Friday, April 01, 2022

BioSig Technologies (BSGM)
Q4 2021 Misses But Pieces Are Falling In Place

BioSig Technologies, Inc. is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace. PURE EP is a computerized system designed to reveal the full range of cardiac signals and to provide physicians with signal clarity during procedures performed to address cardiac arrhythmias. The PURE EP System has received FDA 510(k) clearance and installed its first commercial sale in February 2021. The company looks to apply their unique bioelectronic technology across additional disease conditions, including nervous system disorders, auto-immune diseases, hypertension, and pain.

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.

Q4 2021 reported. Yesterday, BioSig Technologies reported their fourth quarter, missing on top-line expectations, with no unit sales reported. That said, the company continues to roll out a phased commercialization strategy to promote faster revenue growth longer term.

Recent hires are expected to move the needle.  In December 2021, the company introduced Gray Fleming as Chief Commercial Officer and acquired the services of Access Strategy Partners to assist in relationship management. Just last week, the company introduced John Sieckhaus as Chief Operating Officer. All these filled positions are upgrades or new positions that are expected to produce better …

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. 

 

Friday, April 01, 2022

PDS Biotechnology Corp (PDSB)
FY2021 Reported With Clinical Trial Progress

PDS Biotechnology Corp operates as a clinical stage biotechnology company, principally involved in drug discovery in the United States. It is primarily engaged in the treatment of various early-stage and late-stage cancers, including head and neck cancer, prostate cancer, breast cancer, cervical cancer, anal cancer, and other cancers. Its products are based on the proprietary Versamune platform technology, which activates and directs the human immune system to unleash a powerful and targeted attack against cancer cells.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

FY2021 Results Were Within Expectations.  PDS Biotech reported 4Q21 loss of $6.3 million or $(0.23) per share, bringing the FY2021 loss to $16.9 million or $(0.66) per share. On its quarterly conference call, the company discussed pipeline developments in several HPV-positive cancer trials, preclinical products, and its infectious disease platform. Cash at December 31, 2021 was $65.2 million.

PDS0101 Has Recently Achieved Important Milestones.  The VERSATILE-002 trial is testing PDS0101 in combination with Keytruda (pembrolizumab), the PD-1 checkpoint inhibitor. The company has recently presented safety data, announced a preliminary efficacy milestone that allows the trial to continue to completion, and continues to enroll patients …

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. 

 

Image Source: nih.gov

Human Genome Gaps in Understanding are Now Filled by Six New Reports

 

When it was announced in 2003 that the human genome had been mapped, the accomplishment was and continues to be life-changing for the species. But the mapping wasn’t fully complete. While it opened doors to understanding and continues to open doors to medical breakthroughs, it was only 92% complete. That is no longer the case. Yesterday (March 31), the official reports on the first end-to-end human genome map was published.

Now that scientists have a complete map with no significant gaps, the enhanced knowledge will no doubt lead to filling in evolutionary questions while providing insights into birth defects, auto-immune problems, cancer, and aging. The six separate papers just published include parts of the genome that were left uncharacterized because of available DNA sequencing technology two decades ago. After 20 years, these limits have been overcome. This is again momentous for the species as it will lead to discoveries and techniques that will only be realized over time.

While filling gaps in understanding and discovering 99 more new genes believed to code for proteins, the scientists also corrected thousands of errors in an earlier map of human DNA. This map from 2003 has been serving those in the field, including researchers, geneticists, and medical doctors. The original $3 billion Human Genome Project sought to unveil the purpose of every letter of a human’s DNA, but even with refinements made after the original conclusions, it is believed to have found only about 92% of them.

 

Exploiting the new map for medical care or evolution discovery provides another exciting start with new information to assess when figuring out diseases that are known to be inherited, but uncertainty exists as to where the faulty gene resides.

The new map cost a few million dollars to create, according to Adam Phillippy, a computational biologist at the National Human Genome Research Institute. This reflects how technology and understanding have brought down gene sequencing costs.

The twin strands of DNA in human cells contain about three billion letter pairs spread among 23 pairs of chromosomes. The genetic material helps determine eye and hair color, stature, and other physical characteristics, as well as risks for certain diseases. Scientists liken sequencing to solving a jigsaw puzzle, they look at a few segments and try to find what fits. Since there are two strands (one contributed by the mother, the other by the father) they used their computers to focus on only one puzzle, paternal DNA.

Paul Hoffman

Managing Editor, Channelchek

 

Suggested Reading

Ultra-Rapid DNA Sequencing Identifies Rare Diseases in Hours

Pros and Cons of FDA Funded in Part by Companies

Cells that Can be Produced from Stem Cells

Stem-Cell Based Therapy for Alzheimer’s Disease

 

Sources

https://www.science.org/doi/10.1126/science.abj6987

https://www.genome.gov/about-genomics/telomere-to-telomere

https://www.wsj.com/articles/first-gapless-human-genome-map-is-unveiled-years-after-earlier-effort-11648750303

https://theconversation.com/us/technology

https://www.genome.gov/

 

Stay up to date. Follow us:

Image Source: nih.gov

Human Genome Gaps in Understanding are Now Filled by Six New Reports

 

When it was announced in 2003 that the human genome had been mapped, the accomplishment was and continues to be life-changing for the species. But the mapping wasn’t fully complete. While it opened doors to understanding and continues to open doors to medical breakthroughs, it was only 92% complete. That is no longer the case. Yesterday (March 31), the official reports on the first end-to-end human genome map was published.

Now that scientists have a complete map with no significant gaps, the enhanced knowledge will no doubt lead to filling in evolutionary questions while providing insights into birth defects, auto-immune problems, cancer, and aging. The six separate papers just published include parts of the genome that were left uncharacterized because of available DNA sequencing technology two decades ago. After 20 years, these limits have been overcome. This is again momentous for the species as it will lead to discoveries and techniques that will only be realized over time.

While filling gaps in understanding and discovering 99 more new genes believed to code for proteins, the scientists also corrected thousands of errors in an earlier map of human DNA. This map from 2003 has been serving those in the field, including researchers, geneticists, and medical doctors. The original $3 billion Human Genome Project sought to unveil the purpose of every letter of a human’s DNA, but even with refinements made after the original conclusions, it is believed to have found only about 92% of them.

 

Exploiting the new map for medical care or evolution discovery provides another exciting start with new information to assess when figuring out diseases that are known to be inherited, but uncertainty exists as to where the faulty gene resides.

The new map cost a few million dollars to create, according to Adam Phillippy, a computational biologist at the National Human Genome Research Institute. This reflects how technology and understanding have brought down gene sequencing costs.

The twin strands of DNA in human cells contain about three billion letter pairs spread among 23 pairs of chromosomes. The genetic material helps determine eye and hair color, stature, and other physical characteristics, as well as risks for certain diseases. Scientists liken sequencing to solving a jigsaw puzzle, they look at a few segments and try to find what fits. Since there are two strands (one contributed by the mother, the other by the father) they used their computers to focus on only one puzzle, paternal DNA.

Paul Hoffman

Managing Editor, Channelchek

 

Suggested Reading

Ultra-Rapid DNA Sequencing Identifies Rare Diseases in Hours

Pros and Cons of FDA Funded in Part by Companies

Cells that Can be Produced from Stem Cells

Stem-Cell Based Therapy for Alzheimer’s Disease

 

Sources

https://www.science.org/doi/10.1126/science.abj6987

https://www.genome.gov/about-genomics/telomere-to-telomere

https://www.wsj.com/articles/first-gapless-human-genome-map-is-unveiled-years-after-earlier-effort-11648750303

https://theconversation.com/us/technology

https://www.genome.gov/

 

Stay up to date. Follow us:

Thursday, March 31, 2022

Avivagen Inc. (VIVXF)(VIV:CA)
Reports First Quarter 2022 Results

Avivagen Inc is a Canadian based company operating in the healthcare sector. It develops science-based, natural health products for animals. It develops and commercializes products for livestock feeds to replace antibiotics for growth promotion and to help prevent disease by supporting the animal’s own health defenses. Its product range includes OxC-beta, Vivamune health chews, Oximunol chewable tablets, and Carotenoid Oxidation products.

Joe Gomes, Senior Research 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.

1Q22 Results. Avivagen reported revenue of $271,157 (all figures in Canadian $) in the quarter, up from $261,987 last year, and compared to our $300,000 estimate. Net loss for the quarter was $1.6 million, or $0.03 per share versus a net loss of $1.3 million, or $0.03 per share, in the first quarter of 2021. We had forecasted a net loss of $1.4 million, or $0.03 per share. Increased operating expenses due to impairment expenses were the main driver in the increased loss.

Market Still Challenging.  While sales in the Philippines continue apace, Mexico remains frozen. In fact, quarterly revenues were reduced by $89,658 due to returned product from Mexico. Average price per kg of OxC-Beta remained flat at $106.33. While Avivagen has made strides in receiving approvals in other nations, the Company needs to translate approvals into steady, and increasing, sales in more …

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. 

 

Thursday, March 31, 2022

Axcella Therapeutics (AXLA)
Axcella Reports FY2021 With Clinical Data Expected In 2H22

Axcella Health Inc. is a clinical-stage biotechnology company focused on treating complex diseases and improvinge health using endogenous metabolic modulator, or EMM, compositions. Its product candidates are comprised of multiple EMMs that are engineered in distinct combinations and ratios to simultaneously impact multiple biological pathways. The company’s pipeline includes two lead therapeutic candidates:, AXA1665 for the reduction in risk of recurrent overt hepatic encephalopathy (OHE) , and AXA1125 for the treatment of non-alcoholic steatohepatitis (NASH).

Robert LeBoyer, Vice President, Research Analyst, Life Sciences, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Financial Results Reported for 4Q and FY2021.  Axcella Reported a 4Q21 loss of $17.9 million or $(0.46) per share, bringing the full year loss to $64.6 million or $(1.70) per share. Clinical trial enrollment is progressing as expected, with data announcements expected in 2H22. The company reported cash of $55.0 million on December 31, excluding the registered direct offering of $25.0 million completed in March 2022.

Long COVID Phase 2a Trial Has Begun Axcella has begun enrolling patients in a Phase 2a trial designed to test AXA1125 on Long COVID symptoms of fatigue and muscle weakness.  This double-blind placebo-controlled trial treats patients with either AXA1125 or placebo for 28 days. It has a target enrollment of 40 patients, with endpoints including measures of muscle recovery time after exertion …

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. 

 

Wesana Health CEO Daniel Carcillo provides a preview of their upcoming presentation at NobleCon18 NobleCon18 – Noble Capital Markets 18th Annual Small and Microcap Investor Conference – April 19-21, 2022 – Hard Rock, Hollywood, FL 100+ Public Company Presentations | Scheduled Breakouts | Panel Presentations | High-Profile Keynotes | Educational Sessions | Receptions & Networking Events Free Registration Available – More Info News and Advanced Market Data on WSNAF NobleCon18 Presenting Companies About Wesana Wesana Health?helps people transcend barriers in mental health and performance. We innovate in care development through our therapies and patent-pending protocols, and in care delivery through activating a new multidisciplinary, technology-supported clinical model. Learn more at?www.wesanahealth.com.

PDS Biotech Provides Business Update and Reports Fourth-Quarter and Full-Year 2021 Financial Results

Research, News, and Market Data on PDS Biotech

 

Company to host conference call and webcast today, March 31, 2022, at 8:00 AM EDT

FLORHAM PARK, N.J., March 31, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technologies, today provided a business update and announced its financial results for the year ended December 31, 2021.

“I’m very pleased to report that we have undergone a 12-month period of incredible productivity here at PDS Biotech,” commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of the Company. “We’ve made significant clinical progress on our lead oncology candidate, PDS0101, and presented at leading oncology conferences on the promising efficacy and safety results of PDS0101 from two of our ongoing Phase 2 clinical trials. Another phase 2 clinical study of PDS0101 to be led by Mayo Clinic was initiated this month, to evaluate PDS0101 as a potential first-line neo-adjuvant treatment for patients with oropharyngeal cancer prior to transoral robotic surgery. We also recently announced encouraging pre-clinical data from our NIAID-funded universal flu vaccine program. We continue to leverage our unique T-cell activating platforms to advance additional pre-clinical oncology and infectious disease candidates.”

Dr. Bedu-Addo continued: “Over the past year, we completed two licensing transactions and secured additional intellectual property for our expanding pipeline. We also received approval of a US composition of matter and use patent for PDS0101. We strengthened our scientific advisory and leadership teams by adding distinguished immuno-oncology experts to our scientific advisory board and welcomed Matthew Hill as our Chief Financial Officer. We also added more than $52 million to our balance sheet in 2021, significantly extending our cash runway and ability to continue to advance our clinical and pre-clinical programs. We look forward to an equally productive 2022, during which we expect to announce additional data from our ongoing Phase 2 oncology trials for PDS0101, as well as plan to progress at least one of our preclinical programs, PDS0103 into the clinic.”

Fourth Quarter 2021 and Recent Business Highlights:

• Achieved several milestones in the VERSATILE-002 Phase 2 combination trial of PDS0101-KEYTRUDA^® (pembrolizumab) for recurrent and/or metastatic human papillomavirus (HPV)16-associated head and neck cancer. These milestones include:
  • Presented preliminary safety data on a total of 18 checkpoint inhibitor naïve patients at the 2022 Multidisciplinary Head and Neck Cancers Symposium. Highlights from the presentation include the absence of dose-limiting toxicities, drug discontinuation related to toxicity, or any significant immune-related adverse events. Subjects received a median of 4 doses of PDS0101 (range 1-5) and a median of 6 doses of KEYTRUDA^® (range 1-13).
  • Achieved preliminary objective response benchmarks that enabled us to advance towards full enrollment of 54 patients in the checkpoint inhibitor naïve patient cohort.
  • Initiated enrollment in the checkpoint inhibitor-refractory cohort.
• Announced initiation of an investigator-initiated trial with Mayo Clinic for patients with HPV-associated oropharyngeal cancer at high risk of recurrence. The trial will evaluate PDS0101 as monotherapy and in combination with KEYTRUDA^®.
• Announced encouraging preclinical data for the universal flu vaccine that demonstrated a potent neutralization response against multiple strains of the influenza virus and provided protection against infection after challenge with a live H1N1 pandemic strain of influenza in preclinical animal subjects.
• Granted U.S. Patent Application by the United States Patent and Trademark Office for composition of matter and use of PDS0101, extending its U.S. patent protection into 2037.
• Achieved enrollment objective of 30 patients in the checkpoint inhibitor refractory arm of the NCI-led triple combination trial in March 2022.
• Achieved median overall survival at December 31, 2021 of 12 months for 30 HPV16-positive patients who had received at least one evaluation in the NCI-led triple combination trial. Approximately 73% of the patients had failed 3 prior treatment regimens including checkpoint inhibitor therapy.
  
  

Full-Year 2021 Financial Results

For the year ended December 31, 2021, the net loss was approximately $16.9 million, or $0.66 per basic share and diluted share, compared to a net loss of approximately $14.8 million, or $0.89 per basic share and diluted share for the year ended December 31, 2020.

For the year ended December 31, 2021, research and development expenses increased to approximately $11.3 million compared to approximately $7.9 million for the year ended December 31, 2020. The increase of $3.4 million was primarily attributable to an increase in regulatory and clinical costs of $2.6 million, non-cash stock-based compensation of $1.1 million and personnel costs of $0.4 million, partially offset by an overall decrease in manufacturing and facility costs of $0.7 million.

For the year ended December 31, 2021, general and administrative expenses increased to approximately $10.2 million compared to approximately $7.0 million for the year ended December 31, 2020. The $3.2 million increase was primarily attributable to an increase in personnel costs of $1.0 million, non-cash stock-based compensation of $2.5 million, and facilities costs of $0.1 million, partially offset by a decrease in professional fees of $0.4 million.

Total operating expenses for the year ended December 31, 2021 were approximately $21.4 million, an increase of approximately 44% compared to total operating expenses of approximately $14.9 million for the year ended December 31, 2020.

The Company’s cash balance as of December 31, 2021 was $65.2 million. Based on the Company’s available cash resources and cash flow projections, the Company believes this balance is sufficient to fund Company operations and research and development programs through the end of 2023.

Conference Call and Webcast
The conference call is scheduled to begin at 8:00 AM EDT on Thursday, March 31, 2022. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotechnology. A live webcast of the conference call will also be available on the investor relations page of the Company’s corporate website at https://pdsbiotech.com/investors/news-center/events. After the live webcast, the event will be archived on PDS Biotech’s website for six months. 

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technology platforms. Our Versamune^®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them.  The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.  

Our Infectimune™ -based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses including long-lasting memory T-cell responses. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune and Infectimune-based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune and Infectimune-based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Versamune^® is a registered trademark and Infectimune is a trademark of PDS Biotechnology. KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: rich@cg.capital

PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Consolidated Balance Sheets

	December 31, 2021				December 31, 2020
ASSETS
Current assets:
Cash and cash equivalents	$	65,242,622			$	28,839,565
Prepaid expenses and other		1,597,569				1,497,665
Total current assets		66,840,191				30,337,230
Property and equipment, net		86				5,443
Operating lease right-to-use asset		357,611				547,706
Total assets	$	67,197,888			$	30,890,379
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	1,309,403			$	1,415,224
Accrued expenses		2,187,704				1,735,322
Operating lease obligation – short term		258,924				119,904
Total current liabilities		3,756,031				3,270,450
Noncurrent liability:
Operating lease obligation – long term		231,430				490,353
Total liabilities		3,987,461				3,760,803
STOCKHOLDERS’ EQUITY
Common stock, $0.00033 par value, 75,000,000 shares authorized at December 31, 2021 and December 31, 2020, 28,448,612 shares and 22,261,619 shares issued and outstanding at December 31, 2021 and December 31, 2020, respectively		9,387				7,346
Additional paid-in capital		123,904,602				70,907,315
Accumulated deficit		(60,703,562	)			(43,785,085	)
Total stockholders’ equity		63,210,427				27,129,576
Total liabilities and stockholders’ equity	$	67,197,888			$	30,890,379

PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Consolidated Statements of Operations and Comprehensive Loss

	Year Ended December 31,
	2021				2020
Operating expenses:
Research and development expenses	$	11,254,538			$	7,924,450
General and administrative expenses		10,184,773				6,977,936
Total operating expenses		21,439,311				14,902,386
Loss from operations		(21,439,311	)			(14,902,386	)
Other income
Interest income		4,346				55,006
Loss before income taxes		(21,434,965	)			(14,847,380	)
Benefit from income taxes		4,516,488				–
Net loss and comprehensive loss	$	(16,918,477	)		$	(14,847,380	)
Per share information:
Net loss per share, basic and diluted	$	(0.66	)		$	(0.89	)
Weighted average common shares outstanding basic and diluted		25,597,125				16,745,044

PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Consolidated Statements of Cash Flows

	Year Ended December 31,
	2021				2020
Cash flows from operating activities:
Net loss	$	(16,918,477	)		$	(14,847,380	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense		4,074,458				432,321
Stock-based 401K company common match		35,747				19,967
Depreciation expense		5,357				15,608
Operating lease expense		241,031				160,684
Changes in operating assets and liabilities:
Prepaid expenses and other assets		(99,904	)			810,797
Accounts payable		(105,821	)			217,504
Accrued expenses		452,382				637,682
Restructuring reserve		–				(498,185	)
Operating lease liabilities		(170,839	)			(98,133	)
Net cash used in operating activities		(12,486,066	)			(13,149,135	)
Cash flows from financing activities:
Proceeds from exercise of warrants		–				70,459
Proceeds from exercise of stock options		344,125				–
Proceeds from issuances of common stock, net of issuance costs		48,544,998				29,756,502
Net cash provided by financing activities		48,889,123				29,826,961
Net increase in cash and cash equivalents		36,403,057				16,677,826
Cash and cash equivalents at beginning of period		28,839,565				12,161,739
Cash and cash equivalents at end of period	$	65,242,622			$	28,839,565

PDS Biotech Provides Business Update and Reports Fourth-Quarter and Full-Year 2021 Financial Results

Research, News, and Market Data on PDS Biotech

 

Company to host conference call and webcast today, March 31, 2022, at 8:00 AM EDT

FLORHAM PARK, N.J., March 31, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technologies, today provided a business update and announced its financial results for the year ended December 31, 2021.

“I’m very pleased to report that we have undergone a 12-month period of incredible productivity here at PDS Biotech,” commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of the Company. “We’ve made significant clinical progress on our lead oncology candidate, PDS0101, and presented at leading oncology conferences on the promising efficacy and safety results of PDS0101 from two of our ongoing Phase 2 clinical trials. Another phase 2 clinical study of PDS0101 to be led by Mayo Clinic was initiated this month, to evaluate PDS0101 as a potential first-line neo-adjuvant treatment for patients with oropharyngeal cancer prior to transoral robotic surgery. We also recently announced encouraging pre-clinical data from our NIAID-funded universal flu vaccine program. We continue to leverage our unique T-cell activating platforms to advance additional pre-clinical oncology and infectious disease candidates.”

Dr. Bedu-Addo continued: “Over the past year, we completed two licensing transactions and secured additional intellectual property for our expanding pipeline. We also received approval of a US composition of matter and use patent for PDS0101. We strengthened our scientific advisory and leadership teams by adding distinguished immuno-oncology experts to our scientific advisory board and welcomed Matthew Hill as our Chief Financial Officer. We also added more than $52 million to our balance sheet in 2021, significantly extending our cash runway and ability to continue to advance our clinical and pre-clinical programs. We look forward to an equally productive 2022, during which we expect to announce additional data from our ongoing Phase 2 oncology trials for PDS0101, as well as plan to progress at least one of our preclinical programs, PDS0103 into the clinic.”

Fourth Quarter 2021 and Recent Business Highlights:

• Achieved several milestones in the VERSATILE-002 Phase 2 combination trial of PDS0101-KEYTRUDA^® (pembrolizumab) for recurrent and/or metastatic human papillomavirus (HPV)16-associated head and neck cancer. These milestones include:
  • Presented preliminary safety data on a total of 18 checkpoint inhibitor naïve patients at the 2022 Multidisciplinary Head and Neck Cancers Symposium. Highlights from the presentation include the absence of dose-limiting toxicities, drug discontinuation related to toxicity, or any significant immune-related adverse events. Subjects received a median of 4 doses of PDS0101 (range 1-5) and a median of 6 doses of KEYTRUDA^® (range 1-13).
  • Achieved preliminary objective response benchmarks that enabled us to advance towards full enrollment of 54 patients in the checkpoint inhibitor naïve patient cohort.
  • Initiated enrollment in the checkpoint inhibitor-refractory cohort.
• Announced initiation of an investigator-initiated trial with Mayo Clinic for patients with HPV-associated oropharyngeal cancer at high risk of recurrence. The trial will evaluate PDS0101 as monotherapy and in combination with KEYTRUDA^®.
• Announced encouraging preclinical data for the universal flu vaccine that demonstrated a potent neutralization response against multiple strains of the influenza virus and provided protection against infection after challenge with a live H1N1 pandemic strain of influenza in preclinical animal subjects.
• Granted U.S. Patent Application by the United States Patent and Trademark Office for composition of matter and use of PDS0101, extending its U.S. patent protection into 2037.
• Achieved enrollment objective of 30 patients in the checkpoint inhibitor refractory arm of the NCI-led triple combination trial in March 2022.
• Achieved median overall survival at December 31, 2021 of 12 months for 30 HPV16-positive patients who had received at least one evaluation in the NCI-led triple combination trial. Approximately 73% of the patients had failed 3 prior treatment regimens including checkpoint inhibitor therapy.
  
  

Full-Year 2021 Financial Results

For the year ended December 31, 2021, the net loss was approximately $16.9 million, or $0.66 per basic share and diluted share, compared to a net loss of approximately $14.8 million, or $0.89 per basic share and diluted share for the year ended December 31, 2020.

For the year ended December 31, 2021, research and development expenses increased to approximately $11.3 million compared to approximately $7.9 million for the year ended December 31, 2020. The increase of $3.4 million was primarily attributable to an increase in regulatory and clinical costs of $2.6 million, non-cash stock-based compensation of $1.1 million and personnel costs of $0.4 million, partially offset by an overall decrease in manufacturing and facility costs of $0.7 million.

For the year ended December 31, 2021, general and administrative expenses increased to approximately $10.2 million compared to approximately $7.0 million for the year ended December 31, 2020. The $3.2 million increase was primarily attributable to an increase in personnel costs of $1.0 million, non-cash stock-based compensation of $2.5 million, and facilities costs of $0.1 million, partially offset by a decrease in professional fees of $0.4 million.

Total operating expenses for the year ended December 31, 2021 were approximately $21.4 million, an increase of approximately 44% compared to total operating expenses of approximately $14.9 million for the year ended December 31, 2020.

The Company’s cash balance as of December 31, 2021 was $65.2 million. Based on the Company’s available cash resources and cash flow projections, the Company believes this balance is sufficient to fund Company operations and research and development programs through the end of 2023.

Conference Call and Webcast
The conference call is scheduled to begin at 8:00 AM EDT on Thursday, March 31, 2022. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotechnology. A live webcast of the conference call will also be available on the investor relations page of the Company’s corporate website at https://pdsbiotech.com/investors/news-center/events. After the live webcast, the event will be archived on PDS Biotech’s website for six months. 

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technology platforms. Our Versamune^®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them.  The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.  

Our Infectimune™ -based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses including long-lasting memory T-cell responses. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune and Infectimune-based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune and Infectimune-based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Versamune^® is a registered trademark and Infectimune is a trademark of PDS Biotechnology. KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: rich@cg.capital

PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Consolidated Balance Sheets

	December 31, 2021				December 31, 2020
ASSETS
Current assets:
Cash and cash equivalents	$	65,242,622			$	28,839,565
Prepaid expenses and other		1,597,569				1,497,665
Total current assets		66,840,191				30,337,230
Property and equipment, net		86				5,443
Operating lease right-to-use asset		357,611				547,706
Total assets	$	67,197,888			$	30,890,379
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	1,309,403			$	1,415,224
Accrued expenses		2,187,704				1,735,322
Operating lease obligation – short term		258,924				119,904
Total current liabilities		3,756,031				3,270,450
Noncurrent liability:
Operating lease obligation – long term		231,430				490,353
Total liabilities		3,987,461				3,760,803
STOCKHOLDERS’ EQUITY
Common stock, $0.00033 par value, 75,000,000 shares authorized at December 31, 2021 and December 31, 2020, 28,448,612 shares and 22,261,619 shares issued and outstanding at December 31, 2021 and December 31, 2020, respectively		9,387				7,346
Additional paid-in capital		123,904,602				70,907,315
Accumulated deficit		(60,703,562	)			(43,785,085	)
Total stockholders’ equity		63,210,427				27,129,576
Total liabilities and stockholders’ equity	$	67,197,888			$	30,890,379

PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Consolidated Statements of Operations and Comprehensive Loss

	Year Ended December 31,
	2021				2020
Operating expenses:
Research and development expenses	$	11,254,538			$	7,924,450
General and administrative expenses		10,184,773				6,977,936
Total operating expenses		21,439,311				14,902,386
Loss from operations		(21,439,311	)			(14,902,386	)
Other income
Interest income		4,346				55,006
Loss before income taxes		(21,434,965	)			(14,847,380	)
Benefit from income taxes		4,516,488				–
Net loss and comprehensive loss	$	(16,918,477	)		$	(14,847,380	)
Per share information:
Net loss per share, basic and diluted	$	(0.66	)		$	(0.89	)
Weighted average common shares outstanding basic and diluted		25,597,125				16,745,044

PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Consolidated Statements of Cash Flows

	Year Ended December 31,
	2021				2020
Cash flows from operating activities:
Net loss	$	(16,918,477	)		$	(14,847,380	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense		4,074,458				432,321
Stock-based 401K company common match		35,747				19,967
Depreciation expense		5,357				15,608
Operating lease expense		241,031				160,684
Changes in operating assets and liabilities:
Prepaid expenses and other assets		(99,904	)			810,797
Accounts payable		(105,821	)			217,504
Accrued expenses		452,382				637,682
Restructuring reserve		–				(498,185	)
Operating lease liabilities		(170,839	)			(98,133	)
Net cash used in operating activities		(12,486,066	)			(13,149,135	)
Cash flows from financing activities:
Proceeds from exercise of warrants		–				70,459
Proceeds from exercise of stock options		344,125				–
Proceeds from issuances of common stock, net of issuance costs		48,544,998				29,756,502
Net cash provided by financing activities		48,889,123				29,826,961
Net increase in cash and cash equivalents		36,403,057				16,677,826
Cash and cash equivalents at beginning of period		28,839,565				12,161,739
Cash and cash equivalents at end of period	$	65,242,622			$	28,839,565

Wednesday, March 30, 2022

Ayala Pharmaceuticals (AYLA)
Ayala Reports FY21 and Reiterates Trial Data Expectations

Ayala Pharmaceuticals Inc clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. The company’s current portfolio of product candidates, AL101 and AL102, targets the aberrant activation of the Notch pathway with gamma secretase inhibitors. Its product candidate, AL101, is being developed as a potent, selective, injectable small molecule gamma secretase inhibitor, or GSI. It is also developing AL101 for the treatment of T-ALL, an aggressive, rare form of T-cell specific leukemia.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Ayala Reported FY2021 Within Expectations Ayala Reported FY2021 loss of $40.3 million or $(2.80) per share.  This compares with our estimate of a loss of $40.9 million or $(3.00) per share, as both R&D and General Expenses were slightly below our estimates. Cash balance on December 31 was $37.3 million.

One New Study Testing AL101 Is Underway, Another To Begin In 2H22.  The “Window of Opportunity” study testing AL101 in ACC (adenoid cystic carcinoma) has begun treating patients prior to surgery and radiation therapy. This is intended to reduce recurrence rates and improve long-term survival, as well as to define the mechanism and effects of AL101 on cancer. Separately, the Phase 2 trial in T-ALL …

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. 

 

Ayala Pharmaceuticals Reports Full-Year 2021 Financial Results and Provides Corporate Update

Research, News, and Market Data on Ayala Pharmaceuticals

 

– Part A of AL102 RINGSIDE study fully enrolled; interim data expected mid-2022 –

REHOVOT, Israel and WILMINGTON, Del., March 28, 2022 (GLOBE NEWSWIRE) — Ayala Pharmaceuticals, Inc. (Ayala or the Company) (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers today announced full-year 2021 financial results and provided a corporate update.

“2022 is off to a very promising start for Ayala, following a number of important accomplishments across our pipeline of innovative gamma-secretase inhibitors in 2021,” said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. “We are pleased with the progress of our AL102 program in desmoid tumors, having recently completed enrollment in Part A of the open label RINGSIDE study. We are encouraged by initial positive feedback received from investigators so far. We plan to announce initial interim data from Part A around mid-year 2022 and intend to move into Part B, the randomized portion of the study, immediately thereafter. We look forward to announcing additional data readouts and updates on our other clinical programs throughout 2022 including further data on AL101 in adenoid cystic carcinoma.”

2021 and Recent Business and Clinical Highlights

• Completed enrollment of Part A of the Phase 2/3 RINGSIDE study of AL102 in desmoid tumors: 36 patients have been enrolled in Part A of the RINGSIDE study, which is evaluating the safety and tolerability of AL102, as well as tumor volume by MRI at 16 weeks. Ayala expects to report an initial interim data read-out around mid-2022, with Part B of the study commencing immediately thereafter.
  
• Initiated “Window of Opportunity” study of AL101 in adenoid cystic carcinoma (ACC): The study is focused on determining the effects of AL101 for the treatment of ACC and other cancers. The goals of the study are to better understand the mechanism of AL101, determine the best treatment regime and generate data for the future development strategy. The study is being conducted in collaboration with M.D. Anderson Cancer Center and the Adenoid Cystic Carcinoma Research Foundation. 
  
• Presented positive preliminary clinical data from the ongoing ACCURACY trial in ACC: Updated interim data from the 6mg cohort of the Phase 2 ACCURACY study of AL101 in recurrent/metastatic adenoid cystic carcinoma (R/M ACC) were presented at the European Society for Medical Oncology (ESMO) Congress 2021 demonstrating partial responses in three subjects (9%) and stable disease in 20 subjects (61%). At ESMO, the Company also presented preclinical proof of concept data on AL101 in combination with approved cancer therapies in patient-derived ACC tumor models
  
• Initiated Phase 1 trial of AL102 in combination with Novartis’ B-cell maturation antigen (BCMA) targeting agent WVT078 in relapsed/refractory multiple myeloma (MM): inhibition of gamma-secretase with AL102 prevents the cleavage and shedding of BCMA, which is ubiquitously expressed on MM cells. Preclinical data have demonstrated that treatment with AL102 increases the expression of membrane-bound BCMA on the surface of MM cells and could enhance the activity of WVT078. Ongoing patient enrollment continues as planned.
  
• AL101 in Notch-activated triple negative breast cancer: The Company has elected to discontinue the Phase 2 TENACITY study as part of its efforts to focus its resources on the more advanced programs and studies including the RINGSIDE study in desmoid tumors and the ACCURACY study for ACC.
  

Upcoming Milestones

• Initial interim data from the pivotal Phase 2/3 RINGSIDE trial in desmoid tumors (Mid-2022): Ayala expects to report an initial interim data read-out from Part A of the Phase 2/3 RINGSIDE trial of AL102 in desmoid tumors around mid-2022. Part B of the study will be a double-blind placebo-controlled study and will start immediately after dose selection from Part A.
  
• Additional data from the Phase 2 ACCURACY trial of AL101 in ACC: The ongoing ACCURACY trial is an open-label, single-arm Phase 2 clinical trial evaluating AL101 as monotherapy for the treatment of R/M ACC patients with Notch-activated mutations. The first cohort of the trial included 45 subjects dosed at 4 mg of AL101 IV once weekly. Final data from the 4 mg cohort and additional data from the 6 mg cohort,which includes 42 subjects are expected to be reported in the second half of 2022.
  
• Initiate Phase 2 Clinical Trial Evaluating AL102 in T-cell Acute Lymphoblastic Leukemia (T-ALL): Ayala plans to begin a Phase 2 clinical trial evaluating AL101 in R/R T-ALL in the second half of 2022.

Full Year 2021 Financial Results

Cash Position: Cash and cash equivalents were $37.3 million as of December 31, 2021, as compared to $42.4 million as of December 31, 2020.

Collaboration Revenue: Collaboration revenue was $3.5 million for the full year of 2021, as compared to $3.7 million for the full year of 2020.

R&D Expenses: Research and development expenses were $29.9 million for the full year 2021, compared to $22.4 million in 2020. The increase was primarily driven by additional costs in connection with the initiation and advancement of the Phase 2/3 RINGSIDE pivotal study for desmoid tumors.

G&A Expenses: General and administrative expenses were $9.3 million as of December 31, 2021, compared to $7.4 million as of December 31, 2020. The increase was primarily due to higher expenses in connection with our operations as a public company, including director and officer insurance, increased headcount, and stock-based compensation.

Net Loss: Net loss was $40.3 million for the full year 2021, resulting in basic and diluted net loss per share of ($2.80). This compares with a net loss was $30.1 million for the full year of 2020, equivalent to basic and diluted net loss per share of ($3.06).

For further details on the Company’s financial results, refer to our Annual Report on Form 10-K, for the year ended December 31, 2021 filed with the U.S. Securities and Exchange Commission (SEC) on March 28, 2022.

About Ayala Pharmaceuticals
Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers,. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM) (in collaboration with Novartis). AL101, has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations and other gene rearrangements. AL102 is currently in a pivotal Phase 2/3 clinical trial for patients with desmoid tumors (RINGSIDE) and is being evaluated in a Phase 1 clinical trial in combination with Novartis’ BMCA targeting agent, WVT078, in patients with relapsed/refractory Multiple Myeloma. For more information, visit www.ayalapharma.com.

Contacts:

Investors:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com

Ayala Pharmaceuticals:
+1-857-444-0553
info@ayalapharma.com

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements relating to our development of AL101 and AL102, the promise and potential impact of our preclinical or clinical trial data, the timing of and plans to initiate additional clinical trials of AL101 and AL102, the timing and results of any clinical trials or readouts, the sufficiency of cash to fund operations, and the anticipated impact of COVID-19, on our business. These forward-looking statements are based on management’s current expectations. The words ”may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have incurred significant losses since inception and anticipate that we will continue to incur losses for the foreseeable future. We are not currently profitable, and we may never achieve or sustain profitability; we will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of AL101 and AL102; we have identified conditions and events that raise substantial doubt about our ability to continue as a going concern; we have a limited operating history and no history of commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future viability; we are heavily dependent on the success of AL101 and AL102, our most advanced product candidates, which are still under clinical development, and if either AL101 or AL102 does not receive regulatory approval or is not successfully commercialized, our business may be harmed; due to our limited resources and access to capital, we must prioritize development of certain programs and product candidates; these decisions may prove to be wrong and may adversely affect our business; the outbreak of COVID-19, may adversely affect our business, including our clinical trials; our ability to use our net operating loss carry forwards to offset future taxable income may be subject to certain limitations; our product candidates are designed for patients with genetically defined cancers, which is a rapidly evolving area of science, and the approach we are taking to discover and develop product candidates is novel and may never lead to marketable products; we were not involved in the early development of our lead product candidates; therefore, we are dependent on third parties having accurately generated, collected and interpreted data from certain preclinical studies and clinical trials for our product candidates; enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control; if we do not achieve our projected development and commercialization goals in the timeframes we announce and expect, the commercialization of our product candidates may be delayed and our business will be harmed; our product candidates may cause serious adverse events or undesirable side effects, which may delay or prevent marketing approval, or, if approved, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales; the market opportunities for AL101 and AL102, if approved, may be smaller than we anticipate; we may not be successful in developing, or collaborating with others to develop, diagnostic tests to identify patients with Notch-activating mutations; we have never obtained marketing approval for a product candidate and we may be unable to obtain, or may be delayed in obtaining, marketing approval for any of our product candidates; even if we obtain FDA approval for our product candidates in the United States, we may never obtain approval for or commercialize them in any other jurisdiction, which would limit our ability to realize their full market potential; we have been granted Orphan Drug Designation for AL101 for the treatment of ACC and may seek Orphan Drug Designation for other indications or product candidates, and we may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for market exclusivity, and may not receive Orphan Drug Designation for other indications or for our other product candidates; although we have received Fast Track designation for AL101, and may seek Fast Track designation for our other product candidates, such designations may not actually lead to a faster development timeline, regulatory review or approval process; we face significant competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively; we are dependent on a small number of suppliers for some of the materials used to manufacture our product candidates, and on one company for the manufacture of the active pharmaceutical ingredient for each of our product candidates; our existing collaboration with Novartis is, and any future collaborations will be, important to our business. If we are unable to maintain our existing collaboration or enter into new collaborations, or if these collaborations are not successful, our business could be adversely affected; enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates, if approved, and may affect the prices we may set; if we are unable to obtain, maintain, protect and enforce patent and other intellectual property protection for our technology and products or if the scope of the patent or other intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and we may not be able to compete effectively in our markets; we may engage in acquisitions or in-licensing transactions that could disrupt our business, cause dilution to our stockholders or reduce our financial resources; and risks related to our operations in Israel could materially adversely impact our business, financial condition and results of operations.

These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 29, 2022 and our other filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

AYALA PHARMACEUTICALS, INC.

CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands (except share and per share data)

AYALA PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

U.S. dollars in thousands (except shares and per shares data)

BioSig Technologies, Inc. Partners with Summit Blue Capital to Provide Equipment Leasing Services

News and Market Data on BioSig Technologies

 

The leasing and finance program provides a non-recourse financial solution for PURE EP™ to improve purchase flexibility for U.S. hospitals

Westport, CT, March 29, 2022 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced a new partnership agreement with Summit Blue Capital for implementing a leasing and finance program for the Company’s PURE EP™ System.

The Minneapolis-based Summit Blue Capital is a leader in equipment finance and leasing. It offers tailored leasing and financing solutions for its partners and clients in industries such as healthcare, manufacturing, hospitality, technology solutions, and more. Most notably, Summit Blue Capital specializes in simplifying the financing experience and finding solutions to advance commercial roll outs in the healthcare industry.

“We believe that partnering with Summit Blue Capital will have considerable benefits to our commercial plans. We intend to take advantage of the Summit team’s expertise, flexibility, and financial solutions as a leasing partner,” said Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc. “Summit Blue Capital came highly recommended by one of the largest money center U.S. financial institutions. We believe this relationship will help take friction out of the sales cycle and advance our timeline while allowing BioSig to get paid up front per installation. The team at Summit Blue Capital is expected to also help us launch a subscription-based revenue model for our software.”  

“The pathway to purchase is always of great consideration in the capital equipment forum. We anticipate that partnering with Summit Blue Capital will impact our ability to expedite PURE EP’s entrance into new electrophysiology labs across the United States,” commented Gray Fleming, Chief Commercial Officer of BioSig Technologies, Inc.

“BioSig has made significant improvements to the EP market, and they have a unique technology offering with their PURE EP,” said Adam Drill, President of Summit Blue Capital. “Summit Blue Capital is excited to partner with BioSig and execute on a strategic financing and leasing program that we believe will benefit their customer roll out and help position them as a leader in medical technology. We look forward to helping each other and building a solid foundation for the future.”

The PURE EP™ is an FDA 510(k) cleared non-invasive class II device that aims to drive procedural efficiency and efficacy in cardiac electrophysiology. To date, 75 physicians have completed more than 2,150 patient cases with the PURE EP™ System.

Clinical data acquired by the PURE EP™ System in a multi-center study at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Mayo Clinic Jacksonville, and Massachusetts General Hospital was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP™ signals over conventional sources.

About Summit Blue Capital
Summit Blue Capital is a national commercial finance business based in Minnesota. The Company specializes in custom vendor programs and lease lines-of-credit for companies across the United States. Summit Blue is a privately owned and independently operated finance company that serves all industries. For more information, visit www.summitbluecapital.com.

About BioSig Technologies
BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

The Company’s first product, PURE EP™ System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording, and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future 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 and consequently, actual 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) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. 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.

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
55 Greens Farms Road
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x119

Source: BioSig Technologies, Inc.

Cocrystal Pharma provides a preview of their upcoming presentation at NobleCon18 NobleCon18 – Noble Capital Markets 18th Annual Small and Microcap Investor Conference – April 19-21, 2022 – Hard Rock, Hollywood, FL 100+ Public Company Presentations | Scheduled Breakouts | Panel Presentations | High-Profile Keynotes | Educational Sessions | Receptions & Networking Events Free Registration Available – More Info Research News and Advanced Market Data on COCP NobleCon18 Presenting Companies About Cocrystal Pharma Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.