On March 28, 2018 Prometic Life Sciences Inc. (TSX: PLI, OTCQX: PFSCF) (Prometic) reported its fourth quarter and year ended December 31, 2017 highlights and financial results (Press release, ProMetic Life Sciences, MAR 28, 2018, View Source [SID1234525064]).

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"In 2017, Prometic continued to deliver positive clinical activity and tolerability data in its key clinical development programs. Both of our therapeutic platforms’ respective lead drug candidates, PBI-4050 and plasminogen, have great commercial potential targeting both niche and large unmet medical needs," said Pierre Laurin, President and Chief Executive Officer of Prometic. 2017 provided us with the opportunity to strengthen our pipeline of products, realign our clinical program priorities and focus on specific clinical indications where we will be able to play a leading role with defined competitive advantages. We are fortunate to have the ability to pursue clinical development of many different indications with the same assets and we intend to take full advantage of this rare situation".

Commenting on the 2017 financial results, Bruce Pritchard, Prometic’s Chief Operating Officer and Chief Financial Officer said: "With the exception of one large provision relating to the bad debt associated with the SRAM receivable, our underlying 2017 financial results built consistently quarter-to-quarter, finishing in line with our expectations, objectives and earlier guidance. We have stabilized our R&D and administrative, selling and marketing expenses at targeted levels and invested selectively to put in place our commercial infrastructure in anticipation of the commercial launch of plasminogen and other drug candidates.

The recent realignment of our clinical development program will ensure we can prioritize the advancement of our most promising clinical assets consistent with our capital resources in a way that is aligned in both scale and timing, with the financial resources available. We remain mindful of the need to balance the maintenance of an appropriate capitalization level with both the expectation of our shareholders and the availability and cost of financing available. We are fully focused on non-dilutive financing activities, including the pursuit of meaningful licensing opportunities, to deliver that financial flexibility, and to act as a foundation for long-term financial stability."

Small Molecule Therapeutics Highlights and Updates:

Prometic researched the activity of its drug candidates such as PBI-4050 in over 30 different preclinical models in collaboration with universities and institutions. PBI-4050 was also investigated in three separate phase 2 clinical trials, which support the translation of these preclinical results into humans and help pave the way for the initiation of a pivotal phase 3 clinical trial for IPF in the USA.

Update: The Corporation announced the publication in the American Journal of Pathology of the novel antifibrotic mechanism of action of its small molecule lead drug candidate, PBI-4050. The paper entitled "A Newly Discovered Antifibrotic Pathway Regulated by Two Fatty Acid Receptors: GPR40 and GPR84" documents the discovery of an antifibrotic pathway involving these two receptors acting as dual master switches.

PBI-4050 (for Alström Syndrome) – Prometic announced that its orally active lead drug candidate, PBI-4050, was granted an orphan drug designation for the treatment of Alström Syndrome ("AS") by the European Commission. The company also announced that PBI-4050 has been issued a Promising Innovative Medicine ("PIM") designation by the UK Medicines and Healthcare Products Regulatory Agency ("MHRA") for the treatment of AS. An orphan drug designation status had been previously granted, by the FDA, for Prometic’s orally active, anti-fibrotic, lead drug candidate, PBI-4050, for the treatment of Alström Syndrome.

Prometic announced that longer-term data from its on-going Phase 2 open label clinical trial of PBI-4050 in subjects suffering from AS in the UK confirm that the clinical activity previously observed was sustained during prolonged treatment. The clinical study had then enrolled 12 subjects. Given the evidence of clinical activity and continuing tolerability, the Data Safety Monitoring Board (DSMB) and Medicines and Healthcare products Regulatory Agency (MHRA) allowed for two successive extensions in the duration of treatment. The duration of treatment has been extended from the original 24 weeks for an additional 36 weeks, and then once more for a further 12 weeks (for a total of 72 weeks). This last extension was to ensure that subjects could remain on treatment while the regulatory authorities were reviewing a rollover protocol which, if approved, would allow subjects to remain on treatment for an additional period of up to 96 weeks, or until regulatory approval is obtained in the UK.

Update : Prometic reported on March 28, 2018 positive clinical data from ongoing PBI-4050 study in Alström syndrome patients.

PBI-4050 (for IPF) – Prometic received FDA Investigational New Drug (IND) approval to commence its pivotal Phase 3 clinical trial of its oral anti-fibrotic lead drug candidate, PBI-4050, in patients suffering from IPF. The FDA had granted Fast Track designation to PBI-4050 and the candidate also received a Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) as add-on treatment to nintedanib in patients with IPF.

Update: Prometic received IND approval from the FDA to commence its PBI-4050 pivotal Phase 3 clinical trial in patients suffering from Idiopathic Pulmonary Fibrosis ("IPF").

Based on feedback from the FDA, Prometic now will undertake an "all comers study". The enrollment criteria will be greatly simplified so that the study will enroll patients with mild-to-moderate IPF, regardless of whether they are on background standard of care with nintedanib (OFEV) or not. Therefore, the study will provide efficacy data on both PBI-4050 as a stand-alone agent, and as an add-on to nintedanib, and will be part of the dataset to support a simple, all-inclusive indication "for the treatment of IPF". Patients will be randomized to receive placebo, or one of two doses of PBI-4050 (800 mg or 1,200 mg) for a total of 52 weeks. An interim analysis will be conducted at 26 weeks. The primary endpoint is the annual rate of decline in forced vital capacity (FVC), the total amount of air exhaled during a forced breath, (expressed in mL) and measured over 52 weeks (mL/year). Patients taking pirfenidone will be excluded because of a known drug-drug interaction between pirfenidone and PBI-4050.

PBI-4050, PBI-4547 AND PBI-4425 (development and commercialization in China) – In August 2017, the Company entered into a licensing agreement and partnership agreement with Jiangsu Rongyu Pharmaceuticals Co, LTD and Nanjing Rongyu Biothech Co., LTD, affiliates of Shenzhen Royal Asset Management Co., LTD (collectively, "SRAM"), regarding the licensing of the Chinese rights to its small molecules PBI-4050, PBI-4547 and PBI-4425.

Update: In October 2017, the Chinese government disclosed a series of regulatory measures favorable to foreign companies seeking to commercialize therapeutics in China. These reflect the government’s aim to change China from a "Me too" to a "Me first" philosophy of drug development and has now turned China into a "strategic" and "vital" market for pharmaceutical companies. Such measures include changes in the regulatory system allowing the use of clinical data generated outside of China, a faster review thereof as well as lower taxes on selected drugs. The mounting strategic interest in the Chinese market expressed by several pharma companies with whom the Company is having business development discussions, and the fact that we believe that we would be in a position to potentially advance IPF in China independently, has contributed to Prometic’s decision to exercise its right to terminate the agreements with SRAM. By holding 100% of the rights for PBI-4050 and its analogues for all indications in China keeps all of Prometic’s options open to maximise the value of its assets in this important market.

Plasma-Derived Therapeutics Highlights and Updates:

RYPLAZIMTM (plasminogen) – for congenital plasminogen deficiency – Prometic completed the filing of its plasminogen Biologics License Application ("BLA") with the FDA for the treatment of patients with congenital plasminogen deficiency. Prometic’s plasminogen had earlier been granted Orphan Drug and Fast Track Designations by the FDA for said indication.

Prometic announced new long-term clinical data from its pivotal Phase 2/3 trial of RYPLAZIM (plasminogen) in patients with congenital plasminogen deficiency. The data demonstrated that in 10 patients treated with RYPLAZIMTM (plasminogen) for a total of 48 weeks, there was no observed recurrence of lesions and no tolerability issues observed related to this longer-term dosing. Prometic had previously reported clinical data from this pivotal Phase 2/3 trial, in which Prometic observed that RYPLAZIMTM (plasminogen) treatment consistently replaced and maintained the plasminogen concentration in plasma at an adequate level and that all lesions resolved in all 10 patients treated for 12 weeks. Under the same pivotal Phase 2/3 protocol, these 10 patients had been treated for an additional 36 weeks, for a total drug exposure period of 48 weeks.

The FDA granted a Rare Pediatric Disease Designation to Prometic’s RYPLAZIMTM (plasminogen) for the treatment of patients with congenital plasminogen deficiency..

The FDA accepted the filing of Prometic’s BLA for its RYPLAZIMTM (plasminogen) replacement therapy and granted priority review status and set a Prescription Drug User Fee Act (PDUFA) action date for April 14, 2018.

Update: The current BLA filing includes the clinical data on 10 patients with 12 weeks of data for an accelerated regulatory pathway. Since filing the current BLA, Prometic has accumulated additional clinical data encompassing more than 3,200 infusions of RYPLAZIM (plasminogen) over treatment periods exceeding 48 weeks during which similar clinical activity and tolerability profiles, as previously reported, were observed. The original guidance from the FDA was for Prometic to submit such long-term clinical data in a supplemental BLA in order to secure full licensure in 2019. Full licensure would provide for the long-term efficacy and safety data to be included in the prescribing information of RYPLAZIM (plasminogen) which would further support Prometic’s claims of the strong health economics benefit associated with the use of RYPLAZIM (plasminogen).

The FDA’s review of the BLA raised no issues regarding the clinical data for the accelerated approval. The FDA has, however, identified the need for Prometic to make a number of changes in the Chemistry, Manufacturing and Controls (CMC) section of its BLA. These changes require the implementation and validation of additional analytical assays and "in-process controls" in the manufacturing process of RYPLAZIM (plasminogen). While Prometic is expecting to complete said implementation and validation in April 2018, it will be necessary to manufacture additional RYPLAZIM (plasminogen) lots to support the implementation and validation of these process changes. Prometic expects to complete the manufacturing of the additional validation lots in the summer of 2018 and anticipates being able to provide the FDA with such new CMC data for its review in the fourth quarter of 2018, which is beyond the Prescription Drug User Fee Act (PDUFA) date of April 14, 2018. The FDA requested that such CMC data be submitted as an amendment to the current BLA and has invited Prometic to also submit the long-term (48-week) clinical data at the same time instead of through the originally agreed upon supplemental BLA process. This process will allow the FDA to consider granting full-licensure under the current BLA. If granted, this is expected to allow a faster sales ramp-up from launch than could have been achieved had provisional licensure been obtained by the current PDUFA date. The Company continues to interact with the FDA and will provide a further update when it is in a position to disclose a new PDUFA date. The FDA indicated that the submission of the new CMC data will not impact the previously granted designations, including the Priority Review Status, the Orphan Drug Designation and the Rare Pediatric Disease Designation for RYPLAZIM (plasminogen) for the treatment of congenital plasminogen deficiency.

RYPLAZIM (plasminogen) – for IPF – Orphan drug designation status was granted to Prometic’s RYPLAZIM (plasminogen) for the treatment of Idiopathic Pulmonary Fibrosis ("IPF") by the FDA. In an animal model that emulates pulmonary fibrosis in humans, Prometic’s RYPLAZIM (plasminogen) performed favorably compared to recently- approved IPF drugs to treat this condition. We observed that RYPLAZIM (plasminogen) significantly reduced tissue scarring in the lungs, indicating the potential for providing clinically significant improvement and stabilization in lung function.

RYPLAZIM (plasminogen) – for Acute Lung Injury / Acute Respiratory Distress Syndrome – The Company presented new data at the 2017 American Thoracic Society (ATS) International Conference in Washington, D.C. demonstrating the benefits of plasminogen administration in reducing lung injury in a gold standard animal model of ALI/ARDS associated with acute pancreatitis.

Plasminogen – for Chronic Tympanic Membrane Perforation –The Company received approval by the Swedish Medical Products Agency to commence a clinical trial with its plasminogen therapy in patients suffering from chronic tympanic membrane perforation (chronic TMP). The is a dose escalation, randomized, placebo-controlled study designed to investigate the safety, feasibility and initial efficacy of local injections of a novel and proprietary plasminogen formulation for the treatment of chronic tympanic membrane perforation. Up to 33 adult patients are expected to be enrolled. The study is being conducted at a single center in Sweden, under the supervision of Cecilia Engmér Berglin, MD, PhD from the Department of Otorhinolaryngology at Karolinska University Hospital in Stockholm, Sweden. The Karolinska University Hospital is the second largest ear/nose/throat center in the world.

Plasminogen – for Diabetic Foot Ulcers – The Company received approval by the Swedish Medical Products Agency (MPA) Clinical Trial Application (CTA) to commence a Phase 2 clinical trial of its plasminogen therapy in patients suffering from diabetic foot ulcers (DFU). The Phase 2 clinical trial is a prospective, dose escalation study of the safety, feasibility and initial efficacy of subcutaneous plasminogen for the treatment of DFU in 20 adult subjects. The study is being conducted in one study center in Sweden, under the supervision of Dr. Jan Apelqvist, an expert in the field of diabetic foot ulcers and hard to treat wounds from the Department of Endocrinology, Division of Clinical Sciences at Skane University Hospital in Malmö, Sweden.

IVIG for Primary Immunodeficiency Disorder (PIDD) – The Company announced positive interim six-month clinical data from its ongoing pivotal IVIG Phase 3 clinical trial in patients suffering from primary immunodeficiencies (PID). Review of the data by the Data Safety Monitoring Board (DSMB) confirmed no significant safety issues and that clinical activity appeared to be comparable to existing commercial IVIG products. This data meets Health Canada’s requirements for a New Drug Submission (NDS) filing with at least 20 evaluable PID patients treated with Prometic’s IVIG for a minimum six-month period together with comparison data from a similar six-month period during which patients received comparable approved commercial IVIG products. Forty-nine adult and 10 pediatric patients have completed at least six months of treatment with Prometic’s IVIG in the current trial. Comparisons with the approved products include safety, Immunoglobulin (IgG) levels, frequency of infections, use of antibiotics, periods of hospitalization due to severe infections and missed days of school or work.

These results from its pivotal IVIG Phase 3 trial will enable Prometic to complete the clinical portion of its New Drug Submission with Health Canada.

Update: The ongoing non-inferiority phase 3 clinical trial for IVIG in adults, required for the filing of a BLA in the USA, is expected to be completed in the first quarter of 2018 followed by the pediatric cohort completion in the first quarter 2019.

INTER ALPHA-ONE INHIBITOR PROTEINS (IAIP) – for the treatment of Necrotising Enterocolitis in Neonates (NEC) a condition that accounts for approximately 19% of the US’s annual neonatal medical expenditures as well as an estimated $5 billion in annual hospitalization costs in the US.

Update: The Company received from the FDA a Rare Pediatric Disease Designation for its IAIP for the treatment of NEC. In addition to the Rare Pediatric Disease Designation, IAIP was also granted an Orphan Drug Designation by the FDA in February 2018.

Bioseparation Technologies Highlights:

The Company received a $9.5 million purchase order for the supply of affinity resin to an existing client, a global leader in the biopharmaceutical industry. This purchase order is part of an ongoing license and long-term supply agreement previously secured with the client. Supply of the affinity resin (manufactured by Prometic at its Isle of Man facility) to the client began in the second half of 2017 and will continue throughout 2018. Prometic’s client is using the resin for large-scale purification of a therapeutic protein product manufactured in large quantities.

Corporate Highlights:

Prometic closed a $53.1 million bought deal equity offering of common shares through the syndicate of underwriters led by Cantor Fitzgerald Canada Corporation as the lead underwriter and sole bookrunner, and including RBC Dominion Securities Inc., National Bank Financial Inc., Scotia Capital Inc., Desjardins Securities Inc. and Echelon Wealth Partners Inc. Prometic issued 31,250,000 common shares of at a price of $1.70 per share for gross proceeds of $53.1 million. In addition, Prometic completed a concurrent, non-brokered private placement of 5,045,369 common shares of at a price of $1.70 per common share (the "Private Placement") with Structured Alpha LP ("SALP"), an affiliate of Peter J. Thomson’s investment firm, Thomvest Asset Management Inc. following the exercise by SALP of its pre-emptive right to participate in any future public offering of Prometic’s common shares. The $8.6 million in proceeds from the Private Placement were used to offset and reduce the total amount owed by Prometic to SALP pursuant to the previously mentioned Loan entered into in April, 2017.

Prometic closed the previously mentioned USD $80 million (CAD $100 million) credit facility with SALP. As partial consideration for establishing the credit facility, Prometic granted SALP an initial 10 million warrants with an exercise price of CAD $1.70 per common share with a term expiring June 30, 2026, alongside an additional 44 million warrants at the same exercise price and term, which will vest in tranches each time Prometic draws an additional amount of USD $10 million (CAD $12.5 million) under the Credit Facility. Drawing on the first 4 tranches of USD $10 million (CAD $12.5 million) would each cause 5 million warrants to vest, whereas drawing on the second set of 4 tranches of USD $10 million (CDN $12.5 million) would each cause 6 million warrants to vest. All amounts drawn from the credit facility will bear interest of 8.5% per annum and the principal will be repayable on November 30, 2019.

2017 Year-End Financial Results

Total revenues for the year ended December 31, 2017 were $39.1 million compared to $16.4 million for the year ended December 31, 2016. Revenues from milestones and licensing revenues for the year ended December 31, 2017 were $19.7 million; there were no milestones and licensing revenues for the year ended December 31, 2016.

The Company incurred a net loss of $120.0 million during the year ended December 31, 2017 compared to a net loss of $110.7 million in 2016, representing an increase in the net loss of $9.3 million.

The Company incurred total R&D costs of $100.4 million during the year ended December 31, 2017 compared to $87.6 million during the year ended December 31, 2016. R&D expenses include the manufacturing cost of plasma-derived and small molecule therapeutics to be used in clinical trials and other R&D purposes. The manufacturing cost of these therapeutics represents approximately $34.0 million of the $100.4 million in R&D expenses during the year ended December 31, 2017 and $33.2 million of the $87.6 million in R&D expenses during the year ended December 31, 2016. This represents an increase of $0.8 million during the year ended December 31, 2017 compared to the corresponding period in 2016.

Other R&D expenses, excluding the manufacturing cost of therapeutics to be used in R&D activities discussed above, were $66.4 million during the year ended December 31, 2017 compared to $54.4 million for the corresponding period in 2016, representing an increase of $12.0 million. The increase is partially due to higher salary and benefit expenditures by approximately $6.4 million reflecting the increase in employees working on the clinical trials and at our research centers. In addition, Contract Research Organizations ("CRO") and investigator expenses incurred in relation to the clinical trials and pre-clinical activities increased by $2.3 million reflecting the increase in the number of trials in progress, the duration and higher patient enrolment of the trials.

Administrative, selling and marketing expenses amounted to $31.4 million during the year ended December 31, 2017 compared to $28.5 million during the year ended December 31, 2016. The increase is mainly attributable to the increase in consulting expenses of $3.0 million incurred in relation to the preparation for the plasminogen launch.

2017 Fourth Quarter Financial Results

Total revenues for the fourth quarter ended December 31, 2017 were $6.6 million compared to $4.1 million for the fourth quarter ended December 31, 2016. Revenues from the sale of goods amounted to $5.5 million for the fourth quarter ended December 31, 2017, compared to $3.3 million for the quarter ended December 31, 2016. There were no milestones and licensing revenues for the fourth quarters of either 2017 or 2016.

R&D expenses remained stable at $28.2 million during the quarter ended December 31, 2017 compared to $28.0 million for the corresponding period in 2016.

Administrative, selling and marketing expenses amounted to $8.7 million during the fourth quarter of 2017, compared to $12.0 million for the quarter ended December 30, 2016 representing a decrease of $3.2 million due mainly to the severance, salary and benefit expenditures of $2.1 million in rationalization efforts at Telesta following the acquisition in the last quarter of 2016.

Bad debt expense

Bad debt expense was $20.5 million during the year and the quarter ended December 31, 2017 compared to $0.8 million for the corresponding periods in 2016, representing an increase of $19.7 million. The current year expense is due to the write-off, affecting the fourth quarter of 2017, of the amounts due in regards to a license agreement. The licensee having not remitted funds associated with the license fee and initial milestone payment within the specified payment terms was consequently in breach of the agreement. As a result, the Company was in a position to exercise its contractual rights and opted to terminate the agreement in March 2018, thereby returning all the rights previously conferred under the license agreement back to Prometic.

Conference Call Information

Prometic will host a conference call at 8:00 am (ET) on Thursday March 29, 2018. The telephone numbers to access the conference call are (647) 427-7450 and 1-888-231-8191 (toll-free). A replay of the call will be available from Thursday March 29, 2018 at 10:00 am until April 5, 2018. The numbers to access the replay are 1-416-849-0833 (passcode: 9793595) and 1-855-859-2056 (passcode: 9793595). A live audio webcast of the conference call, with slides, will be available through the following : View Source

Additional Information in Respect to the Fourth Quarter and Year ended December 31, 2017

Prometic’s MD&A and 2017 consolidated financial statements for the quarter and year ended December 31, 2017 will be filed on SEDAR (View Source) and will be available on the Company’s website at www.prometic.com.

On March 28, 2018 Tempest Therapeutics Inc.,a development-stage biotechnology company advancing small molecules that modulate anti-tumor immunity pathways, reported the completion of a $70 million Series B financing led by founding investor Versant Ventures and by F-Prime Capital and Quan Capital (Press release, Tempest Therapeutics, 28 28, 2018, View Source [SID1234525046]). The syndicate also includes Lilly Asia Ventures, Foresite Capital and Eight Roads Ventures.

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"We are strong believers in the promise of small molecule therapeutics that target immune cells in the tumor microenvironment," said Brad Bolzon, managing director and chair of Versant and Tempest. "With a portfolio of several high-quality drug candidates and an experienced management team, Tempest is well-positioned to introduce new therapies for multiple malignancies."

Tom Dubensky has been appointed as Tempest CEO, and has recruited an experienced development team to translate these programs into the clinic over the coming months. "We are extremely excited to debut Tempest today and look forward to rapidly advancing a superior IDO inhibitor into the clinic as the first of four new programs," said Dr. Dubensky. "It is very gratifying to have attracted a top-tier syndicate of investors who share our belief in the depth and breadth of Tempest’s pipeline. Our ongoing collaboration with Inception will not only facilitate development of the existing pipeline but also allow for discovery of complementary drug candidates that promote induction of effective anti-tumor immunity."

Tempest is developing first-in-class and best-in-class small molecules that modulate distinct immune response pathways. Proceeds from the Series B financing will support the advancement of lead program TPST-8844 into the clinic in the next 12 months as well as advancement of at least two other programs into the clinic shortly thereafter.

TPST-8844 is a potent inhibitor of IDO, an enzyme that is over-expressed in tumor cells and suppresses the activity of immune cells in the surrounding microenvironment. The combination of an IDO inhibitor and checkpoint inhibitor such as an anti-PD-1 has been shown as a synergistic combination with the potential to be the therapy of choice in multiple malignancies. Tempest’s unpublished preclinical data suggest TPST-8844 has superior features to others currently in development.

TPST-1120 is a first-in-class antagonist of the peroxisome proliferator-activated receptor alpha (PPARα) transcription factor. Tempest has shown that blocking PPARα inflames the tumor microenvironment and activates important tumor-killing immune cells. TPST-1120 has shown durable efficacy in multiple tumor models both as a single agent and in combination with other cancer therapies.

Tempest’s E-prostanoid (EP) receptor antagonists can effectively interrupt the immuno-suppressive effects of prostaglandin. The company has translated its unique insights about EP receptor subtypes to produce novel compounds with increased anti-tumor efficacy compared with pan-EP or single EP inhibitors currently in clinical development.

The company’s molecules were developed by Inception Sciences, a Versant Ventures Discovery Engine led by Peppi Prasit. In late 2017, Tempest spun out as an independent company led by Dr. Dubensky. Dr. Dubensky brings significant expertise in the development and translation of novel immune therapies, having served most recently as chief scientific officer of Aduro Biotech where he led the advancement of first-in-class STING agonists.

In connection with today’s financing Tempest has added three new members to its board of directors: Tom Woiwode, managing director at Versant, Robert Weisskoff, a partner at F-Prime Capital, and Stella Xu, managing director at Quan Capital. They join existing board members Dr. Dubensky, Dr. Prasit and Dr. Bolzon.

On March 28, 2018 -Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a company focused on discovering and developing innovative, protein-based immunotherapies targeting the immune synapse to treat cancer, autoimmune, and inflammatory diseases, reported financial results for the year ended December 31, 2017 (Press release, Alpine Immune Sciences, 28 28, 2018, View Source;oq=Alpine+Immune+Sciences+Provides+Corporate+Update+and+Reports+Full+Year+2017+Financial+Results&aqs=chrome..69i57j69i60l2.1122j0j7&sourceid=chrome&ie=UTF-8 [SID1234525043]).

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"We expect to file an IND in the fourth quarter of 2018 for our lead autoimmune/inflammatory program ALPN-101, a potential first-in-class dual ICOS/CD28 antagonist, and an IND in 2019 for our lead oncology program ALPN-202, a dual PD-L1/CTLA-4 antagonist with CD28 costimulation."

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"We are pleased with the progress we have made and look forward to having two programs entering clinical trials from our proprietary Variant Immunoglobulin Domain (vlgD) technology. The preclinical data we have generated supports the biologic rationale of our approach and we believe Alpine is at the forefront of next-generation therapeutics capable of both inhibiting and/or activating multiple human immune system proteins simultaneously," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. "We expect to file an IND in the fourth quarter of 2018 for our lead autoimmune/inflammatory program ALPN-101, a potential first-in-class dual ICOS/CD28 antagonist, and an IND in 2019 for our lead oncology program ALPN-202, a dual PD-L1/CTLA-4 antagonist with CD28 costimulation."

Alpine will present a poster at the upcoming 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The poster will show data from preclinical experiments in the ALPN-202 program, which is based on a single vIgD protein capable of modulating multiple immune system targets for the treatment of cancer. Alpine’s CD80 vIgD-Fc fusion proteins are capable of antagonizing both PD-L1 and CTLA-4, while providing T cell costimulation via CD28.

Poster Title: CD80 vlgD-Fc proteins combine checkpoint antagonism and costimulatory signaling for potent antitumor immunity
Session Category: Clinical Research
Session Title: Immune Checkpoints 4
Session Date and Time: Tuesday, April 17, 2018 – 1:00 PM – 5:00 PM
Location: McCormick Place South, Exhibit Hall A, Poster Section 25
Poster Board #: 5
2017 Highlights

Completion of Preferred Financing and Merger with Nivalis Therapeutics: On July 24, 2017, Alpine closed its merger with Nivalis Therapeutics. The combined company, named Alpine Immune Sciences, Inc., began trading on the NASDAQ Global market on July 25, 2017 under the ticker symbol "ALPN". Upon completion of the merger, Alpine had approximately $90 million in cash, cash equivalents, and short-term investments. This included $17.0 million in proceeds from the purchase of Alpine convertible preferred shares immediately prior to the merger from current Alpine investors OrbiMed Advisors, Frazier Healthcare Partners, and Alpine BioVentures at a purchase price of $12.74 per share.

American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP): Alpine’s poster at the 2017 ACR/ARHP Annual Meeting disclosed preclinical studies evaluating ALPN-101 program dual ICOS/CD28 antagonists generated by Alpine’s directed evolution platform. ICOSL vIgD-Fc fusion proteins demonstrated potent activity in an animal model of rheumatoid arthritis and in a humanized mouse model of graft vs. host disease (GvHD), suggesting ALPN-101 candidates could have potential clinical utility in multiple inflammatory diseases.

American Society of Hematology (ASH) (Free ASH Whitepaper): At the 59th Annual ASH (Free ASH Whitepaper) Meeting & Exposition, Alpine’s poster disclosed results from a preclinical study of the Company’s lead program, ALPN-101, in a humanized model of graft vs. host disease (GvHD). Results showed Alpine’s ICOSL vlgD-Fc fusion proteins demonstrated therapeutic efficacy, reducing GvHD disease activity and improving survival.

San Antonio Breast Cancer Symposium (SABCS): Alpine’s poster at the 40th Annual SABCS disclosed preclinical data combining vIgDs generated by its novel directed evolution platform with the monoclonal antibody trastuzumab. Alpine scientists fused a costimulatory ICOS/CD28 vIgD to trastuzumab with the goal of activating T cells against HER2-positive tumors in the tumor microenvironment. Results showed these trastuzumab-ICOSL "V-mAbs" promoted T cell proliferation and cytokine secretion.

Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper): At the SITC (Free SITC Whitepaper) 32nd Annual Meeting, Alpine’s poster disclosed distinct preclinical data from multiple novel immuno-oncology programs, all also generated from its vlgD technology. Multiple formats of vIgD-based proteins were functionally active, utilizing multiple mechanisms of action. Some suppressed tumors in an animal model. The demonstrated versatility of the scientific platform suggests it has the potential to contribute to the next generation of immuno-oncology therapeutics.

Full Year 2017 Financial Results

As of December 31, 2017, Alpine had cash, cash equivalents, and short-term investments totaling $81.2 million. Net cash used in operating activities for the year ended December 31, 2017 was $16.6 million compared to $3.8 million for the year ended December 31, 2016. Alpine recorded a net loss of $7.8 million and $1.2 million for the years ended December 31, 2017 and 2016, respectively.

Collaboration revenue for the year ended December 31, 2017 was $1.7 million compared to $2.9 million for the year ended December 31, 2016. The decrease was primarily attributable to the timing of revenue recognized under Alpine’s collaboration agreement with Kite Pharma, Inc., a Gilead (NASDAQ:GILD) company. As previously announced, under the terms of this research collaboration and license agreement, Alpine received upfront payments of $5.5 million, which were initially recorded as deferred revenue and expensed over the period of the research term. The research term of the agreement with Kite was extended in October 2017.

Research and development expenses for the year ended December 31, 2017 were $10.6 million compared to $3.0 million for the year ended December 31, 2016. The increase was primarily attributable to an increase in direct research, contract manufacturing, and process development activities to support ALPN-101, plus increases in research personnel related to expanding research and discovery programs and associated overhead and facility costs.

General and administrative expenses for the year ended December 31, 2017 were $6.1 million compared to $1.1 million for the same period in 2016. The increase was primarily attributable to professional and legal service fees to support the merger with Nivalis and operating as a public company, in addition to personnel-related expenses and costs associated with expanding the company’s operations as it accelerates preclinical activity.

The excess of the estimated fair value of net assets acquired over the acquisition consideration paid for Nivalis resulted in a bargain purchase gain to the statement of operations. This is a non-cash item.

Cash Guidance

The company expects to have cash to fund operations into 2020, including the clinical advancement of its lead autoimmune/inflammatory program, ALPN-101, and its lead oncology program, ALPN-202.

Alpine Immune Sciences, Inc. is focused on developing novel protein-based immunotherapies using its proprietary variant Ig Domain (vIgD) technology. vIgDs are designed to interact with multiple targets, including many present in the immune synapse. Alpine’s vIgDs are developed using its directed evolution platform, which produces proteins capable of either enhancing or diminishing an immune response and thereby may potentially apply therapeutically to cancer, autoimmune, and inflammatory diseases. Alpine has also developed Transmembrane Immunomodulatory Protein (TIP) technology, based on vIgDs, to potentially enhance engineered cellular therapies. For more information, visit www.alpineimmunesciences.com.

Forward-Looking Statements

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding Alpine’s platform technology, potential therapies, potential milestone and royalty payments, future development plans, clinical and regulatory objectives and the timing thereof, expectations regarding the sufficiency of cash to fund operations into 2020, expectations regarding the plans of its collaborator, and expectations regarding the potential efficacy and commercial potential of Alpine’s and its collaborator’s product candidates. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "intend," and other similar expressions among others. These forward-looking statements are based on current assumptions involving risks, uncertainties, and other factors that may cause actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: Alpine’s discovery-stage and pre-clinical programs may not advance into the clinic or result in approved products on a timely or cost-effective basis or at all; Alpine may not achieve additional milestone payments pursuant to its collaborations; the impact of competition; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof, Alpine undertakes no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

"Transmembrane Immunomodulatory Protein," "TIP," "Variant Ig Domain," "vIgD," and the Alpine logo are registered trademarks or trademarks of Alpine Immune Sciences, Inc. in various jurisdictions. All other trademarks belong to their respective owne

On March 28, 2018 -Checkmate Pharmaceuticals (Checkmate), a clinical-stage biopharmaceutical company focused on developing novel approaches for cancer immunotherapy, reported that it will present data at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place in Chicago from April 14 – April 18 (Press release, Checkmate Pharmaceuticals, 28 28, 2018, View Source(AACR)+Annual+Meeting&oq=Checkmate+Pharmaceuticals+to+Present+Data+at+the+2018+American+Association+for+Cancer+Research+(AACR)+Annual+Meeting&aqs=chrome..69i57j69i60.3354j0j7&sourceid=chrome&ie=UTF-8 [SID1234525042]). Data on Checkmate’s Phase 1b trial in subjects with advanced melanoma will be presented in an oral presentation in the Clinical Trials Plenary Session CTPL04 – Novel Immuno-oncology Strategies.

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Oral Presentation Details:

Title: Intratumoral Toll-Like Receptor 9 (TLR9) Agonist, CMP-001, In Combination With Pembrolizumab Can Reverse Resistance To PD-1 Inhibition In A Phase 1b Trial In Subjects With Advanced Melanoma
Abstract No: 10610
Presentation Number: CT144
Date/Time: April 17, 2018; 10:30 AM
Location: North Hall C, McCormick Place North (Level 1)

On March 28, 2018 Moleculin Biotech, Inc. (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported its financial results for the year ended December 31, 2017 (Press release, Moleculin, MAR 28, 2018, View Source [SID1234525040]). Additionally, the Company announced potential upcoming milestones and recent corporate developments.

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Management Discussion
Walter Klemp, Chairman and CEO of Moleculin, said, "We continued to make significant progress in developing Moleculin’s distinctive cancer treatment technologies during 2017. We firmly believe that all three of our highly differentiated technologies have breakthrough potential in effectively treating various cancers. From those three core technologies, we now have six potential drug candidates, two of which we expect will commence clinical trials in 2018, with the possibility of a third before the end of the year.

"Our potentially disruptive technologies include Annamycin, a chemotherapy agent that is active against multidrug resistant tumor cells and has been designed to be non-cardio toxic (unlike currently approved drugs in this class); immuno-stimulating STAT3 inhibitors WP1066 and WP1732 that target glioblastoma and pancreatic cancer; and WP1122, an inhibitor of glycolysis that has been shown in preclinical testing to effectively block the energy supply required by cancer cells and effectively starves the cancer cells to death. Our diverse development portfolio gives Moleculin what I like to call multiple shots on goal."

The Company submitted an application in October 2017 for a Clinical Trial Authorization ("CTA") for Annamycin in Poland. Having met all the requirements, the Ethics Committee in Poland approved the Phase I/II trial of Annamycin for the treatment of relapsed or refractory acute myeloid leukemia ("AML") in December 2017. In March the Company received requests for and provided additional information to the Polish National Office. It expects a response from the Polish National Office in the first half of 2018 and at the earliest mid-April 2018. The start of clinical trials in Poland remains subject to confirmation and approval of the CTA by the Polish National Office. The Company can provide no assurance that it will receive such confirmation on a timely basis, if at all.

In addition, the Company continues to recruit and contract clinics both in the United States and Poland. In the U.S., the Company has one site — University Hospitals Cleveland Medical Center ("UHCMC") — recruiting patients and enrollment has begun. The Company can provide no assurance that it will continue enrollments or begin treatment on a timely basis, if at all.

Mr. Klemp continued, "Additionally, this past December we announced that a physician-sponsored Investigational New Drug ("IND") application for a Phase I trial of Moleculin’s WP1066 in patients with recurrent malignant glioma and brain metastasis from melanoma was allowed by the U.S. Food and Drug Administration ("FDA"). This will be our second drug in clinical trials. The trial will be conducted at the MD Anderson Cancer center to evaluate safety and efficacy. We believe WP1066 represents a new class of oncology drugs able to fight tumors on two fronts by directly inhibiting cell signaling supporting tumor activity, and independently stimulating a natural immune response. This constitutes a new approach to treating brain tumors and tumor metastasis to the brain.

"We also intend to request a clinical trial authorization in Poland for WP1220 for the topical treatment of Cutaneous T-Cell Lymphoma (CTCL), which we expect will become our third compound in clinical trials in 2018. WP1220 is one of our patented STAT3 inhibitors designed to be compatible with topical formulations and was selected based on its preclinical activity in CTCL cell lines and based on the need for better topical treatments for skin cancer.

"As we look ahead to 2019 and beyond, we are excited about a new molecule that we recently licensed from MD Anderson — WP1732 — that shares many of the same characteristics of WP1066, especially its ability to inhibit activated STAT3, which is widely considered a key transcription factor involved in the development and progression of tumors. WP1732 has demonstrated significantly different organ distribution in animal models, suggesting it could be especially well-suited to target systemic solid tumors including pancreatic cancer, one of the most deadly and difficult to treat.

"An important attribute of WP1732 is that it is more water-soluble than WP1066. So, while we have been focused on oral delivery of WP1066, WP1732 is ideally suited to intravenous ("IV") administration, which makes the delivery of the drug potentially more convenient and efficacious. We’ve already started the process of preparing the preclinical data necessary for an IND for WP1732 and we hope to have that preparation completed in 2018.

"I also want to acknowledge the outstanding Scientific Advisory Board that is part of the Moleculin brain trust. Waldemar Priebe, PhD., a Founder of Moleculin and the Company’s Founding Scientist, leads a team of world renown experts in various cancer fields that includes John Paul Waymack, MD; Elihu Estey, MD; and Jorge Cortes, MD. Together with our two Chief Medical Officers, Robert Shepard, MD (Annamycin), and Sandra Silberman, MD (New Products), their expertise and guidance have enabled us at Moleculin to successfully proceed in the development of our highly differentiated compounds. Our expectation is that 2018 will see significant progress in advancing our portfolio of unique cancer treatments," concluded Mr. Klemp.

Fourth Quarter Highlights and Recent Corporate Developments
Moleculin Announces Grant-Funded Collaboration to Expand Understanding of New Discovery – March 20, 2018, the Company announced it has entered into a collaboration with a team of scientists in Poland who have received a $300,000 research grant to expand the understanding of how Moleculin’s leading STAT3 inhibitor WP1066 and the Company’s newly discovered drug candidate, WP1732, create a blockade of transcription factor STAT3 leading to tumor cell death and immune-stimulating effects.

Moleculin Announces Pricing of $9 Million Registered Direct Offering – February 16, 2018, the Company announced that it has entered into a definitive agreement with institutional investors for a registered direct offering of securities with gross proceeds of approximately $9 million.

Moleculin Announces Breakthrough Discovery of a New Molecule for Cancer Treatment – February 15, 2018, the Company announced that, pursuant to its continued collaboration with MD Anderson it has developed and licensed what it believes, based on preclinical testing, is a major breakthrough in its effort to develop a new cancer treatment that selectively kills highly resistant tumors. Specifically, the Company has preclinical evidence to suggest it is capable of influencing a process known as ‘ubiquitination’ to block the activated form of STAT3, an important oncogenic transcription factor. The lead molecule resulting from this new discovery is called WP1732 and it not only appears to share the same key mechanistic properties with WP1066, it has markedly different organ distribution and its dramatically increased solubility makes it ideal for administration via standard IV injection. Importantly, preclinical testing has also shown that WP1732’s properties make it a promising candidate for treating pancreatic cancer.

Moleculin Announces Collaboration with Emory University to Develop Novel Treatment of Pediatric Brain Cancer – February 13, 2018, the Company announced it has entered into an agreement with Emory University to enable expanded cancer research on Moleculin’s WP1066 molecule for the possible treatment of medulloblastoma, a pediatric malignant primary brain tumor. Physician-scientists at Emory University and Children’s Healthcare of Atlanta have requested support to continue research aimed at the development of a novel treatment of medulloblastoma using WP1066 and Moleculin has agreed to supply them with a pure form of WP1066 for preclinical testing for the potential future treatment of patients with the disease. Emory studies so far have indicated that medulloblastoma may be particularly vulnerable to the ability of WP1066 to block the activated form of STAT3, a key signaling protein believed to contribute to the growth and survival of many tumors, including medulloblastoma.

Moleculin Announces Activity with Pancreatic Cancer Drug – February 7, 2018, the Company announced it has been able to show promising tumor suppression activity with its inhibitor of glycolysis, WP1122. The Company’s glycolysis inhibitors have shown a remarkable affinity for concentrating in the pancreas and has solid data showing the ability of WP1122 to inhibit pancreatic tumor growth in mice.

Leading Leukemia Experts Join Moleculin’s Science Advisory Board – January 17, 2018, the Company announced the expansion of its Science Advisory Board to include Drs. Jorge Cortes and Elihu Estey.

Jorge Cortes, M.D., is deputy chair and professor of medicine in the Department of Leukemia at MD Anderson Cancer Center where he directs the CML and AML Programs. Dr. Cortes received his medical degree in 1986 from the Universidad Nacional Autonoma de Mexico, and has been at MD Anderson since 1991. Dr. Cortes, whose clinical interest focuses on new drug development and the management of patients with myelodysplatic syndromes, acute and chronic leukemias, and myeloproliferative disorders, has authored over 900 peer-reviewed medical publications in top-tier journals including New England Journal of Medicine, Lancet Oncology, Lancet Hematology, Journal of Clinical Oncology, Leukemia, Blood and many others.

Elihu Estey, M.D., is a Professor of Medicine in the Division of Hematology at the University of Washington School of Medicine and a Full Member and Director of AML Clinical Research (non-transplant) Clinical Research Division, Fred Hutchinson Cancer Research Center. Dr. Estey has built a distinguished career in cancer research approaching 40 years of active clinical practice with AML patients, providing mentorships for many physicians that have risen to prominence in AML, lectured globally to professional audiences on cancer research and published more than 700 articles on hematologic malignancies, specifically on AML. Additionally, Dr. Estey serves on the European Leukemia Net (ELN) guidelines committee for AML and has served as an advisor for AML studies to the Oncology Drugs Advisory Committee ("ODAC") of the FDA.

Moleculin Expands Leukemia Development Portfolio with Immuno-Stimulating STAT3 Inhibitor – January 10, 2018, the Company announced it has expanded the Company’s development pipeline for the treatment of AML with an immuno-stimulating STAT3 inhibitor. Leading experts in the treatment of AML, Dr. Jorge Cortes and Dr. Sanjay Awasthi requested the Company to expand its clinical research to include WP1066, an immuno-stimulating agent and STAT3 inhibitor, to increase therapeutic options for AML patients. This would potentially be complementary and synergistic with Annamycin and existing first line treatments.

Moleculin Announces Polish Approval for Leukemia Clinical Trial – December 21, 2017, the Company announced that the Ethics Committee in Poland has approved the Company’s Phase I/II clinical trial of Annamycin for the treatment of relapsed or refractory AML.

Moleculin’s WP1066 Drug gets FDA Brain Tumor IND Clearance – December 5, 2017, the Company announced the physician-sponsored IND application for a Phase I trial of Moleculin’s drug WP1066 in patients with recurrent malignant glioma and brain metastasis from melanoma has been allowed by the FDA. WP1066 is the second of Moleculin’s drugs to enter clinical stage and represents a new class of oncology drugs able to fight tumors on two fronts by directly inhibiting cell signaling and independently stimulating a natural immune response. This IND was sponsored by Dr. Amy Heimberger, who will serve as the principal investigator for the Phase I trial at MD Anderson Cancer Center to evaluate safety and efficacy.

Moleculin Appoints Dr. Sandra Silberman as Chief Medical Officer – New Products – November 8, 2017, the Company announced the appointment of Dr. Sandra Silberman as Chief Medical Officer ("CMO") in charge of New Products.

Moleculin Announces MD Anderson has Filed an IND with the FDA on its Drug WP1066 for the Treatment of Brain Tumors – November 1, 2017, the Company announced that responses have been submitted to FDA requests for additional information relating to the physician-sponsored IND application to study WP1066 as a potential treatment for brain tumors.

Moleculin Requests Authorization from the Polish Government to Advance Annamycin – October 24, 2017, the Company announced that it has submitted its request for CTA in Poland which, if allowed, will enable a clinical trial to study Annamycin for the treatment of relapsed or refractory AML in Poland. This will be in addition to the previously announced allowance of Moleculin’s IND filing with the FDA.

Moleculin Announces 14 Qualified Clinical Sites Requesting Participation in Annamycin Trial – October 18, 2017, the Company announced that 14 qualified cancer clinics have requested to participate in its clinical trial to study Annamycin for the treatment of relapsed or refractory AML.

Moleculin Announces Strategic Collaboration to Develop Immuno-stimulating Drug – October 11, 2017, the Company announced that it has entered into an agreement to collaborate with the University of Bergen to expand research on WP1066 and early indications of a possible dual ability to increase immune system response to tumors while also suppressing tumor cell proliferation tumor cell and survival.

Moleculin Signs Agreement with First Hospital for Annamycin Trials – October 3, 2017, the Company announced it has entered into an agreement with the first of several hospitals desiring to become treatment sites for its clinical trial to study Annamycin for the treatment of relapsed or refractory AML.

Moleculin Announces FDA Approval of Annamycin IND – September 26, 2017, the Company announced that the FDA has allowed Moleculin’s IND for the study of Annamycin in relapsed or refractory AML to proceed. This allows Moleculin to begin clinical trials of Annamycin in the U.S.

Anticipated Milestone Potential Timeframe
Announcement that our IND for Annamycin has become effective and that we may begin clinical trials Accomplished
Initial IRB (Institutional Review Board) approvals and site initiations of various clinical sites participating in our Phase I/II clinical trial of Annamycin Accomplished and ongoing through Second Half of 2018
Establishment of a new RP2D for Annamycin Second Half of 2018
A clinician sponsored IND for WP1066 for treatment of adult brain tumors moving forward IND Accomplished; Trial expected to begin First Half of 2018
Announcement of initial Clinical Data for Annamycin trial 2018
Announcement of further benefits of our sponsored research agreement with MD Anderson Accomplished and Ongoing into 2019
Announce CTA for WP1220 for the treatment of cutaneous T-cell lymphoma (CTCL) 2018
Announce WP1122 and WP1732 move into preclinical work 2018
Announce the fourth drug approved for clinical trial 2019
Financial Results for the Year Ended December 31, 2017
Research and Development Expense. Research and development (R&D) expense was $4.5 million and $1.5 million for the years ended December 31, 2017 and 2016, respectively. The increase in R&D of approximately $3.0 million mainly represents an increase of approximately: $2.0 million associated with developing and testing drug product as we prepared for clinical trials; $0.4 million related to an increase in R&D headcount and associated payroll costs; $0.3 million for sponsored research and related expenses; and $0.3 million associated with license fees. The increase in R&D headcount mainly represents the associated costs of increasing the commitments of the Company’s part-time employees and the addition of a second Chief Medical Officer – New Products. These all are a reflection of the increased clinical and pre-clinical activity for its drug portfolio as compared to 2016.

General and Administrative Expense. General and administrative (G&A) expense was $4.1 million and $2.4 million for the years ended December 31, 2017 and 2016, respectively. The increase in G&A of approximately $1.7 million was mainly attributable to: (a) the increase in headcount and associated payroll costs, including additional stock-based compensation expense of $1.0 million; (b) approximately $0.4 million in legal, accounting, consulting, and other professional expenses; (c) $0.2 million in insurance expense; and (d) approximately $0.1 million in occupancy, office and other costs. These increases reflect the increase in support of the Company’s clinical activity described above as compared to 2016.

Net Loss. The net loss for the twelve months ended December 31, 2017 was $9.8 million, which included non-cash expenses of approximately $0.7 million, which was comprised almost completely of stock-based compensation.

Liquidity and Capital Resources
As of December 31, 2017, we had $7.7 million in cash. During 2017, via an equity offering in February of 2017 (the February 2017 Offering), the Company’s at-the-market issuance agreement (ATM), and the exercise of warrants associated with the February 2017 Offering, the Company issued 7.2 million shares of common stock and received $10.1 million in net proceeds. Subsequent to year-end the Company entered into a Purchase Agreement with certain Investors for the sale of 4,290,000 shares of its common stock at a purchase price of $2.10 per share. Concurrently with the sale of the common shares, pursuant to the Purchase Agreement, the Company also sold warrants to purchase 2,145,000 shares of common stock, which have an exercise price of $2.80 per share. This sale of common shares and warrants generated aggregate gross proceeds of approximately $9.0 million with net proceeds approximating $8.3 million (February 2018 Offering). The Company believes that its existing cash and cash equivalents as of December 31, 2017 along with the cash generated by the February 2018 Offering, will be sufficient to fund its planned operations into the first quarter of 2019. Such plans are subject to change depending on clinical enrollment and regulatory progress and the use and supply of drug product.