On March 30, 2020 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases, reported financial results for the fourth quarter ended December 31, 2019 and provided an update on recent operational and business progress (Press release, RAPT Therapeutics, MAR 30, 2020, View Source [SID1234556002])

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2019 was an especially productive year for RAPT with the completion of our initial public offering and the generation of encouraging early clinical data for our two lead immunology-based programs: FLX475 for the treatment of multiple cancers and RPT193 for the treatment of atopic dermatitis and other allergic inflammatory diseases," said Brian Wong, M.D., Ph.D., President and CEO of RAPT Therapeutics. "In addition, we partnered with Hanmi for FLX475 in Asia, a region with a high prevalence of ‘charged’ tumors, and we strengthened our balance sheet substantially with our follow-on offering in February 2020."

Dr. Wong continued, "For our ongoing Phase 1/2 study of FLX475, we continue to enroll and treat patients with multiple types of advanced cancer, though we are monitoring the impact of COVID-19 on our clinical trial sites both within and outside of the U.S. Because of the life-threatening nature of the cancers, we are working site by site to ensure that patients receive treatment and follow up as close to protocol-specified intervals as feasible. Our primary objective is patient safety and we will adapt to local circumstances as needed.

"For RPT193, we successfully completed the healthy volunteer portion of the study. We have made the decision to pause the enrollment of patients with atopic dermatitis in the Phase1b portion of our clinical study for RPT193 in an effort to support clinicians and healthcare facilities that are prioritizing the fight against COVID-19, while safeguarding the health and safety of patients and clinicians who would be involved in our trial. We intend to resume enrollment as soon as practical once we expect patients can be treated and followed up consistently under safer public health conditions."

Financial Results for the Fourth Quarter and Full Year Ended December 31, 2019

Fourth Quarter Ended December 31, 2019

Net loss for the fourth quarter of 2019 was $13.2 million, compared to $9.4 million for the fourth quarter of 2018.

Research and development expenses for the fourth quarter of 2019 were $10.2 million, compared to $8.4 million for the same period in 2018. The increase was primarily due to clinical costs related to the advancement of RPT193 and FLX475 as well as the personnel costs associated with these studies offset by outsourced research and development and lab supplies.

General and administrative expenses for the fourth quarter of 2019 were $2.6 million, compared to $1.3 million for the same period in 2018. The increase was due to an increase in consulting costs as well as accounting and audit-related costs as well as other expenses associated with being a public company.

Full Year Ended December 31, 2019

Net loss for the year ended December 31, 2019 was $43.0 million, compared to $36.1 million for the same period in 2018.

Research and development expenses for the year ended December 31, 2019 were $34.9 million, compared to $31.8 million for the same period in 2018. The increase was primarily due to increases in costs relating to the clinical development of RPT193 and FLX475, facilities and personnel, offset by decreases in costs relating to lab supplies and outsourced research and development.

General and administrative expenses for the year ended December 31, 2019 were $8.7 million, compared to $5.2 million for the same period in 2018. The increase was primarily due to increases in professional service fees related to preparations for our initial public offering.

As of December 31, 2019, we had cash and cash equivalents of $77.4 million. In February 2020, we received net proceeds of approximately $69.7 million resulting from our follow-on public offering of 2,500,000 shares of common stock.

On March 30, 2020 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported financial results for the year ended December 31, 2019 and provided a business update (Press release, Adamis Pharmaceuticals, MAR 30, 2020, View Source [SID1234556000]).

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Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "In light of the recent COVID-19 outbreak and overall economic outlook, we have attempted to determine the impact of the outbreak on our present and future operations, including the impact on our suppliers, manufacturers and commercial partners. The good news is that at the present time we have not seen a material impact of COVID-19 on demand for our products, and we have not yet seen any significant negative impact on our supply chain or distribution network. If the outbreak appreciably worsens and/or if governmental restrictions persist for a protracted period, that could of course affect our outlook."

"Having said that, the outbreak and governmental mandated social distancing and sheltering in place have caused some near-term impact and disruption to our employees and daily operations. For that reason, and to allow some time to gain additional visibility into the 2020 year, we have determined to postpone our regularly scheduled earnings conference call. My sincere hope is that we can have a more meaningful call in the future and provide a clearer picture of the remainder of 2020 and the outlook for the company."

"In the meantime, we remained focused on completing the additional work to allow us to supplement our NDA for our naloxone injection product (ZIMHI). We are actively addressing the issues the FDA raised in the Complete Response Letter we received late last year. We continue to believe ZIMHI can play an important role in combating the ongoing public health crisis of opioid overdose, and we look forward to the eventual approval of ZIMHI. SYMJEPI sales continue to be far lower than we ever expected. We are currently working with Sandoz to determine what needs to occur to accelerate its growth in the epinephrine market. Sales of pharmaceutical preparations through our US Compounding drug outsourcing facility had strong growth for 2019 versus the year prior."

Product Updates

SYMJEPI (epinephrine) Injection

On January 16, 2019, we announced that Sandoz had launched SYMJEPI (epinephrine) 0.3 mg Injection in the U.S. market, initially available in the institutional setting. On July 9, 2019, we announced the full launch (institutional and retail) by Sandoz of both dose forms of the SYMJEPI injection products.

In addition to the U.S., Adamis continues to seek opportunities to market SYMJEPI into other territories. On October 1, 2019, the company announced it had entered into an exclusive distribution and commercialization agreement with Emerge Health to seek registration and commercialize SYMJEPI in both Australia and New Zealand.

ZIMHI (naloxone) Injection

On November 22, 2019, the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the company’s New Drug Application (NDA) relating to its ZIMHI high-dose naloxone injection product for the treatment of opioid overdose. On December 19, 2019, Adamis provided an update indicating that it had provided responses to the comments included in the CRL and submitted them to the FDA along with a request for a meeting. On February 12, 2020, the Company had a Type A meeting with the FDA to discuss the company’s response to the CRL and the process and timeline for resubmission of the NDA to the FDA. At the meeting, Adamis obtained concurrence from the agency on the information required for resubmission of the NDA.

The company believes it can generate the additional data, and assuming successful testing, resubmit the NDA in the second quarter of 2020. The FDA expressed its intent to review the resubmission in a rapid and timely manner consistent with agency guidelines. The company continues to have discussions with potential commercial partners for ZIMHI.

Drug Outsourcing Facility

During the fourth quarter of 2019, the company’s wholly owned drug outsourcing facility, US Compounding (USC), continued to grow its revenues by approximately 13% in the fourth quarter compared to the same quarter in the prior year. For the year, USC increased revenues approximately 22% versus 2018. USC’s increase in revenues was due to the increase in sales of USC’s sterile pharmaceutical formulations resulting in part from an increase in production capacity in order to meet product demand and from increasing sales and marketing efforts.

2019 Financial Results

Adamis total revenues increased approximately 47%, from $15.1 million to $22.1 million, for the year ended December 31, 2018 and 2019, respectively. Total revenues increased by approximately 33%, to $5.5 million from $4.2 million fourth quarter of 2019 compared to the same period in 2018. The increase was primarily attributable to growth in sales of USC’s sterile pharmaceutical products and revenue relating to SYMJEPI.

Selling, general and administrative expenses ("SG&A") for the years ending December 31, 2019 and 2018 were approximately $25.3 million and $26.0 million, respectively, a decrease of approximately 3%. The decrease was primarily attributable to decreases of approximately $2.1 million in compensation expenses, occupancy costs, and other related expenses. These amounts were partially offset by an increase of approximately $1.4 million attributable to increases in consulting, legal, patent, insurance, PDUFA fees, marketing and selling expenses.

Research and development expenses were approximately $10.4 million and $18.8 million for the years ended December 31, 2019 and 2018, respectively, a decrease of approximately 45%. The decrease was primarily due to a decrease in development costs of our product candidates.

Cash and equivalents at the end of the year was approximately $8.8 million. In February, the Company increased its cash position by raising approximately $6.7 million before deducting the placement agent’s fees and other estimated offering expenses, in an equity financing transaction. The net loss for the year was approximately $29.3 million.

Targeted Milestones

●Increasing sales of SYMJEPI in the U.S.;
●Resubmission of New Drug Application for ZIMHI;
●FDA approval and commercial partner for ZIMHI;
●Following FDA approval, begin selling ZIMHI in the U.S.;
●Increasing sales and margins at US Compounding; and
●Completing a Phase III ulcer study in horses.

On March 27, 2020, Equillium, Inc. (the "Company", "we" or "us") reported that it has entered into a purchase agreement (the "Purchase Agreement") with Lincoln Park Capital Fund, LLC ("Lincoln Park"), which provides that, upon the terms and subject to the conditions and limitations set forth therein, we may sell to Lincoln Park up to $15,000,000 of shares of our common stock, par value $0.0001 per share (the "Purchase Shares"), from time to time over the 36‑month term of the Purchase Agreement (Filing, 8-K, Equillium, MAR 27, 2020, View Source [SID1234555999]). Concurrently with the Purchase Agreement, we also entered into a registration rights agreement with Lincoln Park (the "Registration Rights Agreement") pursuant to which we agreed to take specified actions to register the shares of common stock that have been and may be issued to Lincoln Park under the Purchase Agreement for resale pursuant to a registration statement under the Securities Act of 1933, as amended (the "Securities Act").

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Following the satisfaction (or waiver by Lincoln Park) of certain conditions under the Purchase Agreement, we have the right, in our sole discretion, to present Lincoln Park with a purchase notice (a "Purchase Notice"), directing Lincoln Park to purchase up to 75,000 Purchase Shares per business day (a "Regular Purchase"), subject to a maximum commitment by Lincoln Park of $2,000,000 per Regular Purchase. The Purchase Agreement provides for a purchase price per Purchase Share equal to the lesser of: (i) the lowest sale price for our common stock on the Nasdaq Global Market (or any nationally recognized successor thereto) on the purchase date of such shares; and (ii) the average of the three lowest closing sale prices for our common stock on the Nasdaq Global Market (or any nationally recognized successor thereto) during the ten consecutive business days immediately preceding the purchase date of such shares.

In addition, on any date on which we submit a Purchase Notice to Lincoln Park, we also have the right, in our sole discretion, to present Lincoln Park with an accelerated purchase notice (an "Accelerated Purchase Notice") directing Lincoln Park to purchase shares of our common stock (an "Accelerated Purchase") equal to up to the lesser of: (i) three times the number of shares purchased pursuant to such Purchase Notice; and (ii) 30% of the aggregate shares of our common stock traded during all or, if certain trading volume or market price thresholds specified in the Purchase Agreement are crossed on the applicable Accelerated Purchase date, the portion of the normal trading hours on the applicable Accelerated Purchase date prior to such time that any one of such thresholds is crossed (an "Accelerated Purchase Measurement Period"), provided that Lincoln Park will not be required to buy Purchase Shares pursuant to an Accelerated Purchase Notice that was received by Lincoln Park on any business day on which the closing sale price of our common stock on the Nasdaq Global Market (or any nationally recognized successor thereto) is below $1.00 per share. The purchase price per share for each such Accelerated Purchase will be equal to the lesser of: (y) 97% of the volume-weighted average price of our common stock on the Nasdaq Global Market (or any nationally recognized successor thereto) during the applicable Accelerated Purchase Measurement Period on the applicable Accelerated Purchase date; and (z) the closing sale price of our common stock on the Nasdaq Global Market (or any nationally recognized successor thereto) on the applicable Accelerated Purchase date.

We may also direct Lincoln Park on any business day on which an Accelerated Purchase has been completed and all of the shares to be purchased thereunder have been properly delivered to Lincoln Park in accordance with the Purchase Agreement, to purchase shares of our common stock (an "Additional Accelerated Purchase") equal to up to the lesser of: (i) three times the number of shares purchased pursuant to the Regular Purchase made on such date; and (ii) 30% of the aggregate shares of our common stock traded on the Nasdaq Global Market (or any nationally recognized successor thereto) during a certain portion of the normal trading hours on the applicable Additional Accelerated Purchase date as determined in accordance with the Purchase Agreement (an "Additional Accelerated Purchase Measurement Period"), provided that the closing price of our common stock on the Nasdaq Global Market (or any nationally recognized successor thereto) on the business day immediately preceding such business day is not below $1.00. The purchase price per share for each such Additional Accelerated Purchase will be equal to the lesser of: (y) 97% of the volume-weighted average price of our common stock on the Nasdaq Global Market (or any nationally recognized successor thereto) during the applicable Additional Accelerated Purchase Measurement Period on the applicable Additional Accelerated Purchase date; and (z) the closing sale price of our common stock on the Nasdaq Global Market (or any nationally recognized successor thereto) on the applicable Additional Accelerated Purchase date.

The aggregate number of shares that we can sell to Lincoln Park under the Purchase Agreement may in no case exceed 3,523,717 shares of our common stock (which is equal to approximately 19.99% of the shares of our

common stock outstanding immediately prior to the execution of the Purchase Agreement (the "Exchange Cap"), unless: (i) we obtain stockholder approval to issue shares of our common stock above the Exchange Cap; or (ii) the average price of all applicable sales of our common stock to Lincoln Park under the Purchase Agreement equals or exceeds $2.6298 per share (which represents the closing price of our common stock on the Nasdaq Global Market immediately preceding the signing of the Purchase Agreement, plus an incremental amount) such that the transactions contemplated by the Purchase Agreement are exempt from the Exchange Cap limitation under applicable Nasdaq rules; provided that at no time shall Lincoln Park (together with its affiliates) beneficially own more than 4.99% of our issued and outstanding common stock.

The Purchase Agreement contains customary representations, warranties, covenants, closing conditions and indemnification and termination provisions. Sales under the Purchase Agreement may commence only after certain conditions have been satisfied, which conditions include the registration statement covering the resale of the shares of our common stock issued or sold by us to Lincoln Park under the Purchase Agreement shall have been declared effective under the Securities Act by the Securities and Exchange Commission, the delivery to Lincoln Park of a final prospectus covering the shares of our common stock issued or sold by us to Lincoln Park under the Purchase Agreement, approval for listing on The Nasdaq Global Market of the shares of our common stock issued or sold by us to Lincoln Park under the Purchase Agreement, the issuance of 65,374 shares of our common stock to Lincoln Park as commitment shares to Lincoln Park, and the receipt by Lincoln Park of a customary opinion of counsel and other certificates and closing documents. The Purchase Agreement may be terminated by us at any time, at our sole discretion, without any cost or penalty. Lincoln Park has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of our common stock. While we have agreed to reimburse Lincoln Park for a limited portion of the fees it incurred in connection with the Purchase Agreement, we did not pay any additional amounts to reimburse or otherwise compensate Lincoln Park in connection with the transaction. There are no limitations on use of proceeds, financial or business covenants, restrictions on future financings (other than restrictions on our ability to enter into variable rate transactions described in the Purchase Agreement), rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement. We may deliver Purchase Notices under the Purchase Agreement, subject to market conditions, and in light of our capital needs from time to time and under the limitations contained in the Purchase Agreement. Our net proceeds under the Purchase Agreement will depend on the frequency and prices at which we sell shares of our common stock to Lincoln Park. We expect that any proceeds we receive from such sales to Lincoln Park will be used for working capital and general corporate purposes.

The foregoing is a summary description of certain terms of the Purchase Agreement and the Registration Rights Agreement and, by its nature, is incomplete. Copies of the Purchase Agreement and the Registration Rights Agreement are filed as Exhibits 10.1 and 4.1 attached hereto, respectively. The foregoing descriptions of the Purchase Agreement and the Registration Rights Agreement are qualified in their entirety by reference to such exhibits.

The Purchase Agreement and Registration Rights Agreement each contain customary representations and warranties, covenants and indemnification provisions that the parties made to, and solely for the benefit of, each other in the context of all of the terms and conditions of such agreements and in the context of the specific relationship between the parties thereto. The provisions of the Purchase Agreement and Registration Rights Agreement, including any representations and warranties contained therein, are not for the benefit of any party other than the parties thereto and are not intended as documents for investors and the public to obtain factual information about the current state of affairs of the parties thereto. Rather, investors and the public should look to other disclosures contained in our annual, quarterly and current reports we may file with the Securities and Exchange Commission.

On March 30, 2020 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported updated efficacy and safety data in patients with ovarian cancer and non-small cell lung cancer (NSCLC) adenocarcinoma from its ongoing Phase 1 dose escalation study evaluating XMT-1536 (Press release, Mersana Therapeutics, MAR 30, 2020, View Source [SID1234555998]). The Company will host a call today, Monday, March 30, 2020, at 5:00 pm ET during which investigator Debra L. Richardson, MD, Associate Professor of Gynecologic Oncology at the Stephenson Cancer Center at the University of Oklahoma Health Sciences Center and the Sarah Cannon Research Institute and members of the Mersana executive team will present and discuss these data.

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"These data demonstrate that XMT-1536, our first-in-class Dolaflexin ADC targeting NaPi2b, delivers confirmed responses and durable stable disease in heavily pretreated ovarian cancer and NSCLC adenocarcinoma patients who have exhausted all other treatment options. These data also show that XMT-1536 is well tolerated without the severe toxicities of other ADC platforms such as neutropenia, neuropathy and ocular toxicity. Moreover, these data establish the potential for a biomarker-response relationship to identify patients most likely to benefit from XMT-1536," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "We look forward to advancing XMT-1536 for both ovarian cancer and NSCLC adenocarcinoma patients. Having already accumulated meaningful patient experience in the expansion cohorts, we remain on track to provide an interim update in the second quarter of 2020."

Of the 59 patients enrolled, tumor types included 37 ovarian cancer, 11 NSCLC adenocarcinoma, and 11 other tumor types previously disclosed at lower dose levels. Patients were heavily pre-treated, with a median of five prior lines of treatment (range 1-10). These data include new patients dosed at 30, 36 and 43 mg/m2. The majority of the ovarian cancer patients had received prior bevacizumab or PARP inhibitors. All NSCLC adenocarcinoma patients had received prior platinum and immunotherapy. Updated and new data as of February 3, 2020 includes:

·Safety profile consistent with previously reported data at lower doses.
oThe most common treatment-related adverse events (TRAEs) were Grade 1-2 nausea, fatigue, headache and the most frequent Grade 3 TRAE was transient AST elevation.
oThere were no dose limiting toxicities observed in the 43 mg/m2 cohort.
oThere was no reported severe neutropenia, peripheral neuropathy or ocular toxicity.

·Additional confirmed responses in heavily pretreated patients and favorable biomarker-response trend observed.
oFirst confirmed partial response seen in a NSCLC adenocarcinoma patient with prior treatments including carboplatin, pemetrexed, paclitaxel and nivolumab.
oAt the 43 mg/m2 dose level, 2/7 (29%) patients achieved partial responses (PRs) and 4/7 (57%) patients achieved stable disease (SD) for a disease control rate (DCR) of 6/7 (86%). In January 2020, the expansion portion of the Phase 1 study dose was amended from 36 mg/m2 to 43 mg/m2 for newly enrolled patients.
oFor the subset of evaluable patients treated at >30 mg/m2 who had higher NaPi2b expression, 5/15 (33%) achieved PR and 6/15 (40%) achieved SD for a DCR of 11/15 (73%).
oIn contrast, for the subset of evaluable patients treated at >30 mg/m2 who had lower NaPi2b expression, 0/9 (0%) achieved PR and 5/9 (55%) achieved SD for a DCR of 5/9 (55%).

Response – Ovarian Cancer
and NSCLC
adenocarcinoma N=39* N (%)
All Higher
NaPi2b o Lower
NaPi2b oo Indeterminate
NaPi2b **
20 mg/m2 N 10 7 2 1
PR 1 (10%) 0 (0%) 0 (0%) 1 (100%)
SD 6 (60%) 4 (57%) 2 (100%) 0 (0%)
DCR (PR+SD) 7 (70%) 4 (57%) 2 (100%) 1 (100%)
30, 36, 40 mg/m2 N 22 12 7 3
PR 3 (14%) 3 (25%) 0 (0%) 0 (0%)
SD 10 (45%) 6 (50%) 3 (43%) 1 (33%)
DCR (PR+SD) 13 (59%) 9 (75%) 3 (43%) 1 (33%)
43 mg/m2 N 7 3 2 2
PR 2 (29%) 2 (67%) 0 (0%) 0 (0%)
SD 4 (57%) 0 (0%) 2 (100%) 2 (100%)
DCR (PR+SD) 6 (86%) 2 (67%) 2 (100%) 2 (100%)

*Excludes 3 patients discontinued due to investigator/patient choice and 1 without RECIST scan

**Hypocellular specimen/indeterminate for H-score or not determined yet

O Higher NaPi2b Expression: at / above lowest H-score at which response observed (>110)

OO Lower NaPi2b Expression: below the lowest H-score at which response observed (<110)

Mersana plans to enroll approximately 45 patients in each of the ovarian cancer and NSCLC adenocarcinoma patient cohorts in the expansion portion of the XMT-1536 Phase 1 study. The Company expects to present interim data from the dose expansion study in the second quarter of 2020.

Conference Call Details

Mersana Therapeutics will host a conference call and webcast today at 5:00 p.m. ET to review these data. To access the call, please dial 877-303-9226 (domestic) or 409-981-0870 (international) and provide the Conference ID 2889994. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com.

On March 30, 2020 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported financial results for the fourth quarter and year ended December 31, 2019.

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"This past year has been a very productive year for the company. We received orphan drug designations from the FDA, presented updated data at multiple conferences including ASH (Free ASH Whitepaper), ACR, SITC (Free SITC Whitepaper), and the Crohn’s & Colitis Congress, and completed enrollment in our Phase 1 study of ALPN-101, our lead therapeutic for the potential treatment of autoimmune and inflammatory diseases," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. "We have opened enrollment in BALANCE, a trial for ALPN-101 in acute GVHD, and NEON-1, a trial for ALPN-202 in advanced malignancies, beginning the next phase of evolution for the company as we test these novel molecules in patients in need of better therapeutic options."

Recent Corporate and Clinical Highlights

Key Clinical and Preclinical Data Presentations at Biomedical Meetings: We showcased clinical and/or preclinical data for our lead programs, ALPN-101 and ALPN-202, at the following recent medical meetings:

Initial ALPN-101 phase 1 healthy volunteer study data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in December: In adult healthy volunteers, ALPN-101 was well tolerated as single intravenous or subcutaneous doses, without cytokine release, infusion-related reactions, hypersensitivity, or other signs of agonist activity. Dose-dependent pharmacodynamic activity was observed, including inhibition of T cell activation, assessed ex vivo based on inhibition of staphylococcal enterotoxin B (SEB)-induced cytokine production, and inhibition of antibody responses, assessed following immunization with keyhole limpet hemocyanin (KLH). Based on activity in models, together with favorable tolerability and pharmacodynamics in healthy volunteers, ALPN-101 has the potential to be a clinically meaningful immunomodulator for the treatment of inflammatory diseases such as GVHD.
ALPN-101 preclinical data presented at ACR: The two posters presented a unique potency of ALPN-101, often superior even to combinations of biologics individually targeting the CD28 and ICOS pathways, as measured by in vitro assays involving patient-derived immune cells and in vivo mouse models of inflammatory arthritis, lupus, and Sjögren’s Syndrome.
ALPN-202 preclinical data presented in posters at SITC (Free SITC Whitepaper): One poster presented mechanistic data supporting ALPN-202 inhibits both the PD-L1 and CTLA-4 checkpoint pathways while also providing PD-L1-dependent CD28 costimulation, as intentionally designed. A second poster demonstrated the ability of ALPN-202 to improve significantly upon the activity of existing cancer therapeutics when given alone and/or in combination in preclinical models. In addition, crystallographic study suggested ALPN-202 binds PD-L1 and CD28 at distinct, non-overlapping epitopes enabling its potentially unique functionality.
ALPN-101 preclinical data in IBD presented at 2020 Crohn’s & Colitis Congress: These new data showed ALPN-101 modulated inflammatory cytokines in vitro from human IBD peripheral blood mononuclear cells (PBMC) more potently than CD28 or ICOS single-pathway inhibitors, and significantly reduced disease activity in the CD4+CD45RBhi T cell transfer mouse colitis model.
ALPN-101 Received FDA Orphan Drug Designations for the Prevention and Treatment of Acute Graft Versus Host Disease: Earlier this month, the United States Food and Drug Administration (FDA) granted two orphan drug designations for ALPN-101, one for the prevention of and one for the treatment of acute GVHD.

Clinical Trials in Patients Now Open for Both Development Programs: A phase 1b/2 trial of ALPN-101 in acute GVHD (BALANCE, NCT04227938) and a phase 1 trial of ALPN-202 in advanced malignancies (NEON-1, NCT04186637) are now both open for enrollment.

Full Year 2019 Financial Results

As of December 31, 2019, we had cash, cash equivalents, restricted cash, and short-term investments totaling $40.9 million. Net cash used in operating activities for the year ended December 31, 2019 was $35.3 million compared to $28.4 million for the year ended December 31, 2018. We recorded a net loss of $41.9 million and $36.5 million for the years ended December 31, 2019 and 2018, respectively.

Collaboration revenue for the year ended December 31, 2019 was $1.7 million compared to $0.7 million for the year ended December 31, 2018. The increase was primarily attributable to $1.3 million in revenue recognized from the Adaptimmune Collaboration Agreement and a $0.4 million milestone payment from Laurel from the sale of our GSNOR assets.

Research and development expenses for the year ended December 31, 2019 were $35.8 million compared to $29.0 million for the year ended December 31, 2018. The increase was primarily attributable to an increase in clinical trial activity, direct research activities, personnel-related expenses as a result of growth in headcount to support ongoing discovery and development programs, related overhead and facility costs for these programs, and an increase in stock-based compensation.

General and administrative expenses for the year ended December 31, 2019 were $9.5 million compared to $8.4 million for the year ended December 31, 2018. The increase was primarily attributable to personnel-related expenses related to an increase in administrative headcount, increases in professional and legal services, and an increase in facility costs to support the growth of our business.

Fourth Quarter and Full Year 2019 Conference Call and Webcast Details

Alpine will hold a conference call and webcast to discuss results from the fourth quarter and full year 2019 on March 30, 2020 at 4:30 pm EDT. To access the live call by phone, dial (800) 816-3005 (domestic) or (857) 770-0069 (international) using participant passcode 6877935. To access a live webcast of the call, please visit the Investor Relations section of the Alpine Immune Sciences website at ir.alpineimmunesciences.com. The recorded webcast will be available for replay for approximately 30 days following the call.

About ALPN-101

ALPN-101 is a novel Fc fusion protein of a human inducible T cell costimulator ligand (ICOSL) variant immunoglobulin domain (vIgD), a first-in-class therapeutic designed to inhibit simultaneously the CD28 and ICOS inflammation pathways. CD28 and ICOS are closely related costimulatory molecules with partially overlapping roles in T cell activation likely playing a role in multiple autoimmune and inflammatory diseases. In preclinical models of graft versus host disease, inflammatory arthritis, connective tissue disease, and multiple sclerosis, ALPN-101 demonstrates efficacy superior to agents blocking the CD28 – CD80/86 and/or ICOS – ICOSL pathways alone. A phase 1b/2 trial of ALPN-101 in acute GVHD (BALANCE, NCT04227938) is open for enrollment.

About ALPN-202

ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor with the potential to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. A phase 1 trial of ALPN-202 in advanced malignancies (NEON-1, NCT04186637) is open for enrollment.