Friday, August 13, 2021

PDS Biotechnology Corp (PDSB)
Moving Forward With Clinical Milestones On The Horizon

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, Senior Research Analyst, Noble Capital Markets, Inc.

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

Significant Data Was Presented In 2Q21.  PDS Biotechnology reported 2Q21 loss of $0.6 million or $(0.03) per share. Importantly, interim Phase 2 data from the lead trial for PDS0101 presented at the ASCO conference showed strong indications of efficacy. Additional data from this PDS0101 trial and two other Phase 2 trials are expected to be announced around 4Q/1H22.


Increased Cash Allows Clinical Trials To Move Forward.  During 2Q21, the company completed an offering that raised about $52 million in gross proceeds. Cash on hand at June 30, 2021 was $74.7 million. This gives the company sufficient operating cash to continue current operations and new clinical trials. Two additional Versamune platform products, PDS102 and PDS103, are expected to move to clinical …

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 Second Quarter 2021 Financial Results and Provides Business Update

– Enrolled the First Patient in the Phase 2/3 Pivotal Trial of AL102 for the Treatment of Desmoid Tumors

– Multiple Near-Term Milestones Across Clinical-Stage Pipeline

– Updated ACCURACY Trial Data to Be Presented at ESMO 2021-

REHOVOT, Israel and WILMINGTON, Del., Aug. 13, 2021 (GLOBE NEWSWIRE) —  Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a 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, today reported financial results for the period ended June 30, 2021 and highlighted recent progress and upcoming milestones for its pipeline programs.

“Ayala is well positioned for strong clinical progress throughout the remainder of this year. In the second quarter, we continued to advance our pipeline programs and we are gearing up for a data readout from AL101 in our ACCURACY trial in adenoid cystic carcinoma at the upcoming ESMO meeting in September, while also advancing our AL102 clinical trials in desmoid tumors and multiple myeloma,” said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. “Our science is deeply rooted in the promise of predicting, identifying and addressing tumorigenic drivers of cancer and we continue to see value in our approach combining bioinformatics and next-generation sequencing. There remains a significant unmet need among patients with genetically defined cancers and we believe that our pipeline has the potential to address the ongoing shortfalls of existing therapies.”

Recent Business Highlights and Upcoming Milestones:

• Enrolled First Patient in the Phase 2/3 RINGSIDE Trial of AL102 for the Treatment of Desmoid Tumors: Ayala recently enrolled the first patient in its pivotal Phase 2/3 RINGSIDE trial of AL102 for the treatment of desmoid tumors with multiple sites open in the U.S. and globally. Ayala expects to report an initial interim data read-out from part A of the trial in mid-2022, with part B of the study commencing thereafter.
  
• Dosed First Patient in the Phase 1 Trial of AL102 in Combination with Novartis’ BCMA Targeting Agent, WVT087 for the Treatment of Relapsed/Refractory Multiple Myeloma: In April 2021, Ayala announced the dosing of the first patient in the Phase 1 combination trial of AL102 with Novartis’ investigational anti-B-cell maturation antigen (BCMA) agent, WVT078, for the treatment of relapsed and/or refractory (R/R) multiple myeloma (MM).
  
• Phase 2 TENACITY Trial of AL101 for the Treatment of Triple Negative Breast Cancer Continues to Progress: Ayala continues to enroll patients in the Phase 2 TENACITY clinical trial of its potent, selective small molecule gamma secretase inhibitor (GSI), AL101, for the treatment of patients with Notch-activated recurrent or metastatic (R/M) triple negative breast cancer (TNBC). The Company expects to report preliminary data from this ongoing trial in 2022.
  
• On Track to Report Additional ACCURACY Phase 2 Data; Patient Enrollment in 6mg Cohort of Phase 2 ACCURACY Study Completed: Ayala completed enrollment of patients in the 6mg cohort of the Phase 2 ACCURACY study of AL101 for the treatment of R/M adenoid cystic carcinoma (ACC), which includes 42 subjects. Further trial progress updates, including additional data, will be presented at the upcoming European Society for Medical Oncology (ESMO) 2021 Congress being held virtually September 16-21, 2021.
  

Second Quarter 2021 Financial Results

• Cash Position: Cash and cash equivalents were $44.4 million as of June 30, 2021, as compared to $42.0 million as of December 31, 2020.
• Collaboration Revenue: Collaboration revenue was $0.8 million for the second quarter of 2021, as compared to $1.0 million for the same period in 2020.
• R&D Expenses: Research and development expenses were $8.1 million for the second quarter of 2021, compared to $5.1 million for the same period in 2020. The increase was primarily driven by the advancement of Ayala’s clinical programs.
• G&A Expenses: General and administrative expenses were $2.5 million for the second quarter of 2021, compared to $1.5 million for the same period in 2020. The increase was primarily related to costs associated with becoming a public company.
• Net Loss: Net loss was $10.8 million for the second quarter of 2021, resulting in a basic and diluted net loss per share of $0.75 Net loss was $6.7 million for the same period in 2020, resulting in a basic and diluted net loss per share of $0.74.
  

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, primarily in genetically defined patient populations. 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, Triple Negative Breast Cancer (TNBC), 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 in a Phase 2 clinical trial for patients with TNBC (TENACITY) bearing Notch activating mutations and other gene rearrangements. AL102 is currently in a Pivotal Phase 2/3 clinical trials 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.

Investors:
Julie Seidel
Stern Investor Relations, Inc.
+1-212-362-1200
Julie.seidel@sternir.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, upcoming milestones, including without limitation the timing and results of any clinical trials or readouts, patient enrollment and the sufficiency of cash to fund operations. 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: the impact of the COVID-19 pandemic on our operations, including our preclinical studies and clinical trials, and the continuity of our business; we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding; our cash runway; our limited operating history and the prospects for our future viability; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in regulatory approval; our requirement to pay significant payments under product candidate licenses; the approach we are taking to discover and develop product candidates and whether it will lead to marketable products; the expense, time-consuming nature and uncertainty of clinical trials; enrollment and retention of patients; potential side effects of our product candidates; our ability to develop or to collaborate with others to develop appropriate diagnostic tests; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; risks associated with international operations; our ability to retain key personnel and to manage our growth; the potential volatility of our common stock; costs and resources of operating as a public company; unfavorable or no analyst research or reports; and securities class action litigation against us. 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, 2020 filed with the U.S. Securities and Exchange Commission (SEC) on March 24, 2021 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 
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AYALA PHARMACEUTICALS, INC. 
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Helius Medical Technologies, Inc. Reports Second Quarter 2021 Financial Results

NEWTOWN, Pa., Aug. 12, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today reported financial results for the quarter ended June 30, 2021.

Second Quarter and Recent Business Updates

• Frederick Fantazzia appointed Vice President of Sales & Marketing, North America, June 1, 2021
• Dane Andreeff and Jeffrey Mathiesen appointed President & Chief Executive Officer and Chief Financial Officer, respectively, June 14, 2021
• Antonella Favit-Van Pelt, M.D., Ph.D. appointed Chief Medical Officer, July 7, 2021
• New website launched for U.S.-based patients and physicians: https://ponstreatment.com

Second Quarter 2021 Financial Summary

• Revenue: $71 thousand, vs. $133 thousand in Q2 2020
• Operating loss: $6.2 million vs. $3.7 million in Q2 2020
  • Q2 2021 included $1.9 million of increased non-cash stock-based compensation expense comprised of a one-time fully vested stock option grant valued at $1.0 million and stock options granted to key management and sales executives
• Net loss: $6.0 million vs. $3.4 million in Q2 2020
• Cash balance: $7.4 million at June 30, 2021 vs. $3.3 million at December 31, 2020
  

“Helius made important progress during the second quarter and in recent weeks in preparing for U.S. commercialization, following the receipt of U.S. marketing authorization of our PoNS device for MS in late March,” said Dane Andreeff, President and Chief Executive Officer of Helius. “Most notably, we enhanced and expanded our senior leadership team with the appointment of several highly qualified individuals, including a Vice President of Sales and Marketing for North America who will inform and lead our strategy to commercialize in the U.S. We also secured many of the required state licenses that will enable us to distribute and sell our PoNS device and are now cleared to sell in approximately 85% of states in the U.S. Lastly, we continued to develop our go-to-market strategy by refining our plan to initially target the estimated 130,000 MS patients with gait deficit who may require physical therapy. With respect to our operations in Canada, although the country remained severely impacted by the effects of the COVID-19 pandemic during the second quarter, with restrictions on both the clinics and patients we serve, we are cautiously optimistic that these headwinds will moderate in the second half of 2021 as the operating environment begins to recover.”

Mr. Andreeff continued: “During the second half of this year, we will remain keenly focused on pursuing our pre-commercial activities in order to meet our goal of beginning U.S. commercialization of our PoNS Treatment during the first quarter of 2022. Specifically, we plan to begin building our commercial team and appropriately engage centers of excellence to allow them to gain experience with PoNS in the target population, with the goal that they will then disseminate their experience with PoNS to colleagues and health care providers. The focus of these efforts will include the 10 states we have identified that comprise more than 50% of the targeted MS patients. We will also be engaging with payers in our pursuit to establish PoNS pricing in line with benchmark pricing for comparable devices used in the neurorehabilitation space. By executing on these near-term initiatives, we aim to bring our innovative PoNS technology to the aid of U.S. patients as quickly and efficiently as possible, which we believe represents the best path to creating value for our shareholders.”

Second Quarter 2021 Financial Results

Total revenue for the second quarter of 2021 was $71 thousand, compared to $133 thousand in the second quarter of 2020. Product sales represented 89% of total revenue in the second quarter of 2021 compared to 95% in the prior year period. Product sales in both periods were generated through sales of the PoNS device pursuant to supply agreements with PoNS Authorized clinic locations in Canada. License and fee revenue represented 11% of sales in the second quarter of 2021, compared with 5% of sales in the prior year period.

Gross profit for the second quarter of 2021 was $4 thousand, compared to gross profit of $69 thousand in the second quarter of 2020.

Operating expenses for the second quarter of 2021 increased $2.4 million, or 63% year-over-year, to $6.2 million, compared to $3.8 million in the second quarter of 2020. Operating expenses in the second quarter of 2021 included a $1.9 million increase in non-cash stock-based compensation expense comprised of a one-time fully vested stock option grant valued at $1.0 million and stock options granted in conjunction with the addition of key management and sales executives.

Operating loss for the second quarter of 2021 increased $2.5 million, or 66% year-over-year, to $6.2 million, compared to $3.7 million in the second quarter of 2020.

Total other income for the second quarter of 2021 was $185 thousand, compared to total other income of $361 thousand in the second quarter of 2020.

Net loss for the second quarter of 2021 was $6.0 million, or $(2.58) per basic and diluted common share, compared to a net loss of $3.4 million, or $(2.90) per basic and diluted common share, in the second quarter of 2020. Weighted average shares used to compute basic and diluted net loss per common share were 2.3 million and 1.2 million for the second quarter of 2021 and 2020, respectively.

Six Months Ended June 30, 2021 Financial Results

Total revenue for the six months ended June 30, 2021 was $155 thousand, compared to $339 thousand for the six months ended June 30, 2020. Product sales represented 90% of total revenue for the six months ended June 30, 2021, compared to 94% of total revenue for the six months ended June 30, 2020. Product sales in both periods were generated through sales of the PoNS device pursuant to supply agreements with PoNS Authorized clinic locations in Canada. License and fee revenue represented 10% of total revenue for the six months ended June 30, 2021, compared to 6% of total revenue for the six months ended June 30, 2020.

Gross profit for the six months ended June 30, 2021 was $72 thousand, compared to gross profit of $174 thousand for the six months ended June 30, 2020. Operating expenses for the six months ended June 30, 2021 increased $1.8 million, or 23% year-over-year, to $9.7 million, compared to $7.9 million for the six months ended June 30, 2020.

Operating loss for the six months ended June 30, 2021 increased $2.0 million, or 25% year-over-year, to $9.7 million, compared to operating loss of $7.7 million for the six months ended June 30, 2020. Operating expenses in the six months ended June 30, 2021 included a $1.7 million increase in stock-based compensation expense comprised of a one-time fully vested stock option grant valued at $1.0 million and stock options granted in conjunction with the addition of key management and sales executives.

Total other income for the six months ended June 30, 2021 was $324 thousand, compared to $394 thousand of total other expense for the six months ended June 30, 2020.

Net loss for the six months ended June 30, 2021 was $9.3 million, or $(4.29) per basic and diluted common share, compared to net loss of $8.1 million, or $(7.85) per basic and diluted common share, for the six months ended June 30, 2020. Weighted average shares used to compute basic and diluted net per share were 2.2 million and 1.0 million for the six months ended June 30, 2021 and the six months ended June 30, 2020, respectively.

Net cash provided by financing activities during the six months ended June 30, 2021 was $10.8 million.

As of June 30, 2021, the Company had cash of $7.4 million, compared to $3.3 million at December 31, 2020. The Company had no debt outstanding at June 30, 2021.

Conference Call

Management will host a conference call at 5:00 p.m. Eastern Time on August 12, 2021 to discuss the results of the quarter and business outlook. Those who would like to participate may dial 877-407-2988 (201-389-0923 for international callers) and provide access code 13721027. A live webcast of the call will also be provided on the Events section of the Company’s investor relations website at:

https://heliusmedical.com/index.php/investor-relations/events/upcoming-events.

For those unable to participate, a replay of the call will be available for two weeks at 877-660-6853 (201-612-7415 for international callers); access code 13721027. The webcast will be archived on the Events section of the Company’s investor relations website.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNS™). For more information, visit www.heliusmedical.com.

About the PoNS™ Device and PoNS Treatment™

The Portable Neuromodulation Stimulator (PoNS™) is an innovative non-surgical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to provide treatment of gait deficit. The PoNS device is indicated for use in the United States as a short term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. It is authorized for sale in Canada as a class II, non-implantable, medical device intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS, and chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy. The PoNS™ is an investigational medical device in the European Union (“EU”) and Australia (“AUS”). It is currently under premarket review by the AUS Therapeutic Goods Administration.

Cautionary Disclaimer Statement: 

Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “continue,” “will,” “goal,” “aim to” and similar expressions. Such forward-looking statements include, among others, statements regarding the COVID-19 pandemic, including its impact on the Company, the Company’s future growth and operational progress, including pre-commercial activities for the PoNS device, and expected time to begin commercialization of the PoNS device in the U.S..

There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include uncertainties associated with the Company’s capital requirements to achieve its business objectives, the impact of the COVID-19 pandemic, the Company’s ability to train physical therapists in the supervision of the use of the PoNS Treatment, the Company’s ability to secure contracts with rehabilitation clinics, the Company’s ability to obtain national Medicare coverage and to obtain a reimbursement code so that the PoNS device is covered by Medicare and Medicaid, the Company’s ability to build internal commercial infrastructure, secure state distribution licenses, build a commercial team and build relationships with Key Opinion Leaders, neurology experts and neurorehabilitation centers, market awareness of the PoNS device, future clinical trials and the clinical development process, manufacturing and supply chain risks, potential changes to the MCIT program resulting from the 60-day deferral of the program implementation, the product development process and FDA regulatory submission review and approval process, other development activities, ongoing government regulation, and other risks detailed from time to time in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, its Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.

The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.

The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Helius Medical Technologies, Inc.
Unaudited Consolidated Balance Sheets
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Helius Medical Technologies, Inc.
Unaudited Consolidated Statements of Operations and Comprehensive Loss
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Helius Medical Technologies, Inc.
Unaudited Condensed Consolidated Statements of Cash Flows
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CONTACT: Investor Relations Contact:

Westwicke on behalf of Helius Medical Technologies, Inc.
Jack Powell, Vice President
investorrelations@heliusmedical.com

Onconova Therapeutics Reports Second Quarter 2021 Financial Results And Provides Business Update

Conference call and live webcast at 4:30 p.m. ET today

NEWTOWN, Pa., Aug. 12, 2021 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX) (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced financial results for the three months ended June 30, 2021 and provided a business update.

Highlights for the second quarter of 2021 and subsequent weeks include:

• Enrollment in the first cohort of the Phase 1 solid tumor study of ON 123300 in the United States is complete with no dose limiting toxicities (DLT’s) observed. The second cohort is currently open for enrollment.
• The Phase 1 solid tumor study of ON 123300 in China is ongoing with no DLT’s observed to date. The study is currently enrolling the third dose cohort.
• The investigator-initiated Phase 1/2 study evaluating rigosertib in combination with the checkpoint inhibitor nivolumab in KRAS mutated non-small cell lung cancer (NSCLC) continues to progress. Initial data from the trial provide preliminary evidence of the anti-cancer activity of rigosertib-nivolumab combination therapy in patients who had previously failed all standard of care treatment, including checkpoint inhibition, and show that the maximum tolerated dose of rigosertib in combination with nivolumab was not yet determined in the three cohorts of the trial’s dose-escalation phase.
• The first patient was dosed in an investigator-initiated Phase 2 study designed to assess the efficacy and safety of rigosertib in patients with recessive dystrophic epidermolysis bullosa (RDEB)-associated locally advanced/metastatic squamous cell carcinoma (SCC), an ultra-rare and invariably fatal condition.
• The Company strengthened its management team with the appointment of Mark Gelder, M.D., as Chief Medical Officer.
• Preclinical data published in the peer-reviewed journal Molecular Cancer show that rigosertib synergistically enhanced the efficacy of immune checkpoint blockade in a murine melanoma model via the induction of immune-mediated cancer cell death, supporting the continued clinical evaluation of rigosertib in combination with checkpoint inhibitors.

Management Commentary

“During the second quarter we achieved key clinical and corporate milestones,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. “In our lead ON 123300 program, we initiated our U.S. Phase 1 study and recently opened enrollment to the second cohort, and our partner, HanX Biopharmaceuticals, is currently enrolling to the third dose cohort of the complementary Phase 1 study underway in China. Through these trials, which are evaluating different dosing administration regimens, we aim to inform the design of a future Phase 2 basket trial evaluating ON 123300 in multiple high unmet need indications, including CDK 4/6 inhibitor refractory HR+ HER2- metastatic breast cancer. Given ON 123300’s ability in preclinical studies to overcome resistance to the most widely prescribed CDK 4/6 inhibitor, we believe this novel multi-kinase inhibitor has the potential to be a best-in-class therapy for this and other cancers.”

Dr. Fruchtman continued, “Beyond our lead program, we also reported very encouraging preliminary results from the investigator-initiated study evaluating rigosertib plus nivolumab in advanced KRAS-mutated NSCLC. These results highlighted the doublet’s favorable safety profile and provided preliminary evidence of efficacy in an extremely challenging patient population. Additional preliminary data from the trial is expected to be presented at a RAS-focused medical meeting in September. Looking forward, we will continue to leverage investigator-initiated programs to further rigosertib’s clinical development, while maintaining our primary focus and resources on ON 123300. Milestones ahead for the remainder of the year include continued progress of our ON 123300 clinical trials, expansion of rigosertib investigator-initiated studies program, and potentially acquiring new assets to augment our pipeline. With a strong financial position and a talented management team that was recently bolstered by the appointment of Dr. Mark Gelder as CMO, we believe we are well positioned to take advantage of the product development opportunities presented.”

Second Quarter Financial Results

Cash and cash equivalents as of June 30, 2021 were $43.7 million, compared with $19.0 million as of December 31, 2020. The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations for more than eighteen months.

Research and development expenses were $1.9 million for the second quarter of 2021, compared with $4.8 million for the second quarter of 2020. The decrease was primarily related to higher clinical trial and consulting expenses in the 2020 period due to the INSPIRE study.

General and administrative expenses were $2.9 million for the second quarter of 2021, compared with $2.6 million for the second quarter of 2020. The increase was primarily due to expenses related to special meetings by proxy in the 2021 period.

Net loss for the second quarter of 2021 was $4.2 million, or $0.27 per share on 15.8 million weighted average shares outstanding, compared with a net loss for the second quarter of 2020 of $7.4 million, or $0.65 per share on 11.3 million weighted average shares outstanding.

Conference Call and Webcast

Onconova will host an investment community conference call today beginning at 4:30 p.m. Eastern Time, during which management will discuss financial results for the second quarter of 2021, provide a business update and answer questions. Interested parties can participate by dialing (855) 428-5741 (domestic callers) or (210) 229-8823 (international callers) and using conference ID 3876025.

A live webcast of the conference call will be available in the Investors & Media section of the Company’s website at www.onconova.com. A replay of the webcast will be available on the Onconova website for 90 days following the call.

About Onconova Therapeutics, Inc.
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor ON 123300 is being evaluated in two separate and complementary Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China.

Onconova’s product candidate rigosertib is being studied in an investigator-initiated study program, including in a dose-escalation and expansion Phase 1/2a investigator-initiated study targeting patients with KRAS+ non-small cell lung cancer with oral rigosertib in combination with nivolumab.

For more information, please visit www.onconova.com.

Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding the timing of Onconova’s and investigator-initiated clinical development and data presentation plans, and the mechanisms and indications for Onconova’s product candidates. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “preliminary,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, the timing of the Company’s annual stockholder meeting, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Avi Oler
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

(Tables to follow)