

In March 2018, an analysis, entitled "Outcomes in Patients with Acute Kidney Injury Receiving Angiotensin II for Vasodilatory Shock," was presented at the 23rd International Conference on Advances in Critical Care Nephrology AKI & CRRT 2018. The manuscript of this analysis, entitled "Outcomes in patients with vasodilatory shock and renal replacement therapy treated with intravenous angiotensin II," was published online in Critical Care Medicine. The presentation and manuscript detail the outcomes of patients with acute kidney injury (AKI) and vasodilatory shock enrolled in the ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock) Phase 3 study of GIAPREZA. In this post-hoc analysis, the data from 105 AKI patients (GIAPREZA n=45; placebo n=60) requiring renal replacement therapy (RRT) at study drug initiation were analyzed. Survival through day 28 was 53% (95% CI: 38%-67%) for the GIAPREZA group compared to 30% (95% CI: 19%-41%) for the placebo group (p = 0.012). By day 7, 38% (95% CI: 25%-54%) of patients treated with GIAPREZA discontinued RRT compared to 15% (95% CI: 8%-27%) of patients treated with placebo (p = 0.007). Mean arterial pressure (MAP) response at hour 3 was achieved in 53% (95% CI: 38%-68%) of patients treated with GIAPREZA compared to 22% (95% CI: 12%-34%) of patients treated with placebo (p = 0.001).

In February 2018, an abstract, entitled "Effect of Disease Severity on Survival in Patients Receiving Angiotensin II for Vasodilatory Shock," was presented at the Society of Critical Care Medicine’s (SCCM) 47th Critical Care Congress. The abstract, which was published in the January Supplement of Critical Care Medicine, includes results from a pre-specified analysis from the ATHOS-3 Phase 3 study of GIAPREZA in patients with high severity of illness, defined as an APACHE II (Acute Physiology and Chronic Health Evaluation II) score > 30 or baseline MAP < 65 mmHg, despite treatment with high-dose vasopressors. The authors presented data showing a lower 28-day mortality rate in patients with baseline APACHE II scores > 30 in the GIAPREZA group versus the placebo group: 28-day mortality was 51.8% (n = 58) for the GIAPREZA group compared to 70.8% (n = 65) for the placebo group (hazard ratio=0.62 [95% CI: 0.39, 0.98; p=0.037]). In patients with a baseline MAP < 65 mmHg, a trend towards improved 28-day mortality was seen in the GIAPREZA group compared to the placebo group: 28-day mortality was 54.2% (n = 52) for the

Exhibit 99.1

GIAPREZA group compared to 70.4% (n = 50) for the placebo group (hazard ratio=0.66 [95% CI: 0.40, 1.09; p=0.10]).

"This first quarter was the start of an exciting and transformational year for La Jolla, highlighted by the commercial launch of GIAPREZA," said George Tidmarsh, M.D., Ph.D., La Jolla’s President and Chief Executive Officer. "We are excited to bring this new treatment option to the many critically ill patients suffering from septic or other distributive shock."

Results of Operations

As of March 31, 2018, La Jolla had $154.4 million in cash and cash equivalents, compared to $90.9 million as of December 31, 2017. On a pro-forma basis, adjusting for the net proceeds from the May 2018 royalty financing, La Jolla’s cash and cash equivalents as of March 31, 2018 were $279 million. Cash used for operating activities for the three months ended March 31, 2018 was $45.9 million, compared to $22.0 million for the same period in 2017. La Jolla recognized GIAPREZA net product sales of $0.8 million for the three months ended March 31, 2018. La Jolla launched GIAPREZA in March 2018. La Jolla’s net loss for the three months ended March 31, 2018 was $50.5 million, or $2.22 per share, compared to $23.2 million, or $1.26 per share, for the same period in 2017