Table of Contents

As filed with the Securities and Exchange Commission on October 20, 2015January 30, 2018

 

Registration No. 333-       333-222374

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549


AMENDMENT NO. 1

FormTO

FORM S-l

 

REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933


Onconova Therapeutics, Inc.

(Exact name of registrant as specified in its charter)


 

Delaware

(State or other
jurisdiction of
incorporation or
organization)

 

2834

(Primary Standard
Industrial
Classification Code
Number)

 

22-3627252

(I.R.S.
Employer
Identification
No.)

 

Onconova Therapeutics, Inc.

375 Pheasant Run


Newtown, PA 18940
(267) 759-3680

(267)-759-3680
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive
offices)


 

Ramesh Kumar, Ph.D.
President and Chief Executive Officer
Onconova Therapeutics, Inc.
375 Pheasant Run
Newtown, PA 18954
(267) 759-3680
(Name, address, including zip code, and telephone number including area code, of agent for service)


Copies to:

 

Jeffery P. Libson

Donald R. Readlinger
Pepper Hamilton LLP
301 Carnegie Center, Suite 400
Princeton, NJ 08540-6227
609-951-4164


Copy to:

Joanne R. Soslow

Steven M. Skolnick

Morgan, Lewis & Bockius LLP

Michael J. Lerner

1701 Market Street

Lowenstein Sandler LLP

Philadelphia, PA 19103

1251 Avenue of the Americas

(215) 963-5000

New York, New York 10022

(212) 262-6700

 

Approximate date of commencement of proposed sale to the public: As soon as practicable From time to time after the effective date of this registration statement.

If the only securities being registered on this form are being offered pursuant to dividend or interest reinvestment plans, please check the following box.  o

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, other than securities offered only in connection with dividend or interest reinvestment plans, check the following box.o

 

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act of 1933, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.o

 

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act of 1933, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.o

If this Form is a registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective upon filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box.  o

 

If this Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register additional securities or additional classes of securities pursuant to Rule 462(d)413(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.box.  o

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company or an emerging growth company. See the definitions of “ large“large accelerated filer,” “ accelerated filer”, “accelerated filer”, “smaller reporting company” and “smaller reporting“emerging growth company” in Rule 12b-2 of the Exchange Act. (check(Check one)o:

 

Large Acceleratedaccelerated filer

o

Accelerated filer

o

Non-accelerated filer

o (Do not check if a smaller reporting company)

Smaller reporting company

x

Emerging growth company

x

 


If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. o

 

CALCULATION OF REGISTRATION FEE

 

Title of securities to be registered

 

Amount to be
registered

 

Proposed maximum
offering price per
share

 

Proposed maximum
aggregate offering price

 

Amount of registration
fee

 

Common Stock, par value $0,001 per share

 

5,200,000

(1)

$

1.49

(2)

$

7,748,000

 

$

780.23

 

 

 

 

 

 

 

 

 

 

 

Title of Securities to be Registered

 

Amount to
be
Registered (1)

 

Proposed
Maximum
Offering Price
Per
Share (2)

 

Proposed
Maximum
Aggregate
Offering
Price

 

Amount of
Registration
Fee (3)

 

Common Stock, par value $0.01 per share

 

9,947,500

 

$

1.58

 

$

15,717,050

 

$

1,956.78

 

Total

 

9,947,500

 

$

1.58

 

$

15,717,050

 

$

1,956.78

 

(1)Pursuant to Rule 416 under the Securities Act of 1933, as amended (the “Act”), the shares being registered hereunderherein include such indeterminate number of shares as may be issuableissued with respect to the shares being registered hereunder as a result of stock splits, stock dividends or similar transactions. .Includes 1,297,500 shares subject to the underwriter’s option to purchase additional shares.

(2)Estimated pursuant to Paragraph (c) of Rule 457 under the Act solely for the purpose of calculating the registration fee, in accordance with Rule 457(c) under the Securities Act of 1933, as amended, based on the average of the high and low sales prices of theshares of registrant’s common stock on January 26, 2018 as reported on the NASDAQ Global Select Market on October 15, 2015, which is within five business days ofNasdaq Capital Market.

(3)                   The registrant previously paid a $1,867.50 registration fee with the initial filing of this registration statement.


 

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant files a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.determine.

 

 

 



Table of Contents

The information in this prospectus is not complete and may be changed. Neither we nor the selling stockholderWe may not sell these securities until the Securities and Exchange Commission declares our registration statement effective. This preliminary prospectus is not an offer to sell these securities and neither we nor the selling stockholder are not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.

 

Subject to completion, dated October 20, 2015January 30, 2018

 

PRELIMINARY PROSPECTUS

 

 

Onconova Therapeutics, Inc.

 

5,200,000 shares8,650,000 Shares of Common Stock

 

This prospectus relates to the offer and sale of up to 5,200,000We are offering 8,650,000 shares of our common stock, par value $0.01, of Onconova Therapeutics, Inc., a Delaware corporation, by Lincoln Park Capital Fund, LLC, or Lincoln Park or the selling stockholder.

The shares of common stock being offered by the selling stockholder have been or may be issued pursuant to the purchase agreement dated October 8, 2015 that we entered into with Lincoln Park. See “The Lincoln Park Transaction” for a description of that agreement and “Selling Stockholder” for additional information regarding Lincoln Park. The prices at which Lincoln Park may sell the shares will be determined by the prevailing market price for the shares or in negotiated transactions.

We are not selling any securities under this prospectus and will not receive any of the proceeds from the sale of shares by the selling stockholder.

The selling stockholder may sell the shares of common stock described in this prospectus in a number of different ways and at varying prices. See “Plan of Distribution” for more information about how the selling stockholder may sell the shares of common stock being registered pursuant to this prospectus. The selling stockholder is an “underwriter” within the meaning of Section 2(a)(11) of the Securities Act of 1933, as amended.

We will pay the expenses incurred in registering the shares, including legal and accounting fees. See “Plan of Distribution”.

stock. Our common stock is currently quotedlisted on the Nasdaq Global SelectCapital Market under the symbol “ONTX”.“ONTX.” On October 19, 2015,January 26, 2018, the last reported sale price of our common stock on the Nasdaq Global SelectCapital Market was $1.46.$1.58 per share. The public offering price per share will be determined by negotiation between us and the underwriter at the time of pricing, and may be at a discount to the current market price.


 

Investing in our common stock involves substantial risks. See Risk Factors“Risk Factors” beginning on page 10.10 of this prospectus and in the documents incorporated by reference into this prospectus.

 


We are an “emerging growth company” as defined by the Jumpstart Our Business Startups Act of 2012 and, as such,

Per Share

Total

Public offering price

$

$

Underwriting discounts and commissions (1)

$

$

Proceeds, before expenses, to us

$

$


(1)  In addition, we have electedagreed to comply withpay the underwriter a management fee in the amount of 1.0% of the aggregate offering price and to reimburse the underwriter for certain reduced public company reporting requirementsexpenses.  See “Underwriting” for this prospectus and future filings.additional information.

 

We may amend or supplement this prospectus from timehave granted the underwriter an option for a period of 30 days to time by filing amendments or supplements as required. You should read the entire prospectus and any amendments or supplements carefully before you make your investment decision.purchase up to an additional 1,297,500 shares of our common stock.

 

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of anyone’s investment in these securities or determined ifpassed upon the adequacy or accuracy of this prospectus is truthful or complete.prospectus. Any representation to the contrary is a criminal offense.

 


The underwriter expects to deliver the shares of common stock to purchasers on or about           ,  2018.


Sole Book-Running Manager

H.C. Wainwright & Co.


The date of this prospectus is , 2015.2018.

 



Table of Contents

 

TABLE OF CONTENTS

 

Page

PROSPECTUS SUMMARY

1

THE OFFERING

8

RISK FACTORS

10

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

12

USE OF PROCEEDS

15

CAPITALIZATION

16

DILUTION

18

EXECUTIVE COMPENSATION

20

DESCRIPTION OF CAPITAL STOCK

26

UNDERWRITING

29

EXPERTS

33

LEGAL MATTERS

33

WHERE YOU CAN FIND MORE INFORMATION

1

33

INCORPORATION OF INFORMATION BY REFERENCE

1

ABOUT THIS PROSPECTUS

2

PROSPECTUS SUMMARY

2

THE OFFERING

7

SECURITIES OFFERED

8

RISK FACTORS

10

THE LINCOLN PARK TRANSACTION

14

USE OF PROCEEDS

18

THE SELLING STOCKHOLDER

19

DIVIDEND POLICY

21

MARKET PRICE OF COMMON STOCK

22

PLAN OF DISTRIBUTION

23

DESCRIPTION OF CAPITAL STOCK

25

LEGAL MATTERS

27

EXPERTS

2734

 


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WHERE YOU CAN FIND MORE INFORMATION

We file annual, quarterly and current reports, proxy statements and other information with the Securities and Exchange Commission, or “SEC.”  You may read and copy any documents we file with the SEC at the SEC’s Public Reference Room at 100 F Street, NE, Washington, D.C. 20549.  You may obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330.  In addition, our filings with the SEC are available to the public through the SEC’s Internet site at http://www.sec.gov.  Information about us is also available on our website at http://www.onconova.com.  This URL and the SEC’s URL above are intended to be inactive textual references only.  The information on the SEC’s website and our website is not part of, and is not incorporated into, this prospectus.

We have filed a registration statement covering our shares of common stock subject to this offering, of which this prospectus forms a part.  This prospectus, however, does not contain all of the information set forth in the registration statement and the exhibits to the registration statement.  For further information concerning us and the securities we may offer and sell, you should read the entire registration statement and the exhibits to the registration statement. The registration statement has been filed electronically and may be obtained in any manner listed above.  Any statements contained in this prospectus concerning the provisions of any document are not necessarily complete, and, in each instance, reference is made to the copy of such document filed as an exhibit to the registration statement or otherwise filed with the SEC.  Each such statement is qualified in its entirety by such reference.

INCORPORATION OF INFORMATION BY REFERENCE

The SEC allows us to “incorporate by reference” the information we file with it, which means that we can disclose important information to you by referring you to those documents. The information incorporated by reference is considered to be part of this prospectus. We incorporate by reference the documents listed below:

·                                          Our Annual Report on Form 10-K for the fiscal year ended December 31, 2014, which we filed with the SEC on March 30, 2015, including the information required by Part III, Items 10 through 14, of Form 10-K, which is incorporated by reference to our definitive proxy statement for our 2015 annual meeting of shareholders filed on April 29, 2015;

·                                          Our Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, 2015 and June 30, 2015, which we filed with the SEC on May 15, 2015 and August 13, 2015 respectively;

·                                          Our Current Reports on Form 8-K filed with the SEC on October 8, 2015, October 5, 2015, July 8, 2015 and June 17, 2015 (except for Information furnished under Items 2.02 or 7.01 (or corresponding information furnished under Item 9.01 or included as an exhibit) which is not incorporated by reference into this prospectus); and

·                                          The description of our common stock contained in our registration statement on Form 8-A filed on July 23, 2013 (Registration no. 001-36020) with the SEC, including any amendment or report filed for the purpose of updating such description.

We will provide without charge to each person, including any beneficial owner, to whom this prospectus is delivered, upon his or her written or oral request, a copy of any or all documents referred to above which have been or may be incorporated by reference into this prospectus but not delivered with this prospectus excluding exhibits to those documents unless they are specifically incorporated by reference into those documents. You can request those documents from us, at no cost, by writing or telephoning us at: Onconova Therapeutics, Inc., 375 Pheasant Run, Newtown, Pennsylvania, 18940, (267) 759-3036, Attention: Benjamin Hoffman.

ABOUT THIS PROSPECTUS

Unless the context otherwise requires, references in this prospectus to “Onconova,” “Onconova Therapeutics,” “Company,” “we,” “us” and “our” refer to Onconova Therapeutics, Inc. and its consolidated subsidiaries. This prospectus is part of a registration statement that we have filed with the Securities and Exchange Commission, which we refer to as the SEC or the Commission, utilizing a registration process. It is important for you to read and consider all of the information contained in this prospectus and any applicable prospectus before making a decision whether to invest in the common stock. You should also read and consider the information contained in the exhibits filed with our registration statement, of which this prospectus is a part, as described in “Where You Can Find More Information” in this prospectus.

 

You should rely only on the information contained in this prospectus and any applicable prospectus supplement, including the information incorporated by reference. WeNeither we nor the underwriter have not authorized anyone to provide you with different information. We are not offering to sell or soliciting offers to buy, and will not sell, any securities in any jurisdiction where it is unlawful. You should assume that the information contained in this prospectus or any prospectus supplement, as well as information contained in a document that we have previously filed or in the future will file with the SEC is accurate only as of the date of this prospectus, the applicable prospectus supplement or the document containing that information, as the case may be.

 

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PROSPECTUS SUMMARY

 

The items in the following summary are described in more detail laterhighlights certain information contained elsewhere in this prospectus.prospectus and the documents incorporated by reference herein. This summary provides an overview of selected information and does not contain all of the information you will need in making your investment decision. You should consider.  Before investing in our common stock, you shouldcarefully read thethis entire prospectus carefully, including the information set forth under the headings “Risk Factors “ and the consolidateddocuments incorporated by reference herein. You should pay special attention to the “Risk Factors” section of this prospectus and the financial statements and related notes included orother information incorporated by reference in this prospectus.

Our Business

 

Overview

 

We are a clinical-stage biopharmaceutical company focused on discovering and developing novel small molecule drugproduct candidates primarily to treat cancer. Using our proprietary chemistry platform, we have created an extensivea library of targeted anti-cancer agents designed to work against cellular pathways important to cancer cells. We believe that the drugproduct candidates in our pipeline have the potential to be efficacious in a variety of cancers. We have threeone Phase 3 clinical-stage product candidate and two other clinical-stage product candidates (one of which is being developed for treatment of acute radiation syndromes) and several preclinical programs, and the majorityprograms. Substantially all of our current effort is focused on our lead product candidate, rigosertib. Rigosertib is being tested in bothan intravenous and oral formulationsformulation as a single agent, and thean oral formulation also in combination with azacitidine, in clinical trials for patients with higher-risk myelodysplastic syndromes or MDS, and related cancers.(“MDS”).

 

After discussions withOur net losses were $17.9 million and $14.2 million for the U.S. Food and Drug Administration, or FDA, and European Medicines Agency, or EMA, we have designed a randomized controlled Phase 3 trial of rigosertib IV in a population of patients with higher-risk MDS after failure of hypomethylating agent therapy. The pivotal trial, which we refer to as 04-30 or INSPIRE, will enroll higher-risk MDS, or HR-MDS, patients under 80 years of age who had progressed on, or failed to respond to, previous treatment with hypomethylating agents, or HMAs, within the first nine months ended September 30, 2017 and 2016, respectively. As of initiationSeptember 30, 2017, we had an accumulated deficit of HMA treatment, and had their last dose of HMA therapy within six months prior to enrollment in the trial.  The primary endpoint of this study is overall survival, and an interim analysis is anticipated.  This randomized trial of approximately 225 patients is expected to be conducted at about 100 sites globally. In August 2015, we submitted an investigational new drug application, or IND, to the FDA and in September 2015 we submitted Clinical Trial Applications, or CTAs, with the United Kingdom, German and Austrian regulatory agencies for IV rigosertib as a treatment for HR-MDS after failure of HMA therapy. We anticipate enrollment of the first patient in the Phase 3 trial during the fourth quarter of 2015.

We are continuing enrollment in the Phase 2 portion of a clinical trial of rigosertib oral in combination with azacitidine for patients with HR-MDS and acute myelogenous leukemia, or AML, and anticipate completing

enrollment in the fourth quarter of 2015. We are assessing the utility of bone marrow genomic methylation patterns and testing for the identification of patients more likely to respond to treatment with rigosertib oral as a single agent for patients with lower-risk MDS, or LR-MDS.$356.1 million.

 

Rigosertib IV

 

Rigosertib is a small molecule that inhibitswhich we believe blocks cellular signaling in cancer cells by acting as a Ras mimetic.targeting RAS effector pathways. This is believed to be mediated by the bindinginteraction of rigosertib to the Ras-bindingRAS-binding domain or RBD,(“RBD”), found in many RasRAS effector proteins, including the Raf and PI3K kinases. ThisWe believe this mechanism of action provides a new approach to block the interactions between RasRAS and its targets containing RBD sites. Rigosertib is currently being tested in clinical trials as a single agent, and in combination with azacitidine, in clinical trials of patients with MDS and related cancers.MDS. We have enrolled more than 1,1001,300 patients in rigosertib clinical trials.trials for MDS and other conditions. We arewere a party to collaboration agreementsa license and development agreement with Baxalta GmbH, or Baxalta (successor in interest of Baxter Healthcare SA)(as defined below), which grantgranted Baxalta certain rights to commercialize rigosertib in Europe, andEurope. The Baxalta agreement was terminated on August 30, 2016, at which time the European rights reverted to us at no cost. We are party to a collaboration agreement with SymBio, Pharmaceuticals Limited, or SymBio, which grantgrants SymBio certain rights to commercialize rigosertib in Japan and Korea. We have retained development and commercialization rights to rigosertib in the rest of the world, including in the United States.States and Europe, although we could consider licensing commercialization rights to other territories as we continue to seek additional funding.

 

Rigosertib IV for higher-risk MDS

 

In early 2014, we announced topline survival results from our “ONTIME” trial, a multi-center Phase 3 clinical trial of rigosertib IV as a single agent (the “ONTIME” trial). While theversus best supportive care including low dose Ara-C. The ONTIME trial did not meet its primary endpoint of an improvement in overall survival in the intent-to-treat population, although improvements in median overall survival were observed in various

pre-specified and exploratory subgroups of HR-MDShigher-risk MDS patients. As a result, additional clinical work is on-going.

 

During 2014 and 2015, we held meetings with the FDA, EMA,U.S. Food and Drug Administration (“FDA”) European Medicines Agency (“EMA”) and several European national regulatory agenciesauthorities to discuss and seek guidance on a path for approval of rigosertib IV in higher-risk MDS patients whose disease had failed hypomethylating agent, or HMA therapy. After discussions with the FDA and EMA, we have refined theour patient eligibility criteria in the new trial by defining what we believe to be a more homogenous patient population. After regulatory feedback, input from key opinion leaders in the U.S. and Europe and based on learnings from the ONTIME study, we have designed a new randomized controlled Phase 3 trial, referred to as 04-30 orINSPIRE. The INSPIRE with overall survival as a primary endpoint. We plan to enrolltrial is enrolling higher-risk MDS patients in the trial who (i) are under 8082 years of age (ii) hadwho have progressed on, relapsed, or failed to respond to, previous treatment with an HMAHMAs within the first nine months or nine cycles over the course of one year after initiation of HMA treatmenttherapy, and (iii) had their last dose of HMA therapy discontinued within six months prior to enrollment in the 04-30 trial. We expectThe primary endpoint of this study is overall survival of all randomized patients in the INSPIREintent-to-treat (“ITT”) population and the International Prognostic Scoring System- Revised (IPSS-R) Very High Risk subgroup. This randomized trial of approximately 225 patients is expected to be conducted at approximately 100 sites in more than ten countries and to enroll a sufficient number of patients for the trial to be well-powered. In August, we submitted an IND to the FDA and170 sites globally. The first patient in September we submitted CTAs with the United Kingdom, German and Austrian regulatory agencies for IV rigosertib as a treatment for HR-MDS after failure of HMA therapy. We expect to begin enrolling patients into the INSPIRE trial duringwas enrolled at the MD Anderson Cancer Center in December 2015, the first patient in Europe was enrolled in March, 2016, and the first patient in Japan was enrolled in July, 2016.

Enrollment for the INSPIRE Phase 3 trial for second-line higher-risk MDS patients is highly selective and required us to search extensively to identify appropriate candidates meeting the stringent entry criteria. Accordingly, this trial has been opened at more than 175 sites on four continents. Our partner, SymBio Pharmaceuticals, has opened more than 30 sites in Japan for the INSPIRE protocol. As of October 31, 2017, the trial is active at approximately 170 sites in 22 countries. The selection of countries and trial sites is carefully undertaken to ensure availability of appropriate patients meeting eligibility criteria. Since these criteria are purposely designed to be narrow and selective, extensive screening and trial site education is integral to our plan. INSPIRE trial outcome is measured by overall survival and includes a pre-planned interim analysis which is triggered by 88 events (deaths). The timing of interim analysis is difficult to precisely define. Based on our statistical analysis plan, the enrollment rate, and the expected survival in a comparable patient subgroup from the ONTIME trial, we expect the interim analysis to occur late in the fourth quarter of this2017. The interim analysis involves an initial analysis of efficacy by an independent statistical consultant. These results will be submitted to the independent data monitoring committee (DMC). The interim analysis may result in the trial stopping due to futility, trial continuation as planned without any changes, or continuation with changes according to the preset criteria for trial expansion or continued randomization only for the Very High Risk subgroup. The adaptive design element has been reviewed by regulatory agencies in the US and Europe. The actual timing of the interim analysis and its outcome will permit better estimates for complete enrollment and top-line analysis. Since the date of the interim analysis is tied to the unpredictability of reaching a pre-identified number of death events, the precise time of completing the interim analysis, which will be roughly a couple of weeks after reaching the number of events, cannot be forecast precisely, and could occur early next year.

 

In an attempt to optimize enrollment, we have taken proactive measures to increase enrollment including the addition of trial sites in three new countries, replacement of the principal CRO and addition of another CRO to our trial management group. Due to these changes full enrollment may take longer than initially expected. Since the interim analysis could potentially change the required number of patients to be randomized for the trial, a better estimate of these timelines can be provided after this analysis is completed. Should enrollment not return to desired levels, full enrollment may be delayed even if the adaptive design is not required as per the statistical analysis plan.

As called for in the INSPIRE Charter, the DMC has previously conducted two periodic safety

reviews, and after each review, the trial continued per plan.

On January 17, 2018, we announced that we are moving forward with our Phase 3 INSPIRE pivotal trial following the interim analysis, consistent with the recommendation of the DMC. The DMC recommended continuation of the trial with a one-time expansion in enrollment, using a pre-planned sample size re-estimation, consistent with the statistical analysis plan. We remain blinded to the interim analysis results.

The statistical analysis plan for the INSPIRE trial featured an adaptive trial design, permitting several options following the interim analysis, which included continuation of the trial as planned, discontinuation of the trial for futility, trial expansion using pre-planned sample size re-estimation, and trial continuation for only the pre-defined treatment subgroup of patients classified as VHR based on the IPSS-R.

The expanded INSPIRE study will continue to enroll eligible patients based on the current trial design of the overall ITT population and will increase enrollment by adding 135 patients to the original target to reach a total enrollment of 360 patients, with the aim of increasing the power of the trial. Due to the adaptive trial design and the DMC’s assessment, the INSPIRE trial will continue to analyze both the ITT and the VHR population for the primary endpoint of overall survival. The design of the trial with the expanded study enrollment will be identical to the current study design and will include the analysis of the overall survival endpoint in the ITT and the pre-specified VHR subgroup.

As of January 17, 2018, the INSPIRE study was active at approximately 175 trial sites in 22 countries across four continents, and has enrolled more than 170 patients. In Japan, patients have been enrolled to this study by SymBio Pharmaceuticals, our collaboration partner for Japan and Korea. We believe that this trial is the most advanced study for a new therapeutic agent in this indication, and there are no FDA approved therapies specifically for MDS patients after failure of front-line HMAs.

Rigosertib OralSafety and Tolerability of rigosertib in MDS and other hematologic malignancies

A comprehensive analysis of IV and oral rigosertib safety in patients with Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) was presented in December 2016 at the American Society of Hematology (ASH) Annual Meeting. The most commonly reported treatment-emergent adverse events (TEAEs) _ in > 10% of patients with MDS/AML receiving rigosertib intravenous (IV) monotherapy were fatigue (33%), nausea (33%), diarrhea (27%), constipation (25%), anaemia (24%) and pyrexia (24%). The most common > Grade 3 AEs were anaemia (21%), febrile neutropenia (13%), pneumonia (12%) and thrombocytopenia (11%). The most common serious AEs were febrile neutropenia (10%), pneumonia (9%), and sepsis (7%). The most common AEs leading to discontinuation of IV rigosertib were sepsis and pneumonia (3% each).

 

Rigosertib Oraloral in combination with azacitidine infor higher-risk MDS and AML

 

We are nearing full enrollment inIn December 2016, at the Phase 2 portionAmerican Society of an open labelHematology (ASH) Annual Meeting, we presented Phase 1/2 clinicaldata from an oral rigosertib and azacitidine combination trial testingin higher-risk MDS. 33 of 40 MDS patients enrolled were evaluable for response at the time of the analysis. The median age of patients was 66, with 73% being male. The IPSS-R distribution was: 7.5% Low, 12.5% Intermediate, 37.5% High, 32.5% Very High and 10% unknown. 76% of patients responded per 2006 International Working Group (IWG) criteria. Responses were as follows:

Response per IWG 2006

 

 

Overall
Evaluable
(N=33)

 

No prior
HMA
(N-20)

 

Prior
HMA
(N=13)

 

Complete remission (CR)

 

8(24

)%

7(35

)%

1(8

)%

Marrow CR + hematologic improvement

 

10(30

)%

6(30

)%

4(31

)%

Marrow CR alone

 

6(18

)%

3(15

)%

3(23

)%

Hematologic improvement alone

 

1(3

)%

1(5

)%

0

 

Stable disease

 

8(24

)%

3(15

)%

5(38

)%

Overall IWG response

 

25(76

)%

17(85

)%

8(62

)%

Clinical benefit response

 

19(58

)%

14(70

)%

5(38

)%

The median duration of response was 8 months for CR, 12.3 months for marrow CR.

Safety/Tolerability of the Combination:

Oral rigosertib (560 mg qAM, 280 mg qPM) was administered on Day 1-21 of a 28-day cycle. Azacitidine 75 mg/m 2 /day SC or IV was administered for 7 days starting on Day 8. The combination of oral rigosertib and azacitidine was well tolerated. The most common TEAEs in > 10% of patients were nausea (41%), fatigue (39%), diarrhea (37%), constipation (37%) and dysuria (28%). The most common serious AEs were pneumonia (11%) and febrile neutropenia (7%). The most common AEs leading to discontinuation were AML (4%) and pneumonia (4%).

Next steps for rigosertib oral in combination with azacitidine for higher-risk MDS

Following an end of Phase 2 meeting with the approvedFood and Drug Administration (FDA) in September 2016, we began development of a Phase 3 protocol. The Phase 3 trial will be designed as a global 1:1 randomized, placebo-controlled trial of oral rigosertib plus azacitidine compared to azacitidine plus placebo. Based on the results of the Phase 1/2 Study, we plan to use the full dose of injectable azacitidine, as defined in the product insert. The patient population studied in this trial will be first-line (HMA naïve) higher-risk MDS patients. The primary endpoint for assessment of efficacy will be the composite Response Rate of complete remission (CR) + partial remission (PR,) as per the IWG 2006 Response Criteria. Formal FDA review will be sought via the Special Protocol Assessment (SPA) mechanism. We will not commence the Phase 3 trial without additional financing.

While the Phase 3 trial is being designed, we have expanded the Phase 1/2 trial cohort by up to 40 subjects. Under a protocol expansion, we plan to use the expanded cohorts to explore dose optimization by increasing the dose of rigosertib and varying the dose administration scheme of rigosertib oral to identify an optimal dose and schedule. After amendments were filed with the regulatory agencies, we started the expansion phase of this trial in the U.S. sites that participated in the initial trial. The first patient was enrolled in April and since then, more than half of the planned patients have been enrolled in the expansion trial. We plan to add more sites in the U.S. to complete enrollment of the expanded trial.

In June 2017, at the Congress of the European Hematology Association Meeting, we updated the data from the Phase 1/2 trial and highlighted results in AML patients included in this study. Response data was presented on eight evaluable patients with HR-MDSAML who were tested with the rigosertib and AML.  This study isazacitidine combination. For the eight evaluable patients with AML, the combination was well tolerated and the safety profile was similar to single-agent azacitidine, based on our published preclinical data demonstrating synergistic activity of this combination. Wesafety information in the azacitidine FDA approved label. Based on the presented Phase 1 results from this trial at the Annual American Society of Hematology, or ASH, Meeting in December 2014 and at the MDS Symposium in April 2015. These results showed encouraging activity in MDS and AML patients in terms of bone marrow and hematological responses. Patients were treated at the full standard dose of azacitidine. The drug combination has been well tolerated in repetitive cycles.

The Phase 2 portion of the trial has been designed to assess whether treatment withcombination studies, the authors concluded that continued study in AML was warranted. We will not commence further development of rigosertib oral in combination with azacitidine reduces the number of bone marrow blasts, improves peripheral blood counts and delays signs of disease progression in patients with MDS and AML. Patients can be entered into the trial after failing azacitidine and then having oral rigosertib added to azacitidine, or patients can be started de novo on thefor AML without additional financing.

combination. Patient enrollment in the Phase 2 portion of this trial is projected to be completed in the fourth quarter of this year. Data from this study are also expected to be presented at a scientific conference in the fourth quarter.

The Phase 2 combination study includes both de novo patients (i.e. not previously treated with hypomethylating agents, HMAs) and patients who failed treatment with a previous HMA. Consistent with reported Phase 1 results, Bone Marrow Complete Responses (or BMCR), assessed by the International Working Group (or IWG) and Bone Marrow Blast (or BMBL) criteria, have been observed in a majority of the 18 currently evaluable MDS patients. Data from additional Phase 2 patients yet to be evaluated could modify these interim results; we anticipate presentation of updated data at a scientific conference later in 2015.

Rigosertib Oraloral for LR-MDSlower-risk MDS

 

Higher-risk MDS patients suffer from a shortfall in normal circulating blood cells, or cytopenias, as well as elevated levels of cancer cells, or blasts in their bone marrow and sometimes in their peripheral blood, whereas LR-MDSblood. Lower-risk MDS patients suffer mainly from cytopenias, that is low levels of red blood cells, white blood cells or platelets. Thus, LR-MDSlower-risk MDS patients depend on transfusions and growth factors or other therapies to improve their low blood counts.

 

We have explored single agent rigosertib oral as a treatment for LR-MDSlower-risk MDS in two Phase 2 clinical trials, 09-05 and 09-07. In December 2013, we presented data at the Annual ASH Meeting from the 09-05 Phase 2 trial. To date, Phase 2 clinical data have shown encouraging signs of efficacyhas indicated that further study of single agent oral rigosertib in transfusion-dependent, LR-MDS patients.lower-risk MDS patients is warranted. Rigosertib has been generally well tolerated, except for urinary side effects previously reported at the higher dose levels. WeFuture clinical trials will needbe needed to further evaluate dosing and schedule with respect tomodifications and their impact on efficacy and toxicitysafety results of oral rigosertib in LR-MDSlower-risk MDS patients.

 

Data presented from the 09-05 trial also suggested the potential of a genomic methylation assessment of bone marrow cells to prospectively identify LR-MDSlower-risk MDS patients likely to respond to oral rigosertib. We threforetherefore expanded the 09-05 trial by adding an additional cohort of 20 patients to advance the development of this genomic methylation test. EnrollmentTo date, a biomarker which would predict response has not been identified. Further testing and development of oral rigosertib for lower-risk MDS will be required. We will not commence further development of rigosertib oral for lower-risk MDS without additional financing.

Safety and Tolerability of rigosertib oral in this expansion cohort has been completed. WeMDS and other hematologic malignancies

Oral rigosertib as a monotherapy was evaluated in four Phase 1 and 2 studies in MDS and other hematologic malignancies. One study is completed and a clinical study report is available. The most common TEAEs in > 10% of patients were pollakiuria (increased urinary frequency) (35%), fatigue (32%), diarrhea (26%), dysuria (29%) and haematuria (24%). The most common > Grade 3 AEs were anaemia (17%), thrombocytopenia (5%), haematuria (4%) and urinary tract infection (4%). The most common serious AE was pneumonia (6%). The most common AEs leading to discontinuation of patients receiving oral rigosertib as monotherapy were dysuria (8%), urinary tract pain (7%), haematuria (5%) and urinary frequency (5%).

In addition to the above described clinical trials, we are collaborating with a methylation genomics companycontinuing the preclinical and an academic collaboratorchemistry, manufacturing, and control work for IV and oral rigosertib.

Other Programs

The vast majority of our efforts are now devoted to refine the testadvanced stage development of rigosertib for unmet medical needs of MDS patients. Other programs are either paused, inactive or require only minimal internal resources and expect to present these findings later this year.efforts.

 

Briciclib

 

Our third clinical-stageBriciclib, another of our product candidatecandidates, is briciclib, a small molecule targeting an important intracellular regulatory protein, cyclinCyclin D1, which is often found at elevated levels in cancer cells. Cyclin D1 expression is regulated through a process termed cap-dependent translation, which requires the function of eukaryotic initiation factor 4E protein, or eIF4E.protein. In vitro evidence indicates briciclib binds to eIF4E,eukaryotic initiation factor 4E protein, blocking cap-dependent translation of Cyclin D1 and other cancer proteins, such as c-MYC,

leading to tumor cell death. We arehave been conducting a Phase 1 multisitemulti-site dose-escalation trial of briciclib in patients with advanced solid tumors refractory to current therapies. Safety and efficacy assessments have been completedare complete in six of the seven dose-escalation cohorts of patients in this trial. Enrollment inAs of December 2015, the next cohort of patients will begin upon completion of quality control testing requiredInvestigational New Drug (“IND”) for the release of thebriciclib is on full clinical hold following a drug product lot testing failure. We will be required to undertake appropriate remedial actions prior to re-initiating the study sites. Upon completion ofclinical trial and completing the final dose-escalation cohort, we will assess potential further development for briciclib.cohort.

 

Recilisib

 

Our fourth clinical-stageRecilisib is a product candidate recilisib, is being developed in collaboration with the U.S. Department of Defense for acute radiation syndromes. We have completed four Phase 1 trials to evaluate the safety and pharmacokinetics of recilisib in healthy human adult subjects using both subcutaneous and oral formulations. We have also conducted animal studies and clinical trials of recilisib under the FDA’s Animal Efficacy Rule, which permits marketing approval for new medical countermeasures for which conventional human efficacy studies are not feasible or ethical, by relying on evidence from adequate and well-controlled studies in appropriate animal models to support efficacy in humans. We have completed four Phase 1 trialshumans when the results of those studies establish that the drug is reasonably likely to evaluate theproduce a human clinical benefit. Human safety and pharmacokinetics of recilisib in healthy human adult subjects using both subcutaneous and oral formulations.data, however, is still required. Ongoing studies of recilisib, focusing on animal models and biomarker development to assess the efficacy of recilisib are being conducted by third parties with government funding. We anticipate that any future development of recilisib beyond these ongoing studies would be conducted solely with government funding or by collaboration. Use of government funds to finance the research and development in whole or in part means any future effort to commercialize recilisib will be subject to federal laws and regulations on U.S. government rights in intellectual property. Additionally, we are subject to laws and regulations governing any research contracts, grants, or cooperative agreements under which government funding was provided.

Preclinical Product Candidates

 

In addition to our three clinical-stage product candidates, we have several product candidates that target kinases, cellular metabolism or cell division in preclinical development. We may explore additional collaborations to further the development of these product candidates as we focus internally on our more advanced programs. Our most advanced

Positive preclinical stage compound isdata was announced at the American Association for Cancer Research (AACR) annual meeting, which took place April 1-5 in Washington, DC, for ON 123300, a targetedfirst-in-class dual inhibitor of  CDK4-6CDK4/6 + ARK5, and ARK5 kinases.for ON 150030, a novel Type 1 inhibitor of FLT3 and Src pathways. We believe our CDK inhibitor is differentiated from other agents in the market (Palbociclib, Ribociclib and Abemaciclig) or in development (such as the compounds being developed by G1 Therapeutics) by its dual inhibition of CDK4/6 + ARK5. We continue to carry out research to enhance the pre-clinical data package for this compound in an attempt to seek partners for co-development of this novel compound.

 

Recent Developments

At September 30, 2015, we had approximately $22.2 millionIn a preclinical Rb+ve xenograft model for breast cancer, ON 123300 activity was shown to be similar to Palbociclib (Pfizer’s Ibrance®). Moreover, based on the same preclinical model, the new molecule may have the potential advantage of reduced neutropenia when compared to Palbociclib. Whereas both compounds resulted in cashdecreased RBC and cash equivalents. We have taken actions to conserve cash, including headcount and expenditure reductions. We believe that our current cash balance will be sufficient to fund our ongoing trials and current operations into the second quarter of 2016.

On September 30, 2015, we amended our Sales Agreement, dated October 8, 2014, with Cantor Fitzgerald & Co. The amendment, among other things, provides that the Sales Agreement, which would have expired on October 8, 2015, shall continue until terminated by one or both parties pursuant to its terms. During the three months ended September 30, 2015, approximately two million shares were sold under the Sales Agreement for net proceeds of $4,749,000. On October 8, 2015, we entered into a purchase agreement with Lincoln Park, which we refer toplatelet counts in this prospectus as the Purchase Agreement, pursuantpreclinical model system, Palbociclib was found to which Lincoln Park purchased 846,755 shares of our common stock forhave a total purchase price of $1,500,000 as an initial purchase, or the Initial Purchase,more prominent and has agreedstatistically significant (P< 0.05) inhibitory effect on neutrophil counts when compared to purchase from us up to an aggregate of $15,000,000 of our common stock (subject to certain limitations) from time to time over a 36-month period.ON 123300.

Baxalta has confirmed its financial contribution of 50% of the clinical trial costs for the upcoming INSPIRE trial, with a cap of $15 million, pursuant to our collaboration agreement. SymBio has confirmed its interest in enrolling up to 10% of the patients in the INSPIRE trial at its expense.

We are exploring various sources of funding for continued development of rigosertib in MDS and AML. If we are unable to successfully raise sufficient additional capital, through future debt or equity financings or through strategic and collaborative ventures with third parties, we will not have sufficient cash to fund our planned business operations. In that event, we may be forced to limit many, if not all, of our programs and consider other means of creating value for our stockholders or we may be forced to curtail all of our activities and, ultimately, potentially cease operations. Additional financings may only be available on unattractive terms, and could result in significant dilution of stockholders’ interests.

Corporate InformationCORPORATE INFORMATION

 

We were incorporated in Delaware in December 1998 and commenced operations in January 1999.  Our principal executive offices are located at 375 Pheasant Run, Newtown, Pennsylvania 18940, and our telephone number is (267) 759-3680. Our website address is www.onconova.com. The information on, or that can be accessed through, our website is not part of this prospectus.

Implications of Being an Emerging Growth Company

As a company with less than $1.0 billion in revenue during our last fiscal year, we qualify as an “emerging growth company” as defined in the Jumpstart our Business Startups Act of 2012, or the JOBS Act.  An emerging growth company may take advantage of specified reduced reporting requirements and is relieved of certain other significant requirements that are otherwise generally applicable to public companies.  As an emerging growth company,

·                                          we may present only two years of audited financial statements and only two years of related Management’s Discussion & Analysis of Financial Condition and Results of Operations;

·                                          we are exempt from the requirement to obtain an attestation and report from our auditors on the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002;

·                                          we are permitted to provide less extensive disclosure about our executive compensation arrangements;

·                                          we are not required to give our stockholders non-binding advisory votes on executive compensation or golden parachute arrangements; and

·                                          we have elected to use an extended transition period for complying with new or revised accounting standards.

We may take advantage of these provisions until the last day of our fiscal year following the fifth anniversary of the date of the first sale of our common equity securities pursuant to an effective registration statement under the Securities Act of 1933, as amended, or the Securities Act.  However, if certain events occur prior to the end of such five-year period, including if we become a “large accelerated filer,” our annual gross revenues exceed $1.0 billion or we issue more than $1.0 billion of non-convertible debt in any three-year period, we will cease to be an emerging growth company prior to the end of such five-year period.

THE OFFERING

 

On October 8, 2015, we entered into the Purchase Agreement, pursuant to which Lincoln Park purchased 846,755 shares of our common stock for a total purchase price of $1,500,000 as an Initial Purchase and has agreed to purchase from us up to an aggregate of $15,000,000 of our common stock (subject to certain limitations) from time to time over a 36-month period.  Also on October 8, 2015, we entered into a Registration Rights Agreement, or the Registration Rights Agreement, with Lincoln Park, pursuant to which we have filed with the SEC the registration statement that includes this prospectus to register for resale under the Securities Act of 1933, as amended, or the Securities Act, the shares that have been or may be issued to Lincoln Park under the Purchase Agreement.

Other than (i) 846,755 shares of our common stock that we have already issued to Lincoln Park in the Initial Purchase and (ii) 200,000 shares of our common stock that we have already issued to Lincoln Park pursuant to the terms of the Purchase Agreement as consideration for its commitment to purchase additional shares of our common stock under the Purchase Agreement, we do not have the right to commence any further sales to Lincoln Park under the Purchase Agreement until the SEC has declared effective the registration statement of which this prospectus forms a part.   Thereafter, we may, from time to time and at our sole discretion, direct Lincoln Park to purchase shares of our common stock in amounts up to 100,000 shares (which amounts may be increased under certain circumstances) on any single business day up to $1,000,000 per purchase, plus an additional “accelerated amount” under certain circumstances.   There are no trading volume requirements or restrictions under the Purchase Agreement, and we will control the timing and amount of any sales of our common stock to Lincoln Park.  The purchase price of the shares that may be sold to Lincoln Park under the Purchase Agreement will be based on the market price of our common stock preceding the time of sale as computed under the Purchase Agreement without any fixed discount. The purchase price per share will be equitably adjusted for any reorganization, recapitalization, non-cash dividend, stock split, or other similar transaction occurring during the business days used to compute such price. We may at any time in our sole discretion terminate the Purchase Agreement without fee, penalty or cost upon one business day notice.   There are no restrictions on future financings, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement or Registration Rights Agreement other than a prohibition on entering into an Equity Line of Credit.  Lincoln Park may not assign or transfer its rights and obligations under the Purchase Agreement.

As of October 12, 2015, there were 24,773,554 shares of our common stock outstanding, of which 15,727,250 shares were held by non-affiliates.  Although the Purchase Agreement provides that we may sell up to $16,500,000 of our common stock to Lincoln Park, only 5,200,000 shares of our common stock are being offered under this prospectus, which represents 846,755 already purchased by Lincoln Park for proceeds of $1,500,000,  200,000 shares that we issued to Lincoln Park as a commitment fee for making the commitment under the Purchase Agreement and an additional 4,153,245 shares which may be issued to Lincoln Park in the future under the Purchase Agreement.  Lincoln Park may not assign or transfer its rights and obligations under the Purchase Agreement.  If all of the 5,200,000 shares offered by Lincoln Park under this prospectus were issued and outstanding as of the date hereof, such shares would represent 18.0% of the total number of shares of our common stock outstanding and 26.2% of the total number of outstanding shares held by non-affiliates, in each case as of the date hereof.  If we elect to issue and sell more than the 5,200,000 shares offered under this prospectus to Lincoln Park, which we have the right, but not the obligation, to do, we must first register for resale under the Securities Act any such additional shares, which could cause additional substantial dilution to our stockholders.  The number of shares ultimately offered for resale by Lincoln Park is dependent upon the number of shares we sell to Lincoln Park under the Purchase Agreement.

Under the rules of the NASDAQ Global Select Market, in no event may we issue more than 19.99% of our shares outstanding (which is approximately 4,735,925 shares based on 23,691,472 shares outstanding immediately prior to the signing of the Purchase Agreement) under the Purchase Agreement unless we obtain stockholder approval or an exception pursuant to the rules of the NASDAQ Global Select Market is obtained to issue more than 19.99%. This limitation shall not apply if, at any time the Exchange Cap is reached and at all times thereafter, the average price paid for all shares issued and sold under the Purchase Agreement is equal to or greater than $1.56, which was the closing consolidated bid price of our Common Stock on October 7, 2015 including an increment for the commitment shares we issued to Lincoln Park. We are not required or permitted to issue any shares of Common Stock under the Purchase Agreement if such issuance would breach our obligations under the rules or regulations of the NASDAQ Global Select Market.

Issuances of our common stock in this offering will not affect the rights or privileges of our existing stockholders, except that the economic and voting interests of each of our existing stockholders will be diluted as a result of any such issuance. Although the number of shares of common stock that our existing stockholders own will not decrease, the shares owned by our existing stockholders will represent a smaller percentage of our total outstanding shares after any such issuance to Lincoln Park.

SECURITIES OFFERED

Common stock to be offered by the selling stockholderus

 

5,200,0008,650,000 shares consisting of:

Offering Price

 

$1.58  per share

 

Option to purchase additional shares

 

·                  846,755The underwriter has the option to purchase up to 1,297,500 additional shares issued to Lincoln Park inof common stock at the Initial Purchase;

·                  200,000 commitment shares issued to Lincoln Park;public offering price, less underwriting discounts and

·                  4,153,245 shares we may sell to Lincoln Park commissions. The underwriter can exercise this option at any time and from time to time afterwithin 30 days from the effective date of the Registration Statement under the Purchase Agreement.this prospectus.

Common stock outstanding as of October 12, 2015

24,773,554 shares

 

Common stock to be outstanding after giving effect to the issuance of 4,153,245 additional shares under the Purchase Agreementthis offering

 

28,926,79919,421,163 shares, or 20,718,663 shares if the underwriter exercises its option to purchase additional shares of our common stock in full.

 

Use of Proceedsproceeds

 

We estimate that the net proceeds to us from this offering will receive no proceeds frombe approximately $12.1 million, or $14.0 million if the sale ofunderwriter’s option to purchase additional shares of common stock is exercised in full), based on an assumed public offering price of $1.58 per share, the last reported sale price of our common stock on the Nasdaq Capital Market on January 26, 2018, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by Lincoln Park inus. We intend to use the net proceeds from this offering.  However, we may receive up to $16,500,000 under the Purchase Agreement with Lincoln Park. Any proceeds that we receive from sales to Lincoln Park under the Purchase Agreement will be usedoffering to fund the development of our clinical and preclinical programs, for other research and development activities and for general corporate purposes, which may include capital expenditures and funding our working capital needs. See “Use of Proceeds.”Proceeds” on page 15.

 

Risk factors

 

This investment involves a high degreeYou should read the “Risk Factors” section of risk. See “Risk Factors”this prospectus and in the documents incorporated by reference into this prospectus for a discussion of factors you shouldto consider carefully before making an investment decision.deciding to invest in our common stock.

Symbol on Nasdaq Global SelectCapital Market symbol

 

ONTX”ONTX.”

The number of shares of common stock outstanding after this offering is based on 24,773,554 shares of our common stock outstanding after the offering is based on 10,771,163 shares outstanding as of October 12, 2015December 31, 2017, and excludes:excludes as of such date:

 

·                  5,166,577952,628 shares of common stock issuable upon the exercise of stock options outstanding under our 2013 Equity Compensation Plan at December 31, 2017 with a weighted average exercise price of $8.58approximately $40.41 per share; and

·                  3,294,771 shares of common stock issuable upon the exercise of outstanding warrants at December 31, 2017 with a weighted average exercise price of approximately $5.10 per share;

·                  1,345,158 additional57,632 shares of common stock reserved for future issuance under our 2013 Equity Compensation Plan.Plan at December 31, 2017; and

 

To the extent·                  any additional shares of common stock that outstanding options are exercised, you will experience further dilution. In addition, we may chooseissue to raiseLincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to a purchase agreement we entered into on October 8, 2015, which provides that, upon the terms and subject to the conditions and limitation set forth therein, Lincoln Park is committed to purchase up to an aggregate of an additional capital due$15 million of shares of our common stock over the term of the purchase agreement, should we elect to market conditions or strategic considerations even if we believe we have sufficient funds forsell shares to Lincoln Park.

As of January 26, 2018, the total number of our current or future operating plans. Tooutstanding shares of common stock was 10,771,163.

Unless otherwise indicated, all information contained in this prospectus assumes no exercises by the extent thatunderwriter of its option to purchase additional capital is raised through the sale of equity or convertible debt securities, the issuance of these securities could result in further dilution to our stockholders.shares.

RISK FACTORS

 

Our business is influenced by many factors that are difficult to predict, and that involve uncertainties that may materially affect actual operating results, cash flows and financial condition. Before making an investment decision, you should carefully consider these risks, including those set forth below and those described in the “Risk Factors” section of our most recent Annual Report on Form 10-K, as revised or supplemented by our Quarterly Reports on Form 10-Q filed with the SEC since the filing ofon March 29, 2017, and our most recent AnnualQuarterly Report on Form 10-K, each of10-Q for the quarter ended September 30, 2017, as filed with the SEC on November 9, 2017, which is incorporated by reference into this prospectus, as well as any amendment or update to our risk factors reflected in subsequent filings with the SEC, and you should also carefully consider any other information we include or incorporate by reference in this prospectus.

 

Any of the risks we describe below or in the information incorporated herein by reference in this prospectus could cause our business, financial condition or operating results to suffer. The market price of our common stock could decline if one or more of these risks and uncertainties develop into actual events. You could lose all or part of your investment.

 

Risks Associated with this Offering

TheOur management will have broad discretion over the use of any net proceeds from this offering, you may not agree with how we use the proceeds, and the proceeds may not be invested successfully.

Our management will have broad discretion as to the use of any net proceeds from this offering and could use them for purposes other than those contemplated at the time of this offering. Accordingly, you will be relying on the judgment of our management with regard to the use of any proceeds from the sale of shares of common stock in this offering, and you will not have the opportunity, as part of your investment decision, to assess whether the proceeds are being used appropriately. It is possible that the proceeds will be invested in a way that does not yield a favorable, or issuanceany, return for you.

You will experience immediate dilution.

Since the price per share of our common stock to Lincoln Park may causebeing offered is higher than the net tangible book value per share of our common stock, you will suffer substantial dilution andin the salenet tangible book value of the common stock you purchase in this offering. Based on an assumed public offering price of $1.58 per share, the last reported sale price of our common stock on the Nasdaq Capital Market on January 26, 2018, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us, if you purchase shares of common stock acquiredin this offering, you will suffer immediate and substantial dilution of $1.26 per share in the net tangible book value of the common stock as of September 30, 2017. See the section entitled “Dilution” in this prospectus for a more detailed discussion of the dilution you will incur if you purchase common stock in this offering. To the extent outstanding stock options or warrants are exercised, there will be further dilution to new investors.

Our shareholders may experience significant dilution as a result of future equity offerings or issuances and exercise of outstanding options and warrants.

In order to raise additional capital or pursue strategic transactions, we may in the future offer, issue or sell additional shares of common stock or other securities convertible into or exchangeable for shares of our common stock. We cannot assure you that we will be able to sell shares or other securities in any other transaction at a price per share or that have an exercise price or conversion price per shares that is equal to or greater than the price for the securities purchased by Lincoln Park,investors in this offering, and investors purchasing shares or other securities in the future could have rights superior to existing shareholders. The price per

share at which we sell or issue additional shares of common stock or other securities convertible into or exchangeable for our common stock future transactions may be higher or lower than such price.

Sales of a significant number of shares of our common stock in the public markets, or the perception that such sales maycould occur, could causedepress the market price of our common stock to fallstock.

 

On October 8, 2015, we entered into the Purchase Agreement with Lincoln Park, pursuant to which Lincoln Park has committed to purchase up to $16,500,000 of our common stock. Concurrently with the execution of the Purchase Agreement, Lincoln Park purchased 846,755 shares of our common stock for total proceeds of $1,500,000 and we issued 200,000 shares of our common stock to Lincoln Park as a fee for its commitment to purchase shares of our common stock under the Purchase Agreement.  The purchase shares that may be sold pursuant to the Purchase Agreement may be sold by us to Lincoln Park at our discretion from time to time over a 36-month period commencing after the SEC has declared effective the registration statement that includes this prospectus. The purchase price for the shares that we may sell to Lincoln Park under the Purchase Agreement will fluctuate based on the price of our common stock. Depending on market liquidity at the time, sales of such shares may cause the trading price of our common stock to fall.

We generally have the right to control the timing and amount of any sales of our shares to Lincoln Park, except that, pursuant to the terms of our agreements with Lincoln Park.  Additional sales of our common stock, if any, to Lincoln Park will depend upon market conditions and other factors to be determined by us. Lincoln Park may ultimately purchase all, some or none of the shares of our common stock that may be sold pursuant to the Purchase Agreement and, after it has acquired shares, Lincoln Park may sell all, some or none of those shares. Therefore, sales to Lincoln Park by us could result in substantial dilution to the interests of other holders of our common stock. Additionally, the saleSales of a substantial number of shares of our common stock to Lincoln Park, or the anticipation of such sales, could make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales.

We may require additional financing to sustain our operations and without it we may not be able to continue operations.

At June 30, 2015 we had an accumulated deficit of $315.9 million.  Since our inception, we have incurred net losses and generally negative cash flows from our operations. We incurred net losses of $63.8 million, $62.6 million, and $29.9 million forpublic markets could depress the years ended December 31, 2014, 2013 and 2012, respectively. We do not currently have sufficient financial resources to fund our operations or those of our subsidiaries.  Therefore, we need additional funds to continue these operations.

We may direct Lincoln Park to purchase up to $16,500,000 worth of shares of our common stock under our agreement over a 36-month period generally in amounts up to 100,000 shares of our common stock on any such business day, of which Lincoln Park purchased, upon entering into the Purchase Agreement, 846,755 shares of our common stock for total proceeds of $1,500,000.  Assuming a purchase price of $1.46 per share (the closing sale price of the common stock on October 19, 2015) and the purchase by Lincoln Park of the full 4,153,245 purchase shares under the purchase agreement that are registered pursuant to this Registration Statement, additional proceeds to us would only be approximately $6,000,000.

The extent we rely on Lincoln Park as a source of funding will depend on a number of factors including, the prevailing market price of our common stock and impair our ability to raise capital through the extentsale of additional equity securities. We cannot predict the effect that future sales of our common stock would have on the market price of our common stock.

We do not intend to whichpay any cash dividends on our common stock in the foreseeable future and, therefore, any return on your investment in our common stock must come from increases in the fair market value and trading price of our common stock.

We do not intend to pay any cash dividends on our common stock in the foreseeable future and, therefore, any return on your investment in our common stock must come from increases in the fair market value and trading price of our common stock.

If we areissue substantially all of our available authorized shares of common stock in this offering, we will not be able to secure workingissue additional shares for future capital from other sources.raising transactions or strategic transactions unless we obtain stockholders’ approval to amend our certificate of incorporation to increase the number of authorized shares of common stock.

We have 25,000,000 authorized shares of common stock.  As of January 26, 2018, we had 10,711,163 shares of common stock outstanding, 3,294,771 shares of common stock issuable upon the exercise of outstanding warrants, and 952,628 shares of common stock issuable upon the exercise of outstanding options.  As a result, as of January 26, 2018, we had 9,981,438 authorized shares of common stock available for issuance.  If obtaining sufficient funding from Lincoln Park were to prove unavailable or prohibitively dilutive,we issue substantially all of our available authorized shares of common stock in this offering, we will neednot be able to secure another sourceissue additional shares for future capital raising transactions or strategic transactions unless we obtain stockholders’ approval to amend our certificate of fundingincorporation to increase the number of authorized shares of common stock.  This may cause a delay in order to satisfy our workingfuture capital needs.  Even if we sell all $16,500,000 under the Purchase Agreement to Lincoln Park, weraising, collaboration, partnership or other strategic transactions, and may still need additional capital to fully implement our business, operating and development plans.  Should the financing we require to sustain our working capital needs be unavailable or prohibitively expensive when we require it, the consequences could behave a material adverse effect on our business operating results,and financial condition and prospects.

If we are unable to regain compliance with the requirements to maintain a continued listing on the NASDAQ Global Select Market, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.

Our common stock is currently listed for trading on the NASDAQ Global Select Market. We must satisfy NASDAQ’s continued listing requirements or risk delisting, which would have a material adverse effect on our business. On September 29, 2015, we received written notice from NASDAQ notifying us that for the preceding 30 consecutive business days, our Market Value of Listed Securities, or MLVS, had closed below the minimum $50 million requirement for continued listing on the NASDAQ Global Select Market and granting us a 180-day grace period to regain compliance. Compliance can be achieved automatically and without further action if our MVLS closes at $50 million or more for at least 10 consecutive business days at any time during the 180-day compliance period. If we do not regain compliance by March 28, 2016, NASDAQ will notify us that our common stock will be subject to delisting. We are currently considering available options to resolve the listing deficiency and to regain compliance. There can be no assurance that we will be able to regain compliance with the NASDAQ Global Select Market listing requirements.  A delisting of our common stock from the NASDAQ Global Market could materially reduce the liquidity of our common stock and result in a corresponding material reduction in the price of our common stock. In addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, suppliers, customers and employees and fewer business development opportunities.condition.

CCAUTIONARYAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This prospectus includesand the documents incorporated by reference herein and therein contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. All statements, other than statements of historical facts, contained in this prospectus and the documents incorporated by reference herein regarding our strategy, future operations, financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. We may, in some cases, use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements appear in a number of places throughout this reportprospectus and the documents incorporated by reference herein, and include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, protection of our intellectual property portfolio, the degree of clinical utility of our products, particularly in specific patient populations, our ability to develop commercial and manufacturing functions, expectations regarding clinical trial data, our results of operations, cash needs, financial condition, liquidity, prospects, growth and strategies, the industry in which we operate and the trends that may affect the industry or us.

 

By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics and industry change, and depend on the economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. Although we believe that we have a reasonable basis for each forward-looking statement contained in this report,prospectus and in documents incorporated by reference herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this report. In addition, even if our results of operations, financial condition and liquidity, and events in the industry in which we operate are consistent with the forward-looking statements contained in this report, they may not be predictive of results or developments in future periods.prospectus.

 

Actual results could differ materially and adversely from our forward-looking statements due to a number of factors, including, without limitation, risks related to:

 

·                  our need for additional financing for our INSPIRE trial and other operations, and our ability to obtain sufficient funds on acceptable terms when needed, and our current plans and future needs to scale back operations if adequate financing is not obtained;

·                  our ability to continue as a going concern;

·                  our estimates regarding expenses, future revenues, capital requirements and needs for additional financing;

·                  the success and timing of our preclinical studies and clinical trials, including site initiation and patient enrollment, and regulatory approval of protocols for future clinical trials;

·                  our ability to enter into, maintain and perform collaboration agreements with other pharmaceutical companies, for funding and commercialization of our clinical product candidates or preclinical compounds, and our ability to achieve certain milestones under those agreements;

·                  the difficulties in obtaining and maintaining regulatory approval of our product candidates, and the labeling under any approval we may obtain;

·                  our plans and ability to develop, manufacture and commercialize our product candidates;

·                  our failure to recruit or retain key scientific or management personnel or to retain our executive officers;

·                  the size and growth of the potential markets for our product candidates and our ability to serve those markets;

·                  regulatory developments in the United States and foreign countries;

·                  the rate and degree of market acceptance of any of our product candidates;

·                  obtaining and maintaining intellectual property protection for our product candidates and our proprietary technology;

·                  the successful development of our commercialization capabilities, including sales and marketing capabilities;

·                  recently enacted and future legislation and regulation regarding the healthcare system;

·                  the success of competing therapies and products that are or become available;

·                  our dependence on collaboration agreements with other pharmaceutical companies, such as Baxalta and SymBio, for commercializationability to maintain the listing of our productscommon stock on a national securities exchange;

·                  the potential for third party disputes and our ability to achieve certain milestones under those agreements; andlitigation;

·                  the performance of third parties, including contract research organizations or CROs(“CROs”) and third-party manufacturers.manufacturers; and

·                  our expectations regarding CRO transition.

 

Any forward-looking statements that we make in this prospectus and the documents incorporated by reference herein speak only as of the date of such statement, and we undertake no obligation to update such statements to reflectwhether as a result of any new information, future events, changed circumstances or circumstances after the date of this prospectus or to reflect the occurrence of unanticipated events.otherwise. Comparisons of results for current and any prior periods are not intended to express any future trends or indications of future performance, unless expressed as such, and should only be viewed as historical data.

 

You should also read carefully the factors described in the “Risk Factors” section of this prospectus and in our annual report on Form 10-K filed with the SEC on March 30, 2015,documents incorporated by reference herein, to better understand significantthe risks and uncertainties inherent in our business and underlying any forward-looking statements. As a result of these factors, actual results could differ materially and adversely from those anticipated or implied inwe cannot assure you that the forward-looking statements in this reportprospectus and in documents incorporated by reference herein will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not place undue reliance onregard these statements as a representation or warranty by us or any forward-looking statements.other person that we will achieve our objectives and plans in any specified timeframe, or at all.

THE LINCOLN PARK TRANSACTION

General

On October 8, 2015, we entered intoWe obtained the Purchase Agreementindustry, market and the Registration Rights Agreement with Lincoln Park. Pursuant to the terms of the Purchase Agreement, Lincoln Park made the Initial Purchase of 846,755 shares of our common stock for a total purchase price of $1,500,000 and has agreed to purchase from us up to an aggregate of $15,000,000 of our common stock (subject to certain limitations) from time to time over a 36-month period. Pursuant to the terms of the Registration Rights Agreement, we have filed with the SEC the registration statement that includescompetitive position data in this prospectus to register for resale under the Securities Act the shares that have been or may be issued to Lincoln Park under the Purchase Agreement.

Concurrently with the execution of the Purchase Agreement on October 8, 2015, Lincoln Park purchased 846,755 shares ofand in documents incorporated by reference herein from our common stock for total proceeds of $1,500,000, the Initial Purchase,own internal estimates and we issued to Lincoln Park 200,000 shares of our common stockresearch as a fee for its commitment to purchase shares of our common stock under the Purchase Agreement.  We do not have the right to commence any further sales to Lincoln Park under the Purchase Agreement until the SEC has declared effective the registration statement of which this prospectus forms a part. Thereafterwell as from industry and upon satisfaction of the other conditions set forth in the Purchase Agreement, we may, from time to timegeneral publications and at our sole discretion, direct Lincoln Park to purchase shares of our common stock in amounts up to 100,000 shares on any single business day, which amounts may be increased but in no event greater than $1,000,000 per such purchase.  The purchase price per share is based on the market price of our common stock immediately preceding the time of sale as computed under the Purchase Agreement without any fixed discount.    Lincoln Park may not assign or transfer its rightsresearch surveys and obligations under the Purchase Agreement.

Purchase of Shares Under the Purchase Agreement

Under the Purchase Agreement, on any business day selectedstudies conducted by us, we may direct Lincoln Park to purchase up to 100,000 shares of our common stock on any such business day.  On any daythird parties. Industry publications and surveys generally state that the closing sale price of our common stockinformation contained therein has been obtained from sources believed to be reliable. We believe this data is not below $1.50 the purchase amount may be increased, at our sole discretion, to up to 125,000 shares of our common stock, on any day that the closing sale price of our common stock is not below $2.00 the purchase amount may be increased, at our sole discretion, to up to 150,000 shares of our common stock, on any day that the closing sale price of our common stock is not below $2.50 the purchase amount may be increased, at our sole discretion, to up to 175,000 shares of our common stock, on any day that the closing sale price of our common stock is not below $3.00 the purchase amount may be increased, at our sole discretion, to up to 200,000 shares of our common stock and on any day that the closing sale price of our common stock is not below $3.50, the purchase amount may be increased, at our sole discretion, to up to 250,000 shares of our common stock.  The amount of any single Regular Purchase may not exceed $1,000,000 per purchase.     The purchase price per share for each such Regular Purchase will be equal to the lower of:

·                  the lowest sale price for our common stock on the purchase date of such shares; or

·                  the arithmetic average of the three lowest closing sale prices for our common stock during the 10 consecutive business days ending on the business day immediately preceding the purchase date of such shares.

In addition to Regular Purchases described above, we may also direct Lincoln Park, on any business day on which we have properly submitted a Regular Purchase notice and our Closing Price is not below $0.50, to purchase an additional amount of our common stock, which we refer to as an Accelerated Purchase, not to exceed the lesser of:

·                  30% of the aggregate shares of our common stock traded during normal trading hours on the purchase date; and

·                  three times the number of purchase shares purchased pursuant to the corresponding Regular Purchase.

The purchase price per share for each such Accelerated Purchase will be equal to the lower of:

·                  97% of the volume weighted average price during (i) the entire trading day on the purchase date, if the volume of shares of our common stock traded on the purchase date has not exceeded a volume maximum calculatedaccurate in accordance with the Purchase Agreement, or (ii) the portion of the trading day of the purchase date (calculated starting at the beginning of normal trading hours) until such time at which the volume of shares of our common stock traded has exceeded such volume maximum; or

·                  the closing sale price of our common stock on the accelerated purchase date.

In the case of both Regular Purchases and Accelerated Purchases, the purchase price per share will be equitably adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction occurring during the business days used to compute the purchase price.

Other than as set forth above, there are no trading volume requirements or restrictions under the Purchase Agreement, and we will control the timing and amount of any sales of our common stock to Lincoln Park.

Events of Default

Events of default under the Purchase Agreement include the following:

·                  the effectiveness of the registration statement of which this prospectus forms a part lapses for any reason (including, without limitation, the issuance of a stop order), or any required prospectus supplement and accompanying prospectus are unavailable for the resale by Lincoln Park of our common stock offered hereby, and such lapse or unavailability continues for a period of 10 consecutive business days or for more than an aggregate of 30 business days in any 365-day period;

·                  suspension by our principal market of our common stock from trading for a period of three consecutive business days;

·                  the de-listing of our common stock from our principal market, provided our common stock is not immediately thereafter trading on the New York Stock Exchange, the NASDAQ Global Select Market, the NASDAQ Global Market, the NYSE Amex or the OTC Bulletin Board (or nationally recognized successor thereto);

·                  the transfer agent’s failure for five business days to issue to Lincoln Park shares of our common stock which Lincoln Park is entitled to receive under the Purchase Agreement;

·                  any breach of the representations or warranties or covenants contained in the Purchase Agreement or any related agreement which has or which could have aall material adverse effect on us subject to a cure period of five business days;

·                  if we issue more than 19.99% of the Company’s aggregate outstanding Common Stock, determinedrespects as of the date of the Purchase Agreement, in violation of the Nasdaq Global Select Market rules;

·                  any voluntary or involuntary participation or threatened participation in insolvency or bankruptcy proceedings by or against us; or

·                  if at any time we are not eligible to transfer our common stock electronically or a material adverse change in our business, financial condition, operations or prospects has occurred.

Lincoln Park does not have the right to terminate the Purchase Agreement upon any of the events of default set forth above. During an event of default, all of which are outside of Lincoln Park’s control, we cannot initiate any Regular Purchases or Accelerated Purchases under the Purchase Agreement.

Our Termination Rights

We have the unconditional right, at any time, for any reason and without any payment or liability to us, to give notice to Lincoln Park to terminate the Purchase Agreement. In the event of bankruptcy proceedings by or against us, the Purchase Agreement will automatically terminate without action of any party.

No Short-Selling or Hedging by Lincoln Park

Lincoln Park has agreed that neither it nor any of its affiliates shall engage in any direct or indirect short-selling or hedging of our common stock during any time prior to the termination of the Purchase Agreement.

Effect of Performance of the Purchase Agreement on Our Stockholders

All 5,200,000 shares registered in this offering which may be sold by us to Lincoln Park under the Purchase Agreement are expected to be freely tradable. It is anticipated that shares registered in this offering will be sold over a period of up to 36-months commencing on the date that the registration statement including this prospectus becomes effective. The sale by Lincoln Park of a significant amount of shares registered in this offering at any given time could cause the market price of our common stock to decline and to be highly volatile. Lincoln Park may ultimately purchase all, some or none of the remaining 4,153,245 shares of common stock registered in this offering not yet issued. If we sell these shares to Lincoln Park, Lincoln Park may sell all, some or none of such shares. Therefore, sales to Lincoln Park by us under the Purchase Agreement may result in substantial dilution to the interests of other holders of our common stock. In addition, if we sell a substantial number of shares to Lincoln Park under the Purchase Agreement, or if investors expect that we will do so, the actual sales of shares or the mere existence of our arrangement with Lincoln Park may make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect such sales. However, we have the right to control the timing and amount of any sales of our shares to Lincoln Park and the Purchase Agreement may be terminated by us at any time at our discretion without any cost to us.

Pursuant to the terms of the Purchase Agreement, we have the right, but not the obligation, to direct Lincoln Park to purchase up to $16,500,000 of our common stock, inclusive of the 846,755 shares issued to Lincoln Park for the $1,500,000 Initial Purchase and exclusive of the 200,000 shares issued to Lincoln Park as a commitment fee.  Depending on the price per share at which we sell our common stock to Lincoln Park, we may be authorized to issue and sell to Lincoln Park under the Purchase Agreement more shares of our common stock than are offered under this prospectus. If we choose to do so, we must first register for resale under the Securities Act any such additional shares, which could cause additional substantial dilution to our stockholders. The number of shares ultimately offered for resale by Lincoln Park under this prospectus is dependent upon the number of shares we direct Lincoln Park to purchase under the Purchase Agreement.

The following table sets forth the amount of gross proceeds we would receive from Lincoln Park from our sale of shares to Lincoln Park under the Purchase Agreement at varying purchase prices:

Assumed
Average
Purchase Price
Per Share

 

Number of Registered
Shares to be Issued if
Full Purchase (1)(2)

 

Percentage of Outstanding
Shares After Giving Effect to
the Issuance to Lincoln Park
(3)

 

Proceeds from the Sale of
Shares to Lincoln Park Under
the $16.5M Purchase
Agreement

 

$

0.50

 

5,000,000

(4)

17.3

%

$

2,500,000

 

$

1.00

 

5,000,000

(4)

17.3

%

$

5,000,000

 

$

1.50

(5)

5,000,000

(4)

17.3

%

$

7,500,000

 

$

2.50

 

5,000,000

 

17.3

%

$

12,500,000

 

$

4.00

 

4,125,000

 

14.72

%

$

16,500,000

 


(1)         Although the Purchase Agreement provides that we may sell up to $16,500,000 of our common stock to Lincoln Park, we are only registering 5,200,000 shares under this prospectus, which may or may not cover all the shares

we ultimately sell to Lincoln Park under the Purchase Agreement, depending on the purchase price per share. As a result, we have included in this column only those shares that we are registering in this offering.

(2)         The number of registered shares to be issued excludes the 200,000 commitment shares because no proceeds will be attributable to such commitment shares.

(3)         The denominator is based on 23,691,471 shares outstanding as of October 8, 2015 prior to the issuance of shares under the Purchase Agreement, adjusted to include the 846,755 shares issued to Lincoln Park for the $1,500,000 Initial Purchase and the 200,000 shares issued to Lincoln Park as commitment shares in connection with this offering and the number of shares set forth in the adjacent column which we would have sold to Lincoln Park at the applicable assumed average purchase price per share.  The numerator does not include the 200,000 shares issued to Lincoln Park as commitment shares in connection with this offering, and is based on the number of shares registered in this offering to be issued under the Purchase Agreement.  The number of shares in such column does not include shares that may be issued to Lincoln Park under the Purchase Agreement which are not registered in this offering.

(4)         The number of registered shares to be issued assumes that we have received stockholder approval to issue shares above the limits imposed by the NASDAQ Global Select Market.

(5)         The closing sale price of our shares on October 13, 2015.

USE OF PROCEEDS

 

This prospectus relates to shares of our common stock that may be offered and sold from time to time by Lincoln Park. We will receive no proceeds from the sale of shares of common stock by Lincoln Park in this offering. However, we may receive gross proceeds of up to $16,500,000 under the Purchase Agreement. We estimate that the net proceeds to us from this offering will be approximately $12.1 million, based on an assumed public offering price of $1.58 per share, the last reported sale price of our common stock on the Nasdaq Capital Market on January 26, 2018, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.  If the underwriter exercises its option to Lincoln Park pursuant topurchase additional shares in full, we estimate that the Purchase Agreementnet proceeds will be up to $16,415,000 overapproximately $14.0 million, based on an approximately 36-month period, assuming that we sellassumed public offering price of $1.58 per share, the full amountlast reported sale price of our common stock that we haveon the right, but notNasdaq Capital Market on January 26, 2018, and after deducting the obligation, to sell to Lincoln Park under that agreementestimated underwriting discounts and othercommissions and estimated fees and expenses. See “Plan of Distribution” elsewhere in this prospectus for more information

offering expenses payable by us. We currently expectintend to use the net proceeds we receive under the Purchase Agreementfrom this offering to fund the development of our clinical and preclinical programs, for other research and development activities and for general corporate purposes, which may include capital expenditures and funding our working capital needs. We expect from time to time to evaluate the acquisition of businesses, products and technologies for which a portion of the net proceeds may be used, although we currently are not planning or negotiating any such transactions.

THE SELLING STOCKHOLDER

 

This prospectus relates toThe amounts actually expended for each purpose may vary significantly depending upon numerous factors, including the possible resale by the selling stockholder, Lincoln Park, of shares of common stock that have been or may be issued to Lincoln Park pursuant to the Purchase Agreement. We are filing the registration statement of which this prospectus forms a part pursuant to the provisionsamount and timing of the Registration Rights Agreement, which we entered intoproceeds from this offering and progress with Lincoln Parkthe clinical development of our product candidates. Expenditures will also depend upon the establishment of collaborative arrangements with other companies, the availability of additional financing and other factors. Investors will be relying on October 8, 2015 concurrently withthe judgment of our executionmanagement regarding the application of the Purchase Agreement, in which we agreed to provide certain registration rights with respect to sales by Lincoln Parkproceeds of theany sale of shares of our common stock that have been or may be issued to Lincoln Park under the Purchase Agreement.stock.

 

Lincoln Park, as the selling stockholder, may, from time to time, offer and sell pursuant to this prospectus any or allAs of the shares that we have sold or may sell to Lincoln Park under the Purchase Agreement. The selling stockholder may sell some, all or none of its shares. We do not know how long the selling stockholder will hold the shares before selling them, and we currently have no agreements, arrangements or understandings with the selling stockholder regarding the sale of any of the shares.

The following table presents information regarding the selling stockholder and the shares that it may offer and sell from time to time under this prospectus. The table is prepared based on information supplied to us by the selling stockholder, and reflects its holdings as of October 12, 2015. Neither Lincoln Park nor any of its affiliates has held a position or office, or had any other material relationship, with us or any of our predecessors or affiliates. As used in this prospectus, the term “selling stockholder” includes Lincoln Park and any donees, pledgees, transferees or other successors in interest selling shares received after the date of this prospectus, from Lincoln Park as a gift, pledge or other non-sale related transfer. Beneficial ownership is determined in accordancewe cannot specify with Rule 13d-3(d) promulgated by the SEC under the Exchange Act. The percentage of shares beneficially owned prior to the offering is based on 24,773,554 shares of our common stock actually outstanding as of October 12, 2015.

Selling Stockholder

 

Shares
Beneficially
Owned Before
this Offering

 

Percentage of
Outstanding
Shares
Beneficially
Owned Before
this Offering

 

Shares to be Sold in
this Offering

 

Percentage of
 Outstanding
Shares
Beneficially
Owned After
this Offering

 

Lincoln Park Capital Fund, LLC (1)

 

1,046,755

(2)

4.2

%(3)

5,200,000

(4)

*

 


* Less than 1%

(1)         Josh Scheinfeld and Jonathan Cope, the Managing Members of Lincoln Park Capital, LLC, are deemed to be beneficial owners ofcertainty all of the sharesparticular uses of common stock owned by Lincoln Park Capital Fund, LLC. Messrs. Cope and Scheinfeld have shared voting and investment powerthe proceeds from this offering. Accordingly, we will retain broad discretion over the shares being offered underuse of such proceeds. Pending the prospectus filed withuse of the SECnet proceeds from this offering as described above, we intend to invest the net proceeds in connection with the transactions contemplated under the Purchase Agreement. Lincoln Park Capital, LLC is not a licensed broker dealer or an affiliate of a licensed broker dealer.investment-grade, interest-bearing securities.

 

(2)         Represents 846,755 shares of our common stock purchased by Lincoln Park upon entering into the Purchase Agreement for total proceeds of $1,500,000 and 200,000 shares of our common stock issued to Lincoln Park on October 8, 2015 as a fee for its commitment to purchase additional shares of our common stock under the Purchase Agreement which shares are covered by the registration statement that includes this prospectus. See the description under the heading “The Lincoln Park Transaction” for more information about the Purchase Agreement.

(3)         Based on 24,773,554 outstanding shares of our common stock as of October 12, 2015, which includes 846,755 shares of our common stock purchased by Lincoln Park upon entering into the Purchase Agreement for total proceeds of $1,500,000 and 200,000 shares of our common stock issued to Lincoln Park on October 8, 2015 as a fee for its commitment to purchase additional shares of our common stock under the Purchase Agreement .  Although we may at our discretion elect to issue to Lincoln Park up to an additional amount of $15,000,000 of

our common stock under the Purchase Agreement, other than the shares describedA $0.50 increase or decrease in the immediately preceding sentence, such shares are not beneficially owned by Lincoln Park and are not included in determining the percentage of shares beneficially owned before this offering.

DIVIDEND POLICY

We have never declared or paid any cash dividends on our capital stock. We currently intend to retain all available funds and any future earnings to support our corporation and finance the growth and development of our business. We do not intend to pay cash dividends on our common stock for the foreseeable future.

MARKET PRICE OF COMMON STOCK

Our common stock began trading on the NASDAQ Global Select Market on July 25, 2013 under the symbol “ONTX.” Prior to that time, there was no public market for our common stock. Shares sold in our initialassumed public offering on July 24, 2013 were priced at $15.00price of $1.58 per share.  The following table sets forth for the periods indicated the high and low intra-day sale prices per share, of our common stock as reported on the NASDAQ Global Market:

 

 

Price of Common Stock

 

 

 

Low ($)

 

High ($)

 

2015

 

 

 

 

 

Fourth Quarter (through October 19, 2015)

 

$

1.33

 

$

1.68

 

Third Quarter

 

$

1.35

 

$

2.85

 

Second Quarter

 

$

2.26

 

$

2.84

 

First Quarter

 

$

2.07

 

$

4.37

 

 

 

 

 

 

 

2014

 

 

 

 

 

Fourth Quarter

 

$

4.20

 

$

4.38

 

Third Quarter

 

$

4.24

 

$

5.78

 

Second Quarter

 

$

4.10

 

$

6.49

 

First Quarter

 

$

6.05

 

$

16.22

 

 

 

 

 

 

 

2013

 

 

 

 

 

Fourth Quarter

 

$

11.31

 

$

31.13

 

Third Quarter

 

$

19.42

 

$

30.00

 

On October 19, 2015, the last reported sale price of our common stock on the NASDAQ Global SelectNasdaq Capital Market was $1.46 per share.  As of October 12, 2015, we had 169 holders of record of our common stock.  The actualon January 26, 2018, would increase or decrease the net proceeds to us from this offering by $4.0 million, assuming that the number of holdersshares offered by us, as set forth on the cover page of common stock is greater than these numbersthis prospectus, remains the same, after deducting the estimated underwriter discounts and commissions and estimated offering expenses payable by us.

Similarly, each increase or decrease of record holders1,000,000 shares offered by us would increase or decrease the net proceeds to us by approximately $1.5 million, assuming the assumed public offering price of $1.58 per share remains the same, after deducting the underwriting discounts and includes stockholders who are beneficial owners, but whose shares are held in street namecommissions and estimated offering expenses payable by brokers and nominees.  The number of holders of record also does not include stockholders whose shares may be held in trust by other entities.us.

PLAN OF DISTRIBUTIONCAPITALIZATION

 

The common stock offered by this prospectus is being offered by the selling stockholder, Lincoln Park. The common stock may be sold or distributed from time to time by the selling stockholder directly to one or more purchasers or through brokers, dealers, or underwriters who may act solelyfollowing table presents our cash, cash equivalents and capitalization, as agents at market prices prevailing at the time of sale, at prices related to the prevailing market prices, at negotiated prices, or at fixed prices, which may be changed. The sale of the common stock offered by this prospectus could be effected in one or more of the following methods:September 30, 2017:

 

·      ordinary brokers’ transactions;on an actual basis; and

 

·      transactions involving cross or block trades;on an as adjusted basis to give further effect to the sale of 8,650,000 shares of our common stock in this offering at an assumed public offering price of $1.58 per share, the last reported sale price of our common stock on the Nasdaq Capital Market, and after deducting estimated underwriting discounts and commissions and estimate offering expenses payable by us.

You should read this information in conjunction with our consolidated financial statements and notes thereto incorporated by reference into this prospectus.

 

 

September 30, 2017 (unaudited)

 

 

 

Actual

 

As Adjusted

 

Cash and cash equivalents

 

$

7,600,000

 

$

19,678,000

 

Long-term liabilities

 

14,880,000

 

14,880,000

 

 

 

 

 

 

 

Stockholders’ equity*:

 

 

 

 

 

Preferred stock, $0.01 par value, 5,000,000 authorized at March 31,2016 and March 31,2016 Pro Forma, none issued and outstanding at March 31, 2016

 

 

 

Common stock, $0.01 par value, 25,000,000 authorized at September 30,2017 and September 30, 2017 Pro Forma as Adjusted, 9,851,164 shares issued and outstanding at September 30, 2017 and 18,501,164 shares issued and outstanding at September 30, 2017 Pro Forma

 

99,000

 

186,000

 

Additional paid-in capital

 

349,103,000

 

361,094,000

 

Accumulated other comprehensive loss

 

(1,000

)

(1,000

)

Accumulated deficit

 

(356,109,000

)

(356,109,000

)

Total Onconova Therapeutics, Inc. stockholders’ equity

 

(6,908,000

)

5,170,000

 

Non-controlling interest

 

830,000

 

830,000

 

Total stockholders’ equity

 

(6,078,000

)

6,000,000

 


*

The above table is based on 9,851,164 shares of our common stock outstanding as of September 30, 2017 and exclude:

 

·                  through brokers, dealers, or underwriters who may act solely as agents907,373 shares of common stock issuable upon the exercise of stock options outstanding at September 30, 2017 with a weighted average exercise price of approximately $41.09 per share;

·                  3,294,771 shares of common stock issuable upon the exercise of outstanding warrants at September 30, 2017 with a weighted average exercise price of approximately $5.10 per share;

·                  “at the market” into an existing market42,355 shares of common stock reserved for the common stock;

·                  in other ways not involving market makers or established business markets, including direct sales to purchasers or sales effected through agents;

·                  in privately negotiated transactions; orfuture issuance under our 2013 Equity Compensation Plan at September 30, 2017; and

 

·                  any combinationadditional shares of common stock that we may issue to Lincoln Park, pursuant to a purchase agreement we entered into on October 8, 2015, which provides that, upon the foregoing.

In orderterms and subject to comply with the securities laws of certain states, if applicable, the shares may be sold only through registered or licensed brokers or dealers. In addition, in certain states, the shares may not be sold unless they have been registered or qualified for sale in the state or an exemption from the state’s registration or qualification requirement is availableconditions and complied with.

limitation set forth therein, Lincoln Park is committed to purchase up to an “underwriter” withinaggregate of an additional $15 million of shares of our common stock over the meaning of Section 2(a)(11)term of the Securities Act.purchase agreement, should we elect to sell shares to Lincoln Park.

 

Lincoln Park has informedEach $0.50 increase or decrease in the assumed public offering price per share would increase or decrease the amount of cash and cash equivalents and total stockholders’ equity by approximately $4.0 million, assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. We may also increase or decrease the number of shares offered in this offering. Each increase or decrease of 1,000,000 shares offered by us would increase or decrease the as adjusted amount of cash and cash equivalents and total stockholders’ equity by approximately $1.5 million, assuming that it intendsthe assumed public offering price remains the same, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. The as adjusted information discussed above is illustrative only and will be adjusted based on the actual public offering price and other terms of this offering as determined between us and the underwriter at pricing.

DILUTION

If you invest in our common stock in this offering, your interest will be diluted to use an unaffiliated broker-dealer to effectuate all sales, if any,the extent of the difference between the public offering price per share and the net tangible book value per share of our common stock after this offering. As of September 30, 2017, our historical net tangible book value was $(6.08) million, or $(0.62) per share, based on 9,851,164 shares of our common stock outstanding as of September 30, 2017. Our historical net tangible book value per share represents the amount of our total tangible assets reduced by the amount of our total liabilities, divided by the total number of shares of our common stock outstanding as of September 30, 2017. After giving effect to our sale in this offering of  8,650,000 shares of common stock at an assumed public offering price of $1.58 per share, the last reported sale price of our common stock on the Nasdaq Capital Market on January 26, 2018, and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us, our net tangible book value as of September 30, 2017 would have been $6.0 million, or $0.32 per share. This represents an immediate increase of net tangible book value of $0.94 per share to our existing stockholders and an immediate dilution of $1.26 per share to investors purchasing shares in this offering. The following table illustrates this per share dilution.

Assumed public offering price per share

 

 

 

$

1.58

 

Historical net tangible book value per share at September 30, 2017

 

$

(0.62

)

 

 

Increase in net tangible book value per share attributable to investors purchasing our common stock in this offering

 

1.40

 

 

 

As adjusted net tangible book value per share as of September 30, 2017 after giving effect to this offering

 

 

 

0.32

 

Dilution per share to investors purchasing our common stock in this offering

 

 

 

$

   1.26

 

Each $0.50 increase or decrease in the assumed public offering price of $1.58 per share, the last reported sale price of our common stock on the Nasdaq Capital Market on January 26, 2018, would increase or decrease our as adjusted net tangible book value per share after this offering by approximately $0.22, and the dilution per share to new investors purchasing shares in this offering by $0.28, respectively, assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting underwriting discounts and commissions and estimated offering expenses payable by us. We may also increase or decrease the number of shares to be offered in this offering. Each increase or decrease of 1,000,000 shares offered by us would increase or decrease our as adjusted net tangible book value per share by $0.06, and the dilution per share to new investors purchasing shares in this offering by $0.06, assuming that the assumed public offering price remains the same, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. The information discussed above is illustrative only and will be adjusted based on the actual public offering price and other terms of this offering as determined between us and the underwriter at pricing.

The above discussion and table are based on 9,851,164 shares of our common stock outstanding as of September 30, 2017 and exclude:

·                  907,373 shares of common stock issuable upon the exercise of stock options outstanding at September 30, 2017 with a weighted average exercise price of approximately $41.09 per share;

·                  3,294,771 shares of common stock issuable upon the exercise of outstanding warrants at September 30, 2017 with a weighted average exercise price of approximately $5.10 per share;

·                  42,355 shares of common stock reserved for future issuance under our 2013 Equity Compensation Plan at September 30, 2017; and

·                  any additional shares of common stock that itwe may purchase from usissue to Lincoln Park, pursuant to a purchase agreement we entered into on October 8, 2015, which provides that, upon the Purchase Agreement. Such sales will be made at pricesterms and at terms then prevailing or at prices relatedsubject to the then current market price. Each such unaffiliated broker-dealer will beconditions and limitation set forth therein, Lincoln Park is committed to purchase up to an underwriter withinaggregate of an additional $15 million of shares of our common stock over the meaning of Section 2(a)(11)term of the Securities Act.purchase agreement, should we elect to sell shares to Lincoln Park has informed usPark.

To the extent that outstanding options or warrants are exercised, you will experience further dilution. In addition, we may choose to raise additional capital due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. To the extent that additional capital is raised through the sale of equity or convertible debt securities, the issuance of these securities could result in further dilution to our stockholders.

EXECUTIVE COMPENSATION

Overview of Executive Compensation

The compensation committee of our board of directors is responsible for overseeing the compensation of all of our executive officers. In this capacity, our compensation committee annually reviews and approves the compensation of our chief executive officer and other executive officers, including such goals and objectives relevant to the executive officers’ compensation that the committee, in its discretion, determines are appropriate, evaluates their performance in light of those goals and objectives, and sets their compensation based on this evaluation.

2017 Summary Compensation Table

The following table sets forth information for the fiscal years ended December 31, 2017 and 2016 concerning compensation of our principal executive officer and the two most highly compensated executive officers during 2017. We refer to these three executive officers as our “named executive officers.”

Name and Principal Position

 

Year

 

Salary
($)

 

Bonus
($)(1)

 

Option
Awards
($)(2)

 

All Other
Compensation
($)(3)

 

Total
($)

 

Ramesh Kumar, Ph.D.

 

2017

 

538,150

 

 

81,890

 

23,581

 

643,621

 

President and Chief Executive Officer

 

2016

 

413,172

 

254,028

 

177,729

 

19,707

 

864,636

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Steven M. Fruchtman, M.D.

 

2017

 

436,154

 

 

49,105

 

19,315

 

504,574

 

Chief Medical Officer and Senior Vice President, Research and Development

 

2016

 

421,784

 

142,800

 

119,283

 

7,179

 

691,046

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Manoj Maniar, Ph.D.

Senior Vice President, Product Development

 

2017

 

388,977

 

 

36,108

 

14,410

 

439,495

 

 

2016

 

371,453

 

126,186

 

89,703

 

11,930

 

599,272

 


(1) Represents discretionary annual bonus amounts paid.

(2) The entries in the option awards column reflect the grant date fair value of the awards, as calculated for financial statement reporting purposes in    accordance with Accounting Standards Codification (ASC) No. 718, Compensation—Stock Compensation.  The option values were calculated using the Black-Scholes option pricing model. These amounts do not represent the actual value realized by the named executive officers. See Note 10 of the Notes to Consolidated Financial Statements for the fiscal year ended December 31, 2016 for a discussion of the relevant assumptions used to determine the valuation of our stock options for accounting purposes.

(3) Includes amounts paid for insurance premiums on behalf of the named executive officer and matching funds paid pursuant to our 401(k) Plan.

Employment Agreements

We have entered into employment agreements with each such broker-dealer will receive commissions from Lincoln Park that will not exceed customary brokerage commissions. In complianceof our named executive officers, and the compensation of our named executive officers is determined, in large part, by the terms of those employment agreements. Following are descriptions of the material terms of each named executive officer’s employment agreement.

Ramesh Kumar, Ph.D.

We entered into an employment agreement with Dr. Kumar on July 1, 2015, which supersedes any prior employment agreements. The employment agreement continues indefinitely, unless terminated in accordance with the guidelinesterms of the Financial Industry Regulatory Authority, Inc., or FINRA, the maximum consideration or discount to be received by any FINRA member or independent broker dealer may not exceed 8% of the aggregate amount of the securities offered pursuant to this prospectus.agreement.

 

Brokers, dealers, underwritersThe employment agreement provided for an initial base salary of $543,375, subject to adjustment upon annual review by our board of directors, and an annual bonus of up to 55% of such base salary, payable upon our achievement of revenue or agents participating inprofit objectives, specific business plan goals or other performance milestones mutually agreed to by Dr. Kumar and our board of directors, provided that Dr. Kumar remain employed by us throughout the distribution of the shares as agentsperformance year. The bonus may receive compensationbe paid in the form of commissions, discounts, or concessions from the selling stockholder and/or purchasers of the commoncash, stock for whom the broker-dealers may act as agent. The compensation paid to a particular broker-dealer may be less than or in excess of customary commissions. Neither we nor Lincoln Park can presently estimate the amount of compensation that any agent will receive.

We know of no existing arrangements between Lincoln Park or any other stockholder, broker, dealer, underwriter or agent relating to the sale or distribution of theoptions, shares offered by this prospectus. At the time a particular offer of shares is made, a prospectus supplement, if required, will be distributed that will set forth the names of any agents, underwriters or dealers and any compensation from the selling stockholder, and any other required information.

We will pay the expenses incident to the registration, offering, and sale of the shares to Lincoln Park. We have agreed to indemnify Lincoln Park and certain other persons against certain liabilities in connection with the offering of shares of common stock offered hereby, including liabilities arising under the Securities Act or, if such indemnity is unavailable, to contribute amounts required to be paid in respect of such liabilities. Lincoln Park has agreed to

indemnify us against liabilities under the Securities Act that may arise from certain written information furnished to us by Lincoln Park specifically for use in this prospectus or, if such indemnity is unavailable, to contribute amounts required to be paid in respect of such liabilities.

Lincoln Park has represented to us that at no time prior to the Purchase Agreement has Lincoln Park or its agents, representatives or affiliates engaged in or effected, in any manner whatsoever, directly or indirectly, any short sale (as such term is defined in Rule 200 of Regulation SHO of the Exchange Act) of our common stock, or any hedging transaction,a combination thereof, at our compensation committee’s discretion. Dr. Kumar may also be entitled to additional compensation in recognition of extraordinary contributions, at the sole discretion of our compensation committee. On February 12, 2016, we entered into a letter agreement with Dr. Kumar pursuant to which establishesDr. Kumar agreed to a net short positionvoluntary reduction in his base salary from $543,375 to $407,531, effective as of January 1, 2016. For purposes of severance and other benefits calculated based upon base salary, however, Dr. Kumar’s base salary was deemed to remain at $543,375. On December 9, 2016, our board of directors approved the termination of the voluntary salary reduction effective January 1, 2017. Pursuant to this approval, on March 27, 2017, we entered into a letter agreement with respectDr. Kumar under which the voluntary salary reduction was terminated effective January 1, 2017.

Dr. Kumar is entitled to participate in all of our employee benefit plans and programs that are made generally available from time to time to our common stock. Lincoln Park agreedexecutive officers and is entitled to vacation benefits. Pursuant to his employment agreement, Dr. Kumar is entitled to term life insurance coverage in a face amount that is not less than his base salary, a reasonable transportation allowance if we relocate our research facility more than 40 miles from its present location, and up to $10,000 annually for educational programs related to the performance of his duties. If Dr. Kumar dies during his employment, we will be entitled to a $1 million death benefit under a “key man” life insurance policy. Dr. Kumar’s employment agreement contains non-solicitation, non-competition, confidentiality and inventions assignment provisions that, among other things, prevent him from competing with us during the term of his employment and for a specified time thereafter.

If Dr. Kumar’s employment is terminated due to his death, disability, by us for “cause” or by Dr. Kumar without “good reason” during the Purchase Agreement, it, its agents, representativesterm of his employment agreement, we will pay to Dr. Kumar or affiliateshis spouse or estate the balance of his accrued and unpaid salary, unreimbursed expenses, and unused accrued vacation time through the termination date.

If Dr. Kumar’s employment is terminated by us without “cause” or by Dr. Kumar for “good reason,” other than during a change in control protection period, Dr. Kumar will not enter into or effect, directly or indirectly,be entitled to receive severance equal to his current base salary and target bonus for the fiscal year during which his employment ceases. If the termination is during a change in control protection period, Dr. Kumar will be entitled to receive severance equal to two times the sum of his current base salary and target bonus for the fiscal year during which his employment ceases, less any severance previously paid. A change in control protection period commences three months prior to and ends twelve months following a change in control. The Company will also reimburse Dr. Kumar for a portion of his medical insurance costs and all of Dr. Kumar’s incentive stock options that are unvested as of the foregoing transactions.date of such termination would fully vest as of the date of termination.

Steven Fruchtman, M.D.

 

We have advised Lincoln Parkentered into an employment agreement with Dr. Fruchtman on July 1, 2015, which supersedes any prior employment agreements. The employment agreement continues indefinitely, unless terminated in accordance with the terms of the agreement.

The employment agreement provides for an initial base salary of $420,000, subject to adjustment upon annual review, and subject to the compensation committee’s sole discretion, an annual bonus, based on the performance of Dr. Fruchtman and the Company, of up to 40% of such base salary. The bonus may be paid in the form of cash, stock options, shares of our common stock, or a combination thereof, at our compensation committee’s discretion.

Dr. Fruchtman is entitled to participate in all of our employee benefit plans and programs that itare made generally available from time to time to our executive officers and is requiredentitled to complyvacation benefits. Dr. Fruchtman’s employment agreement contains non-solicitation, non-competition, confidentiality and inventions assignment provisions that, among other things, prevent him from competing with Regulation M promulgatedus during the term of his employment and for a specified time thereafter. The Company will reimburse Dr. Fruchtman for reasonable expenses including certain commuting costs to the Company’s offices.

If Dr. Fruchtman’s employment is terminated due to his death, disability, by us for “cause” or by Dr. Fruchtman without “good reason” during the term of his employment agreement, we will pay to Dr. Fruchtman or his spouse or estate the balance of his accrued and unpaid salary, unreimbursed expenses, and unused accrued vacation time through the termination date.

If Dr. Fruchtman’s employment is terminated by us without “cause” or by Dr. Fruchtman for “good reason,” other than during a change in control protection period, Dr. Fruchtman will be entitled to receive severance equal to the sum of his current base salary and target bonus for the fiscal year during which his employment ceases. If the termination is during a change in control protection period, Dr. Fruchtman will be entitled to receive severance equal to the sum of his current base salary and target bonus for the fiscal year during which his employment ceases. A change in control protection period is the twelve months following a change in control. The Company will also reimburse Dr. Fruchtman for a portion of his medical insurance costs and all of Dr. Fruchtman’s incentive stock options that are unvested as of the date of such termination would fully vest as of the date of termination.

Manoj Maniar, Ph.D.

We entered into an employment agreement with Dr. Maniar on July 1, 2015, which supersedes any prior employment agreements. The employment agreement continues indefinitely, unless terminated in accordance with the terms of the agreement.

The employment agreement provides for an initial base salary of $371,135, subject to adjustment upon annual review by our board of directors, and subject to the compensation committee’s sole discretion, an annual bonus, based on the performance of Dr. Maniar and the Company, of up to 40% of such base salary. The bonus may be paid in the form of cash, stock options, shares of our common stock, or a combination thereof, at our compensation committee’s discretion.

Dr. Maniar is entitled to participate in all of our employee benefit plans and programs that are made generally available from time to time to our executive officers and is entitled to vacation benefits. Dr. Maniar’s employment agreement contains non-solicitation, non-competition, confidentiality and inventions assignment provisions that, among other things, prevent him from competing with us during the term of his employment and for a specified time thereafter.

If Dr. Maniar’s employment is terminated due to his death, disability, by us for “cause” or by

Dr. Maniar without “good reason” during the term of his employment agreement, we will pay to Dr. Maniar or his spouse or estate the balance of his accrued and unpaid salary, unreimbursed expenses, and unused accrued vacation time through the termination date.

If Dr. Maniar’s employment is terminated by us without “cause” or by Dr. Maniar for “good reason,” other than during a change in control protection period, Dr. Maniar will be entitled to receive severance equal to nine-twelfths of the sum of his current base salary and target bonus for the fiscal year during which his employment ceases. If the termination is during a change in control protection period, Dr. Maniar will be entitled to receive severance equal to the sum of his current base salary and target bonus for the fiscal year during which his employment ceases. A change in control protection period is the twelve months following a change in control. The Company will also reimburse Dr. Maniar for a portion of his medical insurance costs and all of Dr. Maniar’s incentive stock options that are unvested as of the date of such termination would fully vest as of the date of termination.

Stock Option and Other Compensation Plans

We maintain our 2013 Equity Compensation Plan for the purpose of attracting key employees, directors and consultants, inducing them to remain with us and encouraging them to increase their efforts to make our business more successful. The plan provides for awards of stock options, stock appreciation rights, restricted stock, restricted stock units, deferred shares and other equity-based awards.

The following table contains certain information regarding equity awards held by the named executive officers as of December 31, 2017:

Outstanding Equity Awards at 2017 Fiscal Year-End

Name

 

Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable

 

Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable

 

Option
Exercise
Price
($)

 

Option
Expiration
Date

 

Ramesh Kumar

 

9,376

 

 

57.60

 

3/16/2020

 

 

 

5,251

 

 

61.30

 

12/9/2020

 

 

 

1,033

 

 

61.30

 

12/4/2021

 

 

 

18,754

 

 

132.80

 

12/18/2022

 

 

 

10,500

 

 

150.00

 

7/25/2023

 

 

 

13,500

(1)

 

134.80

 

12/20/2023

 

 

 

13,125

(1)

4,375

 

39.80

 

12/17/2024

 

 

 

5,833

(1)

2,917

 

23.20

 

4/15/2025

 

 

 

4,921

(1)

3,829

 

14.80

 

9/24/2025

 

 

 

14,644

 

 

6.50

 

1/25/2026

 

 

 

18,333

(2)

25,667

 

3.24

 

9/1/2026

 

 

 

4,224

(2)

8,449

 

2.65

 

12/15/2026

 

 

 

13,452

(2)

30,575

 

2.70

 

1/17/2027

 

 

 

 

 

 

 

 

 

 

 

Steven Fruchtman

 

8,750

(1)

3,250

 

43.70

 

1/11/2025

 

 

 

2,333

(1)

1,167

 

24.80

 

4/19/2025

 

 

 

2,250

(1)

1,750

 

14.80

 

9/24/2025

 

 

 

12,410

 

 

6.50

 

1/25/2026

 

 

 

10,416

(2)

14,584

 

3.24

 

9/1/2026

 

 

 

2,533

(2)

5,066

 

2.65

 

12/15/2026

 

 

 

8,066

(2)

18,335

 

2.70

 

1/17/2027

 

 

 

 

 

 

 

 

 

 

 

Manoj Maniar

 

5,625

 

 

57.60

 

3/16/2020

 

 

 

2,625

 

 

61.30

 

12/9/2020

 

 

 

378

 

 

61.30

 

12/4/2021

 

 

 

3,000

 

 

132.80

 

12/18/2022

 

 

 

500

 

 

150.00

 

7/25/2023

 

 

 

4,000

(1)

 

134.80

 

12/20/2023

 

 

 

4,500

(1)

1,500

 

39.80

 

12/17/2024

 

 

 

2,666

(1)

1,334

 

23.20

 

4/15/2025

 

 

 

2,250

(1)

1,750

 

14.80

 

9/24/2025

 

 

 

10,340

 

 

6.50

 

1/25/2026

 

 

 

7,083

(2)

9,917

 

3.24

 

9/1/2026

 

 

 

1,862

(2)

3,725

 

2.65

 

12/15/2026

 

 

 

5,931

(2)

13,482

 

2.70

 

1/17/2027

 


(1) Shares vest in equal monthly installments over four years, 1/48th per month. The first shares vest one month after the date of grant.

(2) Shares vest in equal monthly installments over three years, 1/36th per month. The first shares vest one month after the date of grant.

Potential Payments Upon Termination of Employment or Change in Control

As discussed under the Exchange Act. Withcaption “—Employment Agreements” above, we have agreements with our named executive officers pursuant to which they will receive severance payments upon certain exceptions, Regulation M precludestermination events. The information below describes certain compensation that would be available under our existing plans and arrangements if (i) the selling stockholder, any affiliated purchasers,named executive officer was terminated as of December 31, 2017 or (ii) if a Change in Control, as defined herein, occurred on December 31, 2017 and any broker-dealer or other person who participatesthe named executive officer’s employment had been subsequently terminated on the same date.

Acceleration of Equity Awards

Pursuant to the terms of each named executive officer’s option agreements, in the distribution from bidding for or purchasing, or attempting to induce any person to bid for or purchase any security which is the subject of the distribution until the entire distribution is complete. Regulation M also prohibits any bids or purchases made in order to stabilize the priceevent of a security“Change in connectionControl” that occurs during any time prior to such named executive officer’s Termination of Service (as such terms are defined in our 2013 Equity Compensation Plan) with us, all stock options granted pursuant to such option agreement shall fully vest.

Termination Other than for Cause, Death or Disability; Resignation for Good Reason

The payments and benefits to which each named executive officer would be entitled in the distributionevent the named executive officer’s employment is terminated for any reason other than for cause, death, or disability, or if the named executive officer resigns for good reason, whether or not following a “change in control” is described above.

Equity Compensation Plan Information

The following table summarizes the total number of that security.outstanding options and shares available for other future issuances of options under all of our equity compensation plans as of December 31, 2017. All of the foregoing may affect the marketabilityoutstanding awards listed below were granted under our 2013 Equity Compensation Plan. See “Stock Option and Other Compensation Plans—2013 Equity Compensation Plan” above for a summary of the securities offered by this prospectus.2013 Equity Compensation Plan.

Plan Category

 

Number of Shares to
be Issued Upon
Exercise of

Outstanding

Options,
Warrants and Rights

 

Weighted-Average
Exercise Price of
Outstanding
Options,
Warrants and Rights

 

Number of Shares
Remaining Available
for Future Issuance
Under the Equity
Compensation Plan
(Excluding Shares in
First Column)

 

Equity compensation plans approved by stockholders

 

894,996

 

$

40.41

 

57,632

 

Equity compensation plans not approved by stockholders

 

 

 

 

 

This offering will terminateIn accordance with the terms of the 2013 Equity Compensation Plan, on January 1, 2018, the date that allmaximum aggregate number of shares offered by this prospectus have been sold by Lincoln Park.

Ourof our common stock is quoted on the Nasdaq Global Select Marketthat may be issued under the symbol “ONTX”.plan was automatically increased by 200,000 shares, such that immediately after such increase the number of shares remaining available for future issuance under the plan was 257,632.

DESCRIPTION OF CAPITAL STOCK

 

Our authorized capital stock consists of 75,000,00025,000,000 shares of common stock, par value $0.01 per share, and 5,000,000 shares of preferred stock, par value $0.01 per share. As of October 12, 2015, 24,773,554January 26, 2018, 10,771,163 shares of our common stock, and no shares of our preferred stock, were outstanding.

 

Common Stock

 

Subject to the preferences that may be applicable to any outstanding preferred stock, holders of our common stock are entitled to receive ratably any dividends that may be declared by our board of directors out of funds legally available for that purpose. Holders of our common stock are entitled to one vote for each share on all matters voted on by stockholders, including the election of directors. Holders of our common stock do not have any conversion, redemption, sinking fund or preemptive rights. In the event of our dissolution, liquidation or winding up, holders of our common stock are entitled to share ratably in any assets remaining after the satisfaction in full of the prior rights of creditors and the aggregate liquidation preference of any preferred stock then outstanding. The rights, preferences and privileges of the holders of our common stock are subject to, and may be adversely affected by, the rights of the holders of shares of any series of preferred stock that we may designate and issue in the future. All outstanding shares of our common stock are, and any shares of common stock that we may issue in the future will be, fully paid and non-assessable.

 

Preferred Stock

 

We may issue any class of preferred stock in any series. Our board of directors has the authority, subject to limitations prescribed under Delaware law, to issue preferred stock in one or more series, to establish from time to time the number of shares to be included in each series and to fix the designation, powers, preferences and rights of the shares of each series and any of its qualifications, limitations and restrictions. Our board of directors can also increase or decrease the number of shares of any series, but not below the number of shares of that series then outstanding. Our board of directors may authorize the issuance of preferred stock with voting or conversion rights that could adversely affect the voting power or other rights of the holders of the common stock. The issuance of preferred stock, while providing flexibility in connection with possible acquisitions and other corporate purposes, could, among other things, have the effect of delaying, deferring or preventing a change in control of our company and may adversely affect the market price of our common stock and the voting and other rights of the holders of common stock.

 

Delaware Anti-Takeover Law and Provisions in Our Certificate of Incorporation and Bylaws

 

Delaware Anti-Takeover Law

 

We are subject to Section 203 of the Delaware General Corporation Law. Section 203 generally prohibits a public Delaware corporation from engaging in a “business combination” with an “interested stockholder” for a period of three years after the date of the transaction in which the person became an interested stockholder, unless:

 

·      prior to the date of the transaction, the board of directors of the corporation approved either the business combination or the transaction which resulted in the stockholder becoming an interested stockholder;

·      upon consummation of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding specified shares; or

 

·      at or subsequent to the date of the transaction, the business combination is approved by the board of directors and authorized at an annual or special meeting of stockholders, and not by written consent, by the affirmative vote of at least 662/3%3% of the outstanding voting stock which is not owned by the interested stockholder.

Section 203 defines a “business combination” to include:

 

·      any merger or consolidation involving the corporation and the interested stockholder;

·      any sale, lease, exchange, mortgage, pledge, transfer or other disposition of 10% or more of the assets of the corporation to or with the interested stockholder;

·      subject to exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder;

·      subject to exceptions, any transaction involving the corporation that has the effect of increasing the proportionate share of the stock of any class or series of the corporation beneficially owned by the interested stockholder; or

·      the receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits provided by or through the corporation.

 

In general, Section 203 defines an “interested stockholder” as any person that is:

 

·      the owner of 15% or more of the outstanding voting stock of the corporation;

·      an affiliate or associate of the corporation who was the owner of 15% or more of the outstanding voting stock of the corporation at any time within three years immediately prior to the relevant date; or

·      the affiliates and associates of the above.

 

Under specific circumstances, Section 203 makes it more difficult for an “interested stockholder” to effect various business combinations with a corporation for a three-year period, although the stockholders may, by adopting an amendment to the corporation’s certificate of incorporation or bylaws, elect not to be governed by this section, effective 12 months after adoption.

 

Our certificate of incorporation and bylaws do not exclude us from the restrictions of Section 203. We anticipate that the provisions of Section 203 might encourage companies interested in acquiring us to negotiate in advance with our board of directors since the stockholder approval requirement would be avoided if a majority of the directors then in office approve either the business combination or the transaction that resulted in the stockholder becoming an interested stockholder.

Certificate of Incorporation and Bylaws

 

Provisions of our certificate of incorporation and bylaws may delay or discourage transactions involving an actual or potential change of control or change in our management, including transactions in which stockholders might otherwise receive a premium for their shares, or transactions that our stockholders might otherwise deem to be in their best interests. Therefore, these provisions could adversely affect the price of our common stock. Among other things, our certificate of incorporation and bylaws will:

 

·      permit our board of directors to issue up to 5,000,000 shares of preferred stock, with any rights, preferences and privileges as they may designate;

·      provide that all vacancies on our board of directors, including as a result of newly created directorships, may, except as otherwise required by law, be filled by the affirmative vote of a majority of directors then in office, even if less than a quorum;

·      require that any action to be taken by our stockholders must be effected at a duly called annual or special meeting of stockholders and not be taken by written consent;

·      provide that stockholders seeking to present proposals before a meeting of stockholders or to nominate candidates for election as directors at a meeting of stockholders must provide advance notice in writing, and also specify requirements as to the form and content of a stockholder’s notice;

·      not provide for cumulative voting rights, thereby allowing the holders of a majority of the shares of common stock entitled to vote in any election of directors to elect all of the directors standing for election; and

·      provide that special meetings of our stockholders may be called only by the board of directors or by such person or persons requested by a majority of the board of directors to call such meetings.

 

Transfer Agent and Registrar

 

The transfer agent and registrar for our common stock is Wells Fargo Shareowner Services.Bank, N.A.

 

Listing

 

Our common stock is listed on the Nasdaq GlobalCapital Market under the symbol “ONTX.”

UNDERWRITING

 

LEGAL MATTERSWe have entered into an underwriting agreement dated                    , 2018, with H.C. Wainwright & Co., LLC as the sole book-running manager of this offering. Subject to the terms and conditions of the underwriting agreement, we have agreed to sell to the underwriter and the underwriter has agreed to purchase from us, at the public offering price less the underwriting discounts and commissions set forth on the cover page of this prospectus. The public offering price shown on the cover page of this prospectus was determined by negotiation between us and the underwriter at the time of pricing, and may be at a discount to the current market price.

A copy of the underwriting agreement has been filed as an exhibit to the registration statement of which this prospectus is a part. The shares we are offering are being offered by the underwriter subject to certain conditions specified in the underwriting agreement.

We have been advised by the underwriter that it proposes to offer the shares directly to the public at the public offering price set forth on the cover page of this prospectus. Any shares sold by the underwriter to securities dealers will be sold at the public offering price less a selling concession not in excess of $            per share.

 

The validityunderwriting agreement provides that the underwriter’s obligation to purchase the shares we are offering is subject to conditions contained in the underwriting agreement. The underwriter is obligated to purchase and pay for all of the shares offered by this prospectus.

No action has been taken by us or the underwriter that would permit a public offering of shares in any jurisdiction where action for that purpose is required. None of the shares included in this offering may be offered or sold, directly or indirectly, nor may this prospectus or any other offering material or advertisements in connection with the offer and sales of any of the shares be distributed or published in any jurisdiction, except under circumstances that will result in compliance with the applicable rules and regulations of that jurisdiction. Persons who receive this prospectus are advised to inform themselves about and to observe any restrictions relating to this offering of the shares and the distribution of this prospectus. This prospectus is neither an offer to sell nor a solicitation of any offer to buy the shares in any jurisdiction where that would not be permitted or legal.

The underwriter has advised us that it does not intend to confirm sales to any accounts over which it exercises discretionary authority.

Underwriting Discounts, Commissions and Expenses

We have agreed to pay an underwriter discount equal to 7% of the aggregate gross proceeds raised in this offering.

The following table shows the public offering price, underwriting discounts and commissions and proceeds, before expenses to us. These amounts are shown assuming both no exercise and full exercise of the underwriter’s option to purchase additional securities.

Total

Per Share

Without
Option
Exercise

With
Full Option
Exercise

Public offering price

Underwriting discounts and commissions

Proceeds, before expenses, to us

We estimate the total expenses payable by us for this offering to be approximately $1.6 million, which amount includes (i) an assumed underwriting discounts and commissions of $1.0 million ($1.1 million if the underwriter’s option to purchase additional shares is exercised in full) based upon the assumed public offering price of $1.58 per share (the last reported sale price of our common stock on the Nasdaq Capital Market on January 26, 2018), (ii) an assumed management fee in the amount of $137,000 which represents 1.0% of the assumed aggregate offering price, (iii) $50,000 non-accountable expense allowance payable to the underwriter, (iv) reimbursement of the accountable expenses of the underwriter equal to $110,000 (none of which has been paid in advance), including the legal fees of the underwriter being paid by us, and (v) other estimated expenses of approximately $336,000 which include legal, accounting, printing costs and various fees associated with the registration and listing of our shares.

Underwriter Warrants

We have agreed to issue to the underwriter warrants to purchase a number of shares of our common stock equal to 5% of the aggregate number of shares of common stock sold in this offering. The underwriter warrants will have a term of two years from the issuance date (subject to certain conditions) and an exercise price per share equal to 125% of the public offering price for the shares sold in this offering. Pursuant to FINRA Rule 5110(g), the underwriter warrants and any shares issued upon exercise of the underwriter warrants shall not be sold, transferred, assigned, pledged, or hypothecated, or be the subject of any hedging, short sale, derivative, put or call transaction that would result in the effective economic disposition of the securities by any person for a period of 180 days immediately following the date of effectiveness or commencement of sales of this offering, except the transfer of any security: (i) by operation of law or by reason of our reorganization; (ii) to any FINRA member firm participating in the offering and the officers or partners thereof, if all securities so transferred remain subject to the lock-up restriction set forth above for the remainder of the time period; (iii) if the aggregate amount of our securities held by the underwriter or related persons do not exceed 1% of the securities being offered; (iv) that is beneficially owned on a pro rata basis by all equity owners of an investment fund, provided that no participating member manages or otherwise directs investments by the fund and the participating members in the aggregate do not own more than 10% of the equity in the fund; or (v) the exercise or conversion of any security, if all securities remain subject to the lock-up restriction set forth above for the remainder of the time period. Notwithstanding the foregoing, the underwriter has agreed, to the extent we do not have sufficient authorized shares necessary for the issuance of the underwriter warrants (including, without limitation, reserved shares underlying the underwriter warrants), the exercise period of the underwriter warrants will commence on the date we increase our authorized shares of common stock upon stockholder approval, subject to the limitation on exercise set forth in FINRA Rule 5110(f)(G)(i).

Right of First Refusal

We have also granted the underwriter, for a period of 10 months from the closing date of this offering, a right of first refusal to act as sole book-running manager for each and every future public or private equity or debt offering by us or any of our successors or subsidiaries. We have also agreed to a tail fee equal to the cash and warrant compensation in this offering if any investor to which the underwriter introduced us with respect to this offering during the term of its engagement provides us with further capital in a public or private offering or capital raising transaction, with certain exceptions, during the 6-month period following termination of our engagement of the underwriter.

Option to Purchase Additional Securities

We have granted the underwriter the option to purchase up to 1,297,500 additional shares of common stock at a purchase price of $ 1.58 per share, less the underwriting discounts and commissions. The underwriter may exercise its option at any time, and from time to time, within 30 days from the date of this

prospectus. If any additional shares are purchased pursuant to the option to purchase additional shares of common stock, the underwriter will offer these securities on the same terms as those on which the other securities are being offered herebyhereby.

Nasdaq Capital Market Listing

Our stock is currently traded on the Nasdaq Capital Market under the symbol “ONTX.” On January 26, 2018, the last reported sale price of our common stock was $1.58 per share.

Lock-up Agreements

Our officers and directors and certain other legal matters willof our stockholders have agreed with the underwriter to be passed uponsubject to a lock-up period of 90 days following the date of this prospectus. This means that, during the applicable lock-up period, such persons may not offer for us by Pepper Hamilton LLP, Princeton, New Jersey.sale, contract to sell, sell, distribute, grant any option, right or warrant to purchase, pledge, hypothecate or otherwise dispose of, directly or indirectly, any shares of our common stock or any securities convertible into, or exercisable or exchangeable for, shares of our common stock. Certain limited transfers are permitted during the lock-up period if the transferee agrees to these lock-up restrictions. We have also agreed in the underwriting agreement, subject to certain exceptions, to similar lock-up restrictions on the issuance and sale of our securities for 90 days following the closing of this offering. The underwriter may, in its sole discretion and without notice, waive the terms of any of these lock-up agreements.

 

Stabilization, Short Positions and Penalty Bids

The underwriter may engage in syndicate covering transactions, stabilizing transactions and penalty bids or purchases for the purpose of pegging, fixing or maintaining the price of our common stock:

· Syndicate covering transactions involve purchases of securities in the open market after the distribution has been completed in order to cover syndicate short positions. Such a naked short position would be closed out by buying securities in the open market. A naked short position is more likely to be created if the underwriter is concerned that there could be downward pressure on the price of the securities in the open market after pricing that could adversely affect investors who purchase in the offering.

· Stabilizing transactions permit bids to purchase the underlying security so long as the stabilizing bids do not exceed a specific maximum.

· Penalty bids permit the underwriter to reclaim a selling concession from a syndicate member when the securities originally sold by the syndicate member are purchased in a stabilizing or syndicate covering transaction to cover syndicate short positions.

These syndicate covering transactions, stabilizing transactions and penalty bids may have the effect of raising or maintaining the market prices of our securities or preventing or retarding a decline in the market prices of our securities. As a result, the price of our common stock may be higher than the price that might otherwise exist in the open market. Neither we nor the underwriter make any representation or prediction as to the effect that the transactions described above may have on the price of our common stock. These transactions may be effected on the Nasdaq Capital Market, in the over-the-counter market or on any other trading market and, if commenced, may be discontinued at any time.

In connection with this offering, the underwriter also may engage in passive market making transactions in our common stock in accordance with Regulation M during a period before the commencement of offers or sales of shares of our common stock in this offering and extending through the completion of the distribution. In general, a passive market maker must display its bid at a price not in excess of the highest independent bid for that security. However, if all independent bids are lowered below the passive market maker’s bid that bid must then be lowered when specific purchase limits are exceeded. Passive market making may stabilize the market price of the securities at a level above that which might otherwise prevail in the open market and, if commenced, may be discontinued at any time.

Neither we nor the underwriter make any representation or prediction as to the direction or magnitude of any effect that the transactions described above may have on the prices of our securities. In addition, neither we nor the underwriter make any representation that the underwriter will engage in these transactions or that any transactions, once commenced, will not be discontinued without notice.

Indemnification

We have agreed to indemnify the underwriter against certain liabilities, including certain liabilities arising under the Securities Act, or to contribute to payments that the underwriter may be required to make for these liabilities.

Other Relationships

The underwriter and its respective affiliates have engaged in, and may in the future engage in, investment banking and other commercial dealings in the ordinary course of business with us or our affiliates. The underwriter has received, or may in the future receive, customary fees and commissions for these transactions.

EXPERTS

 

The consolidated financial statements of Onconova Therapeutics, Inc. at December 31, 2016 and 2015, and for the years then ended, appearing in Onconova Therapeutics, Inc.’sour Annual Report (Form 10-K) for the year ended December 31, 20142016 have been audited by Ernst & Young LLP, independent registered public accounting firm, as set forth in their report thereon (which contains an explanatory paragraph describing conditions that raise substantial doubt about the Company’s ability to continue as a going concern as described in Note 1 to the consolidated financial statements) included therein and incorporated herein by reference. Such financial statements are incorporated herein by reference in reliance upon such report given on the authority of such firm as experts in accounting and auditing.

LEGAL MATTERS

The validity of the securities being offered by this prospectus will be passed upon by Morgan, Lewis & Bockius LLP, Philadelphia, Pennsylvania. The underwriter is being represented in connection with this offering by Lowenstein Sandler LLP, New York, New York.

WHERE YOU CAN FIND MORE INFORMATION

We file annual, quarterly and current reports, proxy and information statements and other information with the SEC. Our SEC filings, including the registration statement, are available to the public from the SEC’s website at www.sec.gov. To receive copies of public records not posted to the SEC’s website at prescribed rates, you may complete an online form at www.sec.gov, send a fax to (202) 772-9337 or submit a written request to the SEC, Office of FOIA/PA Operations, 100 F Street, N.E., Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for further information.

We also make available free of charge on our website, www.onconova.com, all materials that we file electronically with the SEC, including our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, Section 16 reports and amendments to those reports as soon as reasonably practicable after such materials are electronically filed with, or furnished to, the SEC. Information contained on our website or any other website is not incorporated by reference into this prospectus and does not constitute a part of this prospectus.

5,200,000 SharesINCORPORATION BY REFERENCE

The SEC allows us to “incorporate by reference” the information we file with it, which means that we can disclose important information to you by referring you to those documents. The information incorporated by reference is considered to be part of this prospectus, and information that we file later with the SEC will automatically update and supersede this information. We incorporate by reference the documents listed below:

·                  Our Annual Report on Form 10-K for the fiscal year ended December 31, 2016 that we filed with the SEC on March 29, 2017, including the information required by Part III, Items 10 through 14, of Form 10-K, which is incorporated by reference to our definitive proxy statement for our 2017 annual meeting of stockholders filed on April 12, 2017;

·                  Our Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, 2017, June 30, 2017 and September 30, 2017 that we filed with the SEC on May 15, 2017, August 14, 2017 and November 9, 2017, respectively;

·                  Our Current Reports on Form 8-K filed with the SEC on April 20, 2017, April 24, 2017, May 18, 2017, May 25, 2017, August 18, 2017, November 13, 2017, November 17, 2017, January 17, 2018 and January 30, 2018;

·                  The description of our common stock contained in our registration statement on Form 8-A filed on July 23, 2013 (Registration no. 001-36020) with the SEC, including any amendment or report filed for the purpose of updating such description; and

·                  All documents filed by us with the SEC pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act on or after the date of this prospectus and before we terminate the offering under this prospectus.

We will provide without charge to each person, including any beneficial owner, to whom this prospectus is delivered, upon his or her written or oral request, a copy of any or all documents referred to above which have been or may be incorporated by reference into this prospectus but not delivered with this prospectus excluding exhibits to those documents unless they are specifically incorporated by reference into those documents. You can request those documents from us, at no cost, by writing or telephoning us at: Onconova Therapeutics, Inc., 375 Pheasant Run, Newtown, Pennsylvania, 18940, (267) 759-3680, Attention: Suzanne Hutchinson.

The most recent information that we file with the SEC automatically updates and supersedes older information. The information contained in any such filing will be deemed to be a part of this prospectus, commencing on the date on which the filing is made.

Information furnished under Items 2.02 or 7.01 (or corresponding information furnished under Item 9.01 or included as an exhibit) in any past or future Current Report on Form 8-K that we file with the SEC, unless otherwise specified in such report, is not incorporated by reference in this prospectus.

 

Onconova Therapeutics, Inc.

 

ONCONOVA THERAPEUTICS, INC.

8,650,000 Shares of Common Stock

 


 

PROSPECTUS

 


 

Sole Book-Running Manager

H.C. Wainwright & Co.


                                  , 20152018

 



Table of Contents

 

PART II
INFORMATION NOT REQUIRED IN PROSPECTUSInformation Not Required In Prospectus

 

Item 13.Other Expenses of Issuance and DistributionDistribution.

 

The following table sets forth theis a statement of estimated costs and expenses payable by the registrant in connection with the saleissuance and distribution of the securities being registered.registered, excluding dealer-manager fees. All expenses incurred with respect to the registration of the common stock will be borne by us. All amounts are estimates. except the SEC registration fee, the FINRA filing fee and the Nasdaq listing of additional shares notification fee.

 

SEC registration fee

 

$

780.23

 

Legal fees and expenses

 

50,000.00

 

Accounting fees and expenses

 

25,000.00

 

Miscellaneous expenses

 

9,219.77

 

Total

 

$

85,000.00

 

Amount to be
Paid

SEC Registration Fee

$

1,958

FINRA Filing Fee

2,866

Nasdaq Fee

5,000

Printing Expenses

30,000

Legal Fees and Expenses

175,000

Accounting Fees and Expenses

75,000

Transfer Agent Fees and Expenses

20,000

Miscellaneous Expenses

26,100

Total

$

335,924

 

Item 14.Indemnification of Directors and OfficersOfficers.

 

We are incorporated under the laws of the State of Delaware. Section 145 of the Delaware General Corporation Law provides that a Delaware corporation may indemnify any persons who are, or are threatened to be made, parties to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of such corporation), by reason of the fact that such person was an officer, director, employee or agent of such corporation, or is or was serving at the request of such person as an officer, director, employee or agent of another corporation or enterprise. The indemnity may include expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person in connection with such action, suit or proceeding, provided that such person acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the corporation’s best interests and, with respect to any criminal action or proceeding, had no reasonable cause to believe that his or her conduct was illegal.

A Delaware corporation may indemnify any persons who are, or are threatened to be made, a party to any threatened, pending or completed action or suit by or in the right of the corporation by reason of the fact that such person was a director, officer, employee or agent of such corporation, or is or was serving at the request of such corporation as a director, officer, employee or agent of another corporation or enterprise. The indemnity may include expenses (including attorneys’ fees) actually and reasonably incurred by such person in connection with the defense or settlement of such action or suit provided that such person acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the corporation’s best interests except that no indemnification is permitted without judicial approval if the officer or director is adjudged to be liable to the corporation. Where an officer or director is successful on the merits or otherwise in the defense of any action referred to above, the corporation must indemnify him or her against the

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expenses which such officer or director has actually and reasonably incurred. Our certificate of incorporation and bylaws provide for the indemnification of our directors and officers to the fullest extent permitted under the Delaware General Corporation Law.

 

Section 102(b)(7) of the Delaware General Corporation Law permits a corporation to provide in its certificate of incorporation that a director of the corporation shall not be personally liable to the corporation or its stockholders for monetary damages for breach of fiduciary duties as a director, except for liability for any:

 

·                  transaction from which the director derives an improper personal benefit;

·                  act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;

·                  unlawful payment of dividends or redemption of shares; or

·                  breach of a director’s duty of loyalty to the corporation or its stockholders.

 

Our certificate of incorporation includes such a provision. Expenses incurred by any officer or director in defending any such action, suit or proceeding in advance of its final disposition shall be paid by us upon delivery to us of an

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undertaking, by or on behalf of such director or officer, to repay all amounts so advanced if it shall ultimately be determined that such director or officer is not entitled to be indemnified by us.

 

As permitted by the Delaware General Corporation Law, we have entered into indemnification agreements with our directors and executive officers. These agreements, among other things, require us to indemnify each director and officer to the fullest extent permitted by law and advance expenses to each indemnitee in connection with any proceeding in which indemnification is available.

 

At present, there is no pending litigation or proceeding involving any of our directors or executive officers as to which indemnification is required or permitted, and we are not aware of any threatened litigation or proceeding that may result in a claim for indemnification.

 

We have an insurance policy covering our officers and directors with respect to certain liabilities, including liabilities arising under the Securities Act.

 

Item 15.Recent Sales of Unregistered SecuritiesSecurities.

On October 8, 2015, the Company entered into the Purchase Agreement with Lincoln Park, pursuant to which the Company has the right to sell to, and Lincoln Park is obligated to purchase from the Company, up to $16.5 million in shares of the Company’s common stock, subject to certain limitations, from time to time, over the 36-month period commencing on the date that this registration statement is declared effective by the SEC and a final prospectus in connection therewith is filed. On October 8, 2015, Lincoln Park purchased 846,755 shares of the Company’s common stock for a total purchase price of $1,500,000 as an initial purchase under the Purchase Agreement and the Company issued 200,000 shares of common stock pursuant to the terms of the Purchase Agreement as consideration for its commitment to purchase additional shares of common stock under the Purchase Agreement. The sale of such shares to Lincoln Park was not registered under the Securities Act because it was made in a transaction exempt from registration under Section 4(a)(2) of the Securities Act and/or Rule 506 promulgated thereunder.

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On January 5, 2016, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with an institutional investor (the “Investor”) providing for the issuance and sale by the Company of 1,936,842 shares of the Company’s common stock at a purchase price of $0.95 per share and warrants to purchase 968,421 shares of the Company’s common stock (the “Private Placement Warrants”) for aggregate gross proceeds of $1,840,000. The shares of the Company’s common stock were offered pursuant to an effective shelf registration statement on Form S-3, declared effective by the SEC on November 20, 2014 (File No. 333-199219). The Private Placement Warrants were issued and sold without registration under the Securities Act in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder and in reliance upon similar exemptions under applicable state laws. Each Private Placement Warrant shall be initially exercisable on the six (6) month anniversary of the issuance date at an exercise price equal to $1.15 per share of common stock, subject to customary adjustments, and have a term of exercise of five (5) years from the initial exercise date. H.C. Wainwright & Co., LLC acted as the Company’s exclusive placement agent for the issuance and sale of the shares of common stock and Private Placement Warrants, and was paid a cash fee equal to 7.5% of the gross proceeds received by the Company from the sale of the securities in the transactions and was reimbursed by the Company for up to $50,000 in expenses.

 

Item 16.Exhibits and Financial Statement SchedulesSchedules.

 

(a) Exhibits

 

Exhibit
Number

Exhibit Description

3.1

Tenth Amended and Restated Certificate of Incorporation of Onconova Therapeutics, Inc. (Incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on July 25, 2013).

3.2

Amended and Restated Bylaws of Onconova Therapeutics, Inc. (Incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on July 25, 2013).

4.1

Form of Certificate of Common Stock (Incorporated by reference to Exhibit 4.1 to Pre-Effective Amendment No. 1 the Company’s Registration Statement on Form S-l filed on July 11, 2013.)

4.2

Eighth Amended and Restated Stockholders’ Agreement, effective as of July 27, 2012, by and among Onconova Therapeutics, Inc. and certain stockholders named therein (Incorporated by reference to Exhibit 4.2 to Pre-Effective Amendment No. 1 to the Company’s Registration Statement on Form S-l filed on July 11, 2013).

4.3

Amendment No. 1 to Eighth Amended and Restated Stockholders’ Agreement, effective as of July 9, 2013 (Incorporated by reference to Exhibit 4.2 to Pre-Effective Amendment No. 1 the Company’s Registration Statement on Form S-l filed on July 11, 2013).

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Exhibit
Number

Exhibit Description

5.1

Opinion of Pepper Hamilton LLP

10.1

*

Development and License Agreement, effective as of September 19, 2012, by and between Onconova Therapeutics, Inc. and Baxter Healthcare SA (Incorporated by reference to Exhibit 10.1 to Pre-Effective Amendment No. 2 the Company’s Registration Statement on Form S-l filed on July 18, 2013).

10.2

*

License Agreement, effective as of July 5, 2011, by and between Onconova Therapeutics, Inc. and SymBio Pharmaceuticals Limited (Incorporated by reference to Exhibit 10.2 to Pre-Effective Amendment No. 2 the Company’s Registration Statement on Form S-l filed on July 18, 2013).

10.3

*

First Amendment to License Agreement, effective as of September 2, 2011, by and between Onconova Therapeutics, Inc. and SymBio Pharmaceuticals Limited (Incorporated by reference to Exhibit 10.3 to the Company’s Registration Statement on Form S-l filed on June 14, 2013).

10.4

*

License Agreement, effective as of January 1, 1999, by and between Onconova Therapeutics, Inc. and Temple University—Of The Commonwealth System of Higher Education (Incorporated by reference to Exhibit 10.4 to the Company’s Registration Statement on Form S-l filed on June 14, 2013).

10.5

*

Amendment to License Agreement, effective as of September 1, 2000, by and between Temple University—Of The Commonwealth System of Higher Education and Onconova Therapeutics, Inc. (Incorporated by reference to Exhibit 10.5 to the Company’s Registration Statement on Form S-1 filed on June 14, 2013).

10.6

*

Amendments to Exclusive License Agreement, effective as of March 21, 2013, by and between Temple University—Of The Commonwealth System of Higher Education and Onconova Therapeutics, Inc. (Incorporated by reference to Exhibit 10.6 to the Company’s Registration Statement on Form S-l filed on June 14, 2013).

10.7

*

Definitive Agreement, effective as of May 12, 2010, by and between Onconova Therapeutics, Inc. and The Leukemia and Lymphoma Society (Incorporated by reference to Exhibit 10.7 to the Company’s Registration Statement on Form S-l filed on June 14, 2013).

10.8

*

First Amendment to Definitive Agreement, effective as of June 23, 2011, by and between Onconova Therapeutics, Inc. and The Leukemia and Lymphoma Society (Incorporated by reference to Exhibit 10.8 to the Company’s Registration Statement on Form S-l filed on June 14, 2013).

10.9

*

Second Amendment to Definitive Agreement, effective as of May 29, 2012, by and between Onconova Therapeutics, Inc. and The Leukemia and Lymphoma Society (Incorporated by reference to Exhibit 10.9 to the Company’s Registration Statement on Form S-l filed on June 14, 2013).

10.10

*

Third Amendment to Definitive Agreement, effective as of January 5, 2013, by and between Onconova Therapeutics, Inc. and The Leukemia and Lymphoma Society (Incorporated by reference to Exhibit 10.10 to the Company’s Registration Statement on Form S-l filed on June 14, 2013).

10.11

Termination of Agreement, effective as of February 5, 2013, by and between Onconova Therapeutics, Inc. and The Leukemia and Lymphoma Society (Incorporated by reference to

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Exhibit
Number

Exhibit Description

Exhibit 10.11 to the Company’s Registration Statement on Form S-l filed on June 14, 2013).

10.12

*

Limited Liability Company Agreement of GBO, LLC, dated as of December 12, 2012, by and between Onconova Therapeutics, Inc. and GVK Biosciences Private Limited (Incorporated by reference to Exhibit 10.12 to the Company’s Registration Statement on Form S-l filed on June 14, 2013).

10.13

+

Onconova Therapeutics, Inc. 2007 Equity Compensation Plan, and forms of agreement thereunder (Incorporated by reference to Exhibit 10.13 to Pre-Effective Amendment No. 1 the Company’s Registration Statement on Form S-l filed on July 11, 2013).

10.14

+

Consulting Agreement, effective as of January 1, 2012, by and between Onconova Therapeutics, Inc. and E. Premkumar Reddy, Ph.D., including Consultant Agreement Renewal, dated February 27, 2013 (Incorporated by reference to Exhibit 10.23 to the Company’s Registration Statement on Form S-1 filed on June 14, 2013).

10.15

+

Form of Indemnification Agreement entered into by and between Onconova Therapeutics, Inc. and each director and executive officer (Incorporated by reference to Exhibit 10.24 to Pre-Effective Amendment No. 1 the Company’s Registration Statement on Form S-1 filed on July 11, 2013).

10.16

+

Onconova Therapeutics, Inc. 2013 Equity Compensation Plan, and forms of agreement thereunder (Incorporated by reference to Exhibit 10.25 to Pre-Effective Amendment No. 1 the Company’s Registration Statement on Form S-1 filed on July 11, 2013).

10.17

+

Onconova Therapeutics, Inc. 2013 Performance Bonus Plan (Incorporated by reference to Exhibit 10.26 to Pre-Effective Amendment No. 1 the Company’s Registration Statement on Form S-1 filed on July 11, 2013).

10.18

Sales Agreement dated October 8, 2014 by and between Onconova Therapeutics, Inc., and Cantor Fitzgerald & Co. (incorporated by reference to Exhibit 1.1 to the Company’s Registration Statement on Form S-3 filed on October 8, 2014).

10.19

Amendment No. 1 to Sales Agreement, dated September 30, 2015, between Onconova Therapeutics, Inc. and Cantor Fitzgerald & Co. (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on October 5, 2015).

10.20

+

Employment Agreement between Onconova Therapeutics, Inc. and Ramesh Kumar, Ph.D (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on July 8, 2015).

10.21

+

Amended and Restated Employment Agreement between Onconova Therapeutics, Inc. and Thomas McKearn, M.D., Ph.D (Incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on July 8, 2015).

10.22

+

Employment Agreement between Onconova Therapeutics, Inc. and Manoj Maniar, Ph.D (Incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed on July 8, 2015).

10.23

+

Amended and Restated Employment Agreement between Onconova Therapeutics, Inc. and Ajay Bansal (Incorporated by reference to Exhibit 10.4 to the Company’s Current Report on Form 8-K filed on July 8, 2015).

10.24

+

Amended and Restated Employment Agreement between Onconova Therapeutics, Inc. and Steven Fruchtman, M.D. (Incorporated by reference to Exhibit 10.5 to the Company’s Quarterly Report on Form 10-Q filed on August 13, 2015).

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Exhibit
Number

Exhibit Description

10.25

Purchase Agreement between the Company and Lincoln Park Capital Fund, LLC, dated October 8, 2015 (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on October 8, 2015).

10.26

Registration Rights Agreement between the Company and Lincoln Park Capital Fund, LLC, dated October 8, 2015 (Incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on October 8, 2015).

21.1

Subsidiaries of Onconova Therapeutics, Inc. (Incorporated by reference to Exhibit 21.1 to the Company’s Annual Report on Form 10-K filed on March 30, 2015).

23.1

Consent of Ernst & Young, LLP.

23.2

Consent of Pepper Hamilton LLP (included in Exhibit 5.1)

24.1

Power of Attorney (included on signature page)


+                                         Indicates management contract or compensatory plan.The exhibits to the registration statement are listed in the Exhibit Index to this registration statement and are incorporated herein by reference.

 

*                                         Confidential treatment has been granted with respect to certain portions of this exhibit.  Omitted portions(b) Financial statement schedules

All schedules have been filed separately withomitted because either they are not required, are not applicable or the Securitiesinformation is otherwise set forth in the financial statements and Exchange Commission.

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Item 17. Undertakings.Undertakings

 

(a)The undersigned registrant hereby undertakes:

 

(1)                                 To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:

 

(i)                                    To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933 (the “Act”);

 

(ii)                                To reflect in the prospectus any facts or events arising after the effective date of this registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and

 

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(iii)                            To include any material information with respect to the plan of distribution not previously disclosed in this registration statement or any material change to such information in this registration statement.

 

Provided, however, that Paragraphs (1)(i), (1)(ii) and (1)(iii) of this section do not apply if the information required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the registrant pursuant to section 13 or section 15(d) of the Exchange Act that are incorporated by reference in the registration statement, or is contained in a form of prospectus filed pursuant to Rule 424(b) that is part of the registration statement.

(2)                                 That, for the purpose of determining any liability under the Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

 

(3)                                 To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.

 

(4)                                 That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser,purchaser:

If the registrant is subject to Rule 430C (§230.430C of this chapter), each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A (§230.430A of this chapter), shall be deemed to be part of and included in the registration statement as of the date it is first used after effectiveness. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is a part of the registration statement will, as to a purchaser with a time of contract of sale prior to such first use, supersededsupersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such date of first use.

 

(h)(5)                                 That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:

(i)                                    Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424 (§230.424 of this chapter);

(ii)                                Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant;

(iii)                            The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and

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(iv)                             Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.

The undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act of 1933, each filing of the registrant’s annual report pursuant to section 13(a) or section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue.

 

The undersigned registrant hereby undertakes that:

ii-(1)6                                 For purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b) (1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective.

(2)                                 For the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

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EXHIBIT INDEX

Exhibit
Number

Exhibit Description

1.1†

Form of Underwriting Agreement

3.1

Tenth Amended and Restated Certificate of Incorporation of Onconova Therapeutics, Inc. (Incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on July 30, 2013).

3.2

Amended and Restated Bylaws of Onconova Therapeutics, Inc. (Incorporated by reference to Exhibit 3.2 to the Company’s Current Report on Form 8-K filed on July 30, 2013).

3.3

Certificate of Amendment to Tenth Amended and Restated Certificate of Incorporation of Onconova Therapeutics, Inc. (Incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on May 31, 2016).

4.1

Form of Certificate of Common Stock (Incorporated by reference to Exhibit 4.1 to Pre-Effective Amendment No. 1 the Company’s Registration Statement on Form S-l filed on July 11, 2013.)

4.2

Eighth Amended and Restated Stockholders’ Agreement, effective as of July 27, 2012, by and among Onconova Therapeutics, Inc. and certain stockholders named therein (Incorporated by reference to Exhibit 4.2 to Pre-Effective Amendment No. 1 to the Company’s Registration Statement on Form S-l filed on July 11, 2013).

4.3

Amendment No. 1 to Eighth Amended and Restated Stockholders’ Agreement, effective as of July 9, 2013 (Incorporated by reference to Exhibit 4.3 to Pre-Effective Amendment No. 1 the Company’s Registration Statement on Form S-l filed on July 11, 2013).

4.4

Form of Warrant Certificate issued pursuant to Warrant Agreement, dated as of July 27, 2016, by and between Onconova Therapeutics, Inc. and Wells Fargo Bank, N.A., as Warrant Agent (Incorporated by reference to Exhibit 4.1 to the Company’s Quarterly Report on Form 10-Q filed on August 15, 2016)

4.5

Form of Warrant Certificate issued pursuant to Warrant Agreement, dated as of July 27, 2016, by and between Onconova Therapeutics, Inc. and Wells Fargo Bank, N.A., as Warrant Agent (Incorporated by reference to Exhibit 4.1 to the Company’s Quarterly Report on Form 10-Q filed on August 15, 2016)

4.6

Form of Pre-Funded Warrants issued as of July 27, 2016 (Incorporated by reference to Exhibit 4.3 to the Company’s Quarterly Report on Form 10-Q filed on August 15, 2016)

5.1

Opinion of Morgan, Lewis & Bockius LLP

10.1*

Development and License Agreement, effective as of September 19, 2012, by and between Onconova Therapeutics, Inc. and Baxter Healthcare SA (Incorporated by reference to Exhibit 10.1 to Pre-Effective Amendment No. 2 the Company’s Registration Statement on Form S-l filed on July 18, 2013).



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10.2*

License Agreement, effective as of July 5, 2011, by and between Onconova Therapeutics, Inc. and SymBio Pharmaceuticals Limited (Incorporated by reference to Exhibit 10.2 to Pre-Effective Amendment No. 2 the Company’s Registration Statement on Form S-l filed on July 18, 2013).

10.3*

First Amendment to License Agreement, effective as of September 2, 2011, by and between Onconova Therapeutics, Inc. and SymBio Pharmaceuticals Limited (Incorporated by reference to Exhibit 10.3 to the Company’s Registration Statement on Form S-l filed on June 14, 2013).

10.4*

License Agreement, effective as of January 1, 1999, by and between Onconova Therapeutics, Inc. and Temple University—Of The Commonwealth System of Higher Education (Incorporated by reference to Exhibit 10.4 to the Company’s Registration Statement on Form S-l filed on June 14, 2013).

10.5*

Amendment to License Agreement, effective as of September 1, 2000, by and between Temple University—Of The Commonwealth System of Higher Education and Onconova Therapeutics, Inc. (Incorporated by reference to Exhibit 10.5 to the Company’s Registration Statement on Form S-1 filed on June 14, 2013).

10.6*

Amendments to Exclusive License Agreement, effective as of March 21, 2013, by and between Temple University—Of The Commonwealth System of Higher Education and Onconova Therapeutics, Inc. (Incorporated by reference to Exhibit 10.6 to the Company’s Registration Statement on Form S-l filed on June 14, 2013).

10.7*

Definitive Agreement, effective as of May 12, 2010, by and between Onconova Therapeutics, Inc. and The Leukemia and Lymphoma Society (Incorporated by reference to Exhibit 10.7 to the Company’s Registration Statement on Form S-l filed on June 14, 2013).

10.8*

First Amendment to Definitive Agreement, effective as of June 23, 2011, by and between Onconova Therapeutics, Inc. and The Leukemia and Lymphoma Society (Incorporated by reference to Exhibit 10.8 to the Company’s Registration Statement on Form S-l filed on June 14, 2013).

10.9*

Second Amendment to Definitive Agreement, effective as of May 29, 2012, by and between Onconova Therapeutics, Inc. and The Leukemia and Lymphoma Society (Incorporated by reference to Exhibit 10.9 to the Company’s Registration Statement on Form S-l filed on June 14, 2013).

10.10*

Third Amendment to Definitive Agreement, effective as of January 5, 2013, by and between Onconova Therapeutics, Inc. and The Leukemia and Lymphoma Society (Incorporated by reference to Exhibit 10.10 to the Company’s Registration Statement on Form S-l filed on June 14, 2013).

10.11*

Termination of Agreement, effective as of February 5, 2013, by and between Onconova Therapeutics, Inc. and The Leukemia and Lymphoma Society (Incorporated by reference to Exhibit 10.11 to the Company’s Registration Statement on Form S-l filed on June 14, 2013).

10.12*

Limited Liability Company Agreement of GBO, LLC, dated as of December 12, 2012, by and between Onconova Therapeutics, Inc. and GVK Biosciences Private Limited (Incorporated by reference to Exhibit 10.12 to the Company’s Registration Statement on Form S-l filed on June 14, 2013).



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10.13

Onconova Therapeutics, Inc. 2007 Equity Compensation Plan, and forms of agreement thereunder (Incorporated by reference to Exhibit 10.13 to Pre-Effective Amendment No. 1 the Company’s Registration Statement on Form S-l filed on July 11, 2013).

10.14

Employment Agreement, effective as of July 1, 2015, by and between Onconova Therapeutics, Inc. and Ramesh Kumar, Ph.D. (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on July 8, 2015).

10.15

Letter Agreement, effective as of January 1, 2016, by and between Onconova Therapeutics, Inc. and Ramesh Kumar, Ph.D. (Incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on February 17, 2016).

10.16

Amended and Restated Employment Agreement, effective as of July 1, 2015, by and between Onconova Therapeutics, Inc. and Thomas McKearn, M.D., Ph.D. (Incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on July 8, 2015).

10.17

Amended and Restated Employment Agreement, effective as of July 1, 2015, by and between Onconova Therapeutics, Inc. and Ajay Bansal. (Incorporated by reference to Exhibit 10.4 to the Company’s Current Report on Form 8-K filed on July 8, 2015).

10.18

Consulting Agreement, effective as of January 1, 2012, by and between Onconova Therapeutics, Inc. and E. Premkumar Reddy, Ph.D., including Consultant Agreement Renewal, dated February 27, 2013 (Incorporated by reference to Exhibit 10.23 to the Company’s Registration Statement on Form S-1 filed on June 14, 2013)

10.19

Form of Indemnification Agreement entered into by and between Onconova Therapeutics, Inc. and each director and executive officer (Incorporated by reference to Exhibit 10.24 to Pre-Effective Amendment No. 1 the Company’s Registration Statement on Form S-1 filed on July 11, 2013).

10.20

Onconova Therapeutics, Inc. 2013 Equity Compensation Plan, and forms of agreement thereunder (Incorporated by reference to Exhibit 10.25 to Pre-Effective Amendment No. 1 the Company’s Registration Statement on Form S-1 filed on July 11, 2013).

10.21

Onconova Therapeutics, Inc. 2013 Performance Bonus Plan (Incorporated by reference to Exhibit 10.26 to Pre-Effective Amendment No. 1 the Company’s Registration Statement on Form S-1 filed on July 11, 2013).

10.22

Employment Agreement, effective as of July 1, 2015, by and between Onconova Therapeutics, Inc. and Dr.Manoj Manair (Incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed on July 8, 2015).

10.23

Employment Agreement, effective as of July 1, 2015, by and between Onconova Therapeutics, Inc. and Mark Guerin (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on February 17, 2016).

10.24

Amended and Restated Employment Agreement between Onconova Therapeutics, Inc. and Steven Fruchtman, M.D. (Incorporated by reference to Exhibit 10.5 to the Company’s Quarterly Report on Form 10-Q filed on August 13, 2015).



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10.25

Purchase Agreement between Onconova Therapeutics, Inc. and Lincoln Park Capital Fund, LLC, dated October 8, 2015 (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on October 8, 2015).

10.26

Dealer-Manager Agreement dated July 7, 2016, between Onconova Therapeutics, Inc. and Maxim Group LLC ((Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on July 13, 2016)

10.27

At Market Issuance Sales Agreement, dated December 5, 2016, between Onconova Therapeutics, Inc. and FBR Capital Markets & Co. (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on December 5, 2016)

10.28

Letter Agreement, effective as of January 1, 2017, by and between Onconova Therapeutics, Inc. and Ramesh Kumar, Ph.D.

21.1

Subsidiaries of Onconova Therapeutics, Inc. (Incorporated by reference to Exhibit 21.1 to the Company’s Annual Report on Form 10-K filed on March 29,2017).

23.1

Consent of Ernst & Young, LLP.

23.2

Consent of Morgan, Lewis & Bockius LLP (included in Exhibit 5.1)

24.1

Power of Attorney (included on the signature page)


          To be filed by amendment

*          Confidential treatment has been requested with respect to certain portions of this exhibit. Omitted portions have been filed separately with the Securities and Exchange Commission.



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SIGNATURES

 

Pursuant to the requirements of the Securities Act of 1933, as amended, Onconova Therapeutics, Inc.the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-3 and has duly caused this registration statement on Form S-l to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Newtown, State of Pennsylvania on the 20th day of October, 2015.January 30, 2018.

 

 

ONCONOVA THERAPEUTICS, INC.Onconova Therapeutics, Inc.

 

 

 

By:

/s/ Ramesh Kumar, Ph.DRAMESH KUMAR, PH.D

 

 

Name:

Ramesh Kumar, Ph.D

 

 

Title:

President and Chief Executive Officer

 

POWER OF ATTORNEY

KNOW ALL MEN BY THESE PRESENTS, that the undersigned officers and directors of Onconova Therapeutics, Inc., a Delaware corporation (the “Corporation”), hereby constitute and appoint each of Ramesh Kumar, Ph.D and Ajay BansalMark Guerin the true and lawful agents and attorneys-in-fact of the undersigned with full power and authority in said agents and attorneys-in-fact, and in any one or more of them, to sign for the undersigned and in their respective names as an officer/director of the Corporation, any and all amendments (including post-effective amendments) to this registration statement on Form S-1 (or any other registration statement for the same offering that is to be effective upon filing pursuant to Rule 462(b) under the Securities Act) and to file the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, and with full power of substitution, hereby ratifying and confirming all that each of said attorneys-in-fact, or his substitute or substitutes, may do or cause to be done by virtue hereof.

 

Pursuant to the requirements of the Securities Act of 1933, this registration statement has been signed by the following persons in the capacities indicated on January 30. 2018.

SignatureName

Title

Date

 

 

 

/s/ Ramesh Kumar, Ph.DRAMESH KUMAR, PH.D.

 

Director, President and Chief Executive Officer (Principal Executive Officer)

October 20, 2015

Ramesh Kumar, Ph.D.

 

/s/ MARK GUERIN

Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)

Mark Guerin

/s/ HENRY S. BIENEN, PH.D.

Director

Henry S. Bienen, Ph.D.

 

 

 

 

 

/s/ Ajay BansalJEROME E. GROOPMAN, M.D.

 

Chief Financial Officer (Principal Financial Officer)

October 20, 2015Director

Ajay Bansal

Jerome E. Groopman, M.D.

 

 

 

 

 

/s/ MICHAEL B. HOFFMAN

Chairman, Board of Directors

Michael B. Hoffman

 

 



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/s/ Mark GuerinJAMES J. MARINO

 

Vice President, Financial Planning and Accounting (Principal Accounting Officer)

October 20, 2015Director

Mark Guerin

James J. Marino

 

 

 

 

 

/s/ Henry S. Bienen, Ph.DVIREN MEHTA, PHARM.D

 

Director

October 20, 2015

Henry S. Bienen, Ph.D.

Viren Mehta, Pharm.D

 

 

 

 

 

/s/ Jerome E. Groopman, M.D.PREMKUMAR REDDY, PH.D

 

Director

October 20, 2015

Jerome E. Groopman, M.D.

Premkumar Reddy, Ph.D

 

 

 

 

 

/s/ Michael B. Hoffman

Chairman, Board of Directors

October 20, 2015

Michael B. Hoffman

/s/ James J. MarinoJACK E. STOVER

 

Director

October 20, 2015

James J. Marino

/s/ Viren Mehta

Director

October 20, 2015

Viren Mehta, Pharm.D

Jack E. Stover

 

 

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/s/ E. Premkumar Reddy, Ph.D

Director

October 20, 2015

E. Premkumar Reddy, Ph.D

/s/ Anne M. VanLent

Director

October 20, 2015

Anne M. VanLent

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EXHIBIT INDEX

Exhibit
Number

Exhibit Description

3.1

Tenth Amended and Restated Certificate of Incorporation of Onconova Therapeutics, Inc. (Incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on July 25, 2013).

3.2

Amended and Restated Bylaws of Onconova Therapeutics, Inc. (Incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on July 25, 2013).

4.1

Form of Certificate of Common Stock (Incorporated by reference to Exhibit 4.1 to Pre-Effective Amendment No. 1 the Company’s Registration Statement on Form S-l filed on July 11, 2013.)

4.2

Eighth Amended and Restated Stockholders’ Agreement, effective as of July 27, 2012, by and among Onconova Therapeutics, Inc. and certain stockholders named therein (Incorporated by reference to Exhibit 4.2 to Pre-Effective Amendment No. 1 to the Company’s Registration Statement on Form S-l filed on July 11, 2013).

4.3

Amendment No. 1 to Eighth Amended and Restated Stockholders’ Agreement, effective as of July 9, 2013 (Incorporated by reference to Exhibit 4.2 to Pre-Effective Amendment No. 1 the Company’s Registration Statement on Form S-l filed on July 11, 2013).

5.1

Opinion of Pepper Hamilton LLP

10.1

*

Development and License Agreement, effective as of September 19, 2012, by and between Onconova Therapeutics, Inc. and Baxter Healthcare SA (Incorporated by reference to Exhibit 10.1 to Pre-Effective Amendment No. 2 the Company’s Registration Statement on Form S-l filed on July 18, 2013).

10.2

*

License Agreement, effective as of July 5, 2011, by and between Onconova Therapeutics, Inc. and SymBio Pharmaceuticals Limited (Incorporated by reference to Exhibit 10.2 to Pre-Effective Amendment No. 2 the Company’s Registration Statement on Form S-l filed on July 18, 2013).

10.3

*

First Amendment to License Agreement, effective as of September 2, 2011, by and between Onconova Therapeutics, Inc. and SymBio Pharmaceuticals Limited (Incorporated by reference to Exhibit 10.3 to the Company’s Registration Statement on Form S-l filed on June 14, 2013).

10.4

*

License Agreement, effective as of January 1, 1999, by and between Onconova Therapeutics, Inc. and Temple University—Of The Commonwealth System of Higher Education (Incorporated by reference to Exhibit 10.4 to the Company’s Registration Statement on Form S-l filed on June 14, 2013).

10.5

*

Amendment to License Agreement, effective as of September 1, 2000, by and between Temple University—Of The Commonwealth System of Higher Education and Onconova Therapeutics, Inc. (Incorporated by reference to Exhibit 10.5 to the Company’s Registration Statement on Form S-1 filed on June 14, 2013).

10.6

*

Amendments to Exclusive License Agreement, effective as of March 21, 2013, by and between Temple University—Of The Commonwealth System of Higher Education and Onconova Therapeutics, Inc. (Incorporated by reference to Exhibit 10.6 to the Company’s Registration

 



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Exhibit
Number

Exhibit Description

Statement on Form S-l filed on June 14, 2013).

10.7

*

Definitive Agreement, effective as of May 12, 2010, by and between Onconova Therapeutics, Inc. and The Leukemia and Lymphoma Society (Incorporated by reference to Exhibit 10.7 to the Company’s Registration Statement on Form S-l filed on June 14, 2013).

10.8

*

First Amendment to Definitive Agreement, effective as of June 23, 2011, by and between Onconova Therapeutics, Inc. and The Leukemia and Lymphoma Society (Incorporated by reference to Exhibit 10.8 to the Company’s Registration Statement on Form S-l filed on June 14, 2013).

10.9

*

Second Amendment to Definitive Agreement, effective as of May 29, 2012, by and between Onconova Therapeutics, Inc. and The Leukemia and Lymphoma Society (Incorporated by reference to Exhibit 10.9 to the Company’s Registration Statement on Form S-l filed on June 14, 2013).

10.10

*

Third Amendment to Definitive Agreement, effective as of January 5, 2013, by and between Onconova Therapeutics, Inc. and The Leukemia and Lymphoma Society (Incorporated by reference to Exhibit 10.10 to the Company’s Registration Statement on Form S-l filed on June 14, 2013).

10.11

Termination of Agreement, effective as of February 5, 2013, by and between Onconova Therapeutics, Inc. and The Leukemia and Lymphoma Society (Incorporated by reference to Exhibit 10.11 to the Company’s Registration Statement on Form S-l filed on June 14, 2013).

10.12

*

Limited Liability Company Agreement of GBO, LLC, dated as of December 12, 2012, by and between Onconova Therapeutics, Inc. and GVK Biosciences Private Limited (Incorporated by reference to Exhibit 10.12 to the Company’s Registration Statement on Form S-l filed on June 14, 2013).

10.13

+

Onconova Therapeutics, Inc. 2007 Equity Compensation Plan, and forms of agreement thereunder (Incorporated by reference to Exhibit 10.13 to Pre-Effective Amendment No. 1 the Company’s Registration Statement on Form S-l filed on July 11, 2013).

10.14

+

Consulting Agreement, effective as of January 1, 2012, by and between Onconova Therapeutics, Inc. and E. Premkumar Reddy, Ph.D., including Consultant Agreement Renewal, dated February 27, 2013 (Incorporated by reference to Exhibit 10.23 to the Company’s Registration Statement on Form S-1 filed on June 14, 2013).

10.15

+

Form of Indemnification Agreement entered into by and between Onconova Therapeutics, Inc. and each director and executive officer (Incorporated by reference to Exhibit 10.24 to Pre-Effective Amendment No. 1 the Company’s Registration Statement on Form S-1 filed on July 11, 2013).

10.16

+

Onconova Therapeutics, Inc. 2013 Equity Compensation Plan, and forms of agreement thereunder (Incorporated by reference to Exhibit 10.25 to Pre-Effective Amendment No. 1 the Company’s Registration Statement on Form S-1 filed on July 11, 2013).

10.17

+

Onconova Therapeutics, Inc. 2013 Performance Bonus Plan (Incorporated by reference to Exhibit 10.26 to Pre-Effective Amendment No. 1 the Company’s Registration Statement on Form S-1 filed on July 11, 2013).



Table of Contents

Exhibit
Number

Exhibit Description

10.18

Sales Agreement dated October 8, 2014 by and between Onconova Therapeutics, Inc., and Cantor Fitzgerald & Co. (incorporated by reference to Exhibit 1.1 to the Company’s Registration Statement on Form S-3 filed on October 8, 2014).

10.19

Amendment No. 1 to Sales Agreement, dated September 30, 2015, between Onconova Therapeutics, Inc. and Cantor Fitzgerald & Co. (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on October 5, 2015).

10.20

+

Employment Agreement between Onconova Therapeutics, Inc. and Ramesh Kumar, Ph.D (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on July 8, 2015).

10.21

+

Amended and Restated Employment Agreement between Onconova Therapeutics, Inc. and Thomas McKearn, M.D., Ph.D (Incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on July 8, 2015).

10.22

+

Employment Agreement between Onconova Therapeutics, Inc. and Manoj Maniar, Ph.D (Incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed on July 8, 2015).

10.23

+

Amended and Restated Employment Agreement between Onconova Therapeutics, Inc. and Ajay Bansal (Incorporated by reference to Exhibit 10.4 to the Company’s Current Report on Form 8-K filed on July 8, 2015).

10.24

+

Amended and Restated Employment Agreement between Onconova Therapeutics, Inc. and Steven Fruchtman, M.D. (Incorporated by reference to Exhibit 10.5 to the Company’s Quarterly Report on Form 10-Q filed on August 13, 2015).

10.25

Purchase Agreement between the Company and Lincoln Park Capital Fund, LLC, dated October 8, 2015 (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on October 8, 2015).

10.26

Registration Rights Agreement between the Company and Lincoln Park Capital Fund, LLC, dated October 8, 2015 (Incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on October 8, 2015).

21.1

Subsidiaries of Onconova Therapeutics, Inc. (Incorporated by reference to Exhibit 21.1 to the Company’s Annual Report on Form 10-K filed on March 30, 2015).

23.1

Consent of Ernst & Young, LLP.

23.2

Consent of Pepper Hamilton LLP (included in Exhibit 5.1)

24.1

Power of Attorney (included on signature page)


+                                         Indicates management contract or compensatory plan.

*                                         Confidential treatment has been granted with respect to certain portions of this exhibit.  Omitted portions have been filed separately with the Securities and Exchange Commission.