Will the CPI Number or Fed Minutes Change the Market Direction this Week?
Market-moving economic reports are likely this week. Those with the highest chance to move markets are March CPI data on Wednesday, then FOMC minutes from the meeting just after last month’s bank failures, and the Producer Price Index on Thursday.
The minutes of the March 21-22 FOMC meeting will be released at 2:00 PM Wednesday, this highly watched information coincides with the half-fiscal year Budget Report from the U.S. Treasury. The FOMC minutes will get a lot of attention, but the U.S. Budget Deficit is likely to receive renewed focus as we approach summer and begin to bump up against the Treasury’s borrowing ceiling.
Monday 4/10
10:00 AM ET, Wholesale Inventories’ second estimate for February is expected to show a 0.2 percent build up; this would be unchanged from the first estimate.
Tuesday 4/11
6:00 AM ET, Small Business Optimism Index has been below the historical average of 98 for 14 months in a row. March’s consensus is 89.0 versus 90.9 in February. The direction of the health of small businesses can foreshadow changes in the stock market.
1:30 PM ET, Austan Goolsbee, President of the Federal Reserve Bank of Chicago will be speaking at a luncheon at the Economic Club of Chicago.
Wednesday 4/12
8:30 AM ET, The Consumer Price Index (CPI) core prices for March are expected to have risen by 0.4 percent versus February’s sharp and higher-than-expected increase of 0.5 percent. Overall, headline inflation prices are expected to have increased 0.3 percent after February’s 0.4 percent rise. Annual rates, which in February were 6.0 percent overall and 5.5 percent for the core, are expected to show 5.2 and 5.6 percent.
9:10 AM ET, Thomas Barkin, President of the Federal Reserve Bank of Richmond will be speaking. He spoke on April 3, indicating his expectations are that low unemployment rates will continue to support the belief that the economy is not at risk of a recession. Inflation, however, is not going away anytime soon, according to Barkin.
10:30 AM ET, The Energy Information Administration (EIA) will provide its weekly information on petroleum inventories in the U.S., whether produced here or abroad. The level of inventories helps determine prices for petroleum products. Markets will be paying close attention after OPEC+ cut production one week ago.
2:00 PM ET, FOMC minutes from the March 21-22 meeting will be released. This report will have two areas that investors will focus on. These are conversations surrounding U.S. bank health, and those discussions related to inflation and interest rates.
2:00 PM ET, the Treasury Statement related to the budget deficit are expected to report a $253.0 billion deficit in March. This would compare with a $192.7 billion deficit in March a year-ago and a deficit in February this year of $262.4 billion. March is the halfway point into the U.S government’s fiscal year.
Thursday 4/13
8:30 AM ET, Producer Price Index (PPI), After dropping 0.1 percent lower on the month in February, this inflation index on the producer level in March is expected to be unchanged. March’s ex-food ex-energy rate is seen up 0.3 percent versus February’s no change.
4:30 PM ET, the Federal Reserve’s Balance Sheet has been receiving heightened attention. After the Silicon Valley Bank collapse the Fed institutes a new method for banks to get assistance, markets will watch to see if this has grown. Also, as interest rates have risen, the fixed income securities held by the Fed have repriced billions lower, Fed watchers are beginning to comment on how dramatic this drop in value has been. The last line investors will focus on is quantitative easing. Specifically, investors will look to see if the Fed is on track with its letting securities mature off its books without reinvestment – this reduces U.S. dollars in circulation.
Friday 4/14
8:30 PM ET, March Retail Sales are expected to have fallen 0.4 percent for a second month in a row. Excluding autos, a 0.4 percent decline is also expected.
9:15 AM ET, Industrial Production is expected to rise 0.3 percent in March after being unchanged in February.
10:00 AM ET, Business Inventories for February are expected to have risen 0.3 percent following a 0.1 percent draw in January.
10:00 AM ET, Consumer Sentiment, which sank five full points in March to 62.0, is expected to improve to 62.7 in the first reading for April.
What Else
Taxes are due April 18 this year. This typically creates a wave of new IRA deposits. On April 13, in NYC there will be a luncheon roadshow with PDS Biotechnology. Noble Capital Markets organize the event, more details are available on Channelchek by clicking here.
NEWTOWN, Pa., April 06, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that its Chief Medical Officer (CMO) Mark Gelder, M.D., recently passed away unexpectedly. Michael Saunders, M.D., has been appointed the interim Chief Medical Officer of the Company.
“The entire Onconova family is deeply saddened by the loss of our beloved friend and colleague,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. “Dr. Gelder dedicated his career to caring for and improving the treatment options available to patients with cancer and his thought leadership and scientific passion will be sorely missed by the oncology community. Mark trained and worked as a gyn oncologist. Because of that experience, he was dedicated to advancing the care of women with reproductive tract cancers. Our goal is to complete the mission Mark started by advancing our trial in endometrial cancer and other cancers as well. We are immensely grateful for his many contributions to Onconova and express our deepest condolences to his family, friends, and colleagues during this difficult time. May he rest in peace.”
Dr. Gelder served as Onconova’s CMO since June 2021. He was an accomplished industry leader with more than 35 years of experience in clinical development, medical affairs, and medical marketing. His previously held the role of CMO at Elevar Therapeutics, Pierian Biosciences (formerly DiaTech Oncology), Accelovance, Inc., and Heron Therapeutics, Inc. Dr. Gelder also had extensive experience at large pharmaceutical companies including Pfizer, Wyeth, and Bayer. He earned his M.D. from the University of Virginia School of Medicine, completed a fellowship in gynecologic oncology, and was a Fellow of the American College of Physicians and the American College of Obstetrics and Gynecology.
Onconova’s Board of Directors will convene at an appropriate time to appoint a new CMO. A search is currently underway by the Company. Onconova does not expect any material impact to the stated timelines associated with its ongoing or planned clinical trials due to this sad news. The Company notes that Dr. Michael Saunders, a noted drug developer and colleague, has been working with Onconova as a consultant and is thus well acquainted with the Company’s compounds in development.
About Onconova Therapeutics, Inc.
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.
Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two separate and complementary Phase 1 dose escalation and expansion studies. These trials are currently underway in the United States and China. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also planning a combination trial of narazaciclib with estrogen blockade in advanced endometrial cancer, as well as its clinical study in additional indications.
Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies, including a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, and a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC).
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding its clinical development and trials, its product candidates, its business and financial position. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “preliminary,” “encouraging,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
STAMFORD, Conn.–(BUSINESS WIRE)– Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm, said today it will release its first-quarter financial results on Monday, May 8, 2023, at approximately 4:15 p.m., U.S. Eastern Time.
The firm will host a conference call with investors and industry analysts at 9 a.m., U.S. Eastern Time, the following day, Tuesday, May 9. Dial-in details are as follows:
The dial-in number for U.S. participants is +1 833-470-1428.
International participants should call +1 404-975-4839.
The security code to access the call is 417295.
Participants are requested to dial in at least five minutes before the scheduled start time.
A recording of the conference call will be accessible on ISG’s website (www.isg-one.com) for approximately four weeks following the call.
About ISG
ISG (Information Services Group) (Nasdaq: III) is a leading global technology research and advisory firm. A trusted business partner to more than 900 clients, including more than 75 of the world’s top 100 enterprises, ISG is committed to helping corporations, public sector organizations, and service and technology providers achieve operational excellence and faster growth. The firm specializes in digital transformation services, including automation, cloud and data analytics; sourcing advisory; managed governance and risk services; network carrier services; strategy and operations design; change management; market intelligence and technology research and analysis. Founded in 2006, and based in Stamford, Conn., ISG employs more than 1,600 digital-ready professionals operating in more than 20 countries—a global team known for its innovative thinking, market influence, deep industry and technology expertise, and world-class research and analytical capabilities based on the industry’s most comprehensive marketplace data. For more information, visit www.isg-one.com.
Vancouver, British Columbia–(Newsfile Corp. – April 6, 2023) – Maple Gold Mines Ltd. (TSXV: MGM) (OTCQB: MGMLF) (FSE: M3G) (“Maple Gold” or the “Company“) is pleased to report results from the final 20% of assays that were received from the previously completed 14,720 metres (“m”) of drilling at the 100%-controlled Eagle Mine Property (“Eagle”). The Company is also pleased to report that more than 7,000 m have now been completed (6,000 m planned) at the Telbel Mine area of the Joutel Project, which is held by a 50/50 joint venture (the “JV”) between the Company and Agnico Eagle Gold Mines Limited.
The final batch of assays received from completed drilling at Eagle correspond to approximately 3,000 m of the 14,720 m drilled to-date. The results continue to demonstrate continuity of mineralization and the potential significance of the multiple horizons/splays to the northwest of the former Eagle mine. Highlights include (see Table 1 and Figure 1 for highlighted results from all Maple Gold drilling at Eagle to-date):
EM-22-008W intersected 6.2 grams per tonne (“g/t”) gold (“Au”) over 2.0 m in the South Mine Horizon (“SMH”) and 4.2 g/t Au over 3.9 m in sediments further downhole.
EM-22-006W1 intersected multiple intercepts including 6.5 g/t Au over 1.2 m and 2.0 g/t Au over 3.0 m in the SMH and 2.3 g/t Au over 3.0 m at the microgabbro/Harricana sediment contact further downhole.
EM-22-006W4 intersected 4.0 g/t Au over 0.7 m within a broader 1.1 g/t Au over 14.2 m intercept within the SMH.
EM-22-017A intersected 2.9 g/t Au over 2.0 m and additional lower grade over broader near-surface intervals (1.0 g/t Au over 15.5 m from 93 m downhole).
“We have come along way since first consolidating the Joutel ground into our JV property package,” stated Matthew Hornor, CEO of Maple Gold. “All of our exploration and drilling work along the past-producing Eagle-Telbel mine trend is designed with the aim of defining high-grade zones of gold mineralization and additional mineral resources to complement the established potentially bulk-mineable resource present at Douay. Our first year of drilling at Eagle has more than covered our exploration spending commitments to earn a 100% interest and we are now in position to finalize our compilation and model updates to support focused follow-up drilling in areas we believe have the most promise to deliver additional high-quality ounces.”
Overview Summary and Key Takeaways from Drilling at Eagle
The Eagle-Telbel Mine trend produced 1.1 Moz at 6.5 g/t Au from 1974 – 1993, during a period when the price of gold averaged approximately $350 per ounce. During the first year of the JV (2021), all historical mining, stope and drilling data was digitized to underpin a new 3D geological model. The Company signed an option agreement to acquire a 100% interest in the Eagle Mine Property (see press release July 19, 2021) and has since completed more than 21,500 m of drilling across the 4 km long Eagle-Telbel Mine trend, with 14,720 m at Eagle (see Figure 1) and more than 7,000 m (assays pending) of JV drilling at Telbel.
The Company’s drilling to-date at Eagle has served to confirm that gold mineralization is not limited to a narrow stratigraphic interval (Eagle-Telbel Mine Horizon) but instead covers a significantly broader stratigraphic interval of over 100 m straddling the Harricana Deformation Zone. Drill core observations also support the Company’s concept of a significant structural component to gold mineralization in the form of an orogenic gold overprint.
Figure 1: Plan view map showing drilling to-date at Eagle with highlighted intercepts.
Several highlights from the Company’s first year of drilling at Eagle are summarized below (see Figure 1 above for locations):
EM-22-005: 4.0 g/t Au over 7.5 m, including 6.4 g/t Au over 3.0 m
EM-22-009: 11.4 g/t Au over 3 m, including 24.4 g/t Au over 1 m
EM-22-013: 2.3 g/t Au over 10.4 m, including 5.0 g/t Au over 3.2 m
EM-22-015: 10.3 g/t Au over 7.8 m, including 41.1 g/t Au over 1.0 m
EM-22-015: 4.3 g/t Au over 3.9 m, including 7.4 g/t Au over 1.5 m
EM-22-016: 3.1 g/t Au over 7.3 m, including 4.0 g/t Au over 3.6 m
When combining the Company’s drilling results and observations with notable historical results and new geophysical data, several priority target areas emerge along the SMH and North Mine Horizon (“NMH”); including multiple cross-plunging target concepts that will form part of the focus for the Company’s next phase of drilling (~5,000 m). The Company has initiated target definition and permitting work for a planned summer 2023 follow-up program at Eagle (see press release March 16, 2023) and priority follow-up targets will also be defined at Telbel once assay results have been received and interpreted from the first phase of deep drilling.
Figure 2: Oblique view showing SMH and NMH trends with grade contouring and highlighted pierce points with corresponding intercepts and target areas.
Table 2: Highlighted Assay Results from Maple Gold Drilling at Eagle to-date
Hole
UTME
UTMN
Azimuth
Plunge
Length (m)
From
To
Interval
Au g/t
EM-22-001
690565
5486334
40.6
-66.8
356.6
132.0
134.6
2.6
1.7
including
133.7
134.6
0.9
4.4
EM-22-002
690565
5486334
22.0
-52.4
243
183.2
185.0
1.8
2.1
EM-22-002
200.4
205.0
4.7
2.4
including
200.4
202.4
2.1
3.8
EM-22-003
690642
5486322
59.1
-70.5
288
Narrow intercepts <1 g/t Au
EM-22-004
690673
5486120
49.9
-56.0
288
139.0
141.0
2.0
1.2
EM-22-005
690758
5486043
22.6
-75.7
714
346.0
360.0
14.0
2.2
including
346.0
353.5
7.5
4.0
including
350.0
353.0
3.0
6.4
EM-22-006
690737
5485828
25.9
-63.2
777.75
539.3
543.0
3.7
1.3
EM-22-007
690736
5485826
23.9
-73.2
985
877.0
878.0
1.0
2.0
EM-22-009
690921
5485639
17.5
71.4
1009
920.4
921.0
0.6
10.8
EM-22-009
951.0
956.0
5.0
1.6
EM-22-009
984.0
993.0
9.0
4.0
EM-22-009
990.0
993.0
3.0
11.4
EM-22-009
991.0
993.0
2.0
15.5
including
992.0
993.0
1.0
24.4
EM-22-010
690841
5485795
32.5
-71.4
570
539.5
540.0
0.5
14.0
EM-22-010
543.0
544.0
1.0
8.3
EM-22-010W
690841
5485795
34.1
-61.2
932
921.0
922.0
1.0
3.7
EM-22-011
690547
5485859
56.7
-62
924
858.3
859.0
0.7
3.2
EM-22-012
691098.7
5485413
35.3
-78.6
1284
1232.2
1234.3
2.1
2.0
EM-22-013
690757.5
5486043
63.8
-69.8
327
257.0
267.4
10.4
2.3
including
257.0
260.2
3.2
5.0
EM-22-014
690565
5486334
64.5
-67.9
646
231.0
231.7
0.7
4.6
EM-22-015
690757.5
5486043
45
-50.1
408
142.5
148.6
6.1
1.6
EM-22-015
164.9
165.5
0.7
4.8
EM-22-015
217.1
221.0
3.9
4.3
including
218.5
220.0
1.5
7.4
EM-22-015
228.0
235.8
7.8
10.3
including
228.5
232.8
4.3
15.9
including
230.0
231.0
1.0
41.1
EM-22-015
246.7
248.4
1.7
4.3
including
247.5
248.4
0.9
7.1
EM-22-015
252.2
255.0
2.8
1.8
EM-22-016
690757.8
5486043
45.1
-62.6
297
193.0
206.2
13.2
2.2
including
193.0
200.3
7.3
3.1
including
196.0
199.6
3.6
4.0
EM-22-016
202.0
206.2
4.2
1.7
EM-22-017A
690643
5486322
41.3
-55.76
201
93.5
109.0
15.5
1.0
including
97.0
103.0
6.0
1.4
EM-22-017A
137.0
144.0
7.0
1.4
including
141.0
143.0
2.0
2.9
EM-22-005W
690795
5486136
2.2
-65.5
364
364.3
365.8
1.5
1.3
624.0
625.0
1.0
1.2
EM-22-006W1
690736.7
5485828
29.5
-57
435.2
476.0
479.0
3.0
2.0
EM-22-006W1
482.8
484.0
1.2
6.5
EM-22-006W1
652.0
655.0
3.0
2.3
including
653.5
654.1
0.6
6.6
EM-22-009W2A
690921
5485639
21.4
-65.9
634
828.0
830.0
2.0
1.4
EM-22-010W1
690841
5485795
30.8
-62
361
583.5
584.0
0.5
1.5
EM-22-008W
690737
5485828
45.6
-58.1
377
527.0
529.0
2.0
6.2
EM-22-008W
630.1
634.0
3.9
4.2
including
631.0
632.5
1.5
6.8
EM-23-006W4
690737
5485828
24.5
-39.4
236
472.0
486.2
14.2
1.1
including
472.0
477.4
5.4
1.4
including
481.6
482.3
0.7
4.0
EM-23-006W4
521.0
523.6
2.6
1.9
EM-22-012W
691098.7
5485413
20
-45.6
524.7
1095.3
1097.4
2.1
1.2
Notes: Drill holes EM-22-006W, EM-22-006X, EM-22-008 and EM-22-009W1 returned no significant assays. Drill hole EM-22-017 was lost at 51 m. True widths estimated at 40% to 70% of downhole width depending on the hole inclination.
Qualified Person
The scientific and technical data contained in this press release was reviewed and prepared under the supervision of Fred Speidel, M. Sc., P. Geo., Vice-President Exploration of Maple Gold. Mr. Speidel is a Qualified Person under National Instrument 43-101 Standards of Disclosure for Mineral Projects. Mr. Speidel has verified the data related to the exploration information disclosed in this press release through his direct participation in the work.
Quality Assurance (QA) and Quality Control (QC)
The Company implements strict Quality Assurance (“QA”) and Quality Control (“QC”) protocols at Eagle covering the planning and placing of drill holes in the field; drilling and retrieving the NQ-sized drill core; drill hole surveying; core transport; core logging by qualified personnel; sampling and bagging of core for analysis; transport of core from site to the Val d’Or, Québec AGAT laboratory; sample preparation for assaying; and analysis, recording and final statistical vetting of results. Check assays for gold are being done on a sample subset at ALS’ laboratory in Val d’Or. For a complete description of protocols, please visit the Company’s QA/QC webpage at www.maplegoldmines.com.
About Maple Gold
Maple Gold Mines Ltd. is a Canadian advanced exploration company in a 50/50 joint venture with Agnico Eagle Mines Limited to jointly advance the district-scale Douay and Joutel gold projects located in Québec’s prolific Abitibi Greenstone Gold Belt. The projects benefit from exceptional infrastructure access and boast ~400 km2 of highly prospective ground including an established gold resource at Douay (SLR 2022) that holds significant expansion potential as well as the past-producing Eagle, Telbel and Eagle West mines at Joutel. In addition, the Company holds an exclusive option to acquire 100% of the Eagle Mine Property.
The district-scale property package also hosts a significant number of regional exploration targets along a 55 km strike length of the Casa Berardi Deformation Zone that have yet to be tested through drilling, making the project ripe for new gold and polymetallic discoveries. The Company is well capitalized and is currently focused on carrying out exploration and drill programs to grow resources and make new discoveries to establish an exciting new gold district in the heart of the Abitibi. For more information, please visit www.maplegoldmines.com.
NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER (AS THAT TERM IS DEFINED IN THE POLICIES OF THE TSX VENTURE EXCHANGE) ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS PRESS RELEASE.
Forward Looking Statements:
This press release contains “forward-looking information” and “forward-looking statements” (collectively referred to as “forward-looking statements”) within the meaning of applicable Canadian securities legislation in Canada, including statements about exploration work and results from current and future work programs. Forward-looking statements are based on assumptions, uncertainties and management’s best estimate of future events. Actual events or results could differ materially from the Company’s expectations and projections. Investors are cautioned that forward-looking statements involve risks and uncertainties. Accordingly, readers should not place undue reliance on forward-looking statements. For a more detailed discussion of such risks and other factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements, refer to Maple Gold Mines Ltd.’s filings with Canadian securities regulators available on www.sedar.com or the Company’s website at www.maplegoldmines.com. The Company does not intend, and expressly disclaims any intention or obligation to, update or revise any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
EDW | EVERY DAY WEED for EVERY DAY THAT ENDS IN A ‘Y’
DENVER, April 6, 2023 /CNW/ – Regional, multi-state cannabis operator, Schwazze, (OTCQX: SHWZ) (NEO: SHWZ) (“Schwazze” or the “Company”), announces today the expansion of its in-house product portfolio with the launch of a new pre-ground, ready-to-roll flower brand, EDW or Every Day Weed. EDW is available now in Colorado with expansion plans for New Mexico coming soon.
As pre-rolls continue to capture flower market share year over year, EDW is designed for the cannabis consumer who wants great flower and consumes it regularly. Pre-ground flower requiring no grinder, EDW is sold in a half-ounce resealable package and is available in indica, sativa and hybrid dominances. The packaging is very lightweight, portable, convenient and comes with its own custom pack of rolling papers, perfect for groups and social gatherings.
“We’re excited to expand our product portfolio with the EDW brand. Schwazze is focused on building a high-quality house of wholesale brands that also deliver great value to cannabis consumers. Given the growth of pre-rolls over the last two years, we are happy to offer a convenient “roll your own” option for our customers,” said Nirup Krishnamurthy, President of Schwazze.
EDW is now available at both Schwazze-owned Star Buds and Emerald Fields retail chains throughout Colorado, among other dispensaries.
About Schwazze
Schwazze (OTCQX: SHWZ NEO: SHWZ) is building a premier vertically integrated regional cannabis company in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. Schwazze’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition.
Medicine Man Technologies, Inc. was Schwazze’s former operating trade name. The corporate entity continues to be named Medicine Man Technologies, Inc. Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth.
Forward-Looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “plan,” “will,” “may,” “continue,” “predicts,” or similar words. Forward-looking statements include the guidance provided regarding the Company’s 2023 performance and annual capital spending. Forward-looking statements are not guarantees of future events or performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified. Consequently, actual events and results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; (v) difficulties in securing regulatory approval to market our products and product candidates; (vi) our ability to successfully execute our growth strategy in Colorado and New Mexico and outside those states, (vii) our ability to identify and consummate future acquisitions that meet our criteria, (viii) our ability to successfully integrate acquired businesses and realize synergies therefrom, (viii) the uncertainty in the application of federal, state and local laws to our business, and any changes in such laws, and (ix) our ability to achieve the target metrics. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise except as required by law.
For more than 70 years, Vectrus has provided critical mission support for our customers’ toughest operational challenges. As a high-performing organization with exceptional talent, deep domain knowledge, a history of long-term customer relationships, and groundbreaking technical expertise, we deliver innovative, mission-matched solutions for our military and government customers worldwide. Whether it’s base operations support, supply chain and logistics, IT mission support, engineering and digital integration, security, or maintenance, repair and overhaul, our customers count on us for on-target solutions that increase efficiency, reduce costs, improve readiness, and strengthen national security. Vectrus is headquartered in Colorado Springs, Colo., and includes about 8,100 employees spanning 205 locations in 28 countries. In 2021, Vectrus generated sales of $1.8 billion. For more information, visit the company’s website at www.vectrus.com or connect with Vectrus on Facebook, Twitter, and LinkedIn.
Joe Gomes, Managing Director – Generalist Analyst, Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
A New Award. Yesterday, V2X was awarded a maintenance contract from the U.S. Navy to provide aircraft maintenance support for Naval Test Wing Pacific (NTWP) VX-30 and VX-31 at Point Mugu, CA and China Lake, CA. The maintenance will consist of flightline maintenance, logistics, and technical support for the two weapons development and test squadrons. The contract is for $440 million and has a seven year period that will end in 2030.
Expanding into the Navy. The specific contract awarded yesterday is the sister to the contract given by the Navy towards Naval Test Wing Atlantic, awarded in April of 2022, also won by Vertex. With the merger of Vertex and Vectrus, the Navy accounted for 24.7% of total revenue for 2022. With both Naval Test Wings contracted under V2X along with a stronger revenue base towards the Navy following the merger, we believe V2X is well positioned to continue to win additional work with the Navy.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Replaces terminated original placement. The original best efforts private placement expected to close near the end of February for gross proceeds up to $4.35 million (currencies in Canadian $), subject to a $3 million minimum, under a listed issuer exemption prospectus, was terminated. The new offering is a non-brokered $2.5 million gross proceeds private placement. Of the original two parts in the February offering, the non-brokered $1.75 million gross proceeds private placement at $0.225/unit portion has closed.
Offering terms revised slightly. The smaller new offering carries slightly different terms than the originally announced listed issuer exemption offering. The new offering units are now priced at $0.20/unit (vs. $0.225/unit), with 12.5 million units being offered. Each unit consists of one Class A share of common and one purchase warrant exercisable at $0.35 with a 5 year expiration. After 6 months, if the volume weighted average trading price exceeds $0.50 for 10 consecutive trading days, ChitogenX can accelerate the expiration date. This new offering is expected to close around April 14, 2023.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Mark Reichman, Senior Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Collaboration with Invest Alberta. LithiumBank executed a Memorandum of Understanding with Invest Alberta Corporation (IAC) to support the development of a lithium production facility at the company’s Boardwalk brine project. Established as a crown corporation of the Government of Alberta, Invest Alberta promotes Alberta as an investment destination of choice to investors in Canada and internationally. LithiumBank’s commercial lithium production facility in northern Alberta could factor importantly in Alberta becoming a destination for critical mineral resource development and as a partner in the electrification supply chain.
Why is this collaboration important? With teams in Calgary and Edmonton along with 11 international locations, IAC connects industry, government partners, and economic development organizations and provides services to facilitate investment in Alberta. The organization will support LithiumBank by promoting the Boardwalk project domestically and internationally, facilitate relationships with key stakeholders and senior government officials, and bolster LithiumBank’s relationships with post-secondary institutions to create a qualified talent pipeline in support of the project.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Much of Market Performance, in Some Cases All, Occur When the Market is Closed
All traders and most investors have experienced this. From one market close to the next, indexes or stocks rise by 1.5% – 3%, and yet there was never a clear opportunity to make a dime after the market open. The frustration is because the market opened with much or all of the day’s gain baked in. It has been proven to be accurate that the most significant revaluation of stocks occurs during the 17 hours when the market is closed, not the 7-hours when it’s open. And any long-term chart will show that the direction of revaluation over time has been upward. Details, along with other phenomena related to night moves, are discussed below.
Background
Historically, stock markets have had a positive return, and most of this change occurs while the exchanges are closed or not during regular trading hours. Historically the tendency is to make most of its daily move between the closing and opening bell.
This has been shown in research papers through the years, and there are even ETFs which purport to take advantage of this statistical phenomenon. Of course this is not an everyday occurrence, in fact today (4/6/23), the S&P 500 opened lower than its previous close but began moving higher than the open around noon.
A well-researched scholarly paper had been published demonstrating these price movements and offered the explanation that stock prices behave very differently with respect to their sensitivity to beta when markets are open for trading versus when they are closed. The paper titled, Asset Pricing: A Tale of Night and Day, by Henderschott, Livdan, and Rösch explained, “stock returns are positively related to beta overnight whereas returns are negatively related to beta during the trading day.”
Image Source: Asset Pricing aTale of Day and Night
One goal of the research was to test the hypothesis that a securities performance relative to beta is only positive during certain periods. In the paper the researchers tested specific days or months by examining the CAPM validity during different time periods within each day, including all times and all days during the week. The authors wrote, “when the stock market is closed, beta is positively related to the cross section of returns. In contrast, beta is negatively related to returns when the market is open.”
The overall thrust of the findings in the 47-page paper are encapsulated in the chart above which plots the performance during opened and closed periods against different beta groupings of stocks over 25 years.
Can Investors Use this Information?
Most retail trading today is commission free, but there is still a bid offer spread and other slippage. For those that would prefer to not have to be active each day, twice a day, Nightshares ETFs were formed to exploit this phenomenon, with a set it and forget it approach. On the surface it would seem to make sense for long term investors. You could own the S&P 500 index ETF, or increase beta exposure for a potentially better performance with a small-cap index ETF.
The founder of Night Shares, Bruce Lavine, pointed out in an interview that over the 20 years through the end of 2022, the SPDR S&P 500 ETF SPY, 0.31% produced a buy-and-hold return of 9.7% annualized. Three-quarters of that return — 7.5% — was produced while the NYSE was closed.
The numbers are even more pronounced in the case of the small-cap Russell 2000 Index, according to Lavine. Over the same 20-year period, all of the index’s net return was produced overnight; during the day session, it actually lost ground on balance. In other words, small-cap portfolios that out-returned large-cap would have been better off if they were not exposed during the day.
Image Credit: Interscatter Data Sharing Contact Lens, UW News (Flickr)
The Challenges Surrounding AI/ML are Taken Head on by the FDA
Should artificial intelligence or machine learning (AI/ML) be allowed to alter FDA approved software in medical devices? If so, where should the guardrails be set? The discussions and debates surrounding AI/ML are heated; some believe the technology may destroy humanity, while others look forward to the speed of advancement it will allow. The FDA is getting out ahead on this debate. This week the agency drafted a list of “guiding principles” intended to begin developing best practices for machine learning within medical devices.
Background
The FDA views its role as protecting patients while at the same time avoiding standing in the way of progress. In the case of ML, not preventing the modification of medical treatments or procedures that would improve outcomes. AI/ML has the potential to more quickly evaluate data sets, improve diagnosis, adjust how used, and overall alter processes based on what is learned.
On April 3, the FDA drafted AI-Enabled Medical Device Life Cycle Plan Guidance, with a comment period ending July 3, 2023. The U.S. regulator’s proposal attempts to find science-based requirements for medical devices powered by artificial intelligence and machine learning. The overall goal is to not slow the implementation of improved new devices that may quickly be modified, updated, and rapidly deliver an improved response to new data.
Greg Aurand, Senior Healthcare Services & Medical Devices Analyst at Noble Capital Markets, summed up the purpose for the FDA’s actions in this way: “The FDA needs to move cautiously, but they don’t wish to slow down healthcare improvements on an ongoing basis.” Aurand gave examples where machine learning has the potential to make better assessments, better decipher data sets such as antibiotic resistance, and improve results while perhaps taming medical expenses. He said, “new draft guidelines from the FDA should make it easier for approval of modifications to occur so previously unrecognized improvements may occur within the guidelines, and the process is less static.”
How is Artificial Intelligence Likely to Revise Medical Devices?
As is written into the FDA guidance, “Artificial intelligence (AI) and machine learning (ML) technologies have the potential to transform health care by deriving new and important insights from the vast amount of data generated during the delivery of health care every day. Medical device manufacturers are using these technologies to innovate their products to better assist health care providers and improve patient care.”
The FDA accepts that a great benefit of AI/ML in software is its ability to learn from real-world use and experience, then the ability to improve its own performance.
How is the FDA Expected to Regulate AI/ML Devices?
Traditionally, the FDA reviews medical devices and improvements through a premarket pathway for approval. The FDA may also review and clear modifications to medical devices, including software as a medical device, depending on the significance or risk posed to patients by that modification. The industry is going through a paradigm shift which the FDA is helping to enable.
The FDA’s current paradigm of medical device regulation was not designed for adaptive artificial intelligence. Under the FDA’s current approach to software modifications it anticipates that many of these artificial intelligence and machine learning-driven software changes to a device need a premarket review. The new regulation is expected to create broader parameters of pre-approval to allow adjustments with set allowable boundaries.
A new framework envisioned by the FDA includes a “predetermined change control plan” in premarket submissions. This plan would include the types of anticipated modifications, referred to as “Software as a Medical Device Pre-Specifications”. The associated methodology used to implement those changes in a measured and controlled approach that manages risk the FDA calls the “Algorithm Change Protocol.”
Take Away
Artificial intelligence will transform many industries, and while some want to hit the pause button on progress, the FDA is trying to define how much control can be left to machine learning. The Guidance released in April with a three-month comment period is expected to allow medical equipment and software designers to progress into the unknown, with all stakeholders having as their goal better outcomes for patients.
If you wish to send requested comments to the FDA, the agency requests it be received by July 3, 2023 to ensure the agency considers your comment on the draft guidance before it begins work on the final version of the guidance.
MELVILLE, N.Y. – Apr. 5, 2023–Comtech (NASDAQ: CMTL) announced today that Descartes Labs will become the Company’s third publicly revealed EVOKE technology partner.
As the third publicly announced EVOKE technology partner, Descartes Labs will work with Comtech to infuse the power of artificial intelligence (AI), Machine Learning (ML), predictive intelligence, and monitoring insights across Comtech’s business verticals. Such data services and solutions are intended to serve Comtech commercial and government customers across the globe and represent a cornerstone of Comtech’s commitment to continually improving the customer experience with innovative services and solutions.
“As our latest EVOKE technology partner, Descartes Labs brings one of the world’s fastest cloud-native supercomputers and industry leading geospatial data analysis capabilities that will enable us to provide commercial and government customers with powerful new insights and services,” said Ken Peterman, President and CEO, Comtech. “We will work together to quickly deliver smart-insight powered technologies that can make the world a better, safer place that leaves no one behind in today’s technology driven society.”
Descartes Labs, Inc. and its wholly owned subsidiary Descartes Labs Government, is a geospatial analytics company that focuses on rapidly prototyping dual-use commercial AI and ML solutions for Government and Fortune 500 companies.
“There is tremendous value in the alliance between Descartes Labs and Comtech,” said Richard Davis, CEO, Descartes Labs. “We are honored to be selected as one of the first EVOKE technology partners. Our core mission is to find the signal in the noise created by a myriad of global data sets using AI/ML. Together with Comtech, we will develop data products that address the growing demand for insights that rely on the fusion of data derived from space technologies, telecommunications networks, and earth observation sensors. The solutions to problems we can solve together is only limited by our own creativity.”
EVOKE is Comtech’s Innovation Foundry, which is led by the company’s Chief Growth Officer, Anirban Chakraborty, and is dedicated to creating and accelerating transformational changes across the global technology landscape. EVOKE engages with customers, partners, and suppliers to push the boundaries of technologies that will lay the foundation of connectivity as well as shape future societies and ecosystems.
About Comtech
Comtech Telecommunications Corp. is a leading global technology company providing terrestrial and wireless network solutions, next-generation 9-1-1 emergency services, satellite and space communications technologies, and cloud native capabilities to commercial and government customers around the world. Our unique culture of innovation and employee empowerment unleashes a relentless passion for customer success. With multiple facilities located in technology corridors throughout the United States and around the world, Comtech leverages our global presence, technology leadership, and decades of experience to create the world’s most innovative communications solutions.For more information, please visit www.comtech.com.
About Descartes Labs
Descartes Labs (DL), and its wholly-owned government subsidiary, Descartes Labs Government, Inc. (DLG), solve the world’s most complex problems. They offer customers an accelerated ability to address operational needs by transforming the world’s data into actionable and predictive insights that impact climate change, sustainability, food security, mission-critical intelligence, humanitarian efforts, and safeguards natural resources at the speed of relevance. DL and DLG’s solutions and services offer unique advantages to our customers that are grounded in an ever-expanding portfolio of dual-use commercial products and capabilities which are enabled by our core technology stack. Descartes Labs is an industry innovator, transforming data to decisions around the world. Descartes Labs is headquartered in Santa Fe, New Mexico.
Forward-Looking Statements
Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results and performance could differ materially from such forward-looking information. The Company’s Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such Securities and Exchange Commission filings.
CALGARY, AB, April 5, 2023 /CNW/ – Alvopetro Energy Ltd. (TSXV: ALV) (OTCQX: ALVOF) announces March 2023 average sales volumes of 2,690 boepd, including natural gas sales of 15.4 MMcfpd, associated natural gas liquids sales from condensate of 120 bopd and 8 bopd of oil sales, based on field estimates. Overall, our sales volumes averaged 2,767 boepd in the first quarter of 2023, an increase of 2% from the fourth quarter of 2022 and a new quarterly record for Alvopetro.
Alvopetro Energy Ltd.’svision is to become a leading independent upstream and midstream operator in Brazil. Our strategy is to unlock the on-shore natural gas potential in the state of Bahia in Brazil, building off the development of our Caburé natural gas field and our strategic midstream infrastructure.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.
All amounts contained in this new release are in United States dollars, unless otherwise stated and all tabular amounts are in thousands of United States dollars, except as otherwise noted.
Abbreviations:bbls = barrelsboepd = barrels of oil equivalent (“boe”) per daybopd = barrels of oil and/or natural gas liquids (condensate) per dayMMcf = million cubic feetMMcfpd = million cubic feet per day
BOE Disclosure. The term barrels of oil equivalent (“boe”) may be misleading, particularly if used in isolation. A boe conversion ratio of six thousand cubic feet per barrel (6Mcf/bbl) of natural gas to barrels of oil equivalence is based on an energy equivalency conversion method primarily applicable at the burner tip and does not represent a value equivalency at the wellhead. All boe conversions in this news release are derived from converting gas to oil in the ratio mix of six thousand cubic feet of gas to one barrel of oil.
Forward-Looking Statements and Cautionary Language. This news release contains “forward-looking information” within the meaning of applicable securities laws. The use of any of the words “will”, “expect”, “intend” and other similar words or expressions are intended to identify forward-looking information. Forward–looking statements involve significant risks and uncertainties, should not be read as guarantees of future performance or results, and will not necessarily be accurate indications of whether or not such results will be achieved. A number of factors could cause actual results to vary significantly from the expectations discussed in the forward-looking statements. These forward-looking statements reflect current assumptions and expectations regarding future events. Accordingly, when relying on forward-looking statements to make decisions, Alvopetro cautions readers not to place undue reliance on these statements, as forward-looking statements involve significant risks and uncertainties. More particularly and without limitation, this news release contains forward-looking information concerning the expected natural gas sales and gas deliveries under the Company’s long-term gas sales agreement. The forward–looking statements are based on certain key expectations and assumptions made by Alvopetro, including but not limited to expectations and assumptions concerning the performance of producing wells and reservoirs, foreign exchange rates, well development and operating performance, the timing of regulatory licenses and approvals, equipment availability, the success of future drilling, completion, testing, recompletion and development activities, expectations regarding Alvopetro’s working interest and the outcome of any redeterminations, environmental regulation, including regulation relating to hydraulic fracturing and stimulation, the ability to monetize hydrocarbons discovered, the outlook for commodity markets and ability to access capital markets, general economic and business conditions, the impact of the COVID-19 pandemic, weather and access to drilling locations, the availability and cost of labour and services, the regulatory and legal environment and other risks associated with oil and gas operations. The reader is cautioned that assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be incorrect. Actual results achieved during the forecast period will vary from the information provided herein as a result of numerous known and unknown risks and uncertainties and other factors. Although Alvopetro believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because Alvopetro can give no assurance that it will prove to be correct. Readers are cautioned that the foregoing list of factors is not exhaustive. Additional information on factors that could affect the operations or financial results of Alvopetro are included in our annual information form which may be accessed on Alvopetro’s SEDAR profile at www.sedar.com. The forward-looking information contained in this news release is made as of the date hereof and Alvopetro undertakes no obligation to update publicly or revise any forward-looking information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws.
Data from Animal Studies on TNX-1700 (recombinant TFF2 – albumin fusion peptide) in Syngeneic Models of Colorectal and Gastric Cancer Will be Presented
CHATHAM, N.J., April 05, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that two posters with research results on TNX-1700 (recombinant TFF2 – albumin fusion peptide) will be presented as posters at the American Association for Cancer Research (AACR) Annual Meeting being held April 14-19, 2023, in Orlando, Fla. These data demonstrate that targeting myeloid-derived suppressor cells (MDSCs) using mTNX-1700, a murine TFF2 – murine serum albumin fusion peptide (mTFF2-MSA) provides additive benefits to PD-1 blockade therapy in advanced and metastatic syngeneic mouse models of colorectal and gastric cancer.
Copies of the Company’s posters will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference. Additional meeting information can be found on the AACR website.
Bruce L. Daugherty1, Rebecca J. Boohaker2, Rebecca Johnstone2, Karr Stinson2, Jin Qian3, Timothy C. Wang3, Seth Lederman1
1. Tonix Pharmaceuticals, Inc., 26 Main Street, Suite 101, Chatham, NJ 07928 2. Southern Research, 2000 9th Ave S, Birmingham, AL 35205 3. Division of Digestive and Liver Diseases, Irving Cancer Research Center, Columbia University Medical Center, New York, NY 10032, USA
Topic:
Oncolytic Viruses, Anticancer Vaccines, and Other Immunomodulatory Therapies
Jin Qian1, Sandra Ryeom1, Bruce Daugherty2, Seth Lederman2, Timothy C. Wang12.
1. Division of Digestive and Liver Diseases, Irving Cancer Research Center, Columbia University Medical Center, New York, NY 10032, USA
2. Tonix Pharmaceuticals, Inc., 26 Main Street, Suite 101, Chatham, NJ 07928
Title:
Combination Immunotherapies 1
Location:
Orange County Convention Center, Orlando, Fla.
Section:
21, #5088
Date:
Tuesday, April 18, 2023
Time:
1:30 p.m. – 5:00 p.m. ET
Tonix Pharmaceuticals Holding Corp.*
Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 study has been completed, and topline results are expected in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), in development for chronic migraine, is currently enrolling with interim data expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation being developed as a treatment for major depressive disorder (MDD), is also currently enrolling with interim data expected in the fourth quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the second quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox, for which a Phase 1 study is expected to be initiated in the second half of 2023. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease portfolio also includes TNX-3900 and TNX-4000, classes of broad-spectrum small molecule oral antivirals.
*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
