On May 8, 2020 EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a pharmaceutical company committed to developing and commercializing innovative ophthalmic products, reported financial results for the first quarter ended March 31, 2020 and highlighted recent corporate developments (Press release, pSivida, MAY 6, 2020, View Source [SID1234557087]).

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"We are pleased with product revenue performance in the first quarter, despite the negative impact on customer demand caused by COVID-19 pandemic-related closures of customer facilities beginning in March. We are encouraged that certain regions across the country are now starting to reopen for business, allowing us to begin resupplying physicians and ambulatory surgery centers with our innovative products," said Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals. "We believe that both YUTIQ and DEXYCU are well-positioned to support physicians and patients in this COVID-19 era, as both products deliver extended duration therapeutic treatment from a single injection, which may reduce the frequency of in-person follow-up visits and contact with the patient’s face and eyes."

Ms. Lurker continued, "We remain committed to our mission of delivering innovative ophthalmic products to patients in need and continue to advance our lead development asset EYP-1901 toward clinical trials. EYP-1901 is an anti-VEGF, tyrosine kinase inhibitor (TKI) six-month sustained release potential therapy using our bioerodible Durasert technology initially targeting wet age-related macular degeneration. Good laboratory practice (GLP) toxicology studies were initiated in March and we remain on schedule to file an Investigational New Drug (IND) application later this year with a Phase 1 clinical trial to follow."

Commercial Performance in First Quarter 2020

Customer demand trended strong for both products during the quarter prior to the emergence of the COVID-19 pandemic in the U.S. causing demand deterioration beginning in March.

During the quarter, public health authorities and government agencies including the Centers for Medicare & Medicaid Services (CMS), recommended the postponement of all

non-essential elective surgeries, including cataract surgery, for an extended period of time during the COVID-19 pandemic. As a result, ambulatory surgery centers (ASCs) closed or limited operations, decreasing DEXYCU product demand and orders. Our sales organization has maintained contact with customers during the pandemic by providing virtual support and education with regard to DEXYCU.

Uveitis and retinal specialist office visits continued to be conducted for YUTIQ, though at reduced frequency, as chronic non-infectious uveitis affecting the posterior segment of the eye can lead to blindness if left untreated.

There have been no disruptions to the supply chains for YUTIQ and DEXYCU and the Company continues to produce finished product for commercial sale.

In April, the Company announced a reorganization of its commercial operations including cancellation or deferral of planned spending to conserve cash due to the COVID-19 pandemic impact on expected revenue. This reorganization was primarily focused on a reduction in the external contract sales organization for DEXYCU. The Company plans to allocate its remaining DEXYCU commercial resources to high-volume ASCs in key U.S. regions.

The Company expects product demand to continue at current decreased levels until COVID-19 related restrictions on elective surgeries and office visits are lifted.

R&D Highlights

In March, the Company initiated GLP toxicology studies for EYP-1901, an anti-VEGF, TKI six-month sustained release product candidate using our bioerodible Durasert technology. EYP-1901 is being developed as a potential treatment for wet age-related macular degeneration, with the potential for future indications in diabetic retinopathy and retinal vein occlusion, all of which are diseases representing attractive market opportunities in need of long-lasting treatments to improve treatment compliance. The Company expects to file an IND with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2020 with a Phase 1 clinical trial to commence shortly thereafter.

Operations Update

In April, the Company received a $2 million loan through the Small Business Administration’s Paycheck Protection Program (PPP) under the Coronavirus Aid, Relief and Economic Security Act of 2020 (the CARES Act). The PPP loan will enable the Company to retain key commercial infrastructure and employees and avoid furloughs as product demand and revenues remain significantly reduced due to ASC and physician office closures necessitated by the COVID-19 pandemic. The Company plans to use the proceeds of the PPP loan to cover payroll costs, rent and utilities in accordance with the CARES Act.

The reorganization announced in April is expected to result in annual savings of approximately $7 million and one-time savings of approximately $10 million from other planned expenditure cancellations and deferrals.

Review of First Quarter Results Ended March 31, 2020

For the three months ended March 31, 2020, total net revenue was $7.5 million compared to $2.0 million for the three months ended March 31, 2019. Net product revenue for the three months

ended March 31, 2020 was $4.7 million, with $3.6 million for YUTIQ and $1.1 million for DEXYCU, compared to net revenue for three months ended March 31, 2019 of $1.2 million, with $543,000 for YUTIQ and $684,000 for DEXYCU.

Net revenue from royalties and collaborations for the three months ended March 31, 2020 totaled $2.8 million compared to $785,000 in the corresponding quarter in 2019.

Operating expenses for the three months ended March 31, 2020 increased to $18.9 million from $16.7 million in the prior year period, due primarily to increased sales and marketing costs and research and development costs. Non-operating expense, net, for the three months ended March 31, 2020 totaled $1.7 million of net interest expense. Net loss for the three months ended March 31, 2020 was $13.2 million, or $0.11 per share, compared to a net loss of $19.2 million, or $0.20 per share, for the prior year quarter.

Cash and cash equivalents at March 31, 2020 totaled $26.3 million compared to $22.2 million at December 31, 2019.

Financial Outlook

We expect that the Company’s cash and cash equivalents combined with projected cash inflows from anticipated YUTIQ and DEXYCU product sales can fund the Company’s operating plan into 2021 under current assumptions for the duration of the COVID-19-related closures across the U.S.

The Company continues to assess additional cash conservation measures to support its operation through the COVID-19 pandemic.

Conference Call Information

EyePoint will host a conference call today, Wednesday, May 6, 2020, at 8:30 AM ET to discuss the results for the first quarter ended March 31 and recent operational developments. To access the conference call, please dial (877) 312-7507 from the U.S. and Canada or (631) 813-4828 (international) at least 10 minutes prior to the start time and refer to conference ID 7972168. A live webcast will be available on the Investor Relations section of the corporate website at View Source A replay of the webcast will also be available on the corporate website.

On May 6, 2020 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported financial results for the first quarter ended March 31, 2020 (Press release, Compugen, MAY 6, 2020, View Source [SID1234557086]).

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"We have entered 2020 well positioned and with significant momentum to advance our clinical programs that address novel, internally-discovered, drug targets for cancer immunotherapy," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "On the clinical front, we recently presented at AACR (Free AACR Whitepaper) updated data from our ongoing Phase 1 dose escalation study of COM701 as a monotherapy and in combination with Opdivo. These encouraging data, which include signals of durable disease control and confirmed partial responses both in the monotherapy and combination arms, further confirm our hypothesis that by blocking PVRIG, an important new checkpoint, COM701 has the potential to broaden the patient population that can benefit from cancer immunotherapy. We also dosed the first patient in the Phase 1 study for COM902, our anti-TIGIT therapeutic antibody, which would enable us to clinically evaluate the dual blockade of PVRIG and TIGIT inhibitory pathways in the DNAM axis."

Dr. Cohen-Dayag added, "Our continued progress and execution enabled us to successfully raise approximately $79 million through an underwritten public offering, which we believe is testament to the growing recognition of our science-driven approach backed by our computational discovery capabilities. With our strengthened balance sheet, we are well positioned to continue our strategic clinical development plans which will be expanded to also include a third clinical trial, a Phase 1/2 triple combination study testing COM701 with Bristol-Myers Squibb’s Opdivo and their investigational TIGIT inhibitor in the second half of this year, as well as advance our early-stage programs to propel our future therapeutic pipeline. We are fortunate that, to date, the COVID-19 pandemic has not significantly impacted our operations, including our clinical development timelines. For now, we are not changing the anticipated data readouts and milestones timelines we previously provided. We are grateful to our employees and clinical investigators for their continued hard work and dedication. In these unique circumstances we remain focused on advancing our clinical and early-stage programs to maintain positive momentum to achieve our goals."

First Quarter 2020 and Recent Highlights

Presented updated data from the dose escalation arms of the Phase 1 trial of COM701 in patients with advanced solid tumors at The 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I

COM701 was well-tolerated through 20 mg/kg IV Q4 weeks as a monotherapy and 10 mg/kg IV Q4 weeks in combination with Opdivo (480 mg IV Q4 weeks) with no dose-limiting toxicities reported.

No increased toxicity was observed in the combination arm.

No patients discontinued treatment due to toxicity of any study drug.

Preliminary COM701 pharmacokinetic data supports IV Q4 weeks dosing, allowing dosing schedule aligned with Opdivo.

Encouraging disease control rates of 69% (11/16) for monotherapy and 75% (9/12) for the combination arm.

50% of patients (6/12) in the combination arm remain on study, some with continued responses observed beyond 200 days of treatment.

Durable responses of stable disease for over six months in six of 28 patients (21%) across treatment arms.

The two patients previously reported with confirmed partial responses, one from the monotherapy arm (microsatellite stable primary peritoneal cancer) and one from the combination arm (microsatellite stable colorectal cancer), remain on treatment.

Enrollment in the COM701 monotherapy dose escalation arm is completed and enrollment in the combination dose escalation arm at 20 mg/kg IV Q4 weeks is ongoing. Enrollment in the monotherapy expansion cohorts is expected to begin in Q2 2020.

Dosed the first patient in a Phase 1 dose escalation clinical trial of COM902, an immuno-oncology therapeutic antibody targeting TIGIT, in patients with advanced malignancies.

Announced plans to expand the Bristol-Myers Squibb collaboration with a Phase 1/2 triple combination study to evaluate COM701 in combination with Opdivo and BMS-986207, Bristol-Myers Squibb’s investigational TIGIT inhibitor. This study is expected to begin in 2H 2020.

Strengthened intellectual property portfolio

Granted EPO Patent No. 3295951, covering the composition of matter for COM701 and backup antibodies including any anti-PVRIG antibody having the binding fragments of COM701 or backup antibodies for the treatment of cancer.

Granted U.S. Patent No. 10,550,173, covering methods of screening for anti-PVRIG antibodies that inhibit the binding of PVRIG with PVRL2.

Granted EPO Patent No. 3258951, covering the use of any anti-PVRIG antibody that activates T cells and/or NK cells, in the treatment of cancer.

Published a peer-reviewed paper in Cancer Immunology Research in collaboration with Bayer demonstrating in vitro T cell activation and in vivo anti-tumor activity of BAY 1905254, a first-in-class immuno-oncology antibody targeting ILDR2. ILDR2 is a novel immune checkpoint discovered computationally by Compugen which is currently being evaluated by Bayer in a Phase 1 study as monotherapy and in combination with Keytruda.

Completed an underwritten public offering of 8,816,339 ordinary shares (including the shares issued in Q2 upon exercise of the underwriters’ option) at $9.00 per share. The net proceeds from the offering were approximately $74 million, after deducting underwriting discounts and commissions and other offering expenses that were paid by the Company.

Financial Results
Research and development expenses for the first quarter ended March 31, 2020 were $4.7 million, compared with $6.3 million in the comparable quarter in 2019. The decrease is attributed mostly to the restructuring process announced at the end of the first quarter of 2019 offset by an increase in expenses associated with clinical-related activities.

Net loss for the first quarter of 2020 was $7.1 million, or $0.10 per basic and diluted share, compared with a net loss of $8.4 million, or $0.14 per basic and diluted share, in the comparable quarter of 2019.

As of March 31, 2020, cash, cash related accounts and short-term and long-term bank deposits totaled approximately $121.2 million, compared with approximately $43.9 million as of December 31, 2019. The increase in cash balances during the first quarter is attributed to approximately $70 million of net proceeds from the underwritten public offering (excluding the shares issued upon exercise of the underwriters’ option in the second quarter), $5.2 million from the exercise of warrants and $7.2 million from the exercise of employee options, offset by operating expenses and working capital. The Company has no debt.

Conference Call and Webcast Information
The Company will hold a conference call today, May 6, 2020, at 8:30 AM ET to review its first quarter 2020 results. To access the conference call by telephone, please dial 1-888-407-2553 from the United States, or +972-3-918-0610 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

On May 6, 2020 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported financial results for the first quarter ended March 31, 2020, and provided a corporate update (Press release, BioCryst Pharmaceuticals, MAY 6, 2020, View Source [SID1234557085]).

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"This is a transformational year for BioCryst as we prepare to launch berotralstat in multiple territories to bring our oral, once-daily prophylactic medicine to HAE patients, and begin generating significant revenue," said Jon Stonehouse, president and chief executive officer of BioCryst.

"We are excited to see the clinical response in treatment-naïve PNH patents at the 50 mg and 100 mg twice-daily dose levels, and more than 98 percent suppression of complement in both alternative pathway assays at the 200 mg and 400 mg twice-daily levels in healthy volunteers," said Dr. William Sheridan, chief medical officer of BioCryst.

"This profile provides strong support for BCX9930 as an oral monotherapy. We look forward to studying 200 mg and 400 mg twice-daily in PNH patients and advancing this program to treat multiple complement-mediated diseases," Sheridan added.

Program Updates and Key Milestones

Hereditary Angioedema (HAE) Program – Berotralstat (BCX7353): Oral, once-daily treatment for prevention of HAE attacks

BioCryst expects three regulatory approvals for berotralstat in 2020 and early 2021. These timelines remain on track.

The U.S. Food and Drug Administration (FDA) is currently reviewing a new drug application for berotralstat and has set an action date of December 3, 2020, under the Prescription Drug User Fee Act (PDUFA).

In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) is reviewing a new drug application (JNDA) for berotralstat under the Sakigake timeline, and the company expects approval in Japan in the second half of 2020.

On March 30, 2020, the company announced that the European Medicines Agency (EMA) had validated its marketing authorization application (MAA) submission for berotralstat and begun their formal review of the MAA under the centralized procedure. An opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected within approximately 12 months from MAA validation.

Ongoing commercial launch preparations are on track in the U.S., EU and Japan. The company does not expect delays due to COVID-19.

On May 5, 2020, the company announced that the United States Patent and Trademark Office issued a notice of allowance for a new composition of matter patent which extends patent protection for berotralstat in the U.S. market by four years through October 2039.
Complement Oral Factor D Inhibitor Program – BCX9930

Low dose cohort (50 mg and 100 mg twice-daily) data in three treatment-naïve paroxysmal nocturnal hemoglobinuria (PNH) patients who completed 28 days of therapy shows BCX9930 inhibited complement and was safe and generally well tolerated.

Patients were severely ill with pre-treatment LDH from 3.7 to 11× the upper limit of normal (ULN) and low hemoglobin of 6.0 to 8.2 g/dL.

All patients had dose-dependent reductions in LDH and increases in hemoglobin.

No drug-related serious adverse events were observed.

No PNH patients experienced rash.

Based on the investigators’ assessment of clinical benefit, all three patients continued on therapy with BCX9930 (100 mg twice-daily) following the 28-day study window.

With the recent enrollment of a fourth patient with PNH, enrollment is now complete in treatment-naïve cohort 1 (50 mg and 100 mg twice-daily). Treatment-naïve cohort 2 (200 mg and 400 mg twice-daily) is expected to begin enrollment upon completion of cohort 1, with data expected in Q3 2020.

The company plans to begin enrolling PNH patients resistant to C5 inhibitors in Q3 2020 and expects to report data from these treatment-resistant patients by the end of 2020.

Data from the 200 mg and 400 mg twice-daily multiple ascending dose (MAD) cohorts in healthy volunteers shows >98 percent suppression of the alternative pathway beyond 12 hours and no dose-limiting adverse events.
Given these data, the company expects to achieve its goal of monotherapy for PNH patients in cohort 2 (200 mg and 400 mg twice-daily).

Additional details can be found on slides, which can be accessed at the Investors’ section of BioCryst’s website at http://www.biocryst.com.

Coronavirus Antiviral Program – Galidesivir (BCX4430)

Patient dosing is underway in Brazil in a randomized, double-blind, placebo-controlled clinical trial to assess the safety, clinical impact and antiviral effects of galidesivir in patients with COVID-19. The trial (NCT03891420) is being funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

Part 1 of the trial is enrolling 24 hospitalized adults diagnosed with moderate to severe COVID-19 confirmed by PCR. Three cohorts of eight patients will be randomized to receive intravenous (IV) galidesivir (n=6) or placebo (n=2) every 12 hours for seven days. Upon completion of part 1 of the trial, an optimized dosing regimen of galidesivir will be selected for part 2 of the trial, based on part 1 results. In part 2 of the trial, up to 42 hospitalized patients with COVID-19 will be randomized 2:1 to receive IV galidesivir or placebo.

In vitro testing of galidesivir against SARS-CoV-2, the virus that causes COVID-19, is underway. Galidesivir has been shown to be active against more than 20 RNA viruses in nine different families, including coronaviruses.

The company also is working closely with the government to increase the supply of galidesivir.
Additional Updates

On April 2, 2020, the company announced the appointment of Anthony Doyle as senior vice president and chief financial officer.

The company remains on track to report data in 2H 2020 from its ongoing Phase 1 clinical trial of BCX9250, an oral ALK-2 kinase inhibitor for treatment of fibrodysplasia ossificans progressiva (FOP), in healthy subjects.
First Quarter 2020 Financial Results

For the three months ended March 31, 2020, total revenues were $4.8 million, compared to $5.9 million in the first quarter of 2019. The decrease was primarily due to reduced peramivir product sales and lower royalty revenues, partially offset by amortization of deferred revenue from the Torii Pharmaceutical, Co. commercialization agreement.

Research and development (R&D) expenses for the first quarter of 2020 increased to $29.9 million from $27.5 million in the first quarter of 2019, primarily due to due to increased spending on the company’s complement-mediated diseases program and other preclinical development initiatives.

Selling, general and administrative (SG&A) expenses for the first quarter of 2020 increased to $15.9 million, compared to $6.2 million in the first quarter of 2019. The increase was primarily due to increased spending on commercial activities and medical affairs to support the U.S. commercial launch of berotralstat in 2020 and contingent legal costs associated with our Seqirus UK Limited (Seqirus) dispute.

Interest and other income were $6.4 million in the first quarter of 2020, compared to $0.6 million in the first quarter of 2019. The increase was primarily due to the partial arbitration award related to our Seqirus dispute.

Interest expense was $3.0 million in the first quarter of 2020, compared to $2.7 million in the first quarter of 2019 and was associated with an increase in the outstanding balance of the company’s secured credit facility in February 2019 and increased interest expense associated with the company’s non-recourse notes payable.

Net loss for the first quarter of 2020 was $37.6 million, or $0.24 per share, compared to a net loss of $31.1 million, or $0.28 per share, for the first quarter of 2019.

Cash, cash equivalents and investments totaled $114.6 million at March 31, 2020, and reflect a decrease from $137.8 million at December 31, 2019. Operating cash use for the first quarter of 2020 was $23.1 million.

Financial Outlook for 2020

BioCryst expects full year 2020 net operating cash use to be in the range of $125 to $150 million, and its operating expenses to be in the range of $135 to $160 million. The company’s operating expense range excludes equity-based compensation expense due to the difficulty in reliably projecting this expense, as it is impacted by the volatility and price of the company’s stock, as well as by the vesting of the company’s outstanding performance-based stock options.

Conference Call and Webcast

BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 4679821. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 4679821.

On May 6, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX), reported it has raised gross proceeds of approximately $60 million through its At-the-Market (ATM) facility, $40 million of which came from longtime shareholder, RA Capital Management (Press release, TG Therapeutics, MAY 6, 2020, View Source [SID1234557084]). The Company sold approximately 3.5 million shares of the Company’s common stock on May 5, 2020, at the then-prevailing market prices.

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TG Therapeutics intends to use the capital raised through the ATM to fund the ongoing development and commercialization of the Company’s lead assets, ublituximab and umbralisib, as well as for research and development activities of the Company’s pipeline, and for general corporate purposes.

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, commented, "On the heels of the positive topline UNITY-CLL data, we were pleased to bolster our balance sheet with $60 million, including $40 million coming unsolicited from a top-tier biotechnology investor. We greatly appreciate their continued confidence in TG and our efforts to bring the best possible treatment options to patients with B-cell diseases. We look forward to an exciting remainder of 2020, with many important upcoming milestones, including completion of our rolling NDA submission for umbralisib in previously treated marginal zone lymphoma and follicular lymphoma, topline data from the ULTIMATE program evaluating ublituximab in multiple sclerosis, as well as a regulatory submission for the combination regimen of umbralisib and ublituximab in chronic lymphocytic leukemia targeted by year-end."

The shares of common stock were sold pursuant to an automatically-effective registration statement that the Company previously filed with the Securities and Exchange Commission. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On May 6, 2020 Constellation Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported its first-quarter 2020 financial results (Press release, Constellation Pharmaceuticals, MAY 6, 2020, View Source [SID1234557083]).

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"In the face of the serious public health and economic impacts of the COVID-19 pandemic, we at Constellation remain focused on our mission of addressing unmet medical needs in cancer and hematological diseases," said Jigar Raythatha, president and chief executive officer of Constellation Pharmaceuticals. "We are continuing to make progress on each of our development programs and are steadily advancing toward our goal of becoming a fully integrated hematology / oncology company with a sustainable product pipeline.

"Our vision is to transform the standard of care in myelofibrosis with CPI-0610. Encouraging preliminary data on CPI-0610 suggest possible disease-modifying effects, including improvement in bone marrow fibrosis, hemoglobin increases, and conversion of transfusion dependence to transfusion independence, as well as spleen volume reductions and symptom improvement – both in combination with ruxolitinib and as a monotherapy.

"We are also working to create novel treatments for patients in other therapeutic areas," Mr. Raythatha concluded. "We believe that our EZH2-inhibitor franchise of CPI-1205 and CPI-0209 provides potential opportunities to treat a wide range of oncology patients, and we aim to achieve important milestones with each of these molecules this year."

Program Updates

CPI-0610

On May 14, we expect three abstracts to publish in association with the European Hematology Association (EHA) (Free EHA Whitepaper). We will provide an update with 12-week data from 29 JAK-inhibitor-naïve (first-line) patients, 24-week data from 15 JAK-inhibitor-naïve patients, and 24-week data from 48 JAK-inhibitor-experienced (second-line) patients.

Data will include preliminary evidence of disease modification, including bone marrow fibrosis, hemoglobin changes, and conversion from transfusion dependence to transfusion independence, in addition to spleen and symptom improvement.

In mid-June, we expect to present a further update in conjunction with the EHA (Free EHA Whitepaper) meeting, including 12-week data from approximately 50 first-line patients, and 24-week data from 25-30 first-line patients and 70-80 second-line patients.

We aim to start a global clinical trial for CPI-0610 in the first-line setting during the second half of 2020.

We continue to plan to meet with the FDA in mid-2020 to discuss the future development of CPI-0610.
EZH2

The ProSTAR trial is fully enrolled and we plan to determine next steps for CPI-1205 after taking a mid-year data cut. As we previously discussed, our plans for any potential Phase 3 program for CPI-1205 will depend on our assessment of these data on duration of effect, as well as other considerations.

The Phase 1 clinical trial for CPI-0209 is proceeding as planned, and we expect to determine a recommended Phase 2 dose in the second half of 2020. Once we have established the Phase 2 dose we plan to start a broad-based expansion study in solid tumors.
Impact of COVID-19

Execution of ongoing clinical trials. Patient safety remains paramount in the execution of our clinical trials. In the face of the COVID-19 pandemic, we continue to treat patients in our MANIFEST, ProSTAR, and CPI-0209 clinical trials.

Patient enrollment in MANIFEST began to slow toward the end of first quarter of 2020. Prior to the pandemic, we had met or exceeded our internal enrollment goal for MANIFEST, and we continue to assess what impact the pandemic could have on our MANIFEST trial timeline. Similarly, while we have had incidences of incomplete data collection to date, we are utilizing provisions of the protocol and recent regulatory guidance that provide potential flexibility in the time and place of data collection, and we will continue to monitor the situation. We expect to provide a data update at EHA (Free EHA Whitepaper) similar to our plans prior to the COVID-19 outbreak.

To date, we have not seen a significant impact of COVID-19 on clinical trials for CPI-1205 or CPI-0209. The ProSTAR trial for CPI-1205 is proceeding, and we continue to expect to do a data cut in mid-2020 and to provide an update shortly thereafter. Our CPI-0209 Phase 1 trial continues as planned before the COVID-19 outbreak and we continue to expect to determine a recommended Phase 2 dose in the second half of 2020.
CPI-0610 Phase 3 clinical trial. Conditions at clinical trial sites caused by COVID-19 may impact the timing of the start of our Phase 3 clinical trial for CPI-0610. However, we still aim to begin this trial in the second half of 2020.

Manufacturing. We have experienced some disruption in our supply chain due to COVID-19. However, supply chain disruptions have not impacted our overall timelines for conducting clinical trials to date, and we continue to manufacture batches for our ongoing clinical trials.
Milestones

The Company anticipates achieving the following milestones during 2020:

CPI-0610 – Provide MANIFEST program update at EHA (Free EHA Whitepaper) in June

CPI-0610 – Initiate Phase 3 clinical trial in second half of 2020

CPI-0610 – Provide additional MANIFEST program update by end of year

CPI-1205 – Provide ProSTAR program update and determine next steps mid-year

CPI-0209 – Provide program update, including recommended Phase 2 dose, by end of year

First Quarter 2020 Financial Results

Cash, cash equivalents, and marketable securities as of March 31, 2020, were $358.8 million, a decrease of 6.5% compared to December 31, 2019, primarily due to operating expenses.

Research and development (R&D) expenses increased 28.1% year over year to $20.1 million in the first quarter of 2020, mainly due to increased clinical trial expenses.

General and administrative (G&A) expenses grew 33.4% year over year to $5.9 million in the first quarter of 2020, primarily due to building out the organization of the company.

The net loss attributed to common shareholders increased 31.0% year over year to $25.4 million for the first quarter of 2020, mainly due to increased R&D and G&A expenses. The net loss per share attributable to common shareholders decreased 18.7% to $0.61 per share due to an increase in shares outstanding as a result of the private placement in October 2019 and the public offering in December 2019, offset in part by the increased net loss.
Financial Guidance

Constellation expects that its current cash, cash equivalents, and marketable securities will enable it to fund operations into the second half of 2022.

Conference Call

Constellation will host a conference call at 8:00 AM EDT on May 6, 2020, to discuss its clinical programs and financial results. The event will be webcast live and can be accessed on the Investor Relations section of Constellation’s website at View Source To participate in the live question-and-answer session, please dial (877) 473-2077 (domestic) or (661) 378-9662 (international) and refer to conference ID 4372778.