On May 16, 2022 Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunomodulatory therapies for the treatment of pain resulting from osteoarthritis in the knee and potentially other articular joints, reported financial results for the first quarter ended March 31, 2022 (Press release, Ampio, MAY 16, 2022, View Source [SID1234614683]).

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First Quarter Financial Results

Net Loss: Net loss was $5.6 million for the first quarter of 2022 compared to net loss of $3.7 million for the first quarter of 2021. Further details on these variances are below.
R&D Expenses: Research and development expenses were $3.7 million for the first quarter of 2022 compared to $2.3 million for the first quarter of 2021. The primary drivers of the increase were increases in (i) clinical trial and sponsored research expenses and (ii) salaries and professional fees.
G&A Expenses: General and administrative expenses were $3.3 million for the first quarter of 2022 compared to $1.5 million for the first quarter of 2021. The primary drivers of the increase were increases in (i) salaries and professional fees and (ii) non-cash stock-based compensation expense.
Cash Position / Liquidity: Cash and cash equivalents on March 31, 2022, totaled $28.8 million, compared to $33.9 million as of December 31, 2021. The decrease of $5.1 million is primarily attributable to cash required to fund business operations. Based on our current cash position and projection of operating expenses and capital expenditures, we believe that we will have sufficient liquidity to fund operations into the second half of 2023.

On May 16, 2022 Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, reported that Ryan Spencer, Chief Executive Officer, reported that it will present at the H.C. Wainwright Global Investment Conference, being held May 23-26, 2022 (Press release, Dynavax Technologies, MAY 16, 2022, https://www.prnewswire.com/news-releases/dynavax-to-present-at-the-hc-wainwright-global-investment-conference-301548166.html [SID1234614682]).

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The on demand presentation will be available, beginning Tuesday, May 24, 2022 at 7:00 a.m. E.T. and may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at View Source

On May 16, 2022 AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options, and improving quality of life for patients, reported that Jim Clemmer, President and Chief Executive Officer, and Stephen Trowbridge, Executive Vice President and Chief Financial Officer, will present at the UBS Global Healthcare Conference at 4:15 p.m. ET on Monday, May 23, 2022 (Press release, AngioDynamics, MAY 16, 2022, View Source [SID1234614680]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live webcast of the presentation will be accessible through the "Investors" section of the Company’s website at www.angiodynamics.com and will be available for replay following the event.

On May 16, 2022 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported financial results for the quarter ended March 31, 2022 and provided a corporate update (Press release, Syros Pharmaceuticals, MAY 16, 2022, View Source [SID1234614679]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"The first quarter of 2022 was very productive for Syros as our team focused on executing across our portfolio in preparation for three data readouts this year, including from the safety lead-ins of the SY-5609 trial in pancreatic cancer and of the SELECT-AML-1 Phase 2 trial of tamibarotene as well as from the dose confirmation study of SY-2101 in APL," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "Given the current market conditions, we will not be starting the Phase 3 trial of SY-2101 until we secure additional capital. In addition, at this time we are deprioritizing the evaluation of SY-5609 in hematologic malignancies. We are focusing our resources to continue our ongoing clinical trials in order to deliver benefit to patients as well as maximize value for our shareholders."

Tamibarotene: Oral RARα agonist

Higher-Risk Myelodysplastic Syndrome (HR-MDS)

Syros is continuing to advance the ongoing SELECT-MDS-1 Phase 3 trial in newly diagnosed RARA-positive patients with HR-MDS and remains on track to report data in the fourth quarter of 2023 or the first quarter of 2024, with a potential new drug application (NDA) filing expected in 2024.

Acute Myeloid Leukemia (AML)

Syros is evaluating tamibarotene in combination with venetoclax/azacitidine compared to venetoclax/azacitidine alone in the ongoing SELECT-AML-1 Phase 2 trial in newly diagnosed unfit RARA-positive patients with AML. Syros expects to report data, including clinical activity, from the safety lead-in portion of the study in the second half of 2022.

SY-2101: Oral arsenic trioxide (ATO)

Syros is advancing the ongoing dose confirmation trial of SY-2101 in patients with newly diagnosed acute promyelocytic leukemia (APL) and expects to announce pharmacokinetic (PK) and safety data from the trial in mid-2022. Given the current market conditions, Syros does not plan to advance SY-2101 into a Phase 3 trial until additional capital is secured.

SY-5609: Oral selective CDK7 inhibitor

Syros is evaluating SY-5609 in combination with chemotherapy in relapsed/refractory metastatic pancreatic cancer patients. The company remains on track to report data, including clinical activity, from the safety lead-in portion of the trial in the second half of 2022. Given the current market conditions, Syros is deprioritizing the development of SY-5609 for the treatment of hematologic malignancies at this time.

In addition, Roche plans for the arm of its ongoing Phase 1/1b INTRINSIC trial arm evaluating SY-5609 in combination with atezolizumab in BRAF-mutant colorectal cancer (CRC) to be open for enrollment in the first half of this year. Under the terms of Syros’ agreement with Roche, Roche is the sponsor of the trial and Syros is supplying SY-5609.

Gene Control Discovery Engine

At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, Syros presented promising CDK12 inhibitor data demonstrating strong anti-tumor activity as a single agent as well as in combination with a DNA damaging agent and a PARP inhibitor in models of breast, lung, and ovarian cancer. Additionally, the CDK12 inhibitor showed anti-tumor activity in a PARP inhibitor resistant patient-derived model (PDX) of ovarian cancer. Syros expects to nominate its next development candidate from the CDK12 inhibitor program in the second half of 2022.

First Quarter 2022 Financial Results

Revenues were $5.5 million for the first quarter of 2022, consisting of $5.1 million in revenue recognized under Syros’ collaboration with Global Blood Therapeutics, Inc. (GBT) and $0.4 million recognized under its collaboration with Incyte Corporation (Incyte). Syros recognized $4.8 million in revenue in the first quarter of 2021, consisting of $4.0 million in revenue recognized under its collaboration with GBT and $0.8 million recognized under its collaboration with Incyte.
Research and development expenses were $25.2 million for the first quarter of 2022, as compared to $20.0 million for the first quarter of 2021. This increase was primarily due to the advancement of the Company’s clinical and preclinical programs and increases in employee-related expenses due to headcount growth.
General and administrative (G&A) expenses were $6.9 million for the first quarter of 2022, as compared to $5.7 million for the first quarter of 2021. This increase was primarily due to increases in employee-related expenses and an increase in patent prosecution costs and consulting fees.
For the first quarter of 2022, Syros reported a net loss of $25.1 million, or $0.40 per share, compared to a net loss of $14.2 million, or $0.23 per share, for the same period in 2021.
Cash and Financial Guidance

Cash, cash equivalents and marketable securities as of March 31, 2022 were $112.9 million, as compared with $143.4 million on December 31, 2021.

Syros believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund its planned operating expenses and capital expenditure requirements into the second quarter of 2023.

Conference Call and Webcast

Syros will host a conference call today at 8:30 a.m. ET to discuss these first quarter 2022 financial results and provide a corporate update.

To access the live conference call, please dial (866) 595-4538 (domestic) or (636) 812-6496 (international) and refer to conference ID 4664097. A webcast of the call will also be available on the Investors & Media section of the Syros website at. An archived replay of the webcast will be available for approximately 30 days following the presentation.

On May 16, 2022 Catamaran Bio, Inc., a biotechnology company developing off-the-shelf chimeric antigen receptor (CAR)-NK cell therapies to treat cancer, reported that it is presenting new preclinical data at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, being held in Washington, DC (Press release, Catamaran Bio, MAY 16, 2022, View Source [SID1234614678]). The data demonstrate successful engineering of CAR-NK cells to preserve and enhance NK cell activity in the immunosuppressive tumor microenvironment.

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"The ability to enable robust functioning of CAR-NK cells in the immunosuppressive solid tumor microenvironment will be critical to the success of cell therapies," said Vipin Suri, PhD, MBA, Chief Scientific Officer of Catamaran Bio. "We are presenting data on a TGFβ receptor that lacks an intracellular signaling domain and acts as a TGFβ trap, as well as proprietary next generation switch receptors that reconfigure inhibitory TGFβ signaling to be stimulatory. Both approaches lead to protection from TGFβ immunosuppression of CAR-NK cells as well as neighboring immune cells. The approaches we are presenting at ASGCT (Free ASGCT Whitepaper) are part of our innovative switch receptor platform which includes multiple strategies to convert other immunosuppressive signals into beneficial signals that stimulate and enhance the therapeutic activity of NK cells."

Highlights of the data presented on TGFβ switch receptors for CAR-NK cell therapies are as follows:

Abstract #313: Dominant Negative Receptor for TGFβ

A TGFβ dominant negative receptor (DNR) was shown to protect the function of both the engineered CAR‑NK cells and neighboring NK cells from the immunosuppressive effects of TGFβ.

CAR-NK cells engineered with this TGFβ DNR demonstrated reduction of downstream TGFβ activity as shown by >90% reduction of SMAD2 phosphorylation (a downstream signal of TGFβ activity) even at supraphysiological doses of TGFβ.
By acting as a sink, the TGFβ DNR also protected neighboring NK cells from immunosuppressive TGFβ signaling, resulting in approximately a 3-fold reduction in potency of TGFβ in inducing SMAD2 phosphorylation.
Co-expression of the TGFβ DNR with a HER2-CAR construct restored CAR-dependent cytotoxicity in the presence of TGFβ.
Abstract #331: Next Generation TGFβ Switch Receptors

Building on its success using TGFβ-DNRs to prevent immunosuppression, Catamaran also engineered synthetic receptors that effectively converted TGFβ signals into cell stimulatory signals.

A diverse set of switch receptors were engineered with a TGFβ receptor extracellular domain, coupled with various intracellular domains.
These proprietary next generation TGFβ switch receptors successfully reversed TGFβ-mediated inhibition, promoted NK cell expansion in vitro, and enhanced NK cell functional responses.
Chronic TGFβ stimulation strengthened NK cell tumor killing and target-induced cytokine secretion, and incorporation of the switch receptors also protected the cells from suppressive TGFβ signaling.