Tyligand Announces First Patient Dosed for Phase 1 Trial of TSN084, A Multi-Kinase Inhibitor to Address Tumor Resistance of Targeted Therapies

On March 9, 2022 Tyligand Bioscience, a clinical-stage biotechnology company focused on developing innovative therapies against drug resistant cancers, reported that the first subject had been dosed in US in a phase 1 trial for its innovative multi-kinase inhibitor TSN084 (Press release, Tyligand Bioscience, MAR 9, 2022, View Source [SID1234644989]). The study includes a dose escalation and dose expansion phase to evaluate the safety, tolerability, and preliminary anti-tumor activity in subjects with advanced or metastatic malignancies, to be conducted both in US and China. The first enrollment was led by Dr. Siqing Fu, Professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, Houston, TX.

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Dr. Tony Zhang, cofounder and CEO of Tyligand Bioscience, commented: "TSN084 is the front runner of the Tyligand pipeline of innovative molecules. It hits a unique combination of kinase targets including CDK8/19 and offers the possibility of synergistic attack against cancers at multiple fronts. We are glad that it has reached this major milestone in a journey toward becoming a drug that can help patients. We appreciate the dedication of our team members, collaborators and clinical investigators for propelling the project forward with impressive quality and speed."

Infinity Pharmaceuticals to Present at the 32nd Annual Oppenheimer Healthcare Conference

On March 9, 2022 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), a clinical-stage biotechnology company developing eganelisib, a first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, reported that management will be presenting a corporate overview and participating in 1-on-1 meetings in the 32nd Annual Oppenheimer Healthcare Conference taking place virtually on March 16th, 2022 (Press release, Infinity Pharmaceuticals, MAR 9, 2022, View Source [SID1234609760]).

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32nd Annual Oppenheimer Healthcare Conference (virtual)

Date: March 16th, 2022

Time: 2:40pm – 3:10pm ET

Speaker: Adelene Perkins, Chief Executive Officer

Format: Company Presentation

Webcast Registration Link.

*a replay will be available following the presentation for 90 days

Chemomab Therapeutics Announces Fourth Quarter and Year End 2021 Financial Results and Provides a Corporate Update

On March 9, 2022 Chemomab Therapeutics, Ltd. (Nasdaq: CMMB), a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, reported financial and operating results for the fourth quarter and year ended December 31, 2021, and provided a corporate update (Press release, Chemomab, MAR 9, 2022, View Source [SID1234609779]).

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2021 Highlights:

In February, announced positive results from a Phase 1b trial in patients with non-alcoholic fatty liver disease. CM-101 appeared safe and well tolerated upon multiple administrations, with evidence for dose dependent target engagement and positive changes in fibrotic biomarkers.

In March, completed a merger transaction, listed the company’s ADS’s on Nasdaq and closed a $45.5M PIPE financing.

In April, dosed the first patient in a CM-101 Phase 2 liver fibrosis biomarker and subcutaneous formulation study.

In June, expanded partnership with AGC Biologics for final optimization and production of GMP manufacturing batches of CM-101.

In September, Dale Pfost, PhD, joined the company as chief executive officer. Chemomab co-founder, former CEO and chief scientific officer Adi Mor, PhD, continues as CSO and a director.

In September, announced a collaboration with researchers at Leeds University to further elucidate the role of CM-101’s target, CCL24, in the vascular damage associated with systemic sclerosis (SSc).

In November, announced that experienced biotechnology executive Donald Marvin joined as chief financial officer, executive vice president and chief operating officer.

In December, received approval from the FDA for first U.S. Investigational New Drug application aimed at expanding clinical activities in Phase 2 trial in primary sclerosing cholangitis.

In December, biotechnology executive and medical and clinical trial expert David Weiner, MD, joined as interim chief medical officer.
In January 2022, the company announced the addition of Jack Lawler, who brings extensive experience managing global clinical trials, as vice president of global clinical development operations. In February 2022, in a planned move approved by the company’s shareholders, CEO Dale Pfost assumed the additional role of Chairman.

Revisions to Chemomab Clinical Programs

Chemomab also announced today that following a comprehensive strategic review it is making revisions to its current clinical programs. The changes are designed to optimize the clinical development of lead product candidate CM-101 by maximizing the clinical information obtained, generating additional important data to support future advancement to registration trials, and decreasing the overall risk in the CM-101 clinical development program in the lead indications of PSC and SSc, as well as potentially in additional indications where the scientific rationale is strong. The key top-line changes to the clinical development programs include the following:

Expanding the company’s commitment to primary sclerosing cholangitis with an enlarged clinical trial that adds an important dose finding component. The company plans to implement a dose finding component to the CM-101 development program by significantly expanding its Phase 2 trial for PSC. The company will be increasing the size of the study by adding additional dose cohorts, including plans to evaluate both a lower and a higher dose level of CM-101 to support future potential registrational trials. In addition, the company plans to add an open-label extension to the trial to evaluate the safety, tolerability and durability of effect over longer treatment durations. Chemomab plans to perform an interim analysis of the currently enrolling dose cohort in the study to assess safety and biomarker data, with an expected read-out in the second half of this year.

Focusing Chemomab’s clinical efforts in systemic sclerosis on establishing earlier biological and clinical proof of concept. Chemomab plans to focus its SSc trial towards establishing biological and clinical proof of concept in this patient population. The company is revising the design of its planned SSc trial in a way that should enable an expedited path to proof of concept data, as well as further elucidation of the different mechanisms of action of CM-101 in treating the skin, lung and vascular damage seen in SSc patients. The company is currently working with key systemic sclerosis researchers and clinical experts to refine and finalize the design and study endpoints of the Phase 2 trial and anticipates that these activities will result in trial initiation in the second half of 2022.

Winding down enrollment in the company’s safety, pharmacokinetic and biomarker liver fibrosis study, yielding a data readout targeted near the end of 2022. The company will be winding down its ongoing safety, tolerability and biomarker trial that is evaluating the subcutaneous formulation of CM-101 in liver fibrosis patients. Chemomab believes the early completion of this study should be sufficient to achieve its key objectives—exploring safety and providing the pharmacokinetic data needed to assess next steps in the development of the subcutaneous formulation—while allowing the company to focus its resources on its lead indications of PSC and SSc. The company will be halting screening and enrollment in the coming weeks and anticipates results near the end of 2022. The data readouts in this study will include safety and tolerability data to support future development of, and deeper insights into CM-101’s mechanism of action and are expected to provide additional data on the anti-inflammatory and antifibrotic activity of CM-101 in liver disease.

The company expects that the proposed changes to the CM-101 development program will provide important data on the clinical dose response relationship to inform the broader development program and to identify the optimal dose to advance in later PSC trials. The modifications are also expected to generate proof of concept data on clinically relevant aspects of SSc, a complex rheumatological disorder, to best inform the development path for a novel, first-in-class therapeutic like CM-101, along with relevant safety and tolerability data to support the evaluation of higher doses and inform decisions on next steps in the development of the subcutaneous formulation.

Chemomab intends to provide more detailed information on these clinical program changes around the time of its first quarter 2022 conference call in May.

"2021 was a transformational year for Chemomab as we became a public company, launched two Phase 2 trials and expanded our management team to include highly experienced biotech executives from the U.S.," said Dale Pfost, PhD, CEO of Chemomab. "With this foundation in place, we conducted a comprehensive review of our clinical programs, which recommended significant changes designed to achieve biological and pharmacological validation for CM-101 sooner and to prepare us to advance to registrational trials in as capital and time-efficient a manner as possible. Overall, we believe that these changes will sharpen our focus on our clinical efforts in PSC and SSC, and accelerate the timelines, particularly in SSc, to achieve meaningful mechanistic, biological and clinical proof of concept data. These revisions are expected to provide more clinical data read-outs over the next 24 months—we anticipate 3-4 data readouts compared to the two previously planned. They are also expected to decrease our capital requirements and enable us to extend our cash runway by about six months through to the end of 2023. We are excited about moving forward with this revised clinical program and look forward to providing more detail on our plans in the next few months."

Fourth Quarter and Full-Year 2021 Financial Highlights

Cash Position: Cash, cash equivalents and short-term bank deposits were $61.2 million as of December 31, 2021, compared to $11.8 million as of December 31, 2020.

Research and Development (R&D) Expenses: R&D expenses were $2.4 million for the quarter and $6.3 million for the full year ended December 31, 2021, compared to $1.3 million and $4.7 million for the same quarter and year in 2020.

General and Administrative (G&A) Expenses: G&A expenses were $2.6 million for the quarter and $6.0 million for the full year ended December 31, 2021, compared to $0.7 million and $1.3 million for the same quarter and year in 2020.

Net Loss: Net loss was $5.0 million, or a net loss of $0.02 per basic and diluted Ordinary Share, for the fourth quarter and $12.5 million, or a net loss of $0.06 per basic and diluted Ordinary Share for the year ended December 31, 2021, compared to $2.0 million, or a net loss of $0.01 per basic and diluted share, for the quarter and $6.0 million, or a net loss of $0.04 per basic and diluted Ordinary Share, for the full year ended December 31, 2020. The weighted average number of Ordinary Shares outstanding, basic and diluted were 207,468,650 and 136,755,498 for the year ended December 31, 2021, and December 31, 2020, respectively.
For further details on the company’s financial results for the year ended December 31, 2021, please refer to the company’s Annual Report on Form 10-K, which will be filed with the SEC before the end of March 2022.

Conference Call
Chemomab management will host a conference call for investors today, Wednesday, March 9, 2022, beginning at 8:00 a.m. Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by clicking this Webcast link to access the live webcast or replay, or by dialing 877-407-9208 (in the U.S.) or 201-493-6784 (outside the U.S. and in Israel) and entering passcode 13727097. The live webcast will also be available on the company’s website at View Source

A replay of the call will be available for 90 days at www.chemomab.com.

ChromaDex Corporation Reports Fourth Quarter and Fiscal Year 2021 Results

On March 9, 2022 ChromaDex Corp. (NASDAQ:CDXC) reported fourth quarter and fiscal year 2021 financial results (Press release, ChromaDex, MAR 9, 2022, View Source [SID1234609795]).

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Fourth Quarter 2021 and Recent Highlights

Total net sales were $17.8 million, up 15% year over year.
Tru Niagen net sales were $14.1 million, a 14% increase year over year.
Gross margin was 61.2%, up 20 basis points year over year.
Net loss was $5.3 million or $0.08 loss per share, an improvement of $0.02 per share year over year.
In January 2022, announced a supply agreement with Designs for Health to sell Niagen in specially-formulated products, available exclusively through the company’s extensive healthcare practitioner network.
The ChromaDex External Research Program (CERP) celebrates 100 published peer-reviewed studies on Niagen and other ingredients. This research conducted by independent investigators has expanded the understanding of nicotinamide riboside (NR) in key health areas including Ataxia-telangiectasia, skeletal muscle, liver health, and heart failure.
Clinical study published in Cell Metabolismfinds that NR supplementation significantly increased cerebral NAD levels, and decreased levels of inflammatory cytokines in Parkinson’s Disease (PD) patients, building on positive preclinical research supporting NR’s positive impact on neurodegenerative diseases. Further studies are underway to understand the role of NR supplementation in Parkinson’s patients.
New U.S. continuation patent reinforces ChromaDex’s intellectual property portfolio of over 40 patents on NR and other NAD precursors by adding protection of a novel manufacturing process of NR and its various salt forms.
Full Year 2021 Highlights

Delivered on latest financial outlook to investors across all metrics. Slightly better than target on research and development, general and administrative expense.
Total net sales of $67.4 million, up 14% from $59.3 million year over year.
Tru Niagen net sales of $56.7 million, a 20% increase from $47.1 million year over year.
Gross margins of 61.5%, a 200 basis point increase year over year.
Announced strategic supply agreements with Health & Happiness Group (H&H), a global leader in premium health, human and pet nutrition and personal care brands, and healthcare technology company, Ro, to sell Niagen in exclusively formulated Swisse and Roman products, respectively. Roman Life launched in September 2021.
Launched Tru Niagen in 3,800 Walmart stores across the United States in June.
Announced partnership with Sinopharm Xingsha, a subsidiary of one of China’s largest pharmaceutical companies, to conduct cross-border sales of Tru Niagen in mainland China, and collaborate to secure health food registration.
"ChromaDex achieved solid net sales growth in 2021 and recent scientific developments continue to validate the market opportunity for Tru Niagen," said Rob Fried, ChromaDex Chief Executive Officer. "In 2022, we expect to introduce a new Tru Niagen product, strengthen our presence in the Asia-Pacific region, and continue to grow the industry-leading ChromaDex External Research Program."

Results of operations for the three months ended December 31, 2021 compared to the prior year quarter

Net Sales for ChromaDex increased 15%, or $2.3 million, to $17.8 million. The increase in net sales was largely driven by growth in sales of Tru Niagen (primarily e-commerce sales) paired with growth in Niagen and other ingredient sales.

Gross Margin improved 20 basis points to 61.2% primarily driven by the positive impact of increased Tru Niagen consumer product sales and product cost savings initiatives.

Operating Expense increased 4%, or $0.7 million, to $16.2 million.

Selling and marketing (S&M) expense increased 37%, or $2.3 million, largely due to brand building activities and efforts to increase consumer awareness and demand.
Increases were partially offset by a 22% decrease, or $1.8 million decline, in general and administrative (G&A) expense primarily related to lower legal expense.
Net Loss was $5.3 million, or $0.08 loss per share, compared to a net loss of $6.1 million or $0.10 loss per share for the fourth quarter of 2020.

Adjusted EBITDA excluding total legal expense, a non-GAAP measure, was a loss of $1.8 million, an increase of $0.7 million from a loss of $1.1 million for the fourth quarter of 2020. See "Reconciliation of Non-GAAP Financial Measures" for a reconciliation of non-GAAP Adjusted EBITDA excluding total legal expense to net loss, the most directly comparable GAAP measure.

Operating Activities had a net cash outflow of $4.9 million compared to break-even operating activities for the fourth quarter of 2020 largely due to changes in working capital.

Results of operations for the year ended December 31, 2021 compared to the prior year

Net Sales for ChromaDex increased 14%, or $8.2 million, to $67.4 million. The increase in net sales was largely driven by growth in sales of Tru Niagen (primarily e-commerce sales and the launch in U.S. Walmart stores) partially offset by lower Niagen and other ingredient sales.

Gross Margin improved 200 basis points to 61.5% as scale, product mix, and cost savings initiatives more than offset inflationary pressures across global supply chains.

Operating Expense increased 24%, or $13.4 million, to $68.6 million.

S&M expense increased 35%, or $7.4 million, largely due to brand building activities and efforts to increase consumer awareness and demand.
G&A expense increased 18%, or $5.6 million, primarily due to increased litigation activity which is now largely behind the Company.
Research and development expense increased 12%, or $0.4 million, driven by increased investments and timing of projects.
Net Loss was $27.1 million, or $0.40 loss per share, compared to a net loss of $19.9 million or $0.33 loss per share for fiscal year 2020.

Adjusted EBITDA excluding total legal expense, a non-GAAP measure, was a loss of $2.5 million, an increase of $1.5 million, compared to a loss of $1.0 million for fiscal year 2020 primarily driven by higher selling and marketing expense, partially offset by higher sales and increased gross margins. See "Reconciliation of Non-GAAP Financial Measures" for a reconciliation of non-GAAP Adjusted EBITDA excluding total legal expense to net loss, the most directly comparable GAAP measure.

Operating Activities had a net cash outflow of $24.2 million compared to $10.6 million for fiscal year 2020 largely due to increases in legal expenditures and changes in working capital.

Cash and cash equivalents totaled $28.2 million at December 31, 2021 compared to $16.7 million at December 31, 2020.

2022 Outlook

Looking forward, for the full year, the Company expects 15-20% revenue growth, driven by its global e-commerce business, as well as growth with existing and new strategic partners. The outlook does not include revenue upside from potential new partnerships in the pipeline. The outlook contemplates continued COVID-19 headwinds for international partners. The Company expects slightly better than 60% gross margin and a reduction in general and administrative expense of $5.0 to $6.0 million, as reported, for full year 2022, driven by lower legal expense. The Company expects to increase investments and resources to drive brand awareness and accelerate its research and development pipeline to capitalize on growth in the nicotinamide adenine dinucleotide (NAD+) market globally. Accordingly, the Company expects an increase in research and development expense of approximately $2.0 million. Selling and marketing expense is expected to be up in absolute dollars, but down slightly as a percentage of net sales, year-over-year.

Investor Conference Call

A live webcast will be held Wednesday, March 9, 2022 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss ChromaDex’s fourth-quarter and fiscal year 2021 financial results and provide a general business update.

To listen to the webcast, or to view the earnings press release and its accompanying financial exhibits, please visit the Investor Relations section of ChromaDex’s website at www.chromadex.com. The toll-free dial-in information for this call is 1-888-510-2008 with Conference ID: 4126168.

The webcast will be recorded, and will be available for replay via the website from 7:30 p.m. Eastern time on March 9, 2022 to 11:59 p.m. Eastern time on March 16, 2022. The replay of the call can also be accessed by dialing 800-770-2030, using the Replay ID: 4126168.

Important Note on Forward Looking Statements:

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as "expects," "anticipates," "intends" "estimates," "plans," "potential," "possible," "probable," "believes" "seeks," "may," "will," "should," "could" or the negative of such terms or other similar expressions. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the quotation from ChromaDex’s Chief Executive Officer, and statements related to the company’s 2022 financial outlook, including but not limited to revenue growth, gross margin, expenses, and investment plans. Other risks that contribute to the uncertain nature of the forward-looking statements include: the impact of the COVID-19 pandemic on our business and the global economy; our history of operating losses and need to obtain additional financing; the growth and profitability of our product sales; our ability to maintain sales, marketing and distribution capabilities; changing consumer perceptions of our products; our reliance on a single or limited number of third-party suppliers; and the risks and uncertainties associated with our business and financial condition in general, described in our filings with the Securities and Exchange Commission (SEC), including, without limitation, our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q as filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and actual results may differ materially from those suggested by these forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement and ChromaDex undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof.

Fortress Biotech to Participate in Three March 2022 Investor Conferences

On March 9, 2022 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, reported that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will participate in three investor conferences in March 2022 (Press release, Fortress Biotech, MAR 9, 2022, View Source [SID1234609811]).

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Details of the events are as follows:

34th Annual ROTH Conference: The company will participate in a fireside chat on Monday, March 14, 2022, at 3:00 p.m. PT and will attend one-on-one meetings during the conference. A webcast of the fireside chat will be available on the Events page under the News & Media section of Fortress’ website: www.fortressbiotech.com for approximately 30 days following the chat.
Oppenheimer’s 32nd Annual Virtual Healthcare Conference: The company will present on Wednesday, March 16, 2022, at 8:40 a.m. ET and will participate in one-on-one meetings during the conference. A webcast of the presentation will be available on the Events page under the News & Media section of Fortress’ website: www.fortressbiotech.com for approximately 30 days following the meeting.
Cantor Fitzgerald’s Rare Orphan Disease Summit: The company will participate in a panel presentation on Wednesday, March 30, 2022, at 8:30 a.m. ET, titled, "Beyond The One-Hit Wonder: How To Build A Rare Disease Pipeline."