On February 25, 2020 Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, reported financial results and business highlights for the fourth quarter and year ended December 31, 2019, and provided full-year 2020 financial guidance (Press release, Vericel, FEB 25, 2020, View Source [SID1234554707]).
Fourth Quarter 2019 Financial Highlights

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Total net product revenues increased 26% to $39.4 million, compared to $31.3 million in the fourth quarter of 2018, marking the eleventh consecutive quarter with record revenues for the reported quarter;

MACI net revenue of $33.6 million and Epicel net revenue of $5.8 million;

Gross margin of 73%, compared to gross margin of 72% in the fourth quarter of 2018;

Net income of $9.5 million, or $0.20 per share, compared to $5.2 million, or $0.11 per share, in the fourth quarter of 2018; and

Non-GAAP adjusted EBITDA of $12.8 million, compared to $7.7 million in the fourth quarter of 2018.
Full-Year 2019 Financial Highlights

Total net product revenues increased 30% to $117.9 million, compared to $90.9 million in 2018;

MACI net revenue of $91.6 million and Epicel net revenue of $26.2 million;

Gross margin of 68%, compared to gross margin of 65% in 2018;

Net loss of $9.7 million, or $0.22 per share, which includes the $17.5 million upfront license payment to MediWound Ltd. for North American rights to NexoBrid;

Non-GAAP adjusted net income, excluding the $17.5 million upfront license payment to MediWound, of $7.8 million, or $0.18 per share, compared to a net loss of $8.1 million, or $0.20 per share, in 2018;

Non-GAAP adjusted EBITDA of $21.2 million, compared to $4.7 million in 2018; and

As of December 31, 2019, the company had $79.0 million in cash and investments, compared to $82.9 million as of December 31, 2018; excluding the $17.5 million license payment to MediWound, the company’s cash balance increased by $13.6 million in 2019.
Business Highlights and Updates

Initiated the MACI sales force expansion from 49 to 76 sales territories and from six to nine sales regions, which remains on track to be implemented on April 1, 2020;

Announced initiation of the NexoBrid Expanded Access Treatment Protocol (NEXT) to treat patients with deep partial- and full-thickness burns in the United States during the preparation and review of the NexoBrid Biologics License Application;

Announced that that the U.S. Biomedical Advanced Research and Development Authority (BARDA) has begun procuring NexoBrid for emergency stockpile as part of the U.S. Department of Health and Human Services’ mission to build national preparedness for public health medical emergencies; and

Planning a mid-2020 submission of the NexoBrid Biologics License Application to the FDA.
"Our fourth-quarter and full-year results reflect a landmark year for the company in which we not only continued to deliver significant revenue growth, but also achieved strong profit growth and added an exciting new product to our portfolio," said Nick Colangelo, President and CEO of Vericel. "With expected sustained strong double-digit growth ahead for MACI, together with continued growth for Epicel and the anticipated launch of NexoBrid, we believe that Vericel is well-positioned to deliver substantial revenue, profit, and cash flow growth in the years ahead."
2020 Financial Guidance
The company expects total net revenues for 2020 to be in the range of $141 million to $146 million, including full-year revenue of approximately $3.0 million from BARDA’s emergency stockpile purchases of NexoBrid.
Fourth Quarter 2019 Results
Total net product revenues for the quarter ended December 31, 2019 increased 26% to $39.4 million, compared to $31.3 million in the fourth quarter of 2018. Total net product revenues for

the quarter included $33.6 million of MACI (autologous cultured chondrocytes on porcine collagen membrane) net revenue and $5.8 million of Epicel (cultured epidermal autografts) net revenue, compared to $25.1 million of MACI net revenue and $6.2 million of Epicel net revenue, respectively, in the fourth quarter of 2018.
Gross profit for the quarter ended December 31, 2019 was $28.8 million, or 73% of net revenues, compared to $22.7 million, or 72% of net revenues, for the fourth quarter of 2018.
Total operating expenses for the quarter ended December 31, 2019 were $19.6 million, compared to $16.7 million for the same period in 2018. The increase in operating expenses was primarily due to a $1.3 million increase in stock-based compensation expense, a $0.7 million increase in MACI sales force expenses driven by the expansion in the second quarter of 2019, and a $0.7 million increase in patient reimbursement support services.
Vericel’s net income for the quarter ended December 31, 2019 was $9.5 million, or $0.20 per share, compared to $5.2 million, or $0.11 per share, for the fourth quarter of 2018.
Non-GAAP adjusted EBITDA was $12.8 million for the quarter ended December 31, 2019, compared to $7.7 million in the fourth quarter of 2018. A table reconciling non-GAAP measures is included in this press release for reference.
Full-Year 2019 Results
Total net product revenues for the year ended December 31, 2019 increased 30% to $117.9 million, compared to $90.9 million in 2018. Total net product revenues included $91.6 million of MACI net revenue and $26.2 million of Epicel net revenue, compared to $67.7 million of MACI net revenue and $23.1 million of Epicel net revenue, respectively, in 2018.
Gross profit for the year ended December 31, 2019 was $80.3 million, or 68% of net revenues, compared to $58.7 million, or 65% of net revenues, in 2018.
Total operating expenses for the year ended December 31, 2019 were $91.5 million, including the $17.5 million upfront license payment to MediWound for North American rights to NexoBrid. Excluding the $17.5 million license payment, operating expenses were $74.0 million, compared to $62.6 million in 2018. Other increases in operating expenses include a $5.0 million increase in stock-based compensation expenses, an incremental $2.6 million in MACI sales force expenses driven by the expansion in the second quarter of 2019, a $2.4 million increase in marketing expenses, and a $1.8 million increase in patient reimbursement support services.
Vericel’s net loss for the year ended December 31, 2019 was $9.7 million, or $0.22 per share, which includes the $17.5 million upfront license payment to MediWound for North American rights to NexoBrid. Non-GAAP adjusted net income, excluding the $17.5 million upfront license payment to MediWound, was $7.8 million, or $0.18 per share, compared to a net loss of $8.1 million, or $0.20 per share, in 2018. A table reconciling non-GAAP measures is included in this press release for reference.

Non-GAAP adjusted EBITDA was $21.2 million for the year ended December 31, 2019, compared to $4.7 million in 2018. A table reconciling non-GAAP measures is included in this press release for reference.
As of December 31, 2019, the company had $79.0 million in cash and investments, compared to $82.9 million as of December 31, 2018. Excluding the $17.5 million license payment to MediWound, the company’s cash balance increased by $13.6 million in 2019.
Conference Call Information
Today’s conference call will be available live at 8:30am Eastern Standard Time and can be accessed through the Investor Relations section of the Vericel website at View Source." target="_blank" title="View Source." rel="nofollow">View Source A slide presentation with highlights from today’s conference call will be available on the webcast and in the Investor Relations section of the Vericel website. Please access the site at least 15 minutes prior to the scheduled start time in order to download the required audio software if necessary. To participate in the live call by telephone, please call (877) 312-5881 and reference Vericel Corporation’s second-quarter 2019 investor conference call. If calling from outside the U.S., please use the international phone number (253) 237-1173.
If you are unable to participate in the live call, the webcast will be available at View Source until February 25, 2021. A replay of the call will also be available until 11:00am (EDT) on March 1, 2020 by calling (855) 859-2056, or from outside the U.S. at (404) 537-3406. The conference ID is 1269587.

On February 25, 2020 Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, reported its financial results for the year ended November 30, 2019 (Press release, Theratechnologies, FEB 25, 2020, View Source [SID1234554706]).

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Fiscal Year 2019 Financial Highlights

Record revenue with net sales of US$63,216,000, up 39.8% from the previous year

Trogarzo sales reach US$27,696,000, up 212% from the previous year

EGRIFTA sales reach US$35,520,000, down 2.2% from the previous year

Strong cash position of US$41,244,000

"Our last fiscal year was one of many accomplishments. In the last twelve months, we managed to obtain approval for Trogarzo in Europe, to launch a new formulation of tesamorelin, EGRIFTA SVTM, to list our shares on NASDAQ, to grow our revenues by 40 percent, to acquire a unique and highly-promising technology platform in oncology, to launch the development program of tesamorelin for the treatment of NASH in HIV and to manage to record a slightly positive EBITDA while investing in Europe and in our developments programs," said Luc Tanguay, President and CEO, Theratechnologies Inc.

"We ended the year with a company stronger than ever and with tools to sustain growth through our commercialized products and a promising pipeline," added Mr. Tanguay.

Fiscal Year 2019 Financial Results

The financial results presented in this press release are taken from the Company’s Management’s Discussion and Analysis, or MD&A, and audited consolidated financial statements for the twelve-month period ended November 30, 2019, which have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB. The MD&A and the audited consolidated financial statements can be found at www.sedar.com, on EDGAR at www.sec.gov and at www.theratech.com. Unless specified otherwise, all amounts in this press release are in U.S. dollars and all capitalized terms have the meaning ascribed thereto in our MD&A. As used herein, EGRIFTA and EGRIFTA SVTM refer to tesamorelin for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. Trogarzo refers to ibalizumab for the treatment of multidrug resistant HIV-1 patients.

For the year ended November 30, 2019

Consolidated revenue for the year ended November 30, 2019 was $63,216,000 compared to $45,217,000 for the same period ended November 30, 2018, an increase of 39.8%. Revenue growth reflects the added contribution of Trogarzo. This was the first full year of commercialization for Trogarzo in the United States where sales reached $27,696,000 as at November 30, 2019. Trogarzo was approved in the United States on March 6, 2018 and has been commercially available since April 30, 2018.

The contribution of EGRIFTA remains significant. For the year ended November 30, 2019, sales of EGRIFTA were $35,520,000 compared to $36,329,000 for the same period last year, representing a decrease of 2.2%. Net sales in 2019 were negatively impacted by an unexpected charge related to government rebates not previously recorded by one of our distributing pharmacies. A portion of units sold to this pharmacy were previously incorrectly identified by the pharmacy as commercial patients, when they were actually government reimbursed patients, who are eligible to rebates.

For the year ended November 30, 2019, cost of sales was $26,076,000 compared to $13,263,000 in the comparable period of Fiscal 2018. Cost of sales includes the cost of goods sold which amounted to $21,125,000 in Fiscal 2019 compared to $9,376,000 in Fiscal 2018. The increase in cost of goods sold is mainly due to the growth of Trogarzo net sales.

Prior to the third quarter of 2018, cost of sales included royalties due under the terms of an agreement terminating our collaboration and licensing agreement with EMD Serono Inc., or EMD Serono. In June 2018, we made a full and final payment of $23,850,000 to EMD Serono which enabled Theratechnologies to realize savings from a reduction of future payment obligations including royalty payments.

The payment in connection with the settlement of the future royalty obligation has been accounted as "Other asset" on the consolidated statement of financial position. Consequently, an amortization of $4,884,000 has been recorded in relation to this transaction in Fiscal 2019 compared to $2,442,000 during Fiscal 2018 and is included in cost of sales.

R&D Expenses amounted to $10,841,000 for Fiscal 2019 compared to $7,994,000 in Fiscal 2018.

The increase in R&D expenses is largely due to regulatory and medical activities in Europe, to the development of tesamorelin and to investments in the oncology platform.

R&D expenses also included medical affairs initiatives aimed at raising awareness among physicians and nurses who interact with patients living with MDR HIV-1 and lipodystrophy, in addition to regulatory affairs activities, such as handling of the European filing of Trogarzo and quality assurance activities.

These expenses were partially offset by the decision of the FDA to release Theratechnologies from its last post-approval commitments relating to EGRIFTA.

Selling expenses for the year ended November 30, 2019 amounted to $26,482,000 compared to $21,693,000 for the same period last year.

The increase in selling expenses is largely associated with preparation work related to the approval and launch of Trogarzo in Europe as well as the launch of EGRIFTA SVTM and the direct-to-consumer campaign in the United States.

The amortization of the intangible asset value established for the EGRIFTA and Trogarzo commercialization rights in North America is also included in selling expenses. We recorded an expense of $2,412,000 in Fiscal 2019 compared to $1,767,000 in Fiscal 2018.

General and administrative expenses for the year ended November 30, 2019 amounted to $8,330,000 compared to $5,828,000 for the same period in Fiscal 2018.

The increase in general and administrative expenses is mainly associated with business growth, increased activity in Europe, the listing on NASDAQ and additional investor relations initiatives.

Finance income, consisting of interest income, for the year ended November 30, 2019 amounted to $1,097,000 compared to $608,000 in Fiscal 2018. Higher finance income is mostly related to a higher average liquidity position.

Finance costs for the year ended November 30, 2019 were $5,080,000 compared to $3,016,000 in Fiscal 2018. Finance costs in Fiscal 2019 mostly represent interest of $3,317,000 on the convertible senior unsecured notes issued on June 18, 2018, compared to $1,486,000 last year.

Finance costs also included accretion expense, which amounted to $1,673,000 during Fiscal 2019 compared to $1,041,000 during Fiscal 2018.

Adjusted EBITDA for Fiscal 2019 was $323,000 compared to $1,664,000 in Fiscal 2018, reflecting increased investments towards building our infrastructure in Europe, the development of our oncology platform and the listing of our common shares on the NASDAQ. These higher expenses were partially offset by higher revenues related to growing Trogarzo sales. See "Non-IFRS Financial Measures" below.

Taking into account the revenue and expense variations described above, we recorded a net loss of $12,496,000 or $0.16 per share in Fiscal 2019 compared to a net loss of $4,700,000 or $0.06 in Fiscal 2018.

As at November 30, 2019, cash, bonds and money market funds amounted to $41,244,000.

Fourth Quarter 2019 Financial Results

Consolidated revenue for the three months ended November 30, 2019 amounted to $16,400,000 compared to $13,983,000 for the same period last year, representing an increase of 17.3%.

For the fourth quarter of Fiscal 2019, sales of EGRIFTA reached $8,731,000 compared to $9,732,000 in the fourth quarter of the prior year. While unit sales to our US distributor were up 5.3% compared to Q4 of 2018, net sales decreased for two main reasons: (i) net sales for Q4 2019 were impacted by an unexpected charge related to government rebates not previously recorded by one of our distributing pharmacies. A portion of units sold to this pharmacy were previously incorrectly identified by the pharmacy as commercial patients, when they were actually government reimbursed patients, who are eligible to rebates, and (ii) net sales for Q4 2018 were positively impacted by the reversal of a provision related to chargebacks and rebates.

In the fourth quarter of 2019, Trogarzo sales amounted to $7,669,000 compared to $4,251,000 for the same quarter of 2018, representing an increase of 80.4%.

For the three-month period ended November 30, 2019, cost of sales was $6,989,000 compared to $4,751,000 in the comparable period of Fiscal 2018. Cost of goods sold was $5,754,000 compared to $3,516,000 for the same period last year. The increase in cost of goods sold is mainly due to higher sales of Trogarzo. Cost of sales include an amortization of $1,221,000 in the fourth quarter of 2019 and of 2018 in connection with the settlement of the future royalty obligation which has been accounted as "Other asset" on the consolidated statement of the financial position.

R&D expenses in the three-month period ended November 30, 2019 amounted to $3,877,000 compared to $2,063,000 in the comparable period of Fiscal 2018. As previously explained, this increase is largely due to investments made towards the approval of Trogarzo in Europe, the development of our oncology platform and of tesamorelin for the treatment of NASH in people living with HIV as well as medical activities related to Trogarzo.

Selling expenses in the three-month period ended November 30, 2019 amounted to $7,673,000 compared to $5,233,000 in the comparable period of Fiscal 2018.

The increase in selling expenses is largely associated with preparation work related to the approval and launch of Trogarzo in Europe as well as to the launch of EGRIFTA SVTM and to the direct-to-consumer campaign in the United States.

The amortization of the intangible asset value established for the EGRIFTA and Trogarzo commercialization rights in North America is also included in selling expenses. We recorded an expense of $642,000 for the fourth quarter of Fiscal 2019 compared to $487,000 for the same quarter the previous year.

General and administrative expenses in the fourth quarter of Fiscal 2019 amounted to $3,258,000 compared to $1,865,000 reported in the same period of Fiscal 2018. The increase is mainly associated with business growth, the expansion in Europe and the listing of our common shares on NASDAQ.

Finance income, consisting of interest income, for the three-month period ended November 30, 2019 was $217,000 compared to $276,000 in the comparable quarter of Fiscal 2018. Lower finance income is a reflection of our slightly lower liquidity position during the fourth quarter of Fiscal 2019 compared to the same period of 2018.

Finance costs for the fourth quarter of Fiscal 2019 were $1,275,000 compared to $1,330,000 for the same quarter of Fiscal 2018. As previously stated, finance costs are mostly comprised of interest on the Notes.

Finance costs also include accretion expense, which was $440,000 for the fourth quarter of 2019 compared to $357,000 for the same period last year. Accretion expense was is mainly associated with the Notes issued in June 2018.

Adjusted EBITDA for the fourth quarter of 2019 was $(3,217,000) compared to $1,996,000 in same period of Fiscal 2018. See "Non-IFRS Financial Measures" below.

The variation from Q4 2018 to Q4 2019 is mainly due to the increased activity in Europe, our investment in new research and development activities and the previously described charges related to government rebates. Our Q4 2018 Adjusted EBITDA was also positively impacted by the reversal of chargebacks and provisions, as previously mentioned.

Taking into account the revenue and expense variations described above, we recorded a net loss of $6,445,000 or $0.08 per share in the fourth quarter of Fiscal 2019 in comparison to a net loss of $983,000 or $0.01 per share in the fourth quarter of 2018.

We ended the fourth quarter of 2019 with $41,244,000 in cash, bonds and money market funds.

For the three-month period ended November 30, 2019, operating activities used $2,760,000 compared to generating $2,622,000 in the comparable period of Fiscal 2018.

In the fourth quarter of Fiscal 2019, changes in operating assets and liabilities had a positive impact on cash flow of $488,000. These changes include an increase of $9,096,000 in accounts payable and accrued liabilities and a decrease in accounts receivable of $1,258,000, which were mainly offset by a $8,082,000 increase in inventories. These changes are related to an increase in our commercial activities.

Non-IFRS Financial Measures

Reconciliation of net profit or loss to adjusted earnings before interest, taxes, depreciation and amortization (Adjusted EBITDA)

Adjusted EBITDA is a non-IFRS financial measure. A reconciliation of the Adjusted EBITDA to net profit (loss) is presented in the table below. We use adjusted financial measures to assess our operating performance. Securities regulations require that companies caution readers that earnings and other measures adjusted to a basis other than IFRS do not have standardized meanings and are unlikely to be comparable to similar measures used by other companies. Accordingly, they should not be considered in isolation. We use Adjusted EBITDA to measure operating performance from one period to the next without the variation caused by certain adjustments that could potentially distort the analysis of trends in our business, and because we believe it provides meaningful information on our financial condition and operating results.

We obtain our Adjusted EBITDA measurement by adding to net profit or loss, finance income and costs, depreciation and amortization, and income taxes. We also exclude the effects of certain non-monetary transactions recorded, such as share-based compensation for the stock option plan, lease inducements and write-downs (or related reversals) of inventories, for our Adjusted EBITDA calculation. We believe it is useful to exclude these items as they are either non-cash expenses, items that cannot be influenced by management in the short term, or items that do not impact core operating

performance. Excluding these items does not imply they are necessarily nonrecurring. Share-based compensation costs are a component of employee remuneration and can vary significantly with changes in the market price of the Company’s shares. In addition, other items that do not impact core operating performance of the Company may vary significantly from one period to another. As such, Adjusted EBITDA provides improved continuity with respect to the comparison of our operating results over a period of time. Our method for calculating Adjusted EBITDA may differ from that used by other companies.

Conference Call Details

A conference call will be held today at 8:30 a.m. (ET) to discuss the results. The conference call will be open to questions from financial analysts. Media and other interested individuals are invited to participate in the call on a "listen-only" basis.

The conference call can be accessed by dialling 1-877-223-4471 (North America) or 1-647-788-4922 (International). The conference call will also be accessible via webcast at View Source Audio replay of the conference call will be available on the same day starting at 11:30 a.m. (ET) until March 10, 2020, by dialling 1-800-585-8367 (North America) or 1-416-621-4642 (International) and by entering the playback code 5896409.

On February 25, 2020 WALTHAM, Mass., Feb. 25, 2020 /PRNewswire/ — Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that it will release its fourth quarter and year-end 2019 financial results on Tuesday, March 3, after the close of the U.S. financial markets (Press release, Syndax, FEB 25, 2020, View Source [SID1234554705]).

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In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET on Tuesday, March 3, to discuss the Company’s financial results and provide a general business update.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 2786075
Domestic Dial-in Number: (855) 251-6663
International Dial-in Number: (281) 542-4259
Live webcast: View Source

For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company’s website, www.syndax.com.

On February 25, 2020 Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on the registration and commercialization of momelotinib, a JAK1, JAK2 & ACVR1 inhibitor with a potentially differentiated therapeutic profile for the treatment of myelofibrosis, reported that Dr. Nick Glover, President and Chief Executive Officer, will present an overview of the company entitled "Building MOMENTUM for Patients with Myelofibrosis" at the Cowen 40th Annual Health Care Conference in Boston, Massachusetts (Press release, Sierra Oncology, FEB 25, 2020, View Source [SID1234554704]).

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The presentation is scheduled for 10:00 a.m. ET on Wednesday, March 4, 2020. A live audio webcast and archive of the presentation will be accessible through www.sierraoncology.com.

On February 25, 2020 ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, is reported that a total of 6,289,851 of the common share purchase warrants issued on February 10 and February 21, 2017 in a non-brokered private placement were exercised at a price of $0.20 per share for gross proceeds of $1,257,970, the vast majority of such proceeds having been received in the last month prior to the February 21, 2020 expiry date (Press release, ProMIS Neurosciences, FEB 25, 2020, View Source [SID1234554703]).

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Commenting on today’s announcement, ProMIS Executive Chairman, Eugene Williams, stated: "We are very pleased to receive the proceeds from warrant exercise. The additional funds will now extend our cash life further into 2020. ProMIS remains focused on developing PMN310 as potential best in class therapy for Alzheimer’s disease."